Systems, devices, and methods for assessing and treating bruxism (teeth grinding)

Abstract

The present invention provides devices, systems, and methods for improved diagnosis, treatment planning, patient monitoring, and compliance tracking for patients with bruxism.

Description

[0001] SYSTEMS, DEVICES, AND METHODS FOR ASSESSING AND TREATING BRUXISM (TEETH GRINDING)

[0002] Cross-Reference to Related Applications

[0003] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63 / 556,497, filed February 22, 2024, U.S. Provisional Application No. 63 / 651,449, filed May 24, 2024, and U.S. Provisional Application No. 63 / 651,450, filed May 24, 2024, the contents of each of which are incorporated by reference herein in their entirety.

[0004] Field of the Invention

[0005] The invention relates generally to systems, devices, and methods for analyzing, assessing and treating bruxism, such as, but not limited to, systems, devices, and methods of manufacturing said devices to provide personalized bruxism treatment planning and monitoring.

[0006] Background

[0007] Bruxism, commonly referred to as tooth grinding, is a condition characterized by involuntary clenching, grinding, and / or gnashing of the teeth. Bruxism can occur when a person is awake or asleep or both. Bruxism is a condition that causes flattened, chipped, cracked or loose teeth, worn tooth enamel, exposed inner layers of the tooth, tooth pain or sensitivity, soreness or tightness in the jaw, headache, facial pain, earaches, and sleep disturbances. Major destruction of the teeth occurs in severe cases.

[0008] Bruxism affects approximately one in five people worldwide, with severe bruxism affecting an estimated 250 million patients globally. Expensive dental restorations such as fillings, dentures, veneers, crowns, bridges, or implants are often required to repair damage caused by severe bruxism, with these patients experiencing up to forty times more dental complications with the dental restoration than similar devices in patients without bruxism.

[0009] Currently, there is no cure for bruxism and the standard clinical management is to mitigate tooth damage and / or pain. In some instances, management may include a plastic, protective bite guard, i.e., a night guard or splint, stress management techniques, and medications. However, these treatments are characterized by poor compliance and thus poor results. Summary

[0010] The invention recognizes that there exists a need for improved diagnosis, treatment planning, patient monitoring, and compliance tracking for patients with bruxism. In this manner, the invention addresses the drawbacks of current bruxism splints / mouth guards and provides novel systems, devices, and methods for analyzing and treating bruxism. In particular, the invention provides systems including smart mouthguard devices, methods of manufacturing, and methods for use in diagnosing, treating, and monitoring bruxism, treatment planning and monitoring for patients with bruxism, and risk assessment related to a severity of bruxism.

[0011] Bruxism may be a silent condition, with many patients unaware of the condition until tooth damage results. The invention recognizes that clinical examination is not accurate enough to identify patients most at risk. This lack of clinical data on the presence and / or severity of bruxism may become problematic for patients requiring expensive dental restoration procedures and advanced dental treatments such as fdlings, dentures, veneers, crowns, bridges, or implants, because bruxism after such procedures results in significantly more complications than patients without bruxism. Complex implant reconstructions are particularly at risk of complications for patients with bruxism. These complications include implant fractures leading to increased treatment costs for remediation of implant damage. The invention recognizes that, to plan complex restorative treatments that are more robust against complications related to bruxism, and to provide patients with the information needed to make decisions on whether to go forward with treatment, there exists a need for clear evidence of the severity of bruxism. Without this information, patients may decline necessary treatment to reinforce their teeth and / or refuse to use protective splints to mitigate post-procedure damage.

[0012] The systems, devices, and methods of the invention address these problems by integrating three-dimensional (3D) design, customization, and advanced manufacturing techniques, and by leveraging advanced algorithms, and patient-specific data inputs to provide highly personalized, high-precision medical devices capable of providing unique, detailed and personalized bruxism data. This allows stakeholders, e.g., clinicians, patients, insurers, labs, materials engineers, and the like, to optimize individual restorative treatments and to engage patients in understanding their need for advanced treatments and long term prevention.

[0013] The systems of the invention include smart mouthguard devices, and methods of manufacturing, incorporating smart splint technology with flexible sensor arrays, embedded microelectronics, and ergonomic designs that may be fully customized to a patient and allow for long-term use by patients with heavy bruxism. The systems of the invention include a data analytics platform and integrated data communication between the smart mouthguard device and the data analytics platform such that data is analyzed and presented to patients and stakeholders in a clinically relevant and user-friendly manner. In particular, systems, devices, and methods of the invention provide data, including biofeedback data, useful in treating bruxism patients with various dental and physical consequences of bruxism. Accordingly, the invention provides improved systems, devices, and methods for diagnosing, treating, and monitoring bruxism, and treatment planning and monitoring for patients with bruxism.

[0014] Further, the invention recognizes that, in the application of botulinum toxin (Botox) to alleviate jaw pain associated with bruxism, there remains a difficulty in identifying and establishing baseline patterns of bruxism for suitable candidates. The invention addresses this problem by providing systems, devices, and methods to positively identify a candidate for selection for Botox treatment for jaw pain related to bruxism and temporomandibular joint (TMJ) disorders, and / or masseter muscle reduction treatment. In particular, the invention provides systems, devices, and methods to determine patient eligibility for Botox treatment, to trend and determine the effect period of Botox on bruxism, TMJ disorders, and / or masseter muscle reduction, and to determine a Botox regimen.

[0015] Further, the invention provides systems and methods for evaluating the risk of damage and / or failure of dental restorations as a result of bruxism. Dental restorations, i.e., procedures that are designed to repair or replace teeth such as fillings, crowns, bridges, implants, dentures, and veneers, are expensive, with patients with bruxism experiencing up to forty times more complications after these procedures than patients without bruxism. The invention recognizes a need for predictive force analysis for these restorations, and provides systems, devices, and methods for determining a risk of damage and / or failure for use in designing and providing dental restoration.

[0016] Further, the invention recognizes that drug-induced bruxism remains an area of concern in the administration of certain drugs, such as certain anti-psychotic drugs, anti-depressants, sleep aids, and drugs for treating anxiety. Drug-induced bruxism may become severe. Systems and methods of the invention provide for Certain drugs are known to cause bruxism, which, in some cases may become severe. The invention addresses this problem by providing systems, devices, and methods to determine a drug dose regimen based on bruxism data of a patient, and trend and determine the efficacy period of the drug regimen as evidenced by monitoring bruxism levels.

[0017] The invention also recognizes that acid reflux, also known as gastroesophageal reflux disease (GERD), is strongly linked to bruxism. The invention provides systems and methods for analyzing acid reflux treatment via monitoring and trending a severity of bruxism to thereby determine a dosage regimen and an efficacy of acid reflux treatment.

[0018] Accordingly, the systems, devices, and methods of the invention represent improvements in understanding, analyzing, and assessing bruxism for improved diagnosing and monitoring of bruxism, treatment planning and monitoring for patients with bruxism, and risk assessment for patients with bruxism. Thus, the invention provides improved systems, devices and methods for evaluating bruxism for various clinical and commercial benefits.

[0019] Smart mouthguard device (smart splint, smart mouthpiece)

[0020] Aspects of the invention provide a mouthpiece, also referred to as a smart splint or oral appliance, that includes a body portion having a top surface and a bottom surface wherein each of the top and bottom surfaces are made to a teeth pattern of a subject; and one or more sensor assemblies disposed within the body and positioned to record data associated with bruxism of the subject.

[0021] In some embodiments of the mouthpiece, the body portion is comprised of a polymer. In some embodiments, the one or more sensor assemblies comprises a plurality of sensors comprising force sensors. In some embodiments, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array.

[0022] In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. Further, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments.

[0023] In some embodiments, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. Further, in some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprises one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0024] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0025] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0026] In some embodiments, the one or more sensor arrays is encased in a deformable layer. Accordingly, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patientspecific anatomy, in some embodiments. In some embodiments, the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0027] In some embodiments, the mouthpiece is customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array. In some embodiments, the mouthpiece is customized based on individual anatomical requirements of the patient-specific anatomy. In some embodiments, the individual anatomical requirements are obtained from a dental scan of the patient.

[0028] In some embodiments, the mouthpiece further comprises an integrated wireless communication module.

[0029] Methods of manufacturing a personalized smart mouthguard device (smart splint}

[0030] Aspects of the invention provide methods for manufacturing a customized smart splint. The method includes the steps of forming a smart mouthguard shell comprising a body portion having a top surface and a bottom surface, wherein the top surface and the bottom surface are each configured to be separately in contact with at least a portion of an upper row or a lower row of teeth of a subject, wherein one or more of the top surface and the bottom surface are configured to conform to a tooth pattern of the row of teeth in which the top surface or the bottom surface is in contact; and embedding one or more sensor assemblies disposed within the body portion between the top surface and the bottom surface and positioned to record data associated with bruxism of the subject. Formation of the shell and embedding of the one or more sensor assemblies comprises receiving data associated with the subject; analyzing the data, via one or more algorithms, to simulate occlusal contacts; and localizing sensor assembly placement based on the simulated occlusal contacts. In some embodiments, the procedure may include manual positioning of the sensors within the device. In some embodiments, the method further comprises providing a computing system comprising a non-transitory, computer-readable storage medium coupled to a processor and encoded with a computer program executable by the processor to cause the computing system to receive the data associated with the subject and generate a three-dimensional (3D) virtual model of the personalized smart mouthguard within a 3D design environment.

[0031] In some embodiments the data associated with the subject comprises one or more high- resolution dental scans, intraoral scans, dental records, and anatomical data

[0032] In some embodiments the data is used as input into the virtual three-dimensional (3D) design environment to create a virtual dental model.

[0033] In some embodiments, the method further comprises receiving optimization data comprising one or more of a shell wall thickness threshold, an occlusion offset tolerance, a material density, and feedback from the subject. In some embodiments, the optimization data includes specification on sensor positioning in a particular area or areas of the smart mouthguard that will provide for optimization of the contours of the smart mouthguard. In some embodiments, the optimization data is used to further create the virtual model of the personalized smart mouthguard within the 3D design environment.

[0034] In some embodiments, the virtual model of the personalized smart mouthguard is overlaid on the virtual dental model. In some embodiments, the method further comprises analyzing, via one or more algorithms, the virtual model of the personalized smart mouthguard for conformance to dentition. In some embodiments, a fit of the personalized smart mouthguard to the subject is determined via analysis of the overlaid virtual model.

[0035] In some embodiments, formation of the shell comprises one or more customized areas based on the conformance to dentition analysis, wherein the customized areas comprise one or more of a crevice block-out area, a minimum thickness area, a tooth offset area, and an inward retention area.

[0036] In some embodiments, the method further comprises simulating a stress and / or a load distribution on one or more of the virtual dental model and the virtual personalized smart mouthguard using finite element analysis (FEA). In some embodiments, sensor assembly placement is based on analysis of one or more of the simulated stress and load distributions.

[0037] In some embodiments, biomechanical data obtained from the simulated stress and / or load distributions is mapped directly onto the virtual dental model. In some embodiments, the method further comprises using the biomechanical data to predict, via one or more algorithms, variations in one or more of occlusal forces and jaw movement patterns of the virtual dental model on the virtual personalized smart mouthguard.

[0038] In some embodiments, the method further comprises utilizing one or more occlusion heat maps to localize sensor positioning, and adjusting the shell formation. In some embodiments, sensor assembly placement is optimized using iterative feedback loops during manufacturing based on the occlusion heat maps.

[0039] In some embodiments, the smart mouthguard may be required to provide biomechanical data in patients where there are one or more missing teeth. This may result in areas of the mouth where there are no opposing pairs of upper and lower teeth to compress the sensor and to provide a direct sensor recording. One or more algorithms may be used to characterize the relative force sensor amplitudes between two or more of the sensors in the smart mouthguard. The biomechanical data obtained directly from the force sensors in one area, via one or more algorithms may be used to extrapolate the biomechanical data in areas with missing teeth and without direct sensor data recordings

[0040] In some embodiments, this indirect extrapolation of force data to areas with missing teeth will be combined with knowledge from virtual or in-vitro mechanical modelling including but not limited to heat maps of occlusion from virtual occlusal analysis, FEA, photoelastic studies or strain gauges.

[0041] In some embodiments, a material composition of the personalized smart mouthguard is selected based on analysis of the overlaid virtual model.

[0042] In some embodiments the 3D design, dimensions, contour, occlusal scheme and orientation of a smart mouthguard or subsequent normal mouthguard without sensors is based on the biomechanical data or virtual modelling of the forces on the virtual tooth model

[0043] In some embodiments, the personalized smart mouthguard is manufactured via one or more of 3D printing, computer numerical control (CNC) machining, and injection moulding.

[0044] In some embodiments, the body comprises a standardized mating plane between each of the bottom surface and the one or more embedded sensor assemblies, the one or more sensor assemblies and the top surface, and bottom surface and the top surface. In some embodiments, the bottom surface comprises a surface material softer than a surface material of the top surface. In some embodiments, the one or more sensor assemblies comprises one or more flexible sensors.

[0045] In some embodiments, the method further comprises embedding a wireless communication module. In some embodiments, the communication module is operable to communicate with one or more computing systems. In some embodiments, the communication module comprises one or more signal processing algorithms configured for real-time data transfer.

[0046] In some embodiments of the mouthpiece, the body portion is comprised of a polymer.

[0047] In some embodiments, the one or more sensor assemblies comprises a plurality of sensors comprising force sensors. In some embodiments, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. Further, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments.

[0048] In some embodiments the sensor cross section is varied along the x and / or y axis to provide greater resolution or sensitivity

[0049] In some embodiments, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. Further, in some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprises one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0050] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0051] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0052] In some embodiments, the one or more sensor arrays is encased in a deformable layer. Accordingly, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patientspecific anatomy, in some embodiments. In some embodiments, the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area. In some embodiments, the mouthpiece is customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array. In some embodiments, the mouthpiece is customized based on individual anatomical requirements of the patient-specific anatomy. In some embodiments, the individual anatomical requirements are obtained from a dental scan of the patient.

[0053] In some embodiments, the mouthpiece further comprises an integrated wireless communication module.

[0054] Systems for assessing a severity of bruxism and treatins bruxism

[0055] Aspects of the invention provide systems for assessing a severity of bruxism and / or treating or managing the effects of bruxism. The systems comprise an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions cause the processor to receive data from the one or more sensor assemblies; analyze the received data via one or more algorithms; and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism.

[0056] In some embodiments, assessing the severity of bruxism comprises determining a bruxism severity level or bruxism severity number based on one or more of the determined parameters.

[0057] In some embodiments, the one or more parameters include one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity, in some embodiments. Further, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria, in some embodiments. In some embodiments the jaw movement pattern comprises one or more of grinding, clenching, a direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0058] In some embodiments, the computing system includes a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further includes a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband and an oral appliance docking station, in some embodiments. Further, operation of the oral appliance is controlled by the system via the user interface, in some embodiments.

[0059] In some embodiments, the received data is displayed on an associated display device via the software application. Analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest, in some embodiments. Further, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type, in some embodiments. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient. In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0060] In some embodiments, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. In some embodiments, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement. The sensors may be positioned such that the output determines a 3D and 4D relationship between the patient’s jaws during jaw movement. The sensors may determine a 3D and 4D relationship between the patient’s jaws with respect to the device during jaw movement. Thus, in some embodiments, the sensors are positioned to determine a slope of the line of jaw movement and a location of jaw movement with respect to, for example the x,y,z axis.

[0061] In some embodiments, the one or more sensors comprises one or more sensor arrays incorporated, or deposited on, in a flex circuit electrode. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0062] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0063] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0064] In some embodiments, the one or more sensor arrays is encased in a deformable layer. In some embodiments, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patientspecific anatomy. Further, in some embodiments, the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0065] In some embodiments, the oral appliance comprises a splint customized to a patientspecific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0066] Systems for assessing biomechanical load on a dental implant and / or teeth

[0067] Aspects of the invention provide systems for assessing biomechanical load on a dental implant and / or teeth. The systems comprise an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions cause the system to receive data from the one or more sensor assemblies, analyze the received data via one or more algorithms, and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of biomechanical load on the dental implant and / or teeth.

[0068] In some embodiments of the systems, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0069] In some embodiments of the systems, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. In particular embodiments, the system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station. In some embodiments, operation of the oral appliance is controlled by the system via the user interface. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. Further, in some embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In particular embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0070] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0071] In some embodiments of the systems, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. In some embodiments, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement. In particular embodiments, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0072] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material. In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0073] In some embodiments, the one or more sensor arrays is encased in a deformable layer. In some embodiments of the systems, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy. In some embodiments, the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0074] In some embodiments of the systems, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0075] Systems for assessing a level of bruxism over time in a patient

[0076] Aspects of the invention provide systems for assessing a level of bruxism over time in a patient. The system comprises an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions executable by the processor cause the system to receive data from the one or more sensor assemblies, analyze the received data via one or more algorithms, determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events, and assess, based on data received from one or more of received data from prior to treatment for bruxism, received data from during treatment for bruxism, and received data from after treatment for bruxism, one or more trends over time related to a severity of bruxism.

[0077] In some embodiments of the systems, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity, in some embodiments. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded. In some embodiments, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. In particular embodiments, operation of the oral appliance is controlled by the system via the user interface. In some embodiments, analysis of the received data is displayed on an associated display device via the software application.

[0078] In some embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In particular embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0079] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0080] In some embodiments of the systems, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Further, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. In particular embodiments, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. The one or more sensor arrays comprises one or more polymeric force sensors, in some embodiments. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0081] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0082] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0083] In some embodiments, the one or more sensor arrays is encased in a deformable layer. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments. In further embodiments, the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0084] In some embodiments, the oral appliance comprises a splint customized to a patientspecific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0085] Methods for treatins bruxism

[0086] The invention provides for using the systems and devices disclosed herein in methods for analyzing, assessing, and treating bruxism or its effects.

[0087] Aspects of the invention provide methods for treating bruxism. The methods may include assessing a severity of bruxism. The methods include the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism.

[0088] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity, in some embodiments. Further, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria, in some embodiments. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, a direction, and linear distance or direction of the movement.

[0089] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. Further, the system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, the received data is displayed on an associated display device via the software application. Further, in some embodiments, the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. For example, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type, in some embodiments. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0090] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0091] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion in some embodiments. In particular embodiments, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement. In some embodiments, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode.

[0092] In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In particular embodiments, the one or more sensor assemblies further comprises a printed circuit board and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0093] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material. In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0094] In some embodiments, the one or more sensor arrays is encased in a deformable layer. Further, in some embodiments, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy. In some embodiments, the one or more sensor arrays comprise sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0095] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0096] In some embodiments, the data received from the one or more sensor assemblies may be correlated with pain parameters of the head and / or neck area. In some embodiments, the pain parameter is a pain severity. In some embodiments, the pain severity is correlated with the one or more parameters of bruxism. In some embodiments, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the pain parameters may be input from a software application on a website or mobile device and displayed in relation to the bruxism parameters. In some embodiments, the efficacy of a patient’s responsiveness to a smart mouthguard therapy is determined at least in part by longitudinal analysis of the bruxism parameters in relation to the pain parameters.

[0097] Methods for diasnosins and assessing bruxism in a patient

[0098] The invention provides for using the systems and devices disclosed herein in methods for diagnosing and assessing bruxism in a patient.

[0099] Aspects of the invention provide methods for diagnosing and assessing bruxism in a patient. The methods include the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism for treatment in the patient.

[0100] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity, in some embodiments. Further, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria, in some embodiments. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0101] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. In particular embodiments, operation of the oral appliance is controlled by the system via the user interface. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. Further, in some embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. The force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type, in some embodiments. The force map is overlaid on an arch of teeth specific to the subject, in some embodiments. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0102] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0103] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. In some embodiments, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement.

[0104] In some embodiments of the methods, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. In particular embodiments, the one or more sensor arrays comprises one or more polymeric force sensors.

[0105] In some embodiments of the methods, the one or more sensor assemblies further comprises a printed circuit board; and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. The one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event, in some embodiments.

[0106] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. Tn this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0107] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0108] In some embodiments, the one or more sensor arrays is encased in a deformable layer. Further, in some embodiments, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy. The one or more sensor arrays comprise sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area, in some embodiments.

[0109] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array. Methods for assessing a level of bruxism over time in a patient

[0110] The invention provides for using the systems and devices disclosed herein in methods for assessing a level of bruxism over time in a patient.

[0111] Aspects of the invention provide methods for assessing a level of bruxism over time in a patient. The methods include the steps of providing a system comprising oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events; and assessing, based on data received from one or more of received data from prior to treatment for bruxism, received data from during treatment for bruxism, and received data from after treatment for bruxism, one or more trends over time related to a severity of bruxism.

[0112] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity, in some embodiments. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0113] In some embodiments, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. In some embodiments, the system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station. In particular embodiments, operation of the oral appliance is controlled by the system via the user interface. Further, in some embodiments, analysis of the received data is displayed on an associated display device via the software application.

[0114] In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0115] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols. In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. In some embodiments, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement.

[0116] The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode, in some embodiments. The one or more sensor arrays comprises one or more polymeric force sensors, in some embodiments. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0117] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0118] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0119] In some embodiments, the one or more sensor arrays is encased in a deformable layer. In some embodiments, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patientspecific anatomy. The one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area, in some embodiments.

[0120] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0121] Methods for using a smart mouthpiece as a diagnostic associated with the use of Botox for treating bruxism and / or masseter muscle reduction

[0122] The invention provides for using the systems and devices disclosed herein in methods for using the devices and systems as a diagnostic associated with the use of Botox for treating bruxism and / or for masseter muscle reduction.

[0123] Aspects of the invention provide methods for determining eligibility of a patient for bruxism treatment with botulinum toxin (Botox). The method includes the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a pattern of bruxism for treatment with Botox.

[0124] In some embodiments, the pattern of bruxism comprises a baseline pattern over a defined time period before treatment with Botox. For example, the defined period of time is two to four weeks inclusive, in some embodiments. In some embodiments, the received data comprises a threshold analysis to identify a patient eligible for bruxism treatment with Botox.

[0125] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In particular embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0126] In some embodiments of the method, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Further, operation of the oral appliance is controlled by the system via the user interface, in some embodiments. Analysis of the received data is displayed on an associated display device via the software application, in some embodiments. In some embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. For example, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type, in some embodiments. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0127] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0128] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0129] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0130] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0131] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patientspecific anatomy, in some embodiments.

[0132] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0133] Methods for determinins a Botox dosage regimen for treatins bruxism

[0134] The invention provides for using the systems and devices disclosed herein in methods for determining a Botox regimen for treating bruxism and / or for masseter muscle reduction.

[0135] Aspects of the invention provide methods for determining a botulinum toxin (Botox) dosage regimen for treating bruxism. The method includes the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an optimum Botox dose level administration.

[0136] In some embodiments of the methods, the determining step is performed on data analyzed over a first defined period of time, wherein the optimum Botox dose level is determined based at least in part on comparison of one or more patterns of bruxism parameters to a baseline pattern of bruxism parameters and / or previous Botox dosage level administration. In some embodiments, the defined period of time is one to four weeks inclusive. In some embodiments, the method further comprises analyzing the received data for a second defined period of time to establish whether the dosage regimen results in a change in bruxism as compared to one or more of the baseline bruxism parameters. In some embodiments, the method further comprises using the analysis of the received data to determine one or more of a Botox dose level change, a dose level for a left and / or right jaw muscle, a dose level for a masseter muscle, a dose level for a temporalis muscle, a low to high dosing regimen, and a high to low regimen.

[0137] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded. In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0138] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0139] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0140] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0141] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. In some embodiments, the systems, devices, and methods of the invention utilize indirect force measurement calculations to assess muscle force or power. The indirect force measurement techniques may include calculating a force by measuring a related physical quantity, for example, strain, displacement, or pressure. The physical quantity may be measured, for example, via one or more sensors such as strain gauges, accelerometers, or pressure transducers. Mathematical models may be applied to convert the measurements into force values. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0142] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0143] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0144] Methods for post-treatment monitoring of Botox treatment for bruxism

[0145] The invention provides for using the systems and devices disclosed herein in methods for post-treatment monitoring of Botox treatment for bruxism and / or for masseter muscle reduction. Aspects of the invention provide methods for post-treatment monitoring of Botox treatment for bruxism. The methods include providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an effective period of Botox dose administration for bruxism treatment. In some embodiments of the methods, the determining step is performed on data analyzed over a first defined period of time, wherein the effective period of the Botox dose administration is determined based on a change in the one or more parameters over the defined period of time. In some embodiments, the method further comprises analyzing the received data for a second defined period of time to establish whether the Botox dose administration results in a change in bruxism as compared to one or more baseline bruxism parameters.

[0146] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded. In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0147] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0148] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event. In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments.

[0149] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0150] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. In some embodiments, the systems, devices, and methods of the invention utilize indirect force measurement calculations to assess muscle force or power. The indirect force measurement techniques may include calculating a force by measuring a related physical quantity, for example, strain, displacement, or pressure. The physical quantity may be measured, for example, via one or more sensors such as strain gauges, accelerometers, or pressure transducers. Mathematical models may be applied to convert the measurements into force values. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0151] The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0152] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0153] Methods for determining eligibility of a patient for masseter muscle reduction treatment with Botox

[0154] The invention provides for using the systems and devices disclosed herein in methods for determining eligibility of a patient for masseter muscle reduction treatment with Botox.

[0155] Aspects of the invention provide methods for determining eligibility of a patient for masseter muscle reduction treatment with botulinum toxin (Botox). The methods include providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a pattern of bruxism for masseter muscle reduction treatment with Botox. In some embodiments of the methods, the pattern of bruxism comprises a baseline pattern over a defined time period before treatment with Botox. In some embodiments, the defined period of time is two to four weeks inclusive. In some embodiments, the received data comprises a threshold analysis to identify a patient eligible for masseter muscle reduction treatment with Botox.

[0156] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0157] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0158] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0159] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0160] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0161] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. In some embodiments, the systems, devices, and methods of the invention utilize indirect force measurement calculations to assess muscle force or power. The indirect force measurement techniques may include calculating a force by measuring a related physical quantity, for example, strain, displacement, or pressure. The physical quantity may be measured, for example, via one or more sensors such as strain gauges, accelerometers, or pressure transducers. Mathematical models may be applied to convert the measurements into force values. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0162] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0163] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0164] Methods for determinins a Botox dosage regimen for masseter muscle reduction treatment

[0165] The invention provides for using the systems and devices disclosed herein in methods for determining a Botox dosage regimen for masseter muscle reduction.

[0166] Aspects of the invention provide methods for determining a botulinum toxin (Botox) dosage regimen for masseter muscle reduction treatment. The methods include providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an optimum Botox dose level administration for masseter muscle reduction treatment.

[0167] In some embodiments, the determining step is performed on data analyzed over a first defined period of time, wherein the optimum Botox dose level is determined based at least in part on comparison of one or more patterns of bruxism parameters to a baseline pattern of bruxism parameters and / or previous Botox dosage level administration. In some embodiments, the defined period of time is one to four weeks inclusive. In some embodiments, the method further comprises analyzing the received data for a second defined period of time to establish whether the dosage regimen results in a change in bruxism as compared to one or more of the baseline bruxism parameters. In some embodiments, the method further comprises using the analysis of the received data to determine one or more of a Botox dose level change, a dose level for a left and / or right jaw muscle, a dose level for a masseter muscle, a dose level for a temporalis muscle, a low to high dosing regimen, and a high to low regimen.

[0168] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded. In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0169] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0170] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0171] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0172] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. In some embodiments, the systems, devices, and methods of the invention utilize indirect force measurement calculations to assess muscle force or power. The indirect force measurement techniques may include calculating a force by measuring a related physical quantity, for example, strain, displacement, or pressure. The physical quantity may be measured, for example, via one or more sensors such as strain gauges, accelerometers, or pressure transducers. Mathematical models may be applied to convert the measurements into force values. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0173] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0174] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0175] Methods for post-treatment monitorins of Botox treatment for masseter muscle reduction

[0176] The invention provides for using the systems and devices disclosed herein in methods for post-treatment monitoring of Botox treatment for masseter muscle reduction.

[0177] Aspects of the invention provide methods for post-treatment monitoring of Botox treatment for masseter muscle reduction. The methods include the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an effective period of Botox dose administration for masseter muscle reduction treatment.

[0178] In some embodiments of the methods, the determining step is performed on data analyzed over a first defined period of time, wherein the effective period of the Botox dose administration is determined based on a change in the one or more parameters over the defined period of time. In some embodiments, the method further comprises analyzing the received data for a second defined period of time to establish whether the Botox dose administration results in a change in bruxism as compared to one or more baseline bruxism parameters.

[0179] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0180] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0181] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0182] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0183] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0184] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. In some embodiments, the systems, devices, and methods of the invention utilize indirect force measurement calculations to assess muscle force or power. The indirect force measurement techniques may include calculating a force by measuring a related physical quantity, for example, strain, displacement, or pressure. The physical quantity may be measured, for example, via one or more sensors such as strain gauges, accelerometers, or pressure transducers. Mathematical models may be applied to convert the measurements into force values. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0185] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0186] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0187] Method for using a smart mouthguard system for predicting a risk of failure of a dental restoration

[0188] The invention provides for using the systems and devices disclosed herein in methods for predicting a risk of failure of a dental restoration.

[0189] Aspects of the invention provide methods for predicting a risk of failure or damage of a dental restoration. The methods include providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith. Further, the method includes receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a risk of failure of a dental restoration.

[0190] In some embodiments, the dental restoration is one or more of a filling, a crown, abridge, an implant, dentures, and a veneer. In some embodiments, assessment of a risk of failure comprises predicting a force load applied to the dental restoration during a bruxism event. In some embodiments, the predicted force applied is determined in relation to a maximum force load capability of the dental restoration. In some embodiments, the risk assessment is used to strengthen the design of the dental restoration.

[0191] In some embodiments, the data received is collected from one or more of before a bruxism event, during a bruxism event, and after a bruxism event.

[0192] In some embodiments of the methods, the one or more parameters may be one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event may be one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding. The system may determine a frequency of a type of bruxism event and / or bruxism activity. Further, the system may determine whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. The jaw movement pattern may include one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded. In some embodiments of the methods, the method further comprises providing a computing system comprising a non-transitory, computer-readable storage medium coupled to a processor and encoded with a computer program executable by the processor to cause the computing system to receive the data associated with the subject and generate a three- dimensional (3D) virtual model of the personalized smart mouthguard within a 3D design environment. The data associated with the subject comprises one or more high-resolution dental scans, intraoral scans, dental records, and anatomical data, wherein the data is used as input into the virtual three-dimensional (3D) design environment to create a virtual dental model, in some embodiments. In some embodiments, a virtual model of the personalized smart mouthguard is created and overlaid on the virtual dental model. The method further comprises analyzing, via one or more algorithms, the virtual model of the personalized smart mouthguard for conformance to dentition.

[0193] In some embodiments the method further comprises simulating stress and load distribution on one or more of the virtual dental model and the virtual personalized smart mouthguard using finite element analysis (FEA). In some embodiments, the biomechanical data obtained from the simulated stress and load distributions is mapped directly onto the virtual dental model. In some embodiments, the method further comprises using the biomechanical data to predict, via one or more algorithms, variations in one or more of occlusal forces and jaw movement patterns of the virtual dental model on the dental restorations.

[0194] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0195] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0196] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profde, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0197] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0198] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. In some embodiments, the systems, devices, and methods of the invention utilize indirect force measurement calculations to assess muscle force or power. The indirect force measurement techniques may include calculating a force by measuring a related physical quantity, for example, strain, displacement, or pressure. The physical quantity may be measured, for example, via one or more sensors such as strain gauges, accelerometers, or pressure transducers. Mathematical models may be applied to convert the measurements into force values. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique. In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0199] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0200] In some embodiments, the risk assessment may be used to plan the number, dimensions, design or distance between dental implants. In some embodiments, the risk assessment may be used to determine the requirement to modify the dimensions, structural strength or biological health of a supporting tooth, and / or soft-tissue or bony structures before or after carrying out dental treatment. In some embodiments the risk assessment may be used to determine the choice of material of dental restorations or dental devices such as dental implants or dental implant components. In some embodiments, the risk assessment may be used in conjunction with a registry of clinical outcomes for implants, natural teeth or other prosthetic tooth replacements.

[0201] Methods for monitorins drug-induced bruxism

[0202] The invention provides for using the systems and devices disclosed herein in methods for monitoring drug-induced bruxism.

[0203] Aspects of the invention provide methods for monitoring drug-induced bruxism. The methods include the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine a severity of drug-induced bruxism.

[0204] In some embodiments, the severity of the drug-induced bruxism is used to determine a dosage regimen of the drug. In some embodiments, a trend over time of the severity of the drug- induced bruxism is used to determine an effective period of a drug dose administration. In some embodiments, the dosage regimen is increased, decreased, or unchanged based on the severity of the drug-induced bruxism. In some embodiments of the methods, the determining step is performed on data analyzed over a first defined period of time, wherein the effective period of the drug dose administration is determined based on a change in the one or more parameters over the defined period of time. In some embodiments, the method further comprises analyzing the received data for a second defined period of time to establish whether the drug dose administration results in a change in bruxism as compared to one or more baseline bruxism parameters.

[0205] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded. In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0206] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0207] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0208] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0209] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0210] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0211] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0212] Aspects of the invention provide methods for evaluating an effect of a medication on bruxism activity. The method includes the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine a change in the bruxism parameters to thereby evaluate the effect of the medication on bruxism.

[0213] In some embodiments, the determining step is performed on data analyzed over a period of time, wherein a medication dose administration is determined based on a change in the one or more parameters over the defined period of time.

[0214] Methods for monitorins bruxism related to acid reflux

[0215] The invention provides for using the systems and devices disclosed herein in methods for monitoring bruxism related to acid reflux.

[0216] Aspects of the invention provide methods for monitoring bruxism for post-treatment assessment of acid reflux. The methods include the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine a severity of bruxism related to acid reflux.

[0217] In some embodiments, the severity of bruxism is used as a proxy for the severity or anatomical extent of gastric acid reflux. In some embodiments, the severity of bruxism is used to determine a dosage regimen of a drug for treating acid reflux. In some embodiments, a trend over time of the severity of bruxism is used to determine an effective period of a drug dose administration for the treatment of acid reflux. In some embodiments, the dosage regimen is increased, decreased, or unchanged based on the severity of the bruxism related to acid reflux.

[0218] In some embodiments of the methods, the determining step is performed on data analyzed over a first defined period of time, wherein the effective period of the drug dose administration is determined based on a change in the one or more parameters over the defined period of time. In some embodiments, the method further comprises analyzing the received data for a second defined period of time to establish whether the drug dose administration results in a change in bruxism as compared to one or more baseline bruxism parameters.

[0219] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0220] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0221] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0222] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0223] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0224] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0225] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0226] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0227] Method for using a smart mouthguard system for correlating bruxism data with other patient health effects and dental risk

[0228] The invention provides for using the systems and devices disclosed herein in methods for correlating bruxism data with other patient health effects and dental risk.

[0229] Aspects of the invention provide methods for using the systems of the invention for correlating bruxism data and / or parameters with other patient data to further understand the overall dental risk and / or health risk of a patient. The methods include the steps of providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events; and analyzing the one or more parameters in conjunction with patient data received as input from a separate source from the oral appliance to assess a dental or health risk of the patient.

[0230] In some embodiments, the one or more parameters comprises sensor output from the one or more sensor assemblies, wherein the sensor output is analyzed in conjunction with the output of a separate intra-oral and / or extra-oral sensor. In some embodiments, the intra-oral sensor is a pH sensor, wherein the one or more sensor assembly data is analyzed in conjunction with output from the pH sensor. In some embodiments, the sensor output is analyzed in conjunction with an output from a sleep monitoring technology. In some embodiments, the sleep monitoring technology comprises one or more technologies for monitoring sleep disordered breathing and monitoring blood oxygenation levels. In some embodiments, the sensor output data may be analyzed in conjunction with one or more electromyography (EMG) electrodes.

[0231] In some embodiments of the methods, the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0232] In some embodiments of the methods, the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Operation of the oral appliance is controlled by the system via the user interface, in some embodiments. In some embodiments, analysis of the received data is displayed on an associated display device via the software application. In particular embodiments, analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. In some embodiments, the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map is overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0233] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0234] In some embodiments of the methods, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The one or more sensor assemblies comprises an inner portion and an outer portion, in some embodiments. Activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments. The one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode in some embodiments. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0235] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0236] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0237] In some embodiments, the one or more sensor arrays is encased in a deformable layer, in some embodiments. The deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy, in some embodiments.

[0238] In some embodiments of the methods, the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0239] Brief Description of the Drawings

[0240] FIG. 1 illustrates a system for analyzing and assessing a severity of bruxism according to one embodiment of the invention.

[0241] FIG. 2A illustrates a top side perspective view of a smart mouthguard device configured to fit to the upper teeth according to one embodiment of the invention. FIG. 2B illustrates a bottom side perspective view of the device according to one embodiment of the invention.

[0242] FIG. 3 illustrates a top side perspective view of a shell according to one embodiment of the device.

[0243] FIG. 4 illustrates an occlusal view and a teeth view of a shell of the device according to one embodiment of the invention.

[0244] FIG. 5 illustrates a device according to one embodiment of the invention.

[0245] FIG. 6 illustrates a smart mouthguard and associated docking station according to one embodiment of the systems of the invention.

[0246] FIG. 7A illustrates finite element analysis (FEA) of a virtual model of a personalized smart mouthguard overlaid on a virtual dental model, according to one embodiment of the methods of the invention.

[0247] FIG. 7B illustrates a front view of a virtual model of a personalized smart mouthguard overlayed on a virtual dental model for analysis during manufacture, according to one embodiment of the invention.

[0248] FIG. 7C illustrates a back view of a virtual model of a personalized smart mouthguard overlayed on a virtual dental model for analysis during manufacture, according to one embodiment of the invention.

[0249] FIG. 7D illustrates a side view of a virtual model of a personalized smart mouthguard overlayed on a virtual dental model for analysis during manufacture, according to one embodiment of the invention.

[0250] FIG. 8 illustrates a method for manufacturing a personalized smart mouthguard according to one embodiment of the methods of the invention.

[0251] FIG. 9 Illustrates customized areas of a personalized smart mouthguard according to one embodiment of the invention.

[0252] FIG. 10 illustrates a summary of bruxism data presented via a GUI on a laptop display, smartphone, and tablet, according to one embodiment of the systems of the invention.

[0253] FIG. 11 illustrates a representation of a method for diagnosing and assessing bruxism according to one embodiment of the invention.

[0254] FIG. 12 illustrates a representation of a method for assessing a level of bruxism over time in a patient according to one embodiment of the methods of the invention. FIG. 13 illustrates a representation of a method for determining eligibility of a patient for bruxism treatment using Botox according to one embodiment of the methods of the invention.

[0255] FIG. 14 illustrates a representation of a method for determining a Botox dosage regimen for treating bruxism and / or for masseter muscle reduction according to one embodiment of the methods of the invention.

[0256] FIG. 15 illustrates a representation of a method for determining a post-treatment monitoring of Botox treatment of bruxism and / or for masseter muscle reduction according to one embodiment of the methods of the invention.

[0257] FIG. 16 illustrates a representation of a method for predicting a risk of damage for a dental restoration.

[0258] Detailed Description

[0259] The invention recognizes that there exists a need for improved diagnosis, treatment planning, patient monitoring, and compliance tracking for patients with bruxism. In this manner, the invention addresses the drawbacks of current bruxism splints / mouth guards and provides novel systems, devices, and methods for treating bruxism. In particular, the invention provides systems, including a digital health platform, using customized, tailored mouthguard devices, methods of manufacturing, and methods for use in understanding and treating bruxism, TMJ disorders, and / or masseter muscle reduction. The systems of the invention provide a detailed bruxism analysis, that includes data analytics for data-driven insights for improved treatment planning and monitoring. The customized design of the smart mouthguards provide for optimal fit and bruxism event recording, and ensure the devices are comfortable and suitable for longterm wear.

[0260] The systems, devices, and methods of the invention address the drawbacks of current treatments for bruxism and recognizes that clinical examination is not accurate enough to identify patients most at risk. In particular, the invention addresses the need for clinical data related to bruxism for patients undergoing complex dental restoration procedures. The invention provides systems, devices, and methods that integrate three-dimensional (3D) design, customization, and advanced manufacturing techniques. Further, the systems, devices, and methods of the invention leverage advanced algorithms and patient-specific data inputs to provide highly personalized, high-precision medical devices capable of providing unique, detailed and personalized bruxism data.

[0261] Overview

[0262] As disclosed in more detail herein, the systems, devices, and methods of the invention include a smart mouthguard device with miniaturized, flexible sensors for precise biomechanics data collection. The smart mouthguard device includes miniaturized, wireless communication modules and signal processing algorithms for real-time data acquisition. The invention provides methods for advanced manufacturing techniques for manufacturing the smart mouthguards for ergonomic design to optimize patient comfort, improve device compliance, and ensure long-term durability. Data from the smart mouthguard may be relayed to the data analytics platform of the systems for real-time data communication between the device and the system. In some embodiments, the systems include Internet of Things (loT) connectivity, thus ensuring seamless integration of data between the smart mouthguard and the system, while also including encryption for safe and reliable data transmission. The system include one or more algorithms, such as machine learning models, for interpreting biomechanics data received and generating actionable insights for clinicians. The system includes predictive analytics and tools for risk assessment, treatment planning, and compliance monitoring. The system also provides interactive visualization via an intuitive dashboard for clinicians and patients to visualize device performance and usage insights. Thus the systems, devices, and methods of the invention provide novel approaches that integrate user-generated data into clinical workflows for personalized care that provide for improved treatment planning, patient monitoring, and compliance tracking.

[0263] Systems for analyzing, assessing, monitoring, and treatins bruxism

[0264] Aspects of the invention provide systems for analyzing, assessing, monitoring, and treating bruxism.

[0265] FIG. 1 illustrates a system for analyzing and assessing a severity of bruxism according to one embodiment of the invention. As disclosed in more detail herein, the systems include an oral appliance 101, also referred to herein as a device, smart mouthguard, mouthguard, and a smart splint. The oral appliance comprises one or more sensor assemblies. The systems may include a docking station 103 configured for storing and charging the oral appliance, and for transmitting and receiving data associated with the oral appliance 101 . The systems include a computing system 105 operably associated with the oral appliance 101 and / or the docking station 103, and configured to communicate with and exchange data therewith. The computing system includes a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions cause the processor to receive data from the one or more sensor assemblies, analyze the received data via one or more algorithms, and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism.

[0266] The computing system 105 may be separately operatively connected to the oral appliance and / or the docking station 103. The computing system 105 may be integrally formed with the oral appliance 101 and / or the docking station 103. The computing system may comprise a non- transitory, computer-readable storage medium 107 coupled to a processor 109 and encoded with the computer program. The computing system may interface with control system architecture on a user interface 111, for example such as a smart phone, touchscreen, or display. The user interface may be integrally formed with the computing system, or may be connected to the computing system via a wired or wireless connection, or may be located remotely. As disclosed in more detail herein, the systems, via the computing system, may interface with a control system architecture comprising, in non-limiting examples, one or more of a computer, a processor, a network, and / or a graphical user interface (GUI) for controlling one or more user inputs, receiving data from the oral appliance and / or docking station, and displaying one or more outputs from the system.

[0267] As disclosed in detail herein, the computing system, may include one or more algorithms configured for analyzing biomechanics data received from the oral appliance and / or the docking station, and generating one or more insights associated with one or more bruxism events. The insights may include, in non-limiting examples, risk assessment, treatment planning, device performance, usage insights, compliance monitoring, the effectiveness of the splint in reducing bruxism activity, the relationship between this reduced activity and pain, the effect of medical, medication or lifestyle related variables on bruxism, the monitoring of these medical / medication or lifestyle variables using bruxism or any of its individual parameters as proxy measures.

[0268] The system may analyze the biomechanics data to determine a jaw movement pattern. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0269] In some embodiments, assessing bruxism comprises determining a bruxism severity level or bruxism severity number based on one or more of the determined parameters. As disclosed herein, the bruxism severity number may be determined, via one or more algorithms, based on, in non-limiting examples, one or more parameters such as biomechanical data received, risk assessment data, patient-specific inputs, i.e., dental scans, anatomical data, x-rays, and the like, a type of bruxism event, a temporal pattern of bruxism activity, a location within a mouth of the subject where the bruxism even occurs, a percentage of bruxism events in the location, a force amplitude of the bruxism, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. A bruxism severity level scale may be algorithmically determined based on various bruxism data used as training data input into one or more machine learning algorithms. The machine learning algorithms may be one or more of a supervised or unsupervised machine learning algorithm. The bruxism severity level or number may be calculated based on the scale of bruxism severity as determined by systems and methods of the invention.

[0270] In some embodiments, the computing system further comprises a user interface operably associated with the computing system. The user interface may be provided via a software application accessible using one or more of a computer, a smartphone, a watch or wristband, and a tablet. The received and analyzed data may be displayed on an associated display device via the software application. In some embodiments, the computing system may include a cloud-based server configured to communicate and exchange data with the oral appliance over a network. The user interface may be provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station, in some embodiments. Further, operation of the oral appliance and / or the docking station may be controlled by the system via the user interface.

[0271] The user interface of the systems may allow a user to interact with and control the operation of the device and / or docking station. For example, the user interface, may include one or more input / output mechanisms, such as a keyboard, knobs, buttons, scroll wheels, or the like, with which a user can interact so as to operate the device and / or the docking station The user interface may be physically connected to the device, may be integrally formed with the device, or may be located remotely. The user interface may be a handheld device, e.g., a smart tablet, a smart phone, or a specialty device produced for the device. User interaction may be implemented on a computer having an I / O device, e.g., a CRT, LCD, LED, or projection device for displaying information to the user and an input or output device such as a keyboard and a pointing device, (e.g., a mouse or a trackball), by which the user may provide input to the computer.

[0272] In some embodiments of the systems, user interaction with the system may be via a form of sensory feedback, for example, visual feedback, auditory feedback, or tactile feedback, and input from the user may be received in any form, including acoustic, speech, or tactile input.

[0273] The systems may provide for receiving and analyzing data associated with various aspects or parameters related to use of the oral appliance and / or the docking station. In some embodiments, the system may include an analytics module or platform. The analytics platform may be integrated with the computing system and / or in communication with the computing system. The systems may include a communication interface as part of the user interface to provide for communication with the subject, a healthcare provider, a caretaker, a clinical research investigator, a database, a monitoring application, and the like. The systems may include loT connectivity. The systems may include data communication between the device and the analytics platform, ensuring seamless integration between data transmitted by the device and / or docking station, and the analytics platform. The communication may be between any of one or more of the device, docking station, data analytics platform, and / or the system. In some embodiments, communication between the device, docking station, data analytics platform, and / or system is real-time or near real-time communication. In some embodiments, the systems include data encryption features as is known to persons skilled in the art, to allow for safe and reliable data transmission.

[0274] In some embodiments, the computing system may be configured to communicate with and exchange data over a network. The network may represent, for example, a private or nonprivate local area network (LAN), personal area network (PAN), storage area network (SAN), backbone network, global area network (GAN), wide area network (WAN), or collection of any such computer networks such as an intranet, extranet or the Internet (i.e., a global system of interconnected network upon which various applications or service run including, for example, the World Wide Web). In alternative embodiments, the communication path between the user interface and the systems of the invention may be, in whole or in part, a wired connection.

[0275] The network may be any network that carries data. Non-limiting examples of suitable networks that may be used as network include Wi-Fi wireless data communication technology, the internet, private networks, virtual private networks (VPN), public switch telephone networks (PSTN), integrated services digital networks (ISDN), digital subscriber link networks (DSL), various second generation (2G), third generation (3G), fourth generation (4G), fifth generation (5G), and future generations of cellular-based data communication technologies, Bluetooth radio, Near Field Communication (NFC), the most recently published versions of IEEE 802.11 transmission protocol standards, other networks capable of carrying data, and combinations thereof.

[0276] In some embodiments, the network may be chosen from the internet, at least one wireless network, at least one cellular telephone network, and combinations thereof. As such, the network may include any number of additional devices, such as additional computers, routers, and switches, to facilitate communications. In some embodiments, the network may be or include a single network, and in other embodiments the network may be or include a collection of networks.

[0277] The system is configured to receive data from the oral appliance, via the one or more sensor assemblies, analyze the data via one or more algorithms, and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism. In non-limiting examples, the one or more parameters may be one or more of a time a bruxism event occurs, a type of bruxism event, a temporal pattern of bruxism activity, a location within a mouth of the subject where the bruxism even occurs, a percentage of bruxism events in the location, a force amplitude of the bruxism, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event.

[0278] The type of bruxism event may be one or more of phasic, tonic, or combined. Phasic bruxism is a type of tooth grinding or clenching in which the jaw muscles contract in short, repetitive bursts, thus creating a rhythmic pattern of muscle activity. Tonic bruxism is a type of teeth grinding or clenching where the jaw muscles contract and remain clenched for a sustained period of time, characterized by a prolonged, continuous muscle contraction. The type of bruxism activity may be one or more of clenching, tapping, and grinding. In some embodiments, the system determines a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria.

[0279] The jaw movement pattern may be one or more of grinding, clenching, thrusting, tapping, movement in a particular direction as defined by, for example, an x,y,z axis in relation to oral appliance. The jaw movement may be a linear distance of movement in a particular direction, as defined, for example, from a zero point or starting point. As disclosed in detail herein, the one or more sensor assemblies may include one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The sensors may include a number of discrete sensors arrange zonally or throughout the device, for example as in a “honeycomb” pattern. In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. In some embodiments, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement. The sensors may be positioned such that the output determines a 3D and 4D relationship between the patient’s jaws during jaw movement. The sensors may determine a 3D and 4D relationship between the patient’s jaws with respect to the device during jaw movement. Thus, in some embodiments, the sensors are positioned to determine a slope of the line of jaw movement and a location of jaw movement with respect to, for example the x,y,z axis.

[0280] As disclosed herein, the received data may be displayed on an associated display device via the software application. Analysis of the received data may be displayed as a force map. The force map may include, in non-limiting examples, a graphical indication of one or more locations within the mouth of a subject where a risk of overload may be highest. Further, the force map may include jaw movement patterns determined during bruxism and / or a bruxism event. The force map may include a force frequency. The force map may include a bruxism type. The system may include a virtual three-dimensional (3D) rendering of a subject’s teeth. The virtual 3D rendering may comprise patient-specific dental records and / or oral scans received as input into the system. The force map may be displayed as overlaid on the 3D rendering of a patient’s teeth. The force map may be displayed as overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented j aw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0281] In some embodiments, the force map and sensor output may be used as direct inputs into a digital articulation system. The 3D rendering of the patient may move on the digital articulation model and the 4D analysis of the bruxism activity may be used to program the movement of the 3D rendering in a way that mimics the patient’s actual bruxism activity

[0282] In one embodiment of this, the bruxism movements may be analysed and the most common or representative combination of jaw movement parameters may be used to illustrate the actual jaw movements during bruxism.

[0283] In another embodiment the bruxism jaw movements simulated on the digital articulation model may be samples of the movements seen wherein for example the most extreme movements may be chosen for illustration.

[0284] In one embodiment of this, the heatmap of contacts may change during the simulated jaw movements to indicate where the greatest force loading occurs during the full range of motion. The simulation may be used to understand the biomechanical loading and areas of greatest risk. In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0285] As disclosed herein, the systems may include a data analytics platform or module for analyzing the data received. Analyzing the data received may be performed by one or more algorithms. Analyzing the data received may include summarizing the bruxism data collected. For example, the data may include a summary of bruxism events per hour, a percentage of nights with bruxism, a type of bruxism activity, a location in the mouth where the bruxism activity occurs, a location in the mount trended over time to denote consistency in force in certain areas over time, a RMMA index trended over time, a distribution of phasic, tonic, and mixed bruxism events, and splint compliance.

[0286] In some embodiments, the data may be analyzed to determine where a risk of overload is highest. The data may be displayed on a virtual arch of the patient’s teeth with a force map such that there is a graphical indication on the arch where the risk of overload is highest. The force map may include a mix of frequency and bruxism type. In some embodiments, the data is displayed within a 3D design environment wherein the jaw movement pattern data may be integrated with a patient’s virtual digital articulator module to allow direct visualisation of the normal jaw movement patterns during bruxism in that patient. This four-dimensional (4D) representation may include an indication, such as colored areas, to indicate where risk is increased by higher forces. Further, the data may be analyzed to indicate where forces are higher and to provide predictive modelling for clinicians in the design of a dental restoration such as a filling, denture, veneer, crown, bridge, or implant. Thus, the systems provide analysis of data that may be used to give the dental technician unique insight in designing restorations within a digital virtual environment. In some embodiments, the data may be integrated with finite element analysis (FEA) and / or other virtual mechanical testing protocols to assist with the testing and design of the restorations.

[0287] Smart mouthguard Technology Aspects of the invention provide a smart mouthguard, referred to interchangeably herein as a device, mouthguard, mouthpiece, and splint. The smart mouthguard may be a customized / personalized protective oral appliance with embedded electronics such as thin film sensors and wireless communications modules configured to record detailed bruxism movements over time and relay the data to the systems of the invention. The data is analyzed via the system to present insights on the level, type, and severity of bruxism events. Thus, the systems of the invention utilize the smart mouthguard technology to provide clinically relevant data to clinicians.

[0288] As disclosed in more detail herein, the smart mouthguard is designed and manufactured to optimize patient comfort and to ensure long-term durability. Accordingly, the device may be worn over extended periods of time for maximum data collection. For example, detailed bruxism data may be recorded from the device during waking or sleeping hours. In non-limiting examples, data may be recorded during sleep according to a time protocol of one day to 4 weeks or more. In some embodiments, data is recorded during sleep for two weeks. In some embodiments, data is recorded during sleep for three weeks. In some embodiments, data is recorded during sleep for four weeks. Data may be recorded before treatment starts. Data may be recorded during treatment. Data may be recorded after treatment. The device is designed for extended treatment protocols and multiple uses. In some embodiments, the device is designed as a disposable device designed for one-time use or for limited use.

[0289] The device may include one or more sensor assemblies. The sensor assemblies may be of a certain configuration, for example, as described in international PCT application No. PCT / EP2014 / 071101 (published as WO2015049321A2) to McAuliffe et al., the contents of which are incorporated by reference herein in its entirety.

[0290] The sensors may be one or more sensors with high specificity in order to detect subtle variations in occlusal forces and jaw movement, for example, the sensors may be in the form of mechanical resonators. The sensor assembly may include, for example, a sensor array comprising one or more polymeric force sensors. A polymeric force sensor is a type of force sensor that utilizes a polymer material as the primary sensing element. The force applied causes a measurable change in the polymer's physical properties, such as its electrical resistance, which may then be translated into a signal representing the force magnitude. The force sensor may be made from polymer that deforms under pressure, thus generating a detectable signal proportional to the applied force. The polymeric material may be any polymeric material commonly used for force sensors, for example conductive polymers such as polyaniline, poly(o-anisidine), soft elastomeric polymers such as silicone rubber, and natural polymers such as collagen, agarose, and alginate. The polymeric material may be any material that changes properties, such as electrical properties such as resistance, when subjected to mechanical force, allowing detection of pressure or strain.

[0291] The sensor array may be made from polyvinylidene fluoride (PVDF). The sensor array may include a carbon nano-fibre conductive filler. The mechanical and conductive properties of the sensor array may be optimised for the particular force range and loading patterns typically seen in a bruxism event.

[0292] In some embodiments, the sensors may comprise one or more of a printed sensor technology and / or a layer or composite construction. The printed sensor technology include, for example, a conductive ink printed on a flexible material. The printed sensor may include a direct-printed sensor array. The direct-printed sensor array may be used as an alternative and / or to complement a layered or composite sensor configuration. The direct-printed sensor or sensor array may be used alone or in conjunction with a layered and / or composite sensor configuration to enhance manufacturing efficiency, device performance consistency, and miniaturization of device electronics. In some embodiments, one or more of the printed sensors are configured to sense multiple properties, for example, pressure and temperature. In some embodiments, the one or more printed sensors or sensor arrays comprise, in non-limiting examples, a flexible force sensor, a clear conductive sensor, a temperature sensor, a strain sensor, and a capacitive touch sensor. In some embodiments, the printed sensor may be a conductive flexible ink that is screen printed on a polymer film. The polymer film may be, for example, thermoplastic polyurethane (TPU), polyester, or Kapton. In some embodiments, the conductive ink is printed on a flexible substrate.

[0293] In some embodiments, the sensors may be wrapped in a flex circuit electrode. The sensors may be a size and type to cover a specific number of teeth. For example, the sensors may be of a size and type to cover one to three teeth, for example comprising two sensors in the anterior area and two sensors in the posterior area. In some embodiments, the anterior sensors may be constructed from a more conductive sensor material than the sensors in the posterior area to take into account forces in the anterior area tending lower than forces applied in the posterior area during a typical bruxism event. Alternatively, the sensor composition may be localized within the oral cavity to measure load change. The relative positioning of the sensors is crucial to sensor signal amplitude as the opposing teeth must contact the sensor array in an optimal position, e.g. as closely as possible to the central portion of the sensor array / pad, to ensure optimal signal amplitude. As the contacts move away from the central portion, the sensor amplitude may reduce. As contact moves off the edge of a sensor, there may still be a signal response, albeit at decreasing amplitude. As the contacts move away from the edge of a sensor and approach adjacent sensors, the signal strength on these adjacent may also increase as the first sensor amplitude decreases. As such, if contact occurs between, but not on, adjacent sensors there may be a sensor response that is proportional to the distance between the contact point and the individual adjacent sensors. By assessing the relative amplitudes of the sensor activations and by comparing these to the maximal record sensor amplitudes for each sensor at baseline testing, during bruxism or at calibration during device fabrication, it is possible to triangulate the position of contacts that do not activate the central portion of the sensors in the array.

[0294] In a further embodiment of this, the temporal sequence of sensor peak activations may allow the identification of the movement pattern of the opposing teeth across the sensor array. This 4D series of sensor peak activations may be used to deduce jaw movement pattern and represent this on a digital articulation model.

[0295] In some embodiments, the smart mouthguard is manufactured for wearing on the upper jaw (upper teeth) of the subject. In some embodiments, the smart mouthguard is manufactured for wearing on the lower jaw (lower teeth) of the subject. The smart mouthguard is manufactured such that opposing teeth contact the sensor assembly as advantageously and precisely as possible.

[0296] FIG. 2A illustrates a top side perspective view of a smart mouthguard device 201 configured to fit to the upper teeth according to one embodiment of the invention. The device may include a shell portion 207 and a body portion disposed within the shell 207. The body portion may include one or more sensors 205 positioned within the body portion, as well as the associated electronics. The body portion may have a defined top surface and bottom surface. The top surface may be in contact with teeth. The bottom surface may be in contact with the shell surface. Alternatively, the top surface and the bottom surface may each be configured to be separately in contact with at least a portion of an upper row or a lower row of teeth of a subject. One or more of the top surface and the bottom surface may be configured to conform to a tooth pattern of the row of teeth in which the top surface or the bottom surface is in contact.

[0297] The smart mouthguard may be designed as a U-shaped or V-shaped device. The device may comprise a low or slim profile, i.e. profile for improved patient comfort, with no protruding areas from the body of the device. The device may be designed with a reduced or removed PCB housing which may be desirable to optimize the form factor. As disclosed in more detail herein, the smart mouthguard is designed to be customized / personalized to a patient for precise data collection and to ensure comfort. The device may be manufactured from dental impressions to allow for a precisely moulded fit to a patient’s upper or lower teeth, thus allowing for an indentation channel 203 conforming to the patient’s teeth. Accordingly, the degree of “V” or “U” shape of the retaining upper or lower arch may be highly variable between patients due to the size and shape of the patient’s jaw.

[0298] The invention recognizes that a standard sized sensor array that cannot be customised to the patient specific anatomy is highly likely to result in sub-optimal sensor positions. The invention provides a smart mouthguard with sensor positions that may be adapted for each individual case.

[0299] FIG. 2B illustrates a bottom side perspective view of the device 201 with sensors 205 arranged within the body according to the configuration suitable for the patient’s particular needs. The arch of the opposing teeth need not follow the shape of the upper arch and may have an irregular horizontal overlap with regard to the upper teeth. The mouthguard may be configured for sensor placement that takes this into account This results in a highly customised configuration that is patient specific. In some embodiments, the sensor array is encased in a plastically stretchable membrane. Accordingly, the sensors may be positioned by stretching the outer membrane into any required position.

[0300] The sensors may be positioned, e.g., embedded, within the body as one or more individual sensors, sensor arrays, or sensor assemblies. The sensors may be positioned as a honeycomb mesh along the body of the device. The sensors may be positioned as discrete sensors arranged in a “honeycomb” configuration zonally or throughout the device. The sensors may be positioned anywhere within the device to achieve patient-specific data collection, for example within the shell of the device, embedded within the body, on a top of the body, on a bottom of the body, or on a side of the body. The device may include flexible printed circuit boards (PCBs) running to a slim PCB embedded in the body. The slim PCB or flexi PCB may be positioned in the device so as to maintain a low profile with no raised or protruding portions that could cause discomfort. The device may be designed with a reduced or removed PCB housing which may be desirable to optimize the form factor. The PCBs may be positioned, for example, as embedded in the body, on a top of the body, on a side of the body, below the body, or within the device shell. The device may include a battery, PCB and associated electronics. The battery and associated electronics may be miniaturized so as to fit within the slim profile of the device shell.

[0301] FIG. 3 illustrates a top side perspective view of a shell according to one embodiment of the device. The shell may be configured to be as smooth as possible with no sharp angles.

[0302] FIG. 4 illustrates an occlusal view and a teeth view of a shell 407 of the device 401 according to one embodiment of the invention. The rigid external surface of the shell covers the body. In this embodiment, the battery and PCB are housed within a slightly raised area of the shell such that the rigid exterior surface of the shell covers the raised area / housing. The raised area, as with the other portions of the shell, may be configured with smooth, rounded edges for maximum patient comfort.

[0303] FIG. 5 illustrates a device 501 according to one embodiment of the invention. Panel A illustrates an occlusal (bottom) view of a device 501 according to one embodiment of the invention. The device 501 includes a shell 507 with soft, rounded edges and a slim profile. In the illustrated embodiment, the device includes a housing as raised flange with smooth, rounded edges. The device may be designed with a reduced or removed housing which may be desirable to optimize the form factor. The housing may be configured to house associated electronics, e.g., the battery, PCBs, wireless communications module, and the like. Panel B illustrates a front perspective view of the device 501. The body 509 with top portion configured to conform to a patient’s teeth visible. Panel C illustrates a side perspective view of the device. The raised housing may be slightly raised in relation to the profile of the body, in some embodiments. In some embodiments, the device does not include a raised housing. In such cases, the associated electronics, e.g., the battery, PCBs, wireless communications module, and the like, are miniaturized to an extent that the device maintains a slim profile with no raised areas. Notably, the device is designed to provide improved comfort and wearability for patients. In some embodiments, the sensor arrays may comprise miniaturized flexible sensors for precise biomechanics data collection, ensuring high performance and durability. As disclosed herein, the design and placement of the sensor assemblies / sensor arrays optimizes biomechanics data acquisition and processing. The sensor assemblies may comprise integrated miniaturized, wireless communication modules and signal processing algorithms for real-time data acquisition. In some embodiments, the systems include one or more signal processing algorithms to ensure data accuracy and reliability.

[0304] As disclosed in more detail herein, in some embodiments, the smart mouthguard is manufactured to optimize patient comfort and positioning of the sensor arrays to improve data collection, improve device compliance, and ensure long-term durability.

[0305] In some embodiments, the one or more sensor assemblies may include one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. The sensors may be individual discrete sensors arranged zonally, locally, or throughout the body, for example, in a honeycomb pattern. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. The sensor assemblies may include an inner portion and an outer portion. In some embodiments, activation of the inner portion versus activation of the outer portion may determine a direction and a linear distance of jaw movement. The sensors and / or sensor arrays may be positioned, for example, as in a “honeycomb” arrangement for maximum coverage for data collection.

[0306] As disclosed herein, in some embodiments, the one or more sensors may include one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. The one or more sensor arrays may be one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies may further include a printed circuit board, and one or more capacitors, wherein the printed circuit board may be operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors may include one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0307] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0308] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0309] In some embodiments, the one or more sensor arrays may be encased in a deformable layer. In some embodiments, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy. Further, in some embodiments, the one or more sensor arrays may include sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0310] In some embodiments, the oral appliance may include a splint or smart mouthguard customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0311] In the integration of the sensor assemblies and microelectronics into the smart mouthguard, the invention recognizes that the integration of highly sensitive materials in between layers of material presents several challenges, typically requiring the material to have certain amount of preloading to achieve a predictable and rapid sensor response. To ensure optimal pre-loading the sensors need to occupy a space in between the layers that is very tightly dimensionally controlled. Accordingly, in some embodiments, a space may be templated in between the hard and soft layers of the device shell such that the space may be the exact same thickness (or nearly the same thickness) as the combined thickness of the sensor and electrode assembly. In some embodiments, this thickness may be about 0.6mm.

[0312] In some embodiments, a custom-made template may be cut from a sheet of medical grade polymer (PVDF or PE) that creates the appropriate amount of space for sensors in their optimal positions. The template may be cut in an arch form that is designed by analysis of the horizontal relationship between the upper and lower arches and positioned on the soft layer during manufacture in a way that ensures that the opposing upper teeth will contact it in the best possible position. In order to ensure there is optimal preloading of the sensors and that the hard and soft layers surround the sensor array with the optimal pressure a “rim lock” may be used. The rim lock may be a design whereby the hard outer layer of the device shell wraps around the cut edge or border of the soft underlayer and effectively contains it as press fit. When the hard outer layer and the soft under layer are brought together during assembly this ensures that not only is it not possible for them to held apart by the sensor array with too little pressure to preload but it also means that the two parts come together in a definite relative position and with an audible snap that verifies the optimal position has been found. The hard and soft outer layers may be adhered together using an ultraviolet light cured urethane acrylate adhesive. The adhesive layer may have an optimal layer thickness of, for example, 0.4 mm. The entire smart mouthguard surface area may include space to accommodate for this layer. Accordingly, a thermoformed adhesive template layer that is conformal over the soft splint layer that is laid down first and is subsequently thermoformed over by the hard layer may be used, such that, when the interfacial adhesive layer is removed, the space left is 0.4 mm. This may be omitted in the very edge of the smart mouthguard so as not to affect the ability of the rim lock to affect the optimal mating between the hard and soft layers.

[0313] Data from the sensor assemblies may be recorded. The data may be recorded by the smart mouthguard, the docking station, and / or the system. Data may be transmitted from the sensor assemblies to the docking station and / or the systems.

[0314] In some embodiments, the microelectronics of the smart splint includes one or more printed circuit boards (PCBs). The PCB may record the resistance change in the polymer via a capacitive discharge time. In some embodiments, there may be a capacity on the individual circuit for each of the sensors and a reference capacitor in parallel. The resistance change alters the charge build up in the capacitor and therefore the discharge time which is then compared to the discharge time of the reference capacitor. The PCB may include a reed switch to control the power draw and a magnet in the docking station may open or closes the reed switch depending on the operation.

[0315] In some embodiments, the smart mouthguard PCB may be operable to function in one or more modes. The one or more modes may include a recording mode and a saving mode. The one or more modes may further include a sleep vigilance mode and a deep sleep mode. The smart mouthguard may be configured to spend a set period of time, for example a “nighttime period” in the vigilance mode wherein it may send very short pulses of current across the circuit for example, once per second. If the resistance of one of the sensors drops below a defined threshold the sampling rate may increase, for example, up to ten times per second. The smart mouthguard may be configured to remain at the increased sampling rate for a length of time after the last sub threshold force input to ensure no further bruxism activity continues. For example, the smart mouthguard may be configured to remain at the increased sampling rate for 2, 4, 6, 8, 10 or more seconds after the last sub threshold force input to ensure no further bruxism activity continues.

[0316] In some embodiments, the systems may include a docking station.

[0317] FIG. 6 illustrates a smart mouthguard 601 and associated docking station 603 according to one embodiment of the systems 600 of the invention. The docking station may be configured to receive the smart mouthguard and serve as a means for charging the smart mouthguard. The docking station may be configured to send data to and received data from the smart mouthguard and / or the computing system. In some embodiments, the docking station and the smart mouthguard communicate over an infrared (IR) communication protocol. The IR communication may be via an IR LED configured to transmit and receive signals between the docking station and the smart mouthguard. In some embodiments, the docking station and / or the computing system is configured to change the smart mouthguard PCB state. In some embodiments, the docking station and / or the computing system is configured to perform diagnostics on the smart mouthguard PCB, and to program threshold values and data acquisition parameters, e.g. sampling rate and the like.

[0318] In some embodiments, the docking station comprises a lid with one or more LEDs positioned on the lid, such that the LEDs may identify a state the smart mouthguard is currently in, e.g. record mode etc.

[0319] In some embodiments, the docking station comprises a serial USB connection and a flash memory storage. The docking station may be powered by a hard wired connection. The docking station may be powered by a rechargeable battery pack. The docking station may be powered by batteries such as, in non-limiting examples, four AA batteries.

[0320] The docking station may comprise a U-shaped, V-shaped, or roughly horseshoe-shaped receiver within the docking station for receiving the smart mouthguard. The docking station may comprise an embedded magnet positioned to optimally activate a reed switch on the smart mouthguard.

[0321] Methods for manufacturing a personalized smart mouthguard device

[0322] The invention provides highly customized systems and methods for improved data collection and analysis, thus resulting in improved understanding and treatment of bruxism in a patient. The high level of customization is achieved through the integration of patient-specific data inputs into the three-dimensional (3D) design environment, advanced algorithmic analysis, and advanced manufacturing techniques. Accordingly, the invention provides a high-precision medical device, i.e., smart mouthguard, for use with systems and methods of the invention.

[0323] Aspects of the invention provide methods for manufacturing a personalized smart mouthguard. In some embodiments, the methods of the invention utilize patient-specific data, for example, high-resolution dental scans, intraoral scans, dental records, and anatomical data, as input into the virtual three-dimensional (3D) design environment. In some embodiments, a virtual dental model of the patient may be created. Further, optimization data associated with a smart mouthpiece may then be used to create a virtual model of the personalized smart mouthguard within the 3D design environment.

[0324] The virtual model of the personalized smart mouthguard may be overlayed on the virtual dental model and analyzed, via one or more algorithms, to evaluate, for example, conformance to dentition. Accordingly, the invention provides methods for manufacturing a personalized smart mouthguard that expand on virtual design features to include Al-driven automation for shell adjustments, and for optimizing sensor placement to ensure customization of the smart mouthguard and improved data collection. The method may include iterative design-feedback loops during manufacturing to enhance ergonomics and optimize data collection.

[0325] The invention provides patient-centric methods for manufacturing a personalized smart mouthguard for use with systems of the invention as disclosed herein. In some embodiments, a dental impression is made of the patient’s teeth, gums, and / or surrounding oral structures. The dental impression may be used to create the virtual dental model, the virtual model of the device, and / or the physical model of the device.

[0326] In some embodiments, the methods may include advanced simulation of stress and load distributions on the personalized smart mouthguard using finite element analysis (FEA) of the virtual dental model and the virtual personalized smart mouthguard. In some embodiments, biomechanical data is mapped directly onto the virtual dental model using data from intraoral scans for ultra accurate modeling of stress and load distributions, and for iterative optimization of the personalized smart mouthguard. Accordingly, manufacture of the personalized smart mouthguard may be fully or partially tailored to pit patient-specific anatomical and biomechanical needs.

[0327] In some embodiments, the FEA includes inputs from patient x-ray data. In this way, bone health may be included in the assessment for the manufacture of the personalized mouthguard. In some embodiments, both x-ray data and dental scans are integrated into the analysis. The dental scans may provide a simplified, surface-level representation of the virtual dental model to provide a topographical framework. In some embodiments, the personalized mouthguard is fabricated to suit the topography, with the sensors positioned at all contact / occlusion points. Further, in some embodiments, the FEA analysis utilizes the topography data and sensor data obtained from the patient wearing the device for a period of time. The FEA computes the complex modeling of these factors to predict predict outcomes. These outcomes may be factored into the design and / or manufacture of the personalized mouthguard. In some embodiments, the system utilizes Al in conjunction with dental x-rays to factor in the impact of bone health condition, i.e., healthy versus diseased bone. The system may be configured to provide, based on the analysis, a comprehensive view of osseointegration into the treatment planning and predictive modelling.

[0328] FIG. 7A illustrates finite element analysis (FEA) of a virtual model of a personalized smart mouthguard overlaid on a virtual dental model, according to one embodiment of the methods of the invention.

[0329] FIG. 7B illustrates a front view of a virtual model of a personalized smart mouthguard overlayed on a virtual dental model for analysis during manufacture, according to one embodiment of the invention.

[0330] FIG. 7C illustrates a back view of a virtual model of a personalized smart mouthguard overlayed on a virtual dental model for analysis during manufacture, according to one embodiment of the invention.

[0331] FIG. 7D illustrates a side view of a virtual model of a personalized smart mouthguard overlayed on a virtual dental model for analysis during manufacture, according to one embodiment of the invention.

[0332] FIG. 8 illustrates a method 820 for manufacturing a personalized smart mouthguard according to one embodiment of the methods of the invention.

[0333] The methods may include forming 821 a smart mouthguard shell comprising a body portion having a top surface and a bottom surface. The top surface and the bottom surface may each be configured to be separately in contact with at least a portion of an upper row or a lower row of teeth of a subject. One or more of the top surface and the bottom surface may be configured to conform to a tooth pattern of the row of teeth in which the top surface or the bottom surface is in contact. The method may include embedding 831 one or more sensor assemblies disposed within the body portion between the top surface and the bottom surface. As disclosed herein, the one or more sensor assemblies may be positioned to record data associated with bruxism of the subject. Formation of the shell and embedding 831 the one or more sensor assemblies may include receiving 823 data associated with the subject / patient, analyzing 825 the received data via one or more algorithms, simulating 827 occlusal contacts, and localizing / positioning 829 the sensor assembly placement based on the simulated occlusal contacts. In some embodiments, the procedure may include manual positioning of the sensors within the device.

[0334] Further, the methods may include one or more machine learning algorithms configured to provide predictive insights into material selection, occlusal adjustments, and long-term risks. Material selection may include materials to maximize durability of specific areas of the personalized smart mouthguard, while maintaining comfort and biocompatibility. The machine learning algorithms may be configured to improve predictive analytics and real-time clinical decision support. In some embodiments, the methods may include incorporation of one or more artificial intelligence (Al) technologies, e.g. machine learning, deep learning, natural language processing, computer vision, and the like, into the data decomposition and FEA modeling to provide a high-precision device. In some embodiments, Al technologies may be used for sensor calibration and drift compensation over time. In some embodiments, the Al-driven sensor calibration and / or drift compensation over time is used to improve measurement reliability of a bruxism event, and to ensure long-term accuracy in bruxism event detection.

[0335] The methods may further include providing a computing system comprising a non- transitory, computer-readable storage medium coupled to a processor and encoded with a computer program executable by the processor to cause the computing system to receive the data associated with the subject and generate a three-dimensional (3D) virtual model of the personalized smart mouthguard within a 3D design environment.

[0336] In some embodiments, the data associated with the subject may include one or more high-resolution dental scans, intraoral scans, dental records, and anatomical data. The data may be used as input into the virtual three-dimensional (3D) design environment to create a virtual dental model.

[0337] In some embodiments, the methods may include receiving optimization data comprising one or more of a shell wall thickness threshold, an occlusion offset tolerance, a material density, and feedback from the subject. In some embodiments, the optimization data includes specification on sensor positioning in a particular area or areas of the smart mouthguard that will provide for optimization of the contours of the smart mouthguard. In some embodiments, the optimization data is used to further create the virtual model of the personalized smart mouthguard within the 3D design environment. The optimization data may be used to further create the virtual model of the personalized smart mouthguard within the 3D design environment. In some embodiments, the virtual model of the personalized smart mouthguard may be overlaid on the virtual dental model. Accordingly, the method may further include analyzing, via one or more algorithms, the virtual model of the personalized smart mouthguard for conformance to dentition. The fit of the personalized smart mouthguard to the subject may be determined via analysis of the overlaid virtual model.

[0338] In some embodiments, formation of the shell may include one or more customized areas based on the conformance to dentition analysis.

[0339] FIG. 9 Illustrates customized areas of a personalized smart mouthguard 901 according to one embodiment of the invention. The customized areas may include one or more of a crevice block-out area 913, a minimum thickness area 911, a tooth offset area 915, and an inward retention area 917. The customized areas may represent advanced features of the personalized smart mouthguard shell. The advanced shell features may include minimal wall thickness thresholds to improve durability. The advanced shell features may include optimized retention zones to ensure conformance to dentition. The advanced shell features may include offset adjustments for improved comfort and compatibility. The advanced shell features may include crevice block-out features to prevent mechanical stress points. As disclosed in more detail herein, the 3D design integration may include heat map utilization for analysis and / or prediction of localization of high-contact zones for optimized sensor placement.

[0340] In some embodiments, the methods further include simulating stress and load distribution on one or more of the virtual dental model and the virtual personalized smart mouthguard using finite element analysis (FEA). In some embodiments, the sensor assembly placement may be based on analysis of one or more of the simulated stress and load distributions. In some embodiments, the biomechanical data obtained from the simulated stress and load distributions may be mapped directly onto the virtual dental model, wherein the method further comprises using the biomechanical data to predict, via one or more algorithms, variations in one or more of occlusal forces and jaw movement patterns of the virtual dental model on the virtual personalized smart mouthguard.

[0341] In some embodiments, the methods may further include utilizing one or more occlusion heat maps to localize sensor positioning, and adjusting the shell formation. The sensor assembly placement may be optimized using iterative feedback loops during manufacturing based on the occlusion heat maps. In some embodiments, a material composition of the personalized smart mouthguard may be selected based on analysis of the overlaid virtual model.

[0342] Accordingly, the methods for manufacture represent novel approaches to integrate usergenerated data into clinical workflows for personalized care by end-to-end customization of a smart mouthguard for use with systems of the invention disclosed herein. End-to-end customization is achieved via advanced computational and manufacturing technologies. The manufacture of the precise, personalized smart mouthguard is achieved using application of advanced machine learning algorithms, patient-specific data inputs, and additive and subtractive manufacturing techniques.

[0343] As disclosed herein, the methods may utilize continuous, real-time feedback loops for optimization of the device design and manufacturing. The device design may be tailored based on individual anatomical and clinical requirements. The design may also include data-driven insights achieved via one or more machine learning algorithms for predictive analytics based on the virtual 3D models.

[0344] The iterative feedback loop may include data on one or more bruxism parameters. The data may be obtained from the smart mouthguard. The data may be modelled using one or more algorithms of the system. The bruxism parameters may be one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. The type of bruxism event may be one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding. The system may determine a frequency of a type of bruxism event and / or bruxism activity. Further, the system may determine whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. The jaw movement pattern may include one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0345] The manufacturing framework may include, in some embodiments, one or more of incorporation of high-resolution scans into a virtual CAD / CAM 3D design environment; virtual articulation through simulation of occlusal contacts to optimize splint geometry; development of premium rule sets, such as wall thickness thresholds, offset tolerances, and retention features; heat map utilization to localize sensor positioning and refine device design; hybrid manufacturing techniques such as 3D printing, CNC methods, injection moulding for soft and hard shell production; dimensional accuracy assessment by providing automated tools for detecting deviations during production; scalable design standards through creation of standardized planar surfaces for sensor integration across devices; optimized sensor array placement to capture biomechanical data without compromising comfort; wireless capabilities using miniaturized components for power and data transmission, improving usability and reducing device footprint; advanced signal processing using one or more algorithms for accurate and reliable data interpretation; secure loT connectivity with encrypted communication to ensure secure data transmission between devices and cloud platforms; interoperability through integration with electronic dental health records for seamless workflow integration. The manufacturing framework may include standardized manufacturing rules including mating plates for sensor placement in which consistent planar surfaces on opposing shells are developed to ensure proper sensor alignment and integration; material innovations via the introduction of durable, biocompatible, and lightweight materials for optimized 3D printing; and real-time dimensional quality control via in-process assessments to detect deviations in wall thickness, occlusion tolerances, and / or material density.

[0346] In some embodiments, the personalized smart mouthguard may be manufactured via one or more of 3D printing, computer numerical control (CNC) machining, and injection moulding. In some embodiments, the body may include a standardized mating plane between each of the bottom surface and the one or more embedded sensor assemblies, the one or more sensor assemblies and the top surface, and bottom surface and the top surface. In some embodiments, the bottom surface comprises a surface material softer than a surface material of the top surface.

[0347] In some embodiments, the one or more sensor assemblies comprises one or more flexible sensors.

[0348] In some embodiments, the method may further comprise embedding a wireless communication module within the smart mouthguard. The wireless communication module may be operable to communicate with one or more computing systems and / or the docking station. The wireless communication module may include one or more signal processing algorithms configured for real-time data transfer.

[0349] As disclosed herein, in some embodiments, the method may include providing a computing system comprising a non-transitory, computer-readable storage medium coupled to a processor and encoded with a computer program executable by the processor to cause the computing system to receive the data associated with the subject and generate a three- dimensional (3D) virtual model of the personalized smart mouthguard within a 3D design environment.

[0350] In some embodiments the data associated with the subject may include one or more high- resolution dental scans, intraoral scans, dental records, and anatomical data

[0351] In some embodiments the data may be used as input into the virtual three-dimensional (3D) design environment to create a virtual dental model.

[0352] In some embodiments, the method may include receiving optimization data comprising one or more of a shell wall thickness threshold, an occlusion offset tolerance, a material density, and feedback from the subject. In some embodiments, the optimization data includes specification on sensor positioning in a particular area or areas of the smart mouthguard that will provide for optimization of the contours of the smart mouthguard. In some embodiments, the optimization data is used to further create the virtual model of the personalized smart mouthguard within the 3D design environment.

[0353] In some embodiments, the virtual model of the personalized smart mouthguard may be overlaid on the virtual dental model. In some embodiments, the method further comprises analyzing, via one or more algorithms, the virtual model of the personalized smart mouthguard for conformance to dentition. In some embodiments, a fit of the personalized smart mouthguard to the subject may be determined via analysis of the overlaid virtual model.

[0354] In some embodiments, the method may include simulating a stress and / or a load distribution on one or more of the virtual dental model and the virtual personalized smart mouthguard using finite element analysis (FEA). In some embodiments, sensor assembly placement may be based on analysis of one or more of the simulated stress and load distributions.

[0355] In some embodiments, the smart mouthguard may be required to provide biomechanical data in patients where there are one or more missing teeth. This may result in areas of the mouth where there are no opposing pairs of upper and lower teeth to compress the sensor and to provide a direct sensor recording. One or more algorithms may be used to characterize the relative force sensor amplitudes between two or more of the sensors in the smart mouthguard. The biomechanical data obtained directly from the force sensors in one area, via one or more algorithms may be used to extrapolate the biomechanical data in areas with missing teeth and without direct sensor data recordings

[0356] In some embodiments, this indirect extrapolation of force data to areas with missing teeth may be combined with knowledge from virtual or in-vitro mechanical modelling including but not limited to heat maps of occlusion from virtual occlusal analysis, FEA, photoelastic studies or strain gauges.

[0357] In some embodiments, biomechanical data obtained from the simulated stress and / or load distributions may be mapped directly onto the virtual dental model. In some embodiments, the method further comprises using the biomechanical data to predict, via one or more algorithms, variations in one or more of occlusal forces and jaw movement patterns of the virtual dental model on the virtual personalized smart mouthguard.

[0358] In some embodiments, the method may include utilizing one or more occlusion heat maps to localize sensor positioning, and adjusting the shell formation. In some embodiments, sensor assembly placement is optimized using iterative feedback loops during manufacturing based on the occlusion heat maps.

[0359] In some embodiments, a material composition of the personalized smart mouthguard may be selected based on analysis of the overlaid virtual model. In some embodiments the 3D design, dimensions, contour, occlusal scheme and orientation of a smart mouthguard or subsequent normal mouthguard without sensors is based on the biomechanical data or virtual modelling of the forces on the virtual tooth model

[0360] In some embodiments, the personalized smart mouthguard is manufactured via one or more of 3D printing, computer numerical control (CNC) machining, and injection moulding.

[0361] In some embodiments, the body comprises a standardized mating plane between each of the bottom surface and the one or more embedded sensor assemblies, the one or more sensor assemblies and the top surface, and bottom surface and the top surface. In some embodiments, the bottom surface comprises a surface material softer than a surface material of the top surface.

[0362] In some embodiments, the one or more sensor assemblies comprises one or more flexible sensors.

[0363] In some embodiments, the method further comprises embedding a wireless communication module. In some embodiments, the communication module is operable to communicate with one or more computing systems. In some embodiments, the communication module comprises one or more signal processing algorithms configured for real-time data transfer.

[0364] In some embodiments of the mouthpiece, the body portion is comprised of a polymer.

[0365] In some embodiments, the one or more sensor assemblies comprises a plurality of sensors comprising force sensors. In some embodiments, the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. In some embodiments, the one or more sensor assemblies comprises an inner portion and an outer portion. Further, activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement, in some embodiments.

[0366] In some embodiments the sensor cross section is varied along the x and / or y axis to provide greater resolution or sensitivity

[0367] In some embodiments, the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. In some embodiments, the one or more sensor arrays comprises one or more polymeric force sensors. Further, in some embodiments, the one or more sensor assemblies further comprises a printed circuit board, and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors comprises one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

[0368] In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0369] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0370] In some embodiments, the one or more sensor arrays may be encased in a deformable layer. Accordingly, the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patientspecific anatomy, in some embodiments. In some embodiments, the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0371] In some embodiments, the mouthpiece is customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array. In some embodiments, the mouthpiece is customized based on individual anatomical requirements of the patient-specific anatomy. In some embodiments, the individual anatomical requirements are obtained from a dental scan of the patient.

[0372] In some embodiments, the mouthpiece further comprises an integrated wireless communication module.

[0373] Data analytics platform

[0374] Aspects of the invention provide one or more data analytics platforms integrated within the systems. The data analytics platform may be configured to analyze data received during the manufacturing process for precision fabrication of the smart mouthguard device. The data analytics platform may be configured to analyze data received from the smart mouthguard before, during, and after a bruxism event. The data analytics system may be configured to analyze data associated with bruxism of a patient and apply the data to designing dental restorations, i.e. fillings, dentures, veneers, crowns, bridges, or implants within a digital environment to evaluate force loading and provide risk assessment.

[0375] As disclosed herein, in some embodiments, predictive modelling is integrated into the data analysis to model load distribution on dental implants and restorations. In some embodiments, the predictive modelling of load distribution is used to identify patients at risk of a prosthetic or dental restoration failure due to excessive occlusal force. In some embodiments, the predictive modelling of load distribution is used to inform material selection for implants, prosthetics, and restorations based on these risk assessments. The data analytics platform may be configured to receive as input data associated with bruxism of a patient, one or more high-resolution dental scans, intraoral scans, dental records, and anatomical data, and integrate the data within a 3D virtual design environment for predictive analysis of force for use in designing dental restorations such as fillings, dentures, veneers, crowns, bridges, or implants. The data may be used to assess a biomechanical load on teeth. The data may be used to assess a level of bruxism over time. In some embodiments, the data is integrated with FEA analysis and / or other virtual mechanical testing protocols to test and design the dental restorations. In some embodiments the data includes optimization data comprising one or more of a shell wall thickness threshold, an occlusion offset tolerance, a material density, and feedback from the subject, wherein the optimization data is used to further create a virtual model of the personalized smart mouthguard, and / or dental restorations.

[0376] In some embodiments, data is transferred from the smart mouthguard via the docking station. In some embodiments, data is transferred from the smart mouthguard directly to the data analytics platform. The data may initially be transferred as a CSV fde in a directory within the program fdes. The CSV fde may include data acquisition parameters such that the transferred data is recognized as belonging to a specific patient and to verify the accuracy of the data transferred.

[0377] The data analytics platform may include one or more algorithms. The algorithms may be hosted on the computing system. The algorithms may be hosted on a web service. The algorithm may include analysis of the data time stamps and may categorize events with certain characteristics, for example a certain duration or range of durations, or patterns. The algorithm analyzes the data compared to input parameters in order to characterize the data as a bruxism event. The algorithm counts the number of bruxism events per hour and reports them over the time period, e.g. night, as a number of events per hour. The algorithm further analyses whether the bruxism is in the low- or high-frequency category, based on input parameters, and generates a report of such. The input parameters may be PSG research diagnostic criteria. Polysomnography (PSG) research diagnostic criteria are used to diagnose sleep disorders.

[0378] The data analytics platform also determines if the temporal pattern of activity is a grinding (rhythmic) or clenching (sustained) movement. The location in the mouth of the patient is also recorded and the data is analyzed to report a percentage of total bruxism events occurring in each area / location. The force amplitude from the raw data may be calculated based on the degree of the resistance drop of the force sensors. The force response curve is non-linear although relatively predictable. In some embodiments, the analytics platform is configured to determine the mathematical function defining the force response curve for precise analysis and predictive modelling. The force may be determined in SI units. The force may be qualitatively determined as a percentage of maximum voluntary contraction or by comparing its amplitude to a mean of bruxism event amplitudes across a number of bruxism recordings.

[0379] The location in the mouth where the bruxism occurs may be reported as right, left, anterior, and posterior. The location in the mouth may be reported based on a sensor location, wherein the sensors are given a position description relative to the smart mouthguard and / or the patient’s teeth pattern. The relative amplitude of the sensor response for adjacent sensors may determine the position of contacts on the splint that are not entirely centred on the sensor pad and thereby triangulate more specific tooth positions. As disclosed herein, this level of detailed sensor data can only be achieved with the optimal sensor placement and integration techniques of the invention.

[0380] The jaw movement pattern (grinding or clenching with actual direction and linear movement) may be determined by analysing the temporal sequence, temporal spacing and relative amplitude of the sensor response curve peaks and troughs. The location of the jaws relative to one another in a virtual environment requires the positioning of the sensors to be digitally registered relative to the specific anatomy of the teeth and jaws. In this way, patients and clinicians are better able to understand a bruxism condition and associated treatment, and to prevent future damage, thus providing better clinical outcomes.

[0381] Bruxism data may be summarized and displayed on a GUI. The GUI may be a laptop, a smartphone, a tablet, a smart watch, or the like. The data may be accessed and displayed via an interactive application. The data may be summarized and displayed in an interactive graph form. The interactive application may include features designed to encourage compliance with wearing the device such as gamification features and / or positive virtual rewards. The data may be displayed, in non-limiting examples, as multi-night bruxism recordings, areas of the mouth affected by bruxism, compliance with wearing the smart mouthguard, a frequency of bruxism events, an intensity of bruxism events, a jaw movement pattern. The data may be displayed in any form, such as graphical, tabular, summarized, and as an overlay of a virtual model of the patient’s mouth. FIG. 10 illustrates a summary of bruxism data presented via a GUI on a laptop display, a smartphone and a tablet, according to some embodiments of the systems of the invention. In some embodiments, the data may be analyzed to determine where a risk of overload is highest. The data may be displayed on a virtual arch of the patient’s teeth with a force map such that there is a graphical indication on the arch where the risk of overload is highest. The force map may include a mix of frequency and bruxism type. In some embodiments, the data is displayed within a 3D design environment wherein the jaw movement pattern data may be integrated with a patient’s virtual digital articulator module to allow direct visualisation of the normal jaw movement patterns during bruxism in that patient. This four-dimensional (4D) representation may include an indication, such as colored areas, to indicate where risk is increased by higher forces. Further, the data may be analyzed to indicate where forces are higher and to provide predictive modelling for clinicians in the design of a dental restoration such as a filling, dentures, veneers, crowns, bridges, or implants. Thus, the systems provide analysis of data that may be used to give the dental technician unique insight in designing restorations within a digital virtual environment. In some embodiments, the data may be integrated with finite element analysis (FEA) and / or other virtual mechanical testing protocols to assist with the testing and design of the restorations.

[0382] Systems for assessing a biomechanical load on a dental implant and / or teeth

[0383] Aspects of the invention provide systems for assessing biomechanical load on a dental implant and / or teeth. The systems comprise an oral appliance as disclosed herein. For example, the oral appliance / smart mouthguard may include one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions may cause the system to receive data from the one or more sensor assemblies, analyze the received data via one or more algorithms, and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of biomechanical load on the dental implant and / or teeth.

[0384] In some embodiments of the systems, the one or more parameters may include one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event. In some embodiments, the type of bruxism event may be one or more of phasic, tonic, or combined. In some embodiments, the type of bruxism activity may be one or more of clenching and grinding. In some embodiments, the system may determine a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system may determine whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern may include one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw movement, a consistency of bruxism activity affecting particular areas within the mouth (local areas), a triangulation of the specific location of affected teeth by the relative activation of amplitudes of adjacent sensors. In some embodiments, the system determines a singular bruxism workload by area parameter to represent the combination of one or more of a duration / frequency of hits, the force of the hits, the vector of movement of the hits, the consistency of the hits in affecting particular areas. As used herein, the term “hits” may refer to, in non-limiting examples, individual sensor activation, sensor array activation, a combination of sensor activation, a combination of sensor array activation, a combination of individual sensor and sensor array activation, or any other means in which aspects of a bruxism event are measured and / or recorded.

[0385] As disclosed herein, in some embodiments of the systems, the computing system may include a cloud-based server configured to communicate and exchange data with the oral appliance over a network. In particular embodiments, the system further may include a user interface operably associated with the computing system, The user interface may be provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch or wristband, and an oral appliance docking station. In some embodiments, operation of the oral appliance may be controlled by the system via the user interface. In some embodiments, analysis of the received data may be displayed on an associated display device via the software application. Further, in some embodiments, analysis of the received data may be displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest. As disclosed herein, the force map may be one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type. In some embodiments, the force map may be overlaid on an arch of teeth specific to the subject. In some embodiments, the force map is integrated with a digitally articulated model or digitally represented jaw motion of a specific subject. In some embodiments, the force map, in graphical or digital form is related to the output of other jaw movement tracking data, muscle activation data, or a representation of static occlusal loading during bite analysis on an awake patient.

[0386] In some embodiments, the force data is integrated directly into, for example, a summarized oral health report, a pain report, a design in a lab CAD program, or a virtual model of the smart mouthguard such as for research and development purposes. In some embodiments the force data is integrated with other medical, dental, and / or psychological variables for reporting purposes. In this way, the systems of the invention provide for utilizing the force data, as input into further medical, dental, and / or psychological assessment. The force data may thus be integrated into the analysis for various reporting and analysis protocols.

[0387] In some embodiments of the systems, the one or more sensor assemblies may include one or more sensors positioned as one or more of an axially split sensor profde, a radially split sensor profile, and an asymmetrically segmented sensor profile. In some embodiments, the relative amplitude of activation of sensors may be used to determine a more precise location of occlusal contact either directly on or adjacent to a sensor or sensors in the array. In some embodiments, the one or more sensor assemblies may include an inner portion and an outer portion. In some embodiments, activation of the inner portion versus activation of the outer portion may determine a direction and a linear distance of jaw movement. In particular embodiments, the one or more sensors may include one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode. In some embodiments, the one or more sensor arrays may include one or more polymeric force sensors. In some embodiments, the one or more sensor assemblies further includes a printed circuit board, and one or more capacitors. In some embodiments, the printed circuit board may be operable to record a change in resistance in the polymer via a capacitive discharge time. In some embodiments, the one or more polymeric force sensors may include one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event. In some embodiments, force sensing is achieved via one or more electrodeposited layers. The layers may be in a grid. The electrodeposited layers may be, for example, in a solid rectangular sensor configuration. The electrodeposited layers may be configured as a strain gauge placed either directly in an occlusion area or in a side wall. The one or more electrodeposited layers may act as a sensor / probe to detect minute force variations in the device during a bruxism event. In some embodiments, the electrodeposited layer may include one or more of nickel, cobalt, and / or an alloy of nickel or cobalt. In some embodiments, deposition parameters, such as current density, electrolyte composition, and the like, may be adjusted to achieve mechanical properties for precisely controlled force sensitivity. In some embodiments, the microstructure of the deposited layer, for example, a grain size and crystal orientation, is manipulated to achieve force sensitivity suitable for detecting minute changes in force. In this way the electrodeposited layer may indirectly measure a bruxism event by measuring a deflection in the smart mouthguard material.

[0388] In some embodiments, the system may include one or more indirect force measurement techniques for calculating force by measuring a related physical quantity and mathematically calculating a force associated with a bruxism event. For example, the system may be configured to measure strain, displacement, and / or pressure. Thus the sensors may be one or more of a deposited coating, a strain gauge, an in-line strain gauge, an accelerometers, and a pressure transducer. In some embodiments, an indirect measure of strain in the device is calculated. For example, the indirect measurement of strain may include calculating strain by measuring a related physical quantity such as displacement, rather than directly measuring the deformation itself. In some embodiments, deformation is measured. In some embodiments, strain is measured using one or more displacement sensors such as Linear Variable Differential Transducers (LVDTs) to determine strain based on the measured displacement. In some embodiments, strain may be measured via digital image correlation (DIC) to analyze surface deformations to infer strain distribution across the surface of the device. In some embodiments, the one or both of strain and force are measured via an indirect measurement technique. In some embodiments, one or both of strain and force are measured via a direct measurement technique.

[0389] In some embodiments, the one or more sensor arrays may be encased in a deformable layer. As disclosed herein, in some embodiments of the systems, the deformable layer may allow positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy. In some embodiments, the one or more sensor arrays may include sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

[0390] In some embodiments of the systems, the oral appliance may comprise a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

[0391] Systems for assessing a level ofbruxism over time in a patient

[0392] Aspects of the invention provide systems for assessing a level ofbruxism over time in a patient. The system comprises an oral appliance, i.e. a smart mouthguard as disclosed herein. The smart mouthguard includes one or more sensor assemblies. The system further includes a computing system, as disclosed herein, operably associated with the oral appliance and configured to communicate with and exchange data therewith. The computing system includes a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions executable by the processor may cause the system to receive data from the one or more sensor assemblies, analyze the received data via one or more algorithms, determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events, and assess, based on data received from one or more of received data from prior to treatment for bruxism, received data from during treatment for bruxism, and received data from after treatment for bruxism, one or more trends over time related to a severity of bruxism.

[0393] In some embodiments of the systems, the one or more parameters may include one or more of a time, a type ofbruxism event, a type of bruxism activity, a temporal pattern ofbruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage ofbruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type ofbruxism event. In some embodiments, the type ofbruxism event may be one or more of phasic, tonic, or combined. In some embodiments, the type ofbruxism activity may be one or more of clenching and grinding. In some embodiments, the system may determine a frequency of a type of bruxism event and / or bruxism activity. In some embodiments, the system may determine whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria. In some embodiments, the jaw movement pattern may include one or more of grinding, clenching, direction, and linear distance of the movement. In some embodiments, the jaw movement pattern may include one or more of a location in the mouth affected by the jaw ...

Claims

Claims1. A system for treating bruxism, the system comprising: an oral appliance comprising one or more sensor assemblies; and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to: receive data from the one or more sensor assemblies; analyze the received data via one or more algorithms; and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism.

2. The system of claim 1, wherein the one or more parameters comprise one or more of a time of a bruxism event, a duration of a bruxism event, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event.

3. The system of claim 2, wherein the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity.

4. The system of claim 3, wherein the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria.

5. The system of claim 2, wherein the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement.

6. The system of claim 2, wherein the jaw movement pattern comprises one or more of a specific location in the mouth affected by the jaw movement and a consistency of bruxism activity affecting a specific location within the mouth.

7. The system of claim 6, wherein the system calculates a triangulation of the specific location by a relative activation of amplitudes of adjacent sensors.

8. The system of claim 7, wherein the system determines a bruxism workload by specific location parameter, wherein the parameter represents one or more of a duration and / or frequency of sensor activation, a force related to sensor activation, a vector of movement of the sensor activation, and a consistency of sensor activation in affecting the specific location.

9. The system of claim 1, wherein the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network.

10. The system of claim 9, wherein the system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch, a wristband, and an oral appliance docking station.

11. The system of claim 10, wherein operation of the oral appliance is controlled by the system via the user interface.

12. The system of claim 10, wherein analysis of the received data is displayed on an associated display device via the software application.

13. The system of claim 12, wherein analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest.

14. The system of claim 13, wherein the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type.

15. The system of claim 13, wherein the force map is overlaid on an arch of teeth specific to the subject.

16. The system of claim 13, wherein the force map is integrated with a digitally articulated models or digitally represented jaw motion a specific subject.

17. The system of claim 16, wherein the force map is represented in a digital form and is related to one or more of an output of other jaw motion tracking data, muscle activation data, and a representation of a static occlusal loading during bite analysis on an awake patient.

18. The system of claim 1, wherein the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile.

19. The system of claim 18, wherein the one or more sensor assemblies comprises an inner portion and an outer portion.

20. The system of claim 19, wherein activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement.

21. The system of claim 20, wherein a relative amplitude of activation of the one or more sensor assemblies is used to determine a location of occlusal contact either directly on or adj cent to a sensor or sensors in the array.

22. The system of claim 18, wherein the one or more sensors comprises one or more sensor arrays incorporated in, or deposited on, a flex circuit electrode.

23. The system of claim 22, wherein the one or more sensor arrays comprises one or more polymeric force sensors.

24. The system of claim 23, wherein the one or more sensor assemblies further comprises: a printed circuit board; and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time.

25. The system of claim 23, wherein the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

26. The system of claim 22, wherein the one or more sensor arrays is encased in a deformable layer.

27. The system of claim 26, wherein the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy.

28. The system of claim 27, wherein the one or more sensor arrays comprises sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

29. The system of claim 1, wherein the oral appliance comprises a splint customized to a patientspecific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

30. A method for assessing bruxism, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith;receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism.

31. The method of claim 30, wherein the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event.

32. The method of claim 31, wherein the type of bruxism event is one or more of phasic, tonic, or combined and the type of bruxism activity is one or more of clenching and grinding, wherein the system determines a frequency of a type of bruxism event and / or bruxism activity.

33. The method of claim 32, wherein the system determines whether the frequency of a type of bruxism event and / or type of bruxism activity is in a high or low frequency category according to defined diagnostic criteria.

34. The method of claim 31, wherein the jaw movement pattern comprises one or more of grinding, clenching, direction, and linear distance of the movement.

35. The method of claim 30, wherein the computing system comprises a cloud-based server configured to communicate and exchange data with the oral appliance over a network.

36. The method of claim 31, wherein the system further comprises a user interface operably associated with the computing system, wherein the user interface is provided via a software application accessible using one or more of a computer, a smartphone, a tablet, a watch, a wristband, and an oral appliance docking station.

37. The method of claim 36, wherein operation of the oral appliance is controlled by the system via the user interface.

38. The method of claim 36, wherein analysis of the received data is displayed on an associated display device via the software application.

39. The method of claim 38, wherein analysis of the received data is displayed as a force map comprising a graphical indication of one or more locations within the mouth of a subject where a risk of overload is highest.

40. The method of claim 39, wherein the force map comprises one or more of jaw movement patterns during bruxism, a force frequency, and a bruxism type.

41. The method of claim 39, wherein the force map is overlaid on an arch of teeth specific to the subject.

42. The method of claim 39, wherein the force map is integrated with a digital articulator model of a specific subject.

43. The method of claim 30, wherein the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile.

44. The method of claim 43, wherein the one or more sensor assemblies comprises an inner portion and an outer portion.

45. The method of claim 44, wherein activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement.

46. The method of claim 43, wherein the one or more sensors comprises one or more sensor arrays incorporated in a flex circuit electrode.

47. The method of claim 46, wherein the one or more sensor arrays comprises one or more polymeric force sensors.

48. The method of claim 47, wherein the one or more sensor assemblies further comprises: a printed circuit board; and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time.

49. The method of claim 46, wherein the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

50. The method of claim 46, wherein the one or more sensor arrays is encased in a deformable layer.

51. The method of claim 50, wherein the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy.

52. The method of claim 51, wherein the one or more sensor arrays comprise sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

53. The method of claim 30, wherein the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

54. A mouthguard comprising:a body portion have a top surface and a bottom surface wherein each of the top and bottom surfaces are made to a teeth pattern of a subject; and a plurality of sensors disposed within the body and positioned to record data associated with teeth grinding of the subject.

55. The mouthguard of claim 54, wherein the body portion is comprised of a polymer.

56. The mouthguard of claim 54, wherein the plurality of sensors are force sensors.

57. The mouthguard of claim 54, wherein the one or more sensor assemblies comprises one or more sensors positioned as one or more of an axially split sensor profile, a radially split sensor profile, and an asymmetrically segmented sensor profile.

58. The mouthguard of claim 57, wherein the one or more sensor assemblies comprises an inner portion and an outer portion.

59. The mouthguard of claim 58, wherein activation of the inner portion versus activation of the outer portion determines a direction and a linear distance of jaw movement.

60. The mouthguard of claim 57, wherein the one or more sensors comprises one or more sensor arrays incorporated in a flex circuit electrode.

61. The mouthguard of claim 60, wherein the one or more sensor arrays comprises one or more polymeric force sensors.

62. The mouthguard of claim 61, wherein the one or more sensor assemblies further comprises: a printed circuit board; and one or more capacitors, wherein the printed circuit board is operable to record a change in resistance in the polymer via a capacitive discharge time.

63. The mouthguard of claim 61, wherein the one or more polymeric force sensors comprise one or more mechanical and conductive properties optimized for a force range and a loading pattern associated with a bruxism event.

64. The mouthguard of claim 61, wherein the one or more sensor arrays is encased in a deformable layer.

65. The mouthguard of claim 64, wherein the deformable layer allows positioning of the sensor arrays within the oral appliance during manufacturing wherein the one or more sensor arrays are aligned to a patient-specific anatomy.

66. The mouthguard of claim 65, wherein the one or more sensor arrays comprise sensors of a same or different sensor material and / or composition localized within the oral appliance to an area of the patient-specific anatomy based on a load and / or force in the area.

67. The mouthguard of claim 54, wherein the oral appliance comprises a splint customized to a patient-specific anatomy, wherein opposing teeth of a subject contact the one or more sensor arrays substantially at a center portion of the sensor array.

68. A method for manufacturing a personalized smart mouthguard, the method comprising: forming a smart mouthguard shell comprising a body portion having a top surface and a bottom surface, wherein the top surface and the bottom surface are each configured to be separately in contact with at least a portion of an upper row or a lower row of teeth of a subject, wherein one or more of the top surface and the bottom surface are configured to conform to a tooth pattern of the row of teeth in which the top surface or the bottom surface is in contact; and embedding one or more sensor assemblies disposed within the body portion between the top surface and the bottom surface and positioned to record data associated with bruxism of the subject, wherein formation of the shell and embedding of the one or more sensor assemblies comprises: receiving data associated with the subject; analyzing the data, via one or more algorithms, to simulate occlusal contacts; andlocalizing sensor assembly placement based on the simulated occlusal contacts.

69. The method of claim 68, wherein the method further comprises providing a computing system comprising a non-transitory, computer-readable storage medium coupled to a processor and encoded with a computer program executable by the processor to cause the computing system to receive the data associated with the subject and generate a three-dimensional (3D) virtual model of the personalized smart mouthguard within a 3D design environment.

70. The method of claim 69, wherein the data associated with the subject comprises one or more high-resolution dental scans, intraoral scans, dental records, and anatomical data.

71. The method of claim 70, wherein the data is used as input into the virtual three-dimensional (3D) design environment to create a virtual dental model.

72. The method of claim 71, further comprising receiving optimization data comprising one or more of a shell wall thickness threshold, an occlusion offset tolerance, a material density, and feedback from the subject, wherein the optimization data is used to further create the virtual model of the personalized smart mouthguard within the 3D design environment.

73. The method of claim 72, wherein the virtual model of the personalized smart mouthguard is overlaid on the virtual dental model, wherein the method further comprises analyzing, via one or more algorithms, the virtual model of the personalized smart mouthguard for conformance to dentition.

74. The method of claim 73, wherein a fit of the personalized smart mouthguard to the subject is determined via analysis of the overlaid virtual model.

75. The method of claim 74, wherein formation of the shell comprises one or more customized areas based on the conformance to dentition analysis, wherein the customized areas comprise one or more of a crevice block-out area, a minimum thickness area, a tooth offset area, and an inward retention area.

76. The method of claim 74, further comprising simulating stress and load distribution on one or more of the virtual dental model and the virtual personalized smart mouthguard using finite element analysis (FEA).

77. The method of claim 76, wherein the sensor assembly placement is based on analysis of one or more of the simulated stress and load distributions.

78. The method of claim 76, wherein biomechanical data obtained from the simulated stress and load distributions is mapped directly onto the virtual dental model.

79. The method of claim 76, wherein the method further comprises using the biomechanical data to predict, via one or more algorithms, variations in one or more of occlusal forces and jaw movement patterns of the virtual dental model on the virtual personalized smart mouthguard.

80. The method of claim 74, further comprising utilizing one or more occlusion heat maps to localize sensor positioning, and adjusting the shell formation, wherein sensor assembly placement is optimized using iterative feedback loops during manufacturing based on the occlusion heat maps.

81. The method of claim 74, wherein a material composition of the personalized smart mouthguard is selected based on analysis of the overlaid virtual model.

82. The method of claim 72, wherein the personalized smart mouthguard is manufactured via one or more of 3D printing and computer numerical control (CNC) machining.

83. The method of claim 72, wherein the body comprises a standardized mating plane between each of the bottom surface and the one or more embedded sensor assemblies, the one or more sensor assemblies and the top surface, and bottom surface and the top surface.

84. The method of claim 83, wherein the bottom surface comprises a surface material softer than a surface material of the top surface.

85. The method of claim 68, wherein the one or more sensor assemblies comprises one or more flexible sensors.

86. The method of claim 68, wherein the method further comprises embedding a wireless communication module, wherein the communication module is operable to communicate with one or more computing systems.

87. The method of claim 86, wherein the communication module comprises one or more signal processing algorithms configured for data transfer.

88. A system for assessing biomechanical load on a dental implant and / or teeth, the system comprising: an oral appliance comprising one or more sensor assemblies; and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to: receive data from the one or more sensor assemblies; analyze the received data via one or more algorithms; and determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of biomechanical load on the dental implant and / or teeth.

89. A method for diagnosing and assessing bruxism in a patient, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies;analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a severity of bruxism for treatment in the patient.

90. A system for assessing a level of bruxism over time in a patient, the system comprising: an oral appliance comprising one or more sensor assemblies; and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith, the computing system comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to: receive data from the one or more sensor assemblies; analyze the received data via one or more algorithms; determine, based on analysis of the received data, one or more parameters associated with one or more bruxism events; and assess, based on data received from one or more of received data from prior to treatment for bruxism, received data from during treatment for bruxism, and received data from after treatment for bruxism, one or more trends over time related to a severity of bruxism.

91. A method for assessing a level of bruxism over time in a patient, the system comprising: providing a system comprising oral appliance comprising one or more sensor assemblies; and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events; and assessing, based on data received from one or more of received data from prior to treatment for bruxism, received data from during treatment for bruxism, and received data from after treatment for bruxism, one or more trends over time related to a severity of bruxism.

92. A method for determining eligibility of a patient for bruxism treatment with botulinum toxin (Botox), the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a pattern of bruxism for treatment with Botox.

93. The method of claim 92, wherein the pattern of bruxism comprises a baseline pattern over a defined time period before treatment with Botox.

94. The method of claim 93, wherein the defined period of time is two to four weeks inclusive.

95. The method claim 93, wherein analyzing the received data comprises a threshold analysis to identify a patient eligible for bruxism treatment with Botox.

96. A method for determining a botulinum toxin (Botox) dosage regimen for treating bruxism, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an optimum Botox dose level administration.

97. The method of claim 96, wherein the determining step is performed on data analyzed over a first defined period of time, wherein the optimum Botox dose level is determined based at leastin part on comparison of one or more patterns of bruxism parameters to a baseline pattern of bruxism parameters and / or previous Botox dosage level administration.

98. The method of claim 97, wherein the defined period of time is one to four weeks inclusive.

99. The method claim 97, wherein the method further comprises analyzing the received data for a second defined period of time to establish whether the dosage regimen results in a change in bruxism as compared to one or more of the baseline bruxism parameters.

100. The method of claim 99, wherein the method further comprises using the analysis of the received data to determine one or more of a Botox dose level change, a dose level for a left and / or right jaw muscle, a dose level for a masseter muscle, a dose level for a temporalis muscle, a low to high dosing regimen, and a high to low regimen.

101. A method for post-treatment monitoring of Botox treatment for bruxism, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an effective period of Botox dose administration for bruxism treatment.

102. The method of claim 101, wherein the determining step is performed on data analyzed over a first defined period of time, wherein the effective period of the Botox dose administration is determined based on a change in the one or more parameters over the defined period of time.

103. The method claim 102, wherein the method further comprises analyzing the received data for a second defined period of time to establish whether the Botox dose administration results in a change in bruxism as compared to one or more baseline bruxism parameters.

104. A method for determining eligibility of a patient for masseter muscle reduction treatment with botulinum toxin (Botox), the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a pattern of bruxism for masseter muscle reduction treatment with Botox.

105. The method of claim 104, wherein the pattern of bruxism comprises a baseline pattern over a defined time period before treatment with Botox.

106. The method of claim 105, wherein the defined period of time is two to four weeks inclusive.

107. The method claim 105, wherein analyzing the received data comprises a threshold analysis to identify a patient eligible for masseter muscle reduction treatment with Botox.

108. A method for determining a botulinum toxin (Botox) dosage regimen for masseter muscle reduction treatment, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an optimum Botox dose level administration for masseter muscle reduction treatment.

109. The method of claim 108, wherein the determining step is performed on data analyzed over a first defined period of time, wherein the optimum Botox dose level is determined based at least in part on comparison of one or more patterns of bruxism parameters to a baseline pattern of bruxism parameters and / or previous Botox dosage level administration.

110. The method of claim 109, wherein the defined period of time is one to four weeks inclusive.

111. The method claim 109, wherein the method further comprises analyzing the received data for a second defined period of time to establish whether the dosage regimen results in a change in bruxism as compared to one or more of the baseline bruxism parameters.

112. The method of claim 108, wherein the method further comprises using the analysis of the received data to determine one or more of a Botox dose level change, a dose level for a left and / or right jaw muscle, a dose level for a masseter muscle, a dose level for a temporalis muscle, a low to high dosing regimen, and a high to low regimen.

113. A method for post-treatment monitoring of Botox treatment for masseter muscle reduction, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to determine an effective period of Botox dose administration for masseter muscle reduction treatment.

114. The method of claim 113, wherein the determining step is performed on data analyzed over a first defined period of time, wherein the effective period of the Botox dose administration is determined based on a change in the one or more parameters over the defined period of time.

115. The method claim 114, wherein the method further comprises analyzing the received data for a second defined period of time to establish whether the Botox dose administration results in a change in bruxism as compared to one or more baseline bruxism parameters.

116. A method for predicting a risk of failure or damage of a dental restoration, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby assess a risk of failure of a dental restoration.

117. The method of claim 116, wherein the dental restoration is one or more of a filling, a crown, a bridge, an implant, dentures, and a veneer.

118. The method of claim 116, wherein assessment of a risk of failure comprises predicting a force load applied to the dental restoration during a bruxism event.

119. The method of claim 118, wherein the predicted force load applied is determined in relation to a maximum force load capability of the dental restoration.

120. The method of claim 116, wherein the risk assessment is used to strengthen the design of the dental restoration.

121. The method of claim 116, wherein the risk assessment is used to plan one or more of a number of dental restorations, a dimension of a dental restoration, a design of a dental restoration, and a distance between one or more dental restorations.

122. The method of claim 1 16, wherein the risk assessment is used to determine one or more of whether to modify a dimensions of a dental restoration, a structural strength or biological health of a supporting a tooth, a soft-tissue or a bony structure before or after carrying out dental treatment.

123. The method of claim 116, wherein the risk assessment is used to determine one or more of a choice of material of a dental restoration and a dental restoration component.

124. The method of claim 116 wherein the risk assessment is used in conjunction with a registry of clinical outcomes for implants, natural teeth or other prosthetic tooth replacements.

125. The method of claim 116, wherein the data received is collected from one or more of before a bruxism event, during a bruxism event, and after a bruxism event.

126. The method of claim 116, wherein the one or more parameters comprise one or more of a time, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject, a percentage of bruxism events in the location, a force amplitude, a jaw movement pattern, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, a rhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event.

127. The method of claim 126, wherein the type of bruxism event may be one or more of phasic, tonic, or combined.

128. The method of claim 126, wherein the type of bruxism activity is one or more of clenching and grinding.

129. The method of claim 126, further comprising determining a frequency of a type of bruxism event and / or bruxism activity.

130. The method of claim 126, further comprising receiving data associated with a subject, wherein the data associated with the subject comprises one or more high-resolution dental scans, intraoral scans, dental records, and anatomical data.

131. The method of claim 130, wherein the data is used as input into the virtual three- dimensional (3D) design environment to create a virtual dental model.

132. The method of claim 131, further comprising receiving optimization data comprising one or more of a shell wall thickness threshold, an occlusion offset tolerance, a material density, and feedback from the subject, wherein the optimization data is used to create a virtual model of the personalized smart mouthguard within the 3D design environment.

133. The method of claim 132, wherein the virtual model of the personalized smart mouthguard is overlaid on the virtual dental model.

134. The method of claim 133, further comprising simulating stress and load distribution on one or more of the virtual dental model and the virtual personalized smart mouthguard using finite element analysis (FEA).

135. The method of claim 133, wherein biomechanical data obtained from the simulated stress and load distributions is mapped directly onto the virtual dental model.

136. The method of claim 134, wherein the method further comprises using the biomechanical data to predict, via one or more algorithms, variations in one or more of occlusal forces and jaw movement patterns of the virtual dental model on the virtual personalized smart mouthguard to thereby assess a risk of failure of a dental restoration.

137. The method of claim 116, further comprising combining a sensor output with data from an output of one or more separate intra-oral or extra-oral sensors.

138. The method of claim 137, wherein the sensor output is combined with data from a pH sensor, wherein the sensor output and the data from the pH sensor are further analyzed in conjunction with each other.

139. The method of claim 137 wherein the sensor output is combined with data from an output of a one or more sleep monitoring technologies comprising one or more of a technology monitoring sleep disordered breathing and a technology monitoring blood oxygenation, wherein the sensor output and the data from the sleep monitoring technology are further analyzed in conjunction with each other.

140. The method of claim 137, wherein the sensor output is analysed in conjunction with an electromyography (EMG) electrode.

141. A method for correlating bruxism data with pain parameters of a head and neck area, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events; and correlating the one or more parameters associated with bruxism with one or more pain parameters of the head and neck area.

142. The method of claim 141, wherein the one or more pain parameters is a pain severity, wherein the pain severity is correlated one or more of a time of a bruxism event, a type of bruxism event, a type of bruxism activity, a temporal pattern of bruxism activity, a location within a mouth of a subject of a bruxism event, a percentage of bruxism events in the location, a force amplitude of a bruxism event, a jaw movement pattern of a bruxism event, a summary of bruxism events per measure of time, a percentage of bruxism events per measure of time, arhythmic masticatory muscle activities (RMMA) index per measure of time, a location distribution of the type of bruxism event.

143. The method of claim 141, wherein the one or more pain parameters are input from a software application and displayed in relation to the one or more bruxism parameters.

144. The method of claim 141, wherein an efficacy of a patient’s responsiveness to bruxism therapy is determined at least in part by longitudinal analysis of the one or more bruxism parameters in relation to the one or more pain parameters.

145. A method for monitoring drug-induced bruxism, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby determine a severity of drug-induced bruxism.

146. A method for monitoring the effect of medications on bruxism activity, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby determine an effect of the medication on bruxism activity.

147. The method of claim 146, wherein determining is performed on data analyzed over a period of time, wherein a medication dose administration is determined based on a change in the one or more parameters over the defined period of time.

148. A method for monitoring bruxism for post-treatment assessment of acid reflux, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; and determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events to thereby determine a severity of drug-induced bruxism related to acid reflux.

149. The method of claim 148, wherein a measure of the severity of the bruxism is used as a proxy for a severity of gastric acid reflux.

150. A method for determining a dental risk of a patient, the method comprising: providing a system comprising an oral appliance comprising one or more sensor assemblies, and a computing system operably associated with the oral appliance and configured to communicate with and exchange data therewith; receiving data from the one or more sensor assemblies; analyzing the received data via one or more algorithms; determining, based on analysis of the received data, one or more parameters associated with one or more bruxism events; and analyzing the one or more parameters in conjunction with patient data received as input from a separate source to assess a dental risk of the patient.

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