Systems and methods for providing guidance on orthodontic treatment involving use of orthodontic devices

Abstract

A computer-implemented method for use in providing guidance regarding an orthodontic treatment is provided. Orthodontic treatment involves using an orthodontic device to move teeth of a subject. The method includes receiving status information indicative of a usage of the first orthodontic device, and receiving subject discomfort information indicative of subject discomfort. The method further includes determining a stimulation event corresponding to a change in use of the first orthodontic device (e.g., inserting or removing the first orthodontic device). Stimulation discomfort information (subject discomfort information corresponding to the stimulation event) is determined, and orthodontic treatment metrics are generated and output using the stimulation discomfort information.

Description

Technical Field

[0001] The present invention relates to systems and methods for providing guidance regarding orthodontic treatments delivered using orthodontic devices. In particular, the present invention relates to systems and methods for use in assessing treatment progress by combining temporal status information (information indicating whether orthodontic devices are being worn by a subject) and temporal subject discomfort information. Background Art

[0002] Orthodontic devices include devices used to maintain or change the position of a subject's teeth. Orthodontic aligners are a set of tightly fitting retainers that are worn on a subject's teeth, usually for a fixed period of time recommended by a dental professional. They are used to remedy overcrowding and / or spacing problems, and can also be used to straighten teeth. Aligners are custom made; they are designed to gradually change the position of a subject's teeth to a desired position based on the subject's teeth. The aligners in the set are worn sequentially, one after the other, with each aligner being designed to move the teeth closer to the desired position.

[0003] It is generally recommended that the subject wear the aligners for at least 22 hours a day and follow a schedule established for when it is time to transition from one aligner to the next. Failure to follow the schedule may result in the treatment taking longer than expected. If the subject's teeth have not moved to the desired position within the desired time period, the transition to the next aligner may need to be delayed. This may be inconvenient for the subject as they will be forced to schedule additional appointment(s).

[0004] The timing for changing braces in a treatment schedule is usually based on a population mean. For a particular patient, the best time to change braces may be earlier or later than the population mean.

[0005] The fit of an orthodontic device (and therefore the progress of treatment) can be assessed remotely by analyzing images of the orthodontic device while the orthodontic device is being worn. However, the subject may find this inconvenient. Furthermore, dental professionals may find this method of assessing the progress of treatment inconvenient because it is not a continuous measurement and is prone to human error.

[0006] It would be desirable to expedite treatment success while minimizing inconvenience to the subject.

[0007] WO 2020 / 112735 A2 describes a compliance device configured to be positioned within a patient's mouth, the compliance device comprising a sensor configured to detect whether an orthodontic appliance is at least partially positioned within the patient's mouth. Summary of the invention

[0008] The invention is defined by the claims.

[0009] According to an example in accordance with one aspect of the present invention, there is provided a computer-implemented method for use in providing guidance regarding an orthodontic treatment involving moving teeth of a subject using an orthodontic device, the method comprising:

[0010] receiving status information indicating whether a first orthodontic device is in use; receiving subject discomfort information indicating a level of discomfort experienced by a subject;

[0011] determining a stimulation event corresponding to a change in use of the first orthodontic device based on the state information, wherein the stimulation event comprises insertion or removal of the first orthodontic device, or insertion of another orthodontic device; determining stimulation discomfort information, wherein the stimulation discomfort information comprises subject discomfort information corresponding to the stimulation event; and

[0012] generating an orthodontic treatment metric based on the stimulus subject discomfort information, the orthodontic treatment metric indicating the fitting of the first orthodontic device and / or the progress of the orthodontic treatment;

[0013] Wherein receiving the subject discomfort information includes receiving information indicating the subject discomfort from a bio-information sensing device for measuring a physiological response of the subject.

[0014] The inventors have recognized that measuring subject discomfort during a stimulation event (i.e., during insertion or removal of an orthodontic device) can provide valuable insight into the fitting of the orthodontic device and / or the progress of an orthodontic treatment involving the use of the orthodontic device. Accordingly, temporal state information is obtained to identify the time / time period corresponding to the insertion / removal of the orthodontic device. Subject discomfort information corresponding to the time / time period of the stimulation event is identified and used to generate an orthodontic treatment metric.

[0015] The status information may be time information indicating whether the orthodontic device is in use (i.e., whether the orthodontic device is being worn by the subject). The subject discomfort information may be time information indicating the level of discomfort (pain) experienced by the subject, and by receiving the subject discomfort information via a bio-information sensing device for measuring the subject's physiological response, an objective and more accurate, efficient and / or reliable method for determining the subject's discomfort level is provided.

[0016] An orthodontic device is a device that includes a removable mouth piece and is used to change the position of a subject's teeth. For example, an orthodontic device may be an aligner or a removable brace.

[0017] The stimulation event may involve the insertion or removal of a first orthodontic device, or the insertion of another orthodontic device (eg, a subsequent aligner).

[0018] The fitting of the first orthodontic device may be understood as whether the first orthodontic device is fitted to the subject, whether the first orthodontic device is invalid, whether the first orthodontic device needs to be replaced, and / or whether the stimulation discomfort information is unexpected / abnormal. The progress of the orthodontic treatment may be understood as whether there is a problem with the orthodontic treatment, whether there is no problem with the orthodontic treatment, whether the first orthodontic device is invalid, and / or whether the first orthodontic device needs to be replaced.

[0019] The orthodontic treatment metric may indicate at least one of: the stimulus discomfort information is unexpected; the stimulus discomfort information is abnormal; the first orthodontic device is adapted to the subject; the first orthodontic device is not adapted to the subject; there is a problem with the orthodontic treatment; there is no problem with the orthodontic treatment; the first orthodontic device is ineffective; and / or the first orthodontic device needs to be replaced.

[0020] Generating orthodontic treatment metrics may include:

[0021] determining a subject discomfort level associated with the stimulus event from the stimulus discomfort information; and

[0022] The subject discomfort level associated with the stimulus event is compared to a reference stimulus discomfort level.

[0023] The reference stimulus discomfort level may be a subject discomfort level associated with a previous stimulus event. For example, the reference subject discomfort level may be obtained by measuring a baseline subject discomfort level when the orthodontic device is first inserted / removed. Alternatively, the reference stimulus discomfort level may be a subject discomfort level measured when the orthodontic device was last inserted / removed. In some embodiments, the reference stimulus discomfort may be a predefined threshold. Typically, the reference stimulus discomfort level may correspond to a reference discomfort level when the subject is at rest (i.e., when the orthodontic device is physiologically at rest).

[0024] The reference stimulation discomfort level may indicate an expected range of discomfort levels associated with the treatment, and determining the orthodontic treatment metric may include:

[0025] comparing a subject discomfort level associated with the stimulus event to a reference stimulus discomfort level; and

[0026] In response to determining that the subject discomfort level associated with the stimulation event is outside of an expected range, an orthodontic treatment metric is generated indicating that the discomfort level associated with the stimulation event is unexpected.

[0027] The reference stimulus discomfort level may be a fit threshold value indicative of a subject discomfort level associated with an adequate fit, and determining the orthodontic treatment metric may include:

[0028] comparing a subject discomfort level associated with the stimulus event to an adaptation threshold; and

[0029] In response to determining that the subject discomfort level associated with the stimulation event is equal to or greater than the fit threshold, generating an orthodontic treatment metric indicative of fit of the orthodontic device to the subject; and

[0030] In response to determining that the subject discomfort level associated with the stimulation event is less than the fit threshold, an orthodontic treatment metric is generated indicating that the orthodontic device is not a fit for the subject.

[0031] When the subject discomfort level associated with inserting / removing / replacing an orthodontic device is above the fit threshold, it can be determined that the orthodontic device is (still) applying enough pressure on the subject's teeth to deliver effective treatment. When the subject discomfort level associated with inserting / removing / replacing an orthodontic device is below the fit threshold, it can be determined that the orthodontic device is not applying enough pressure on the subject's teeth to deliver effective treatment. The fit threshold can change over time.

[0032] The reference stimulation discomfort level may be an abnormality threshold. The method may include: comparing a subject discomfort level associated with the stimulation event to an abnormality threshold, wherein the abnormality threshold is higher than the adaptation threshold, the abnormality threshold indicating a maximum discomfort level associated with normal treatment; and

[0033] In response to determining that the subject discomfort level associated with the stimulation event is greater than or equal to the abnormality threshold, generating an orthodontic treatment metric indicative of abnormal treatment, and

[0034] In response to determining that the subject discomfort level associated with the stimulation event is below the abnormality threshold, an orthodontic treatment metric is generated that is indicative of normal treatment.

[0035] The reference stimulation discomfort level may be a minimum stimulation threshold. The method may include: comparing a subject discomfort level associated with the stimulation event to the minimum stimulation threshold; and

[0036] In response to determining that the subject discomfort level associated with the stimulation event is below a minimum stimulation threshold, an orthodontic treatment metric is generated indicating that the orthodontic device is ineffective.

[0037] The computer-implemented method may further include:

[0038] identifying a plurality of stimulus events based on the state information;

[0039] determining, for each stimulus event, a level of subject discomfort associated with the stimulus event;

[0040] determining a treatment profile based on a subject discomfort level associated with the stimulus event; and

[0041] comparing the orthodontic treatment curve to the expected treatment curve; and

[0042] An orthodontic treatment progress metric is generated and output, wherein the treatment progress metric represents a difference between the treatment curve plot and the expected treatment curve plot.

[0043] The method may include generating an orthodontic treatment function representing the subject discomfort over time.The method may further include comparing the orthodontic treatment function to an expected treatment function, wherein the expected treatment function indicates expected subject discomfort over time according to the subject's treatment plan.

[0044] The computer-implemented method may further include:

[0045] analyzing the subject discomfort information to identify discomfort patterns associated with insertion and / or removal of orthodontic devices; and

[0046] Status information is generated based on the discomfort pattern, wherein the status information includes a predicted time for insertion and / or removal of an orthodontic device.

[0047] The computer-implemented method may include:

[0048] receiving oral care routine data indicating a start time and an end time for use of the oral care device, and

[0049] Status information indicative of usage of the first orthodontic device is predicted based on the oral care routine data.

[0050] The timing of the stimulation event may be predicted based on historical subject discomfort information.The timing of insertion and / or removal of the first orthodontic appliance may be predicted based on the timing of usage of the oral healthcare appliance.

[0051] The computer-implemented method may further include:

[0052] Identify multiple stimulus events;

[0053] determining, for each stimulus event, a subject discomfort level associated with the corresponding stimulus event;

[0054] determining the rate of change of the subject's discomfort level; and

[0055] In response to determining that the rate of change of the subject discomfort is less than or equal to the progress threshold, a treatment progress metric indicative of a lack of treatment progress is generated and output.

[0056] The rate of change of the subject discomfort level can be determined based on the subject discomfort level associated with the plurality of stimulation events. If the rate of change is higher than expected, this can indicate that the treatment is progressing faster than expected. If the rate of change is lower than expected, this can indicate that the treatment is progressing slower than expected. Based on this information, a treatment progress metric reflecting the relevant determination can be generated and output.

[0057] The computer-implemented method may further include:

[0058] receiving status information indicating usage of a second orthodontic device;

[0059] identifying, based on the state information associated with the second orthodontic device, a subsequent stimulation event corresponding to a change in usage of the second orthodontic device;

[0060] For a second orthodontic device, determining stimulation discomfort information, wherein the stimulation discomfort information includes subject discomfort information corresponding to a subsequent stimulation event; and

[0061] Stimulation discomfort information associated with the first orthodontic device is compared to stimulation discomfort information associated with the second orthodontic device.

[0062] A subsequent stimulation event is a stimulation event associated with a second orthodontic device that follows a stimulation event associated with a first orthodontic device. The first orthodontic device and the second orthodontic device may be aligners. The first orthodontic device and the second orthodontic device may refer to removable braces.

[0063] Receiving the status may include receiving information from a sensor.The sensor may be coupled to the orthodontic device and may be configured to sense the status of the orthodontic device by measuring an environmental parameter.

[0064] The sensor may be coupled to the oral care device and may be configured to monitor use of the oral care device.The oral care device may be a toothbrush.

[0065] The sensor may be coupled to a storage container for storing the orthodontic device.

[0066] According to another aspect of the present invention, there is provided an orthodontic system for use in providing guidance on orthodontic aligner treatment, the system comprising:

[0067] a discomfort monitor for generating information about discomfort in a subject;

[0068] a condition monitor for generating orthodontic device condition information; and

[0069] A processor configured to:

[0070] receiving status information indicating usage of a first orthodontic device;

[0071] receiving subject discomfort information indicating subject discomfort;

[0072] determining a stimulation event corresponding to a change in usage of the first orthodontic device based on the status information;

[0073] determining stimulation discomfort information, wherein the stimulation discomfort information includes subject discomfort information corresponding to the stimulation event; and

[0074] generating an orthodontic treatment metric based on stimulus subject discomfort information;

[0075] The discomfort monitor includes a bio-information sensing device for measuring a physiological response of the subject.

[0076] The bio-information sensing device may be adapted to measure skin conductance of the subject.

[0077] The system may further include a second orthodontic device, and the processor may be configured to:

[0078] receiving status information indicating usage of the second aligner;

[0079] determining a stimulation event corresponding to a change in usage of a second orthodontic device based on the status information;

[0080] determining stimulation discomfort information, wherein the stimulation discomfort information includes subject discomfort information corresponding to the stimulation event; and

[0081] The stimulation discomfort information associated with the first aligner is compared with the stimulation discomfort information associated with the second aligner.

[0082] The processor may be configured to perform the steps of the above-described computer-implemented method.

[0083] The orthodontic system may further include:

[0084] a sensor coupled to the orthodontic device and configured to sense a state of the orthodontic device by measuring an environmental parameter; or

[0085] a sensor coupled to an oral care device and configured to monitor usage of the oral care device, wherein the oral care device is preferably a toothbrush; or

[0086] a sensor coupled to a storage container for storing an orthodontic device, wherein the sensor is configured to sense whether the orthodontic device is inside the housing; or

[0087] A display configured to display orthodontic treatment progress metrics.

[0088] According to another aspect of the present invention, there is provided a computer program product, the computer program product comprising instructions, which, when the program is executed by a computer, cause the computer to perform the above-mentioned computer-implemented method.

[0089] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0090] For a better understanding of the invention, and in order to more clearly show how the invention may be implemented, reference will now be made, by way of example only, to the accompanying drawings, in which:

[0091] Figure 1 is a flow chart illustrating a computer-implemented method according to one or more embodiments of the present invention;

[0092] Figure 2 It is shown Figure 1 diagram of elements of a computer-implemented method;

[0093] Figure 3 It is shown Figure 1 A flowchart of an example of a computer-implemented method;

[0094] Figure 4 It is shown Figure 1 A flowchart of another example of a computer-implemented method;

[0095] Figure 5 It is shown Figure 1 A flowchart of another example of a computer-implemented method;

[0096] Figure 6 It is shown Figure 1 A flowchart of another example of a computer-implemented method of; and

[0097] Figure 7 is a schematic diagram showing one embodiment of an orthodontic system according to the present invention. DETAILED DESCRIPTION

[0098] The present invention will be described with reference to the accompanying drawings.

[0099] It should be understood that the detailed description and specific examples, although indicating exemplary embodiments of the device, system and method, are intended only for illustrative purposes and are not intended to limit the scope of the invention. These and other features, aspects and advantages of the device, system and method of the present invention will become better understood from the following description, the appended claims and the accompanying drawings. It should be understood that the drawings are only schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the drawings to indicate the same or similar parts.

[0100] The present invention provides a computer-implemented method for use in providing guidance regarding an orthodontic treatment. The orthodontic treatment involves moving a subject's teeth using an orthodontic device. Figure 1As shown in , the method includes receiving 101 status information indicating usage of a first orthodontic device and receiving 103 subject discomfort information indicating subject discomfort. The method also includes determining 105 a stimulus event corresponding to a change in usage of the first orthodontic device (e.g., insertion or removal of the first orthodontic device). Determining 107 the stimulus discomfort information (the subject discomfort information corresponding to the stimulus event), and using the stimulus discomfort information to generate 109 and output (e.g., for display) an orthodontic treatment metric.

[0101] The inventors have recognized that by evaluating the discomfort experienced by a subject during the insertion / removal of an orthodontic device, insight into how well the orthodontic device fits the subject and, therefore, whether the orthodontic device is able to provide effective treatment can be obtained. In addition, this information can be used to evaluate the progress of the treatment delivered by the orthodontic device. The insertion / removal of the orthodontic device can be used as a standardized stimulus that gives a context to the measured changes in the subject's discomfort. Therefore, in an embodiment of the present invention, temporal subject discomfort information is collected. In addition, temporal state information is collected-the temporal state information indicates when the orthodontic device is being worn by the subject and when it is not being worn. The subject discomfort information and state information are used to determine the subject discomfort level associated with the stimulation event (i.e., the insertion / removal of the orthodontic device). The discomfort level associated with the stimulation event can be used to evaluate the fitting of the orthodontic device, and / or compared with a reference subject discomfort level (e.g., an expected discomfort level, or a previously measured subject discomfort level) to evaluate the progress of the treatment.

[0102] Monitoring treatment in this way can lead to better health outcomes by enabling remote assessment of wearing compliance and remote detection of progress. It can also help reduce the number of dental visits required throughout the treatment. Furthermore, it can help achieve lower care costs by facilitating dental professionals to remotely detect when an appointment is needed. Additionally, monitoring treatment in this way can enable early detection of problems with treatment and therefore early intervention.

[0103] The subject discomfort information and status information include time signals that can be synchronized. As subjects insert orthodontic devices, it can be expected that they will experience increased discomfort, and the discomfort signal (e.g., in conjunction with Figure 1 The increased discomfort (e.g., the transient peak shown in step 103 of ) will reflect this increased discomfort. If the discomfort signal indicates that the increase in discomfort is too small or not present at all, it can be assumed that the subject inserted the orthodontic device too easily. That is, the orthodontic device does not / no longer applies significant pressure to the teeth. If the orthodontic device does / no longer applies significant pressure to the teeth, this may indicate that the treatment schedule should be adjusted. For example, if the orthodontic device is an aligner, it may be time to move on to the next aligner.

[0104] Similarly, when it is detected that an orthodontic device has been removed, the change in the discomfort signal provides information about how much effort the subject needs to remove the orthodontic device (e.g., tighter aligners are more effective and more difficult to remove). Thus, the discomfort signal will show a decrease in the level of discomfort, which provides information about how effective the aligner is. The decrease in the discomfort signal is greater for more effective orthodontic devices than for less effective orthodontic devices.

[0105] The subject discomfort level associated with the stimulation event can be evaluated by comparing it to a reference stimulation discomfort level. For example, the reference stimulation discomfort level can be an expected subject discomfort level according to the treatment stage. This can be evaluated by comparing with a predefined threshold discomfort level or by comparing the subject discomfort level to an expected treatment curve graph, which indicates the expected discomfort level associated with the stimulation event according to time. The threshold discomfort level can be determined by consulting a dentist, using a normalized population mean. Alternatively, the threshold discomfort level can be the standard deviation of the setting from the discomfort measured with or without the use of an aligner. In other examples, the reference stimulation level can be a subject discomfort level experienced by the subject in association with a previous stimulation event. In this way, it is possible to analyze how the subject discomfort changes over time.

[0106] The status information and subject discomfort information may be collected continuously.Alternatively, the collection of subject discomfort information may be triggered by the insertion / removal of an orthodontic device.

[0107] like Figure 1 As shown in , the computer-implemented method includes receiving 101 status information. The status information is shown as a binary signal that changes according to time. When the orthodontic device is not being worn, the signal is low, and when the orthodontic device is being worn, the signal is high. The vertical line indicates the orthodontic device at time t w Next, object discomfort information is received 103. Figure 1 The subject discomfort information shown in is a graph of the subject's galvanic skin response versus time. In the next step, the subject discomfort information is analyzed to identify the time point t at which the orthodontic device is inserted. w In addition, a portion of the subject discomfort information corresponding to the insertion of the orthodontic device (ie, the stimulus discomfort information) is identified 107. The stimulus discomfort information is analyzed to assess the subject discomfort level and to generate an orthodontic treatment metric. Figure 1 In the embodiment of the present invention, the stimulation discomfort information indicates that the discomfort level associated with the stimulation event is high enough so that the pressure exerted by the orthodontic device on the teeth is commensurate with effective treatment, but not so high that the discomfort level indicates a treatment problem / abnormality. Therefore, the orthodontic treatment metric indicates that the fit of the orthodontic device is acceptable.

[0108] In some embodiments, the progress of treatment can be evaluated by comparing the discomfort levels associated with the stimulation events of different orthodontic devices. For example, when the orthodontic device is an aligner, the orthodontic treatment involves wearing a set of aligners, each aligner in the set moves the teeth of the object closer to the desired position. By comparing the stimulation discomfort information associated with different aligners, it can be evaluated whether the aligners work in a similar manner (and deliver effective treatment). In more detail, it is expected that each aligner in the group will cause a similar level of discomfort when it is inserted / removed. The level of discomfort depends on the pressure applied by the aligner on the teeth, which in turn depends on the geometry of the aligner. By comparing the discomfort levels associated with each aligner, it can be determined whether one aligner causes significantly more or less discomfort than other aligners. If it is measured that one of the aligners in the group causes a different level of discomfort compared to other aligners, this can indicate that it does not work in the same way as other aligners, and therefore needs to be checked by a dental professional.

[0109] Typically, the state information may be obtained using a sensor configured to sense the state of the orthodontic device. Alternatively, the state information may be generated by the subject. That is, the subject may report when a stimulation event will occur or has occurred.

[0110] In an embodiment in which a sensor is used to obtain status information, the sensor may be an environmental sensor coupled to the orthodontic device. For example, the sensor may be a temperature sensor configured to sense local temperature. Because the basal body temperature in the mouth is relatively high (compared to the ambient temperature outside the mouth of the subject), it is possible to evaluate whether the orthodontic device is being worn based on temperature. The temperature sensor will measure an elevated temperature when the orthodontic device is being worn by the subject compared to when the orthodontic device is not in use. Alternatively, the sensor may be configured to detect the presence of saliva by measuring electrical conductivity or thermal conductivity. In another example, the orthodontic device may include a light source (e.g., a photodiode), and the sensor may be an optical sensor configured to measure changes in light irradiation and / or reflection. In yet another example, the orthodontic device may include two triboelectric contact portions and a sensor configured to detect a triboelectric signal generated by the triboelectric portion when the triboelectric portion is brought into contact. In another example, the sensor may be a mechanical pressure sensor arranged to detect a bite force / shear force associated with being worn.

[0111] Alternatively, a sensor coupled to a storage container for holding an orthodontic device may be used to generate the status information. The sensor may be arranged to detect the presence / absence of an orthodontic device in the storage container, thereby providing information indicating whether the orthodontic device is being worn by the subject.

[0112] In some other embodiments, oral care routine data can be used to determine state information. The inventors have recognized that the timing of the stimulus event can be determined (estimated) or predicted based on the oral care routine data. In particular, the oral care routine data can include information indicating the time when the subject performs an oral care process (e.g., brushing / flossing / rinsing their teeth). Before the subject begins the oral care process, they will typically remove their orthodontic device. Once the oral care process has been completed, the subject will reinsert their orthodontic device. Therefore, the time of insertion and / or removal can be determined (or predicted) based on the timing (or expected timing) of the oral care process. Oral care routine data can be received from an oral care device (e.g., a toothbrush) or from a wearable sensor (e.g., a smart watch configured to sense a mobile pattern associated with an oral care process). In some embodiments, oral care routine data can be obtained from a remote sensor (e.g., a camera for detecting heat / movement).

[0113] In some embodiments, status information may be determined by predicting a time to insert and / or remove a first orthodontic device based on data indicating a timing of use of the oral care device. For example, the oral care device may be a toothbrush communicatively coupled to a software application. The method may include receiving information indicating a start time of use of the software application and an end time of use of the software application, and predicting a time to insert and / or remove the first orthodontic device based on the start and end times of use of the software application. For example, the insertion time may be predicted to be a few minutes (e.g., 1 minute to 3 minutes) before the start time of use of the software application. The removal time may be predicted to be a few minutes (e.g., 1 minute to 3 minutes) after the end time of use of the software application.

[0114] The subject discomfort information may be obtained using a sensor configured to sense subject discomfort by monitoring a physiological response (eg, electrodermal activity, such as galvanic skin response).

[0115] Skin conductance is mediated by electrodermal activity (i.e., sweating). This has been shown to be associated with the experience of pain (see, e.g., H. Storm, "Changes in skin conductance as a tool to monitor nociceptive stimulation and pain", Curr. Opin. Anaesthesiol., vol. 21, no. 6, pp. 796-804, 2008). Therefore, skin conductance can be used to monitor subject discomfort.

[0116] The electrodermal system behaves uniformly across the body. However, the exocrine palmar and sole sweat glands are particularly responsive to psychological stimuli, such as pain. High skin conductance levels and peaks in the skin conductance signal reflect emotional arousal, while low levels and smooth signals reflect relaxation and comfort (see, e.g., SDK Reibig, "Autonomic nervous system activity in motion: A review", Biol. Psychol., vol. 84, no. 3, pp. 394-421, 2010).

[0117] In case of pain, the galvanic skin system becomes activated and the sweat glands are filled. This causes a decrease in skin resistance and, therefore, an increase in skin conductance. Shortly afterwards, the values ​​return to their previous (baseline) levels. This produces an identifiable peak in the skin conductance signal (which may be referred to as the galvanic skin response EDR), and the amplitude of the peak shows the intensity of excitation of the sympathetic nerves, which in turn correlates with the acute pain level. These peaks are stimulus specific, appear after a short time delay (usually about 1s to 2s), and decline after the event.

[0118] Skin conductance may be measured via a galvanic skin response (GSR) measurement device.

[0119] Skin conductance can show both psychological stress and pain (discomfort). Painful and non-painful arousal events can be detected by analyzing the skin conductance signal and identifying relevant peaks in the signal. For example, relevant peaks can be identified based on the sum of the heights of the leading edges in the peaks, or the area under the peak curve during a certain time interval, or relevant peaks can be identified based on frequency domain analysis (e.g., based on peaks that exhibit predetermined spectral features or characteristics). Additional measures of the phase and tonal components of skin conductance can be found in the following literature: The handbook of psychophysiology by JT Cacioppo, LG Tassinary, and GG Berntson, 3rd edition, volume 44, New York: Cambridge University Press, 2007; and also in the following literature: Electrodermal activity by W. Boucsein, 2nd edition, New York NY: Springer Science + Business Media, 2012.

[0120] Skin conductance is not the only biosignal associated with pain and mental stress. For example, heart rate, PPG signals, eye movements, facial expressions, or pupil dilation can also be associated with emotional arousal. For example, for heart rate, a data series of heart rate values ​​over time can be measured, and peaks in the heart rate are used instead of peaks in skin conductance to detect pain and / or arousal events. In addition, in the case of painful / non-painful arousal, there is a reduction in heart rate changes. Therefore, in some embodiments, one or both of heart rate and / or heart rate changes (HRV) can be used as bio / physiological signals. For heart rate, pain causes upward spikes (increased peaks in the heart rate signal). For HRV, pain causes downward spikes (decreases) in the HRV signal.

[0121] Another example is detecting facial expressions associated with arousal, such as pained expressions, clenched teeth, etc. A camera may be used to capture image data of the face, and a facial analysis algorithm is used to detect changes in facial expressions.

[0122] Another example is measuring electrical activity in muscles of different groups.

[0123] Another example is tracking pupil size or the movement of eyelids, e.g. with the aid of a camera.

[0124] Another example is measuring blood flow, where blood flow increases in response to arousal.

[0125] Another example is measuring blood pressure, where blood pressure increases in response to arousal.

[0126] In some embodiments, a subject's discomfort (pain) level can be determined based on the presence of a galvanic skin response, the amplitude of the galvanic skin response, the half-life of the galvanic skin response (i.e., how long it takes for the galvanic skin response to drop to half its value), or the change in the galvanic skin response relative to a reference level.

[0127] Alternatively, the subject discomfort information may be generated by the subject. That is, the subject may report the level of discomfort experienced.

[0128] Figure 2 2 is a schematic diagram showing various ways in which object discomfort information 212 and state information 210 may be collected. Figure 2As shown in , the status information can be self-reported, or it can be obtained from a sensor (e.g., a storage container sensor, a sensor coupled to the orthodontic device, an oral care routine sensor, or an oral care device sensor). In some embodiments, status information 210 indicating that there has been a change in the use of the orthodontic device can trigger the collection of subject discomfort information 212. The data collected from the sensors / reports is processed by an algorithm to generate the subject discomfort information. The subject discomfort information and the status information are then synchronized to facilitate the evaluation of the subject discomfort information corresponding to the stimulus events 214, 216 (insertion and removal of the orthodontic device). Alternatively, the subject discomfort information 212 can be obtained without being triggered by a detected change in use. In such an embodiment, the subject discomfort information and the status information are synchronized so that the subject discomfort information corresponding to the stimulus events 214, 216 (insertion and removal of the orthodontic device) can be identified and evaluated.

[0129] Figure 3 An example of a computer-implemented method according to the present invention is shown. Figure 3 In the method shown in , the orthodontic device state is predicted based on the object discomfort information. In an initial step, the computer receives 301 temporal object discomfort information. The inventors have recognized that the object discomfort information will typically include a recognizable pattern in the discomfort signal multiple times a day (before / after eating, before / after brushing teeth, etc.), which indicates when the object inserts and removes the orthodontic device. Therefore, the temporal object discomfort information can indicate changes in the discomfort level of the object over a relatively long period of time (for example, within a week or more weeks). The object discomfort information is processed to identify patterns in the object discomfort information and to identify the time when the stimulus event typically occurs. In this way, the computer predicts 303 orthodontic device state information. That is, the computer predicts the time when the object is wearing / has worn the orthodontic device. Based on the predicted orthodontic device state and the object discomfort information, the computer identifies 307 the stimulus event and the stimulus discomfort information corresponding to the event (i.e., the stimulus discomfort information). The method also includes generating 309 orthodontic treatment metrics based on the object discomfort information.

[0130] Figure 4 An example of subject discomfort information collected by a biosignal sensor is shown. The biosignal sensor is adapted to measure skin conductance indicative of subject discomfort. The first biosignal 405 includes data collected in conjunction with a first orthodontic device. The dashed line shows a baseline level of subject discomfort (i.e., subject discomfort prior to wearing the orthodontic device). At time t s At time t, the orthodontic device is inserted into the subject's mouth. sThe amplitude of the biosignal increases significantly following a stimulation event at . The second biosignal 407 includes data collected in conjunction with the first orthodontic device at a later time period, for example after a few weeks have passed. The amplitude of the second biosignal 406 is relatively low. The first biosignal 405 and the second biosignal 407 can be compared to determine whether the first orthodontic device is still providing effective treatment. If the peak associated with the second biosignal 407 is significantly lower than the peak associated with the first biosignal 405, this can indicate that the first aligner is no longer providing effective treatment. For example, the amplitude of each peak and / or the difference Δ in the peak amplitudes can be determined. The difference is the amplitude Δ, which represents the level of tooth movement brought about by the orthodontic device. Therefore, by monitoring Δ, the progress of the treatment can be assessed.

[0131] Orthodontic treatment metrics can be used to help assess aligner fit and / or treatment progress based on relative peak amplitude / change in peak amplitude. For example, if the amplitude of the peak of the second biosignal 407 is significantly lower than the peak associated with the first biosignal, a treatment metric can be generated indicating that the second aligner does not have a good fit. If the difference in peak amplitude is lower than expected, a treatment progress metric can be generated indicating poor treatment progress.

[0132] Figure 5 is a flow chart illustrating another example of a computer implemented method 50. In the method, a computer receives status information and determines that a stimulation event has occurred. In the left hand column, the stimulation event is the insertion of an orthodontic device. In the right hand column, the stimulation event is the removal of an orthodontic device. In both cases, detecting that the stimulation event has occurred results in performing a measurement of subject discomfort. In this way, the method determines stimulation discomfort information. The stimulation discomfort information indicates a level of discomfort experienced by the subject in response to the stimulation event. In view of the treatment stage, the treatment progress can be evaluated by comparing the level of discomfort experienced by the subject in response to the stimulation event with an expected level of discomfort. For example, the expected treatment progress can be a function that defines the expected subject discomfort. The treatment progress can also be evaluated by comparing the change in the subject discomfort level over time with the expected change in the subject discomfort over time. Determining that the measured subject discomfort is different from the expected level of subject discomfort, or that the expected change in subject discomfort is different from the expected change in subject discomfort, indicates that there is a problem with the treatment. Therefore, a treatment progress metric is generated that indicates that there is a problem with the treatment. As shown in FIG. Figure 5 As shown in , a dental professional may be informed of orthodontic treatment metrics (eg, by transmitting a display signal for displaying the orthodontic treatment metrics). Monitoring treatment in this manner may facilitate convenient and early identification of treatment problems.

[0133] The inventors have recognized that in order to assess treatment progress, it would be useful to be able to assess whether the level of discomfort experienced by the subject is excessive. This can be assessed by comparing the subject discomfort level corresponding to the stimulation event to an abnormality threshold. The abnormality threshold is a threshold level of subject discomfort above which (or at and above) the subject discomfort is considered excessive. Excessive subject discomfort may be associated with treatment problems (e.g., health problems within the mouth) and / or non-compliance by the subject.

[0134] Typically, the insertion of an orthodontic device will increase the level of discomfort experienced by the subject for a short period of time (e.g., a few hours). The inventors have recognized that if the elevated level of discomfort to the subject extends for a long period of time (e.g., multiple days), this may indicate that the treatment is not proceeding appropriately, possibly due to the orthodontic device not being properly fitted. Accordingly, the method may include obtaining stimulation discomfort information for a plurality of stimulation events, and determining whether the subject's discomfort level decreases at an expected rate, or whether it remains substantially the same. This may be assessed by determining the rate of change of the stimulation discomfort level and comparing it to a progression threshold, wherein the progression threshold is indicative of a minimum expected rate of change. If the rate of change of the stimulation discomfort level is below the progression threshold, an orthodontic progress metric is generated indicating that there is a problem with the treatment. If Figure 5 As shown in , treatment progress metrics can be communicated to the dental professional (eg, by transmitting a display signal for displaying orthodontic treatment metrics). Monitoring treatment in this manner can facilitate convenient and early identification of treatment problems.

[0135] Figure 6 is a flow chart illustrating another example of a computer-implemented method 60. In the method, a computer receives status information and determines that a stimulus event has occurred. In the left-hand column, the stimulus event is the insertion of an orthodontic device. In the right-hand column, the stimulus event is the removal of an orthodontic device. In both cases, detecting that the stimulus event has occurred results in performing a measurement of subject discomfort. In this way, the method determines stimulus discomfort information. The stimulus discomfort information indicates a level of discomfort experienced by the subject in response to the stimulus event. In view of the treatment stage, the treatment progress can be evaluated by comparing the level of discomfort experienced by the subject in response to the stimulus event with an expected level of discomfort. For example, the expected treatment progress can be a function that defines the expected subject discomfort. The treatment progress can also be evaluated by comparing the change in the subject discomfort level over time with the expected change in the subject discomfort over time. Determining that the measured subject discomfort is different from the expected subject discomfort level, or that the expected change in subject discomfort is different from the expected change in subject discomfort, indicates that there is a problem with the treatment.

[0136] The present inventors have recognised that in order to assess treatment progress, it would be useful to assess whether the orthodontic device is fitting closely enough to deliver effective treatment. This can be determined by assessing whether the level of discomfort experienced by the subject is of a level indicative of effective treatment. In particular, the discomfort level can be compared to a minimum stimulation threshold that indicates the minimum amount of subject discomfort that is expected to provide the orthodontic device is fitting well enough to deliver effective treatment. If the subject discomfort level corresponding to a stimulation event is below the minimum stimulation threshold, it can be determined that the orthodontic device is not fitting well enough (e.g., no longer fitting well enough) to deliver effective treatment. Thus, a treatment progress metric is generated that indicates that the orthodontic device should be replaced. Such as Figure 6 As shown in , a dental professional may be informed of orthodontic treatment measurements (eg, by transmitting a display signal for displaying the orthodontic treatment measurements).

[0137] Figure 7 is a schematic diagram illustrating the functionality of a system according to one or more embodiments of the present invention. The system 70 includes a first orthodontic device 72 for moving teeth of an object, a bio-information sensing device including a bio-signal sensor 71 for sensing discomfort of the object, and a state monitor 73 for monitoring the state of the orthodontic device 72. The bio-signal sensor is configured to measure the physiological response of the object. In particular, the bio-signal sensor is configured to measure the skin conductance of the object. The system 70 further includes a processor 75 and a display 77. The bio-signal sensor 71 collects object discomfort information, which is output to the processor 75. The processor 75 receives state information indicating the use of the first orthodontic device 72, and receives object discomfort information indicating discomfort of the object. The processor uses this information to identify stimulation events corresponding to changes in the use of the first orthodontic device. In addition, the processor identifies object discomfort information corresponding to the stimulation event, i.e., stimulation discomfort information. The processor analyzes the stimulation discomfort information to generate an orthodontic treatment metric. The orthodontic treatment metric is transmitted to and displayed by the display 77. The processor can analyze the stimulation discomfort information by comparing the stimulation discomfort information with a treatment threshold and / or an adaptation threshold and / or an abnormality threshold.

[0138] The orthodontic device may be any removable orthodontic device including a mouthpiece. Preferably, the orthodontic device is an aligner or a removable brace.

[0139] The subject discomfort information may be obtained continuously, or it may be triggered by determining that a stimulus event has occurred. Likewise, in embodiments where the timing of a stimulus event is predicted (e.g., based on oral care routine data or historical subject discomfort information), measurement of the subject discomfort information may be triggered to occur at the time when the stimulus event is predicted to occur.

[0140] In embodiments where the subject discomfort level or the rate of change of the subject discomfort level is compared to a threshold, the threshold may be changed during the course of treatment.

[0141] By studying the drawings, the disclosure and the appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments when practicing the claimed invention. In the claims, the word "comprising" does not exclude other elements or steps, and the word "one" or "an" does not exclude a plurality.

[0142] The functions implemented by a processor may be implemented by a single processor or by multiple separate processing units, which may be collectively considered to constitute a “processor.” Such processing units may be remote from each other in some cases and communicate with each other in a wired or wireless manner.

[0143] The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.

[0144] The computer program may be stored / distributed on a suitable medium, such as an optical storage medium or solid-state medium supplied together with or as part of other hardware, but the computer program may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunications systems.

[0145] If the term "suitable for" is used in the claims or the specification, it should be noted that the term "suitable for" is intended to be equivalent to the term "configured to". If the term "arrangement" is used in the claims or the specification, it should be noted that the term "arrangement" is intended to be equivalent to the term "system" and vice versa.

[0146] Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A computer-implemented method for use in providing guidance regarding an orthodontic treatment, wherein the orthodontic treatment involves moving a subject's teeth using an orthodontic device, the method include: receiving status information indicating whether a first orthodontic device is in use; receiving subject discomfort information indicative of a level of discomfort experienced by the subject; determining a stimulation event corresponding to a change in usage of the first orthodontic device based on the status information, wherein the stimulation event comprises insertion or removal of the first orthodontic device or insertion of another orthodontic device; determining stimulation discomfort information, wherein the stimulation discomfort information includes subject discomfort information corresponding to the stimulation event; and generating an orthodontic treatment metric based on the stimulus subject discomfort information, the orthodontic treatment metric indicating the fitting of the first orthodontic device and / or the progress of the orthodontic treatment; Wherein receiving the subject discomfort information comprises receiving information indicating the subject discomfort from a bio-information sensing device for measuring a physiological response of the subject.

2. The computer-implemented method of claim 1, wherein the orthodontic treatment metric is generated include: determining a subject discomfort level associated with the stimulation event from the stimulation discomfort information; as well as The subject discomfort level associated with the stimulation event is compared to a reference stimulation discomfort level.

3. The computer-implemented method of claim 2, wherein the reference stimulus discomfort level indicates an expected range of discomfort levels associated with treatment, and determining the orthodontic treatment metric include: comparing the subject discomfort level associated with the stimulus event to the reference stimulus discomfort level; as well as In response to determining that the subject discomfort level associated with the stimulation event is outside of the expected range, an orthodontic treatment metric is generated indicating that the discomfort level associated with the stimulation event is unexpected.

4. A computer-implemented method according to any preceding claim, further comprising: include: identifying a plurality of stimulus events based on the state information; determining, for each stimulus event, a level of subject discomfort associated with the stimulus event; determining a treatment profile based on a level of discomfort of the subject associated with a stimulus event; as well as comparing the orthodontic treatment curve graph to an expected treatment curve graph; and An orthodontic treatment progress metric is generated and output, wherein the treatment progress metric represents a difference between the treatment curve profile and the expected treatment curve profile.

5. A computer-implemented method according to any preceding claim, further comprising: include: analyzing the subject discomfort information to identify discomfort patterns associated with insertion and / or removal of the orthodontic device; as well as generating the status information based on the discomfort pattern, wherein the status information includes a predicted time for insertion and / or removal of the orthodontic device; or receiving oral care routine data indicating a start time and an end time for use of the oral care device, and Status information indicative of usage of the first orthodontic device is predicted based on the oral care routine data.

6. A computer-implemented method according to any preceding claim, further comprising: include: Identify multiple stimulus events; determining, for each stimulus event, a subject discomfort level associated with the corresponding stimulus event; determining a rate of change of the subject's discomfort level; as well as In response to determining that the rate of change of subject discomfort is less than or equal to a progress threshold, a treatment progress metric indicative of a lack of treatment progress is generated and output.

7. A computer-implemented method according to any preceding claim, further comprising: include: receiving status information indicating usage of a second orthodontic device; identifying, based on the state information associated with the second orthodontic device, a subsequent stimulation event corresponding to a change in usage of the second orthodontic device; determining stimulation discomfort information for the second orthodontic device, wherein the stimulation discomfort information includes subject discomfort information corresponding to the subsequent stimulation event; and The stimulation discomfort information associated with the first orthodontic device is compared with the stimulation discomfort information associated with the second orthodontic device.

8. A computer-implemented method according to any preceding claim, wherein receiving a status comprises receiving information from a sensor, and preferably: wherein the sensor is coupled to the orthodontic device and is configured to sense a state of the orthodontic device by measuring an environmental parameter; or wherein the sensor is coupled to an oral care device and is configured to monitor usage of the oral care device, wherein the oral care device is preferably a toothbrush; or Wherein the sensor is coupled to a storage container for storing the orthodontic device.

9. An orthodontic system for use in providing guidance on the disposition of an orthodontic aligner, the system include: a discomfort monitor for generating information about discomfort in a subject; a condition monitor for generating orthodontic equipment status information; as well as A processor configured to: receiving status information indicating usage of a first orthodontic device; receiving subject discomfort information indicating subject discomfort; determining a stimulation event corresponding to a change in usage of the first orthodontic device based on the status information; determining stimulation discomfort information, wherein the stimulation discomfort information includes subject discomfort information corresponding to the stimulation event; and generating an orthodontic treatment metric based on the stimulus subject discomfort information; Wherein the discomfort monitor comprises a bio-information sensing device for measuring a physiological response of the subject.

10. The orthodontic system of claim 1, wherein the bio-information sensing device is adapted to measure skin conductance of the subject.

11. The orthodontic system of claim 9 or claim 10, further comprising a second orthodontic device, wherein the processor is configured to: receiving status information indicating usage of the second aligner; determining a stimulation event corresponding to a change in usage of the second orthodontic device based on the status information; determining stimulation discomfort information, wherein the stimulation discomfort information includes subject discomfort information corresponding to the stimulation event; and The stimulation discomfort information associated with the first aligner is compared with the stimulation discomfort information associated with the second aligner.

12. An orthodontic system according to any preceding claim, wherein the processor is configured to perform the steps of any one of claims 1 to 8.

13. An orthodontic system according to any preceding claim, further comprising: include: a sensor coupled to the orthodontic device and configured to sense a state of the orthodontic device by measuring an environmental parameter; or a sensor coupled to an oral care device and configured to monitor usage of the oral care device, wherein the oral care device is preferably a toothbrush; or a sensor coupled to a storage container for storing the orthodontic device, wherein the sensor is configured to sense whether the orthodontic device is inside the housing; or A display is configured to display the orthodontic treatment progress metric.

14. A computer program product comprising instructions which, when the program is executed by a computer, cause the computer to perform the method according to any one of claims 1 to 8.

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