Customized modular multi-material mouthguard and method for making same

Abstract

A mouthguard is described that includes an externally exposed impact protection region defined by a first material property and configured to cover an anterior tooth, an internally exposed occlusal cushion region defined by a second material property and configured to cover a posterior tooth, and an internally exposed intermediate region defined by a third material property and configured to be positioned between the occlusal cushion region and the impact protection region, wherein the first material property, the second material property, and the third material property are different. A method of making the corresponding mouthguard is also described.

Description

[Technical Field]

[0001] The present invention relates to a mouthguard, preferably for use in contact sports such as ice hockey, and a method for making the mouthguard. [Background technology]

[0002] Athletes involved in various sports activities are susceptible to cranial and / or orofacial injuries when subjected to traumatic head impacts. Mouthguards can be worn by athletes to reduce dental damage during oral impacts. However, despite their proven protective effect, athletes tend to be hesitant to wear mouthguards due to their bulkiness and perceived discomfort. Factors affecting an athlete's comfort include the retention, appearance, and bite / lip feel of the mouthguard, as well as the ease of breathing and speaking, which may affect the athlete's competitive performance.

[0003] Various sports involve a variety of impact-related injuries, whether from the ball / puck / stick, another player, or the ground. For example, a hockey stick can produce a concentrated impact that generates a high level of force. Meanwhile, in American football, the striker's padded shoulder can strike a wide area of ​​another player's chin or torso. These types of impacts, in fact, produce different stress patterns, thus necessitating different mouthguards tailored to maximize protection for each sport.

[0004] An impact to the jaw can cause injury through direct and indirect mechanisms. Directly, that is, at the site of impact, the force of the impact can cause destructive stress. For example, an impact to the jaw can directly cause destructive stress in the dentos-bone complex. Indirectly, that is, at a site different from the site of impact, an impact to the jaw can cause brain injury through head rotation. For example, head rotation due to impact can cause traumatic brain tissue deformation. Thus, a traumatic impact to the jaw can lead to brain injury and cause a concussion. Currently available mouthguards are primarily designed to protect against direct injury. Currently available mouthguards, including off-the-shelf and custom-made mouthguards, require compromises in cost, comfort, level of protection, and / or lead time.

[0005] Non-customized mouthguards, such as pre-made, boil-and-bite, and microwave-and-bite, are affordable and readily available, but they are uncomfortable and provide ineffective protection. The thermosoftening material in these mouthguards allows the shape of the mouthguard to be molded to the wearer's teeth. However, molding is imprecise and limited, and the thermosoftening material is not very effective at protecting against impacts. Therefore, the thickness (i.e., vertical depth) required to adequately reduce the risk of injury with these types of mouthguards comes at the expense of wearer comfort. While mouthguards can be trimmed, for example with scissors, this limits the improvement in comfort and fit, and trimming can be performed imprecisely and unfamiliarly by the wearer.

[0006] U.S. Patent Application Publication No. 2006 / 065277 provides a dual-tray boil-and-bite mouthguard. This mouthguard includes an inner tray comprised of a softer, thermosoftenable plastic and an outer tray comprised of a harder plastic. In addition to the problems associated with the thickness and imprecise molding of boil-and-bite mouthguards, the soft inner tray must be surrounded by a hard outer tray to provide structural support for the inner tray, further exacerbating the problems associated with bulky mouthguards, such as user discomfort and respiratory obstruction. The ridges on the underside of the hard tray engage with the teeth of the mandible (opposite jaw) to prevent relative movement between the mouthguard and the lower jaw, further increasing the mouthguard's bulk and reducing user comfort due to the sensation of a hard surface against the lower teeth.

[0007] U.S. Patent Application Publication No. 2007 / 084471 describes a mouthguard that includes a removable shock-absorbing insert on the inner surface of the front wall of the appliance to protect the teeth. The insert is made of a crushable material with an open-cell structure. However, the compression-based energy absorption mechanism of the open-cell soft insert requires a large thickness to reduce the force transmitted to the teeth during a strong direct impact (which reduces user comfort). Furthermore, the use of an undercut interface with converging edges requires a large thickness of the insert to secure the insert in place via a mechanical snap-in mechanism upon impact.

[0008] WO 2018 / 063295 describes a multi-layered boil-and-bite mouthguard. Impact protection is provided by the increased thickness of the mouthguard at the expense of user comfort. Furthermore, a textured outer surface is required to increase the surface area of ​​the thicker portions, match the softening temperature with the thinner portions of the mouthguard, and facilitate molding.

[0009] U.S. Patent No. 6,082,363 discloses a three-layer mouthguard, which includes a thermosoftening liner that allows the mouthguard to be molded to the user's teeth, a thermoplastic U-rail base that provides structural support during molding, and a non-softening, low-compression, shock-absorbing frame. The rubber-like frame is integrated into the mouthguard base and extends throughout the entire mouthguard. The frame has homogeneous mechanical properties. Homogeneous mechanical properties of materials used throughout the mouthguard do not effectively protect the wearer from direct and indirect injury mechanisms after impact.

[0010] Other types of boil-and-bite guards use multi-layer structures that provide non-protective functions to the device. For example, U.S. Patent Application Publication No. 2014 / 238418 relates to a multi-layer guard in which flavoring agents are selectively used in each layer to encourage the wearer to keep the guard in their mouth for extended periods of time.

[0011] Prior art has also introduced custom-made mouthguards in which thermoplastic sheets are layered over a 3D impression model of the wearer's teeth and then gradually trimmed. While this is the current gold standard, maintaining uniform and accurate dimensions of the final custom-made mouthguard during the thermoforming process remains problematic. Furthermore, while it is possible to create a more rigid customized mouthguard by sandwiching an additional hard layer between softer layers, the effectiveness of such mouthguards is limited because many known hard materials cannot be easily thermoformed. Therefore, the choice of hard layer material for such thermoformed mouthguards is limited, and the deformed hard layer exerts pressure on the teeth, resulting in poor user comfort.

[0012] U.S. Patent Application Publication No. 2019 / 0344150 discloses a method of sandwiching an additional hard layer between soft layers by 3D printing based on the shape of a thermoformed inner soft layer. However, this method significantly increases the workload and processing time of the customization process because an additional personal scan is required after laminating the first soft layer onto a 3D impression model of the wearer to create the hard layer. Furthermore, if the hard layer is damaged by a severe impact, the mouth guard becomes unusable because the hard layer, which is permanently fixed between the interconnected soft layers, cannot be replaced.

[0013] The difficulties of the traditional manufacturing process for customized mouth guards, which involves thermoforming a film layer by layer onto a dental jaw model, can be overcome by using additive manufacturing, which generates the desired design based on a digital 3D model that conforms to the shape of specific teeth. However, prior art mouth guards using additive manufacturing suffer from the same problems as thermoforming and traditional (boil-and-bite) methods. In particular, prior art mouth guards manufactured by additive manufacturing are limited in the availability of materials that can be used uniformly throughout the entire mouth guard.

[0014] U.S. Patent Application Publication No. 2020 / 282639 describes the 3D printing of tooth-straightening dental aligners and tooth-protecting mouthguards. Both appliances contain a single, hard polymer layer with the exact final shape of the design. While this single, hard polymer layer can be beneficial in applying corrective forces to the teeth during realignment treatment, it offers limited protection during impacts due to the minimal cushioning it provides and limited dispersion of impact forces. The thickness required to achieve the desired level of protection with soft, single-layer 3D-printed appliances compromises user comfort, similar to off-the-shelf appliances.

[0015] WO 2018 / 064782 provides a 3D printed dental splint that includes a first, softer laminate that faces the teeth and a second, harder laminate that surrounds the first laminate. The softer laminate accommodates the teeth but requires stabilization and reinforcement by the harder laminate. It can therefore be seen that the dental splint of WO 2018 / 064782 has a similar structure and similar drawbacks with respect to bulkiness and user discomfort associated with the dual-tray boil-and-bite mouthguard of U.S. Patent Application Publication No. 2006 / 065277. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] US Patent Application Publication No. 2006 / 065277 [Patent Document 2] US Patent Application Publication No. 2007 / 084471 [Patent Document 3] International Publication No. 2018 / 063295 [Patent Document 4] U.S. Patent No. 6,082,363 [Patent Document 5] US Patent Application Publication No. 2014 / 238418 [Patent Document 6] US Patent Application Publication No. 2019 / 0344150 [Patent Document 7] US Patent Application Publication No. 2020 / 282639 [Patent Document 8] International Publication No. 2018 / 064782 Summary of the Invention [Problem to be solved by the invention]

[0017] The inventors have discovered that composite mouthguards with different properties in specific tooth regions can provide maximum direct and indirect protection. Specifically, the inventors have found that specific properties in the anterior and occlusal regions can effectively protect the wearer from direct and indirect injury mechanisms after impact. A hard material in the anterior region can distribute focal impact forces and reduce the risk of incisor injury, while a soft, cushion-like material in the occlusal region can promote occlusion, thereby stimulating neck muscle activity, thereby increasing head stability and / or reducing forces transmitted to the skull after impact. By modularly integrating separately manufactured components with different properties, the present invention provides the flexibility to fine-tune the materials used in specific tooth regions, and material selection is no longer limited to chemically bondable, thermoformable compositions, allowing for greater freedom in terms of material selection.

[0018] As conventional lamination methods are only suitable for providing composite mouthguards with very limited shape, geometry and material properties (e.g. stiffness) in different areas, one of the aims of the present invention is to provide design flexibility, enhance structural details and ease the fabrication process through a digital manufacturing approach.

[0019] Thus, the present invention, through its modular design with replaceable components, maximizes the direct and indirect protection of the mouthguard, enhances comfort, and provides durability as well as adaptability for a variety of sports. Furthermore, in conventional mouthguards, the mouthguard's interconnected, permanently bonded structure provides no opportunity to replace broken or damaged components after a devastating impact. For example, while any rigid components typically become inoperable after a hard impact, the present invention provides an easy way to replace damaged components. [Means for solving the problem]

[0020] The mouth guard of the present invention provides impact protection through two mechanisms. The mouth guard provides neck muscle activation that reduces head rotation and improves head stability during a traumatic impact due to special features at the rear of the mouth guard. This provides improved protection against rotation-induced brain damage. The mouth guard also provides improved impact protection due to special features at the front of the mouth guard for impact energy dispersion. This provides improved protection against traumatic injuries resulting from an impact, such as direct damage to anatomical structures like the teeth and / or jaw. The combination of improved head stability and improved impact protection provides a superior level of overall user protection. For example, the stiffer anterior insert improves load distribution and therefore improves protection against dental trauma, while the softer posterior insert promotes bite-induced neck muscle activation and therefore improves protection against brain injury.

[0021] The impact protection region can improve load distribution, thus improving protection against dental trauma. The occlusal cushion region can be configured to promote bite-induced neck muscle activity, thus improving protection against brain injury. Mouth guards according to the present invention can therefore be configured with one or more regions having material properties that impart a particular protective function to the mouth guard. For example, the (first) material properties defining the impact protection region can be material properties that provide the protective function of the impact protection region, such as protection against direct injury from traumatic contact. The (second) material properties defining the occlusal cushion region can be material properties that provide the protective function of the occlusal cushion region, such as protection against rotation-induced brain injury by inducing jaw clenching and neck muscle activity.

[0022] Optionally, the level of bite-induced neck muscle activity can be altered by adjusting the material properties of the bite cushion region. In this manner, adjusting the material of the bite cushion region may increase or decrease the attenuation of the impact force transmitted from the jaw to the brain and / or skull.

[0023] The material properties defining the region of the guard that provide the protective function of the region of the guard may be the material properties of the region at the temperature of the guard / region in use, i.e. the protective properties of the material of the region may be the material properties of the region at room temperature and / or at the temperature of the oral cavity / mouth and / or at high (non-boiling) temperatures.

[0024] The features described herein allow for mouthguards with multiple regions, where some regions have material properties that differ from the material properties of other regions, and each different material property / region can provide a different protective function to the mouthguard.

[0025] The present invention provides a mouthguard, the mouthguard optionally comprising: an externally exposed impact protection region defined by a first material property and configured to cover the anterior teeth; and an internally exposed bite cushion region defined by a second material property and configured to cover the molar teeth.

[0026] Optionally, the first material property and the second material property are different. Optionally, the externally exposed impact protection area does not cover the molar teeth. Optionally, the internally exposed bite cushion area does not cover the front teeth. Optionally, there is an area between the impact protection area and the front teeth.

[0027] Optionally, the exposed impact protection area is the only portion of the mouthguard that includes the material of the exposed impact protection area, meaning that the exposed impact protection area can be made of a unique, relatively hard material that is not present in other portions of the mouthguard, allowing the other portions of the mouthguard to be made of a relatively soft material that promotes occlusion, thereby promoting neck muscle activity and helping to avoid brain injury during an impact.

[0028] The regions are each typically homogeneous in that the entire defined region is made of the same material having the same material properties throughout the region.

[0029] The mouth guard may further include an intermediate region defined by a third material characteristic. Optionally, the third material characteristic is different from the first material characteristic and the second material characteristic. The intermediate region may be configured to be located between the bite cushion region and the impact protection region.

[0030] Optionally, the regions are configured to chemically bond or mechanically interlock.

[0031] The present invention provides a mouthguard, the mouthguard optionally comprising: an externally exposed impact protection region defined by a first material property and configured to cover the anterior teeth; an internally exposed occlusal cushion region defined by a second material property and configured to cover a molar; and and an internally exposed intermediate region defined by a third material property and configured to be positioned between the bite cushion region and the impact protection region.

[0032] Optionally, the first material property, the second material property, and the third material property are different.

[0033] The present invention may, for example, be a composite mouthguard that includes regions with distinct properties. The regions may be made of different materials (i.e., different material compounds / compositions) to provide different properties. The mouthguard may thus facilitate differentiation of materials used in different regions of the mouthguard. The mouthguard may thus allow for more precise utilization of materials and / or material properties in regions of the mouthguard where those properties will provide the most beneficial effect. In this manner, the protection provided by the mouthguard may be optimized. More efficient use of materials reduces the thickness of the mouthguard required to provide the desired degree of protection. In this manner, the bulk of the mouthguard may be reduced, improving comfort for the user.

[0034] Additionally, the features described herein allow for more efficient mouthguard design. Specifically, the described features allow for more targeted utilization of different materials in composite mouthguards that include regions with distinct properties. By precisely using different materials and providing different material properties in regions where the guard provides maximum protection, the protection provided by the mouthguard can be optimized. That is, the protective function of each region can be provided and / or optimized by a combination of the region's material properties and the region's location, e.g., relative to a user's particular teeth.

[0035] The combination of composite materials and the concept of modularity, i.e., the mouthguard having different components corresponding to different areas of the mouthguard with different material properties, allows for the flexibility to fine-tune the materials used in specific tooth areas, thus maximizing the direct and indirect protective performance of the mouthguard and / or tailoring it to different sports.

[0036] Optimizing the materials used in the mouthguard can also reduce the bulk of the mouthguard, improving comfort for the wearer and reducing interference with breathing, speaking, and other activities necessary for optimal athletic performance.

[0037] The different functional properties of the mouthguard can be individually customized in a simple and efficient way by adjusting the material properties of different areas. By adjusting the different areas separately, the different functions of the mouthguard can be adjusted precisely and efficiently. The mouthguard can therefore be precisely customized to the needs of the user.

[0038] The interface between the intermediate region and the bite cushion region may include a mechanical interlock.

[0039] The interface between the intermediate region and the impact protection region may comprise a mechanical interlock.

[0040] Different pieces and / or regions of the mouth guard may thus be joined by mechanical interlocking of interlocking portions on the different pieces and / or regions. The interlocking portions facilitate assembly of the mouth guard without the need for additional fastening materials, such as adhesives or sealants. This, for example, may reduce the complexity of the mouth guard by requiring less material to fabricate the mouth guard. Similarly, fewer processing steps may be required to fabricate the mouth guard, improving the efficiency and ease of fabrication. Furthermore, material and / or fabrication costs may be reduced. Some users may be allergic to adhesives or resins, and by using interlocking portions instead of adhesives or resins to join the mouth guard pieces, the risk of adverse hypersensitivity reactions in the user may be minimized.

[0041] Furthermore, assembly of the mouthguard through mechanical interlocking of different pieces and / or regions means that the material components of the regions are not limited to chemically bondable material compositions. Therefore, the materials of the regions can be optimized without such limitations on material selection. The interlocking portions therefore allow for greater flexibility in the design of the mouthguard, allowing for more precise fine-tuning of the properties of the materials used. For example, the materials comprising the bite cushion region, the impact protection region, and / or the intermediate region can be fine-tuned to optimize the specific protective function of that region. The material of the bite cushion region can be tailored to provide optimized (e.g., maximized) bite-induced neck muscle activity. The material of the impact protection region can be individually tailored to optimize the distribution / attenuation of impact forces. Therefore, the entire mouthguard can be optimized to have two functions: improving the direct and indirect protective performance of the mouthguard, respectively.

[0042] The intermediate region and the bite cushion region may comprise the same material (i.e., the same material compound / composition), which may reduce the complexity of the guard, for example, by requiring fewer materials and / or processing steps to fabricate the guard.

[0043] The internal structure of the intermediate region may be different from the internal structure of the bite cushion region.

[0044] The occlusal cushion region may have a porous structure. The occlusal cushion region may have a perforated structure. This allows for the material properties of the occlusal cushion region to be easily modified, for example, by increasing the porosity and / or perforations of the occlusal cushion region, thereby decreasing its apparent hardness. This is particularly useful in mouthguards having an intermediate region and an occlusal cushion region that comprise the same material.

[0045] The intermediate region and / or the bite cushion region may comprise an elastomeric and / or polymeric material. The bite cushion region may comprise a material capable of withstanding a tensile strain of at least 50%.

[0046] The intermediate region and / or bite cushion region may comprise a soft, flexible polymeric material, such as a material configured to withstand a tensile strain of 70% or greater, and may be made from a thermoplastic polyurethane and / or photopolymer containing acrylate and / or methacrylate and / or functional urethane monomers / oligomers and / or mixtures thereof.

[0047] The bite cushion region may include a fatigue resistant material that can withstand repeated bites for a prescribed number of cycles.

[0048] The hardness of the intermediate region may be greater than the hardness of the occlusal cushion region. The hardness of the occlusal cushion region may be 40 to 80, preferably 60 to 80, on the Shore A scale. More preferably, the hardness of the occlusal cushion region is 55 to 75, preferably 65 to 75, on the Shore A scale. The hardness of the intermediate region may be 60 to 95, preferably 70 to 95, on the Shore A scale. More preferably, the hardness of the intermediate region may be 75 to 85, on the Shore A scale.

[0049] For example, the bite cushion region may comprise a soft, flexible polymeric material having a hardness of 60-80 on the Shore A scale, and / or may have a compressive stiffness of 8-20 MPa, and / or may be fatigue resistant.

[0050] For example, the intermediate region may comprise a relatively soft, flexible polymeric material having a hardness of 70 to 95 on the Shore A scale, and / or may have a compressive stiffness of 15 to 40 MPa.

[0051] At least one interface between the regions may include a mechanical interlock. Optionally, the mechanical interlock includes an interlocking feature.

[0052] Optionally, the interlocking feature is configured to be positioned to reduce discomfort to a user.Optionally, the interlocking feature is configured to be positioned over an area between the first tooth and the second tooth.

[0053] At least one region may be configured to be removable from the other region.

[0054] Removable guard segments of the same type, e.g., segments containing the same regions of the guard, may be interchangeable. Removable guard segments may be interchangeable with segments having the same or different material properties. Interchanging guard segments with different properties allows the guard to be adapted to meet various end-user requirements. For example, the degree of impact protection can be customized by interchanging the impact protection regions. When the guard induces occlusion, neck muscle activity occurs, improving head stability. Interchanging the bite cushion regions allows the degree of occlusion to be customized. Interchanging the bite cushion regions also allows the degree of neck muscle activity and head stabilization to be customized. In this way, the guard can be adapted for use in various sports, e.g., sports requiring different degrees and / or types of protection depending on the nature of the sport and / or the expected magnitude and / or location of the impact force. Similarly, replacing damaged components of the guard can extend the life of the guard. For example, components damaged by traumatic impact and / or wear and tear during use can be replaced with new, undamaged components.

[0055] The mouthguard may include a first material (i.e., a first material compound / composition) having a first inherent material property and a second material (i.e., a second material compound / composition) having a second inherent material property, optionally, the first inherent material property being different from the second inherent material property.

[0056] The hardness of the occlusal cushion region may be 40 to 80 on the Shore A scale, preferably 60 to 80. More preferably, the hardness of the occlusal cushion region may be 55 to 75 on the Shore A scale, preferably 65 to 75 on the Shore A scale.

[0057] The impact protection region may comprise a thermoplastic and / or thermosetting material made of a photosensitive resin. Optionally, the impact protection region comprises a stress concentration feature. Optionally, the impact protection region is a first impact protection region configured to be removable from other regions of the mouth guard. Optionally, the first impact protection region may be interchangeable with a second impact protection region. Optionally, the second impact protection region may have different properties from the first impact protection region. Optionally, the second impact protection region may have the same properties as the first impact protection region. Optionally, the second impact protection region may have the same appearance as the first impact protection region. Optionally, the second impact protection region may have a different appearance from the first impact protection region.

[0058] The Young's modulus of the impact protection region may be 0.5 to 5 GPa. Preferably, the Young's modulus of the impact protection region may be 2 to 3 GPa. Ideally, the Young's modulus of the impact protection region may be 1 GPa or more.

[0059] The mouth guard may be configured to be offset forward from the front teeth, optionally by at least 1 millimeter to provide space for the hard insert (impact protection area) to flex to absorb impact energy.

[0060] Optionally, the front teeth for which the mouthguard is configured to be offset anteriorly are central incisors.

[0061] Optionally, the anterior teeth for which the mouth guard is configured to be offset anteriorly are central incisors and / or lateral incisors and / or canines.

[0062] The forward offset provides more efficient energy dissipation throughout the guard, improving the protective performance of the guard, which is particularly useful in guards with hard inserts, such as impact protection areas.

[0063] The mouthguard may include a gap region in a front portion of the mouthguard. Optionally, the gap region includes a gap of at least 1 millimeter. Optionally, the gap region is configured to overlie the front teeth. Optionally, the front teeth are central incisors. Optionally, the front teeth are central incisors and / or lateral incisors and / or canines.

[0064] The gap areas provide more efficient energy dissipation throughout the guard, thereby improving the protective performance of the guard. The increased protection provided by the gap areas is particularly effective in guards with hard inserts, such as impact protection areas. In prior art boil-and-bite type guards, the nature of the molding process by the user makes it impossible to create gap areas in a predictable manner, or even to create gap areas at all.

[0065] The occlusal cushion area may be configured to cover a single molar. The occlusal cushion area may be configured to cover two molars. The occlusal cushion area may be configured to cover a premolar.

[0066] The impact protection area may be configured to cover two incisors. The impact protection area may be configured to cover a central incisor and / or a lateral incisor and / or a canine.

[0067] The present invention can provide a 3D printed mouthguard, optionally comprising: a first mouthguard piece; and and a second mouth guard piece.

[0068] Optionally, the first and second mouth guard pieces are configured to mechanically interlock. Mechanical interlocking of the mouth guard pieces simplifies assembly of the mouth guard by eliminating the need for additional fastening materials, such as adhesives or sealants. This, for example, may reduce the complexity of the mouth guard by requiring fewer materials to fabricate the mouth guard. Similarly, fewer processing steps may be required to fabricate the mouth guard, improving efficiency and ease of production. Furthermore, material and / or production costs may be reduced. Some users are allergic to adhesives or resins, and using an interlocking portion instead of an adhesive or resin to connect the mouth guard pieces minimizes the risk of adverse hypersensitivity reactions in the user.

[0069] Optionally, the first mouthguard piece and the second mouthguard piece are configured to be chemically bonded. The chemical bonding of the two mouthguard pieces secures the two pieces together. For example, the chemical bonding of the two mouthguard pieces can secure the bonded pieces in place and prevent subsequent separation of the two bonded pieces.

[0070] Optionally, the first mouthguard piece is detachable from the second mouthguard piece.

[0071] The present invention provides a method for making a mouth guard, the method comprising: Obtain a digital model of the tooth shape, Generate a customized digital model of the mouthguard based on the digital model of the teeth, and 3D printing the mouthguard based on a customized digital model of the mouthguard.

[0072] Optionally, generating the customized digital model of the mouth guard based on the digital model of the teeth comprises providing an anterior offset of the mouth guard from the anterior teeth. Optionally, generating the customized digital model of the mouth guard based on the digital model of the teeth comprises providing a gap region in an anterior portion of the mouth guard.

[0073] Optionally, the mouthguard comprises an externally exposed impact protection region defined by a first material property and configured to cover the anterior teeth.

[0074] Optionally, the anterior offset of the mouthguard from the anterior teeth is an anterior offset from the central incisors.Optionally, the anterior offset of the mouthguard from the anterior teeth is an anterior offset from the central incisors, and / or lateral incisors, and / or canines.

[0075] Optionally, the gap region is configured to overlie an anterior tooth. Optionally, the anterior tooth is a central incisor, and / or a lateral incisor, and / or a canine.

[0076] Optionally, generating a customized digital model of the mouthguard based on the digital model of the teeth comprises subtracting the digital model of the teeth from the digital mouthguard model, so that the shape of the mouthguard can be precisely customized to the user's anatomy, providing a mouthguard with a more precise fit and more predictable protective effect.

[0077] The method may include generating a first customized digital model of a first mouthguard segment. The method may include generating a second customized digital model of a second mouthguard segment. Optionally, the first customized digital model and the second customized digital model are generated based on the digital model of the tooth profile. Optionally, the first and second mouthguard segments are configured to mechanically interlock. Optionally, the first mouthguard piece and the second mouthguard piece are configured to chemically bond together.

[0078] The method may include separately 3D printing a first mouthguard segment and a second mouthguard segment based on the first customized digital model and the second customized digital model. For example, the first mouthguard segment and the second mouthguard segment may be printed using different materials, and / or using different printers, and / or at different times, and / or using a single printer.

[0079] The method may include simultaneously 3D printing a first mouthguard segment and a second mouthguard segment based on the first customized digital model and the second customized digital model. For example, the first mouthguard segment and the second mouthguard segment may be printed simultaneously and / or in the same process and / or using a single printer, such as a multi-jet printer. Optionally, the first mouthguard segment and the second mouthguard segment may be printed simultaneously using different materials.

[0080] The method may include simultaneously 3D printing a first mouthguard segment and a second mouthguard segment based on the first customized digital model and the second customized digital model. For example, the first mouthguard segment and the second mouthguard segment may be simultaneously printed using a multi-material printer.

[0081] The present invention provides a method of making a mouthguard, the method optionally including obtaining a digital model of the dental impression. The method may include generating a first customized digital model of a first mouthguard segment. The method may include generating a second customized digital model of a second mouthguard segment. Optionally, the first customized digital model and the second customized digital model are generated based on the digital model of the tooth profile. Optionally, the first and second mouthguard segments are configured to mechanically interlock. Optionally, the first mouthguard piece and the second mouthguard piece are configured to chemically bond together.

[0082] The method may include separately 3D printing a first customized digital model piece and a second mouthguard piece based on the first customized digital model and the second customized digital model. The method may include mechanically interlocking the first and second mouthguard segments. The method may include chemically bonding the first and second mouthguard pieces together. Optionally, the first mouthguard piece is detachable from the second mouthguard piece.

[0083] The present invention provides a method of making a mouthguard, the method optionally including obtaining a digital model of the dental impression. The method may include generating a first customized digital model of a first mouthguard segment. The method may include generating a second customized digital model of a second mouthguard segment. The method may include generating a third customized digital model of a third mouthguard segment.

[0084] Optionally, the first customized digital model, the second customized digital model, and / or the third customized digital model are generated based on the digital model of the tooth profile. Optionally, one of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece is configured to mechanically interlock with a different one of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece. Optionally, one of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece is configured to chemically bond with a different one of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece.

[0085] The method may include separately 3D printing a first mouthguard segment and a second mouthguard segment, and / or a third mouthguard segment based on the first customized digital model, the second customized digital model, and the third customized digital model. The method may include simultaneously 3D printing a first mouthguard segment and a second mouthguard segment, and / or a third mouthguard segment based on the first customized digital model, the second customized digital model, and the third customized digital model. Optionally, generating the first customized digital model, the second customized digital model, and / or the third customized digital model based on the digital model of the teeth shape may include subtracting the digital model of the teeth shape from the digital mouthguard segment model.

[0086] The method may include providing an interlock feature. Optionally, the interlocking features are configured to be positioned to reduce discomfort to the user. Optionally, the interlocking feature is configured to be disposed on a region between the first tooth and the second tooth. Optionally, providing the interlocking feature may include forming the first interlocking feature on one of the first customized digital model, the second customized digital model, and / or the third customized digital model. The method may include subtracting the first interlock feature from a different one of the first customized digital model, the second customized digital model, and the third customized digital model.

[0087] Providing the interlock feature may include generating a digital model of the first interlock feature. Optionally, the digital model of the first interlock feature is a separate digital model from the other digital models. The method may include subtracting a first portion of the digital model of the first interlock feature from one of the first customized digital model, the second customized digital model, and / or the third customized digital model. The method may include subtracting a second portion of the digital model of the first interlock feature from a different one of the first customized digital model, the second customized digital model, and / or the third customized digital model. The method may include mechanically interlocking one or more of the first mouthguard segment, the second mouthguard segment, and the third mouthguard segment. The method may include chemically bonding one or more of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece.

[0088] The method may include adhering one or more of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece. The method may include fusing one or more of the first mouthguard piece, the second mouthguard piece, and the third mouthguard piece. Optionally, generating any one of the first customized digital model, the second customized digital model, and / or the third customized digital model may include subtracting a different one of the first customized digital model, the second customized digital model, and / or the third customized digital model from any one of the first customized digital model, the second customized digital model, and / or the third customized digital model.

[0089] The method may include adjusting a thickness of an externally exposed impact protection region defined by a first material property and configured to cover the anterior teeth. The method may include adjusting a thickness of an internally exposed occlusal cushion region defined by a second material property and configured to cover a molar tooth.

[0090] Optionally, the 3D printing may include printing with a photocurable resin. Optionally, the 3D printing may include exposing the photocurable resin to radiation. Optionally, the 3D printing may include printing with fusible filaments. Optionally, the method may include printing using a fused deposition modeling 3D printer. The method may include making a mouth guard configured as disclosed herein. Optionally, mouthguards are designed for use in a particular dental arch, e.g., the upper or lower dental arch, and cover and protect the teeth in the arch for which they are designed for use.

[0091] Mouthguards are typically customized mouthguards that are supplied in the form in which they are used. As such, mouthguards typically do not require heating, such as boiling, to conform to the user's teeth. Instead, the mouthguard is manufactured in the correct shape to fit the user's mouth.

[0092] Mouthguard materials are selected for their protective properties, not their ability to soften and maintain a molded shape under heat. Thus, mouthguard materials may not soften under heat and conform to the shape of the teeth during the boil-and-bite process. [Brief explanation of the drawings]

[0093] Arrangements of the present disclosure will be further described, by way of example only, with reference to the accompanying drawings, in which:

[0094] [Figure 1] FIG. 1 is a diagram showing a mouth guard. [Figure 2A] FIG. [Figure 2B] FIG. 2B is a bottom view of the mouth guard of FIG. 2A. [Figure 3] FIG. [Figure 4] FIG. [Figure 5A] FIG. [Figure 5B] FIG. 5B is a front-side view of the mouth guard of FIG. 5A. [Figure 5C] FIG. 5B is a front-side view of the mouth guard of FIG. 5A with the impact protection area removed. [Figure 5D] FIG. 12 is a front-side view of the removed impact protection area with stress concentration features. [Figure 5E] FIG. 10 is a top view of the removed impact protection area with stress concentration features. [Figure 6A] FIG. 1 is a front view of a portion of a mouth guard with the impact protection area removed. [Figure 6B]FIG. 6B is a side view of a portion of the mouth guard of FIG. 6A with an attached impact protection area. [Figure 7] FIG. 1 shows a mouthguard applied to the upper dental arch. [Figure 8] 1A and 1B are diagrams illustrating a method for making a mouth guard. [Figure 9] 1A and 1B are diagrams illustrating a method for making a mouth guard. [Figure 10A] FIG. 10 shows test results showing improvements in muscle activity and bite force with a mouthguard. [Figure 10B] FIG. 10 shows test results showing improvements in muscle activity and bite force with a mouthguard. [Figure 11] FIG. 10 is a test result diagram showing a numerical simulation of a mouthguard with a hard insert and an anterior offset. [Figure 12] FIG. 10 is a test results diagram showing data from an in vitro impact test of a mouthguard with a hard insert and an anterior offset. DETAILED DESCRIPTION OF THE INVENTION

[0095] The inventors have confirmed that an impact to the jaw can cause injury through various mechanisms. Specifically, an impact to the jaw can cause injury through direct and indirect mechanisms. Directly, i.e., at the site of impact, the impact force can cause destructive stress. For example, an impact to the jaw can directly cause destructive stress in the tooth-bone complex. Indirectly, i.e., at a site different from the site of impact, head rotation resulting from an impact to the jaw can cause brain injury. For example, head rotation due to impact can result in traumatic brain tissue deformation. Therefore, a traumatic impact to the jaw can lead to brain injury resulting in a concussion.

[0096] Previously available mouth guards provide a basic level of protection from direct injury. The features described herein provide protection against multiple different mechanisms of trauma that can be induced by impact to the jaw in a manner not previously achieved. That is, the described features provide protection against injuries from both direct and indirect mechanisms of impact. The combination of improved protection against direct destructive stresses, particularly due to the specialized front portion of the mouth guard, and improved protection against traumatic brain tissue deformation (e.g., jaw occlusion and neck muscle activation, causing greater head stability), particularly due to the specialized rear portion of the mouth guard, provides superior overall protection. In this way, greater combined protection against brain injury (concussion) and bone injury is provided.

[0097] It can be appreciated that the features described herein may additionally or alternatively provide protection against impacts to any location that cause acceleration and / or deceleration of the head. An example of a mouthguard 100 is provided in Figures 1 to 7. The mouthguard 100 may comprise an impact protection region 10, an optional bite cushion region 20, and / or an intermediate region 30.

[0098] The impact protection area 10 is configured to provide protection from direct damage upon impact by providing protection from traumatic impact to the teeth. The bite cushion area 20 is configured to provide protection from consequential injury during impact by increasing head stability and / or reducing the transmission of forces to the skull.

[0099] For example, by enabling biting on the mouth guard, the occlusal cushion area 20 provides jaw clenching and activation of neck muscles such as the sternocleidomastoid (SCM) muscle. Thus, the occlusal cushion area 20 reduces rotation and improves head stability during traumatic impact, thereby protecting against rotation-induced brain injury.

[0100] Additionally or alternatively, by altering jaw configuration, for example, by providing separation between the head of the mandibular condyle and the mandibular fossa of the skull, the bite cushion region 20 can reduce the transmission of force from the jaw to the skull. In this way, the brain experiences lower transmitted forces during impact and is therefore protected from injury. Through one or more of the mechanisms described above for reducing brain injury, the bite cushion region 20 can thus provide an anti-impact effect.

[0101] The intermediate region 30 is configured to improve energy dissipation throughout the mouthguard. The intermediate region 30 may additionally or alternatively be configured to mount the impact protection region 10 and / or the bite cushion region 20. Different regions of the mouthguard may be defined by different properties, such as different material properties. Additionally or alternatively, different regions of the mouthguard may be defined by their different materials (i.e., different material compounds / compositions).

[0102] For example, the impact protection region 10 may comprise a harder and / or stiffer and / or stronger material. The impact protection region 10 may have a higher Shore hardness and / or Young's modulus compared to other regions of the mouthguard. For example, the impact protection region 10 may comprise a thermoplastic material and / or a thermoset material.

[0103] The bite cushion region 20 may comprise a less hard and / or softer and / or more resilient material. The bite cushion region 20 may have a lower hardness and / or a lower Young's modulus compared to other regions of the mouthguard. The intermediate region 30 may comprise a flexible and / or elastic material.

[0104] The intermediate region 30 and the bite cushion region 20 may comprise the same type of material. For example, the intermediate region 30 and the bite cushion region 20 may both comprise an elastomeric material and / or a polymeric material and / or a rubber-like material.

[0105] The intermediate region 30 and the occlusal cushion region 20 may have some similar material properties. For example, the occlusal cushion region 20 and / or the intermediate region 30 may comprise a material capable of withstanding a tensile strain of at least 50%, e.g., 50-70%, more preferably at least 70%, or 70% or more. The intermediate region 30 and the occlusal cushion region 20 may have some different material properties. For example, the intermediate region 30 may comprise a material that is harder than the occlusal cushion region 20. The intermediate region 30 may have a higher hardness and / or a higher Young's modulus compared to the occlusal cushion region 20.

[0106] In this way, different areas of the guard can be provided with more targeted use of different materials. By using different materials in a way that provides different material properties in areas of the guard that provide the greatest protection, the performance of the guard may be improved and the protection provided by the guard may be optimized. For example, the front and back sides of the mouth guard may include different regions having different material properties.

[0107] As illustrated in Figures 1-7, the impact protection region 10 can occupy the front region of the mouth guard 100. The front region of the mouth guard is configured to cover the teeth in the front of the mouth. The impact protection region 10 can therefore cover areas of the mouth that are at higher risk of traumatic impact. For example, the impact protection region 10 can protect the teeth most at risk from impact by a projectile such as a hockey puck. Preferably, the impact protection region 10 is configured to cover the user's front teeth.

[0108] The portion of the mouthguard occupied by the impact protection region 10 may be customized, for example, according to the requirements of the end user. By customizing the width of the impact protection region 10, the degree of protection provided can be customized. For example, increasing the width of the impact protection region 10 increases the degree of protection provided. However, increasing the width of the impact protection region 10 may further reduce the user's comfort level. Therefore, the width of the impact protection region 10 may be customized to provide a compromise between the degree of protection and the user's comfort level. For example, the impact protection region 10 may occupy an area of ​​the front half of the mouthguard. Alternatively, the impact protection region 10 may occupy an area extending beyond the front half of the mouthguard.

[0109] The number of teeth covered by the impact protection region 10 may be customized depending on, for example, the level of protection desired by the user and / or the areas likely to be impacted during use of the mouth guard. Additionally or alternatively, the number of teeth covered by the impact protection region 10 may be customized to provide a compromise between the degree of protection and the user's comfort level. For example, the impact protection region 10 may be configured to cover and / or extend between two incisors. The impact protection region 10 may be configured to cover a central incisor, a lateral incisor, and / or a canine. The impact protection region 10 may be configured to cover two central incisors, two lateral incisors, and / or two canines. The impact protection region 10 may be configured to cover any combination of anterior teeth.

[0110] 1-7, the occlusal cushion region 20 occupies the posterior region of the mouthguard 100. The posterior region of the mouthguard is configured to cover teeth in the posterior portion of the mouth. The occlusal cushion region 20 may therefore cover teeth that have a greater degree of engagement during jaw clenching. For example, the occlusal cushion region 20 may cover teeth that transmit greater forces to the mouthguard during clenching. In this way, the cushioning effect of the occlusal cushion region 20 may be concentrated in portions of the mouthguard that experience greater loading forces during clenching.

[0111] For example, the occlusal cushion area 20 may be configured to cover a user's back teeth, such as molars. The occlusal cushion area 20 may be configured to cover molars and / or premolars. The occlusal cushion area 20 may be configured to cover two molars and / or two premolars. The occlusal cushion area 20 may be configured to cover any combination of back teeth.

[0112] Additionally or alternatively, the cushioning effect of the bite cushion region may be concentrated in a portion of the mouthguard to better encourage occlusion of certain teeth and provide stronger and / or specific neck muscle activation. For example, the bite cushion region may be configured to cover the molars for activation of neck muscles such as the sternocleidomastoid.

[0113] Additionally or alternatively, the posterior location of the bite cushion region 20 may alter jaw configuration to reduce force transmission from the jaw to the skull. For example, the bite cushion region 20, when located on the posterior lateral portion of the mouth guard, may have a shape and / or thickness that increases the separation between the condyles of the mandible and the mandibular fossa of the skull.

[0114] FIG. 1 illustrates a mouthguard 100 configured to be applied to the maxillary dental arch. The mouthguard has an inner surface configured to face the teeth and / or adjacent gingiva of the maxilla. The mouthguard has an outer surface configured to face the buccal mucosa and / or teeth of the mandible. The inner and outer surfaces of the mouthguard may include different regions having different material properties. By using different materials in areas that provide the greatest protection for the mouthguard, the performance of the mouthguard may be improved and the protection provided by the mouthguard may be optimized.

[0115] For example, the inner surface of the mouth guard may include an occlusal cushion region 20. The occlusal cushion region may therefore directly contact the occlusal surfaces of the teeth to more effectively engage and / or cushion the teeth.

[0116] Preferably, the bite cushion region 20 may occupy primarily the inward-facing portion of the mouthguard. For example, the bite cushion region 20 may be exposed to the interior. The inward-facing portion of the mouthguard occupied by the bite cushion region 20 may include the base portion and / or horizontal portion of the mouthguard. For example, the bite cushion region 20 may occupy the occlusal surface portion of the mouthguard.

[0117] As illustrated in Figures 1-4, bite cushion region 20 includes an inner surface portion and an outer surface portion. For example, Figures 1, 3, and 4 show bite cushion region 20 having the full depth of the mouth guard. Thus, bite cushion region 20 may associate with both the upper and lower teeth to increase cushioning effect and / or increase tooth engagement during clenching.

[0118] 2A and 2B show bite cushion region 20, which includes a major medial surface portion and a minor lateral surface portion. The minor lateral surface portion includes a mechanical interlock portion 40 configured to extend through intermediate region 30 to the lateral surface portion of the mouth guard.

[0119] As illustrated in Figures 1 to 7, the outer surface may include an impact protection area 10. The impact protection area 10 may therefore protect the teeth most at risk from traumatic impacts. Preferably, the impact protection region 10 can occupy a portion of the mouth guard that faces primarily outward. For example, the impact protection region 10 may be exposed to the outside. The portion of the mouth guard that faces outward that is occupied by the impact protection region 10 can include the side and / or vertical portions of the mouth guard. For example, the impact protection region 10 may occupy the labial and / or buccal side portions of the mouth guard.

[0120] 1-7, the impact protection region 10 includes an outer surface portion but not an inner surface portion. In this way, the teeth and / or adjacent gums are not exposed to the hard material of the impact protection region 10, improving comfort for the user. The internal shielding of the hard impact protection region 10 by, for example, the intermediate region 30, improves the safety of the mouthguard in the event of an impact by minimizing the risk of injury to the user from hard protrusions within the mouthguard.

[0121] 1-7 includes the medial and lateral surfaces of the mouth guard. In this manner, the medial region 30 can be configured to couple the impact protection region 10 to the bite cushion region 20. For example, the medial region 30 can mechanically couple the impact protection region 10 to the bite cushion region.

[0122] The intermediate region 30 is therefore located between the impact protection region 10 and the bite cushion region 20, and can have limited or no overlap at the boundaries of the impact protection region 10 and the bite cushion region 20. By physically separating the impact protection region 10 and the bite cushion region 20, interference between the different material properties of the different regions can be reduced, allowing the different regions of the mouthguard to more reliably and accurately provide their specialized functions.

[0123] For example, the horizontal / lateral extent of the impact protection area 10 may have limited overlap or no overlap with the horizontal / lateral extent of the occlusal cushion area 20. The position of the posterior boundary of the impact protection area 10 may be anterior to the position of the anterior boundary of the occlusal cushion area 20 (see, for example, Figures 1 to 4).

[0124] The impact protection region 10 may occupy primarily or exclusively the non-occlusal side of the mouthguard, and the occlusal cushion region 20 may occupy primarily or exclusively the occlusal side of the mouthguard. The impact protection region 10 may occupy primarily or exclusively the lateral side of the mouthguard, and the occlusal cushion region 20 may occupy primarily or exclusively the medial side of the mouthguard. The impact protection region 10 may be configured so as not to cover molar teeth. The occlusal cushion region 20 may be configured so as not to cover anterior teeth.

[0125] The material properties of the mouthguard can be precisely tailored to provide a predetermined function. For example, specific locations on the mouthguard can have distinct attributes that can be tailored for a specific function. Optionally, the material properties of the mouthguard at a specific location can be optimized for the primary function of the mouthguard at that specific location. Portions of the mouthguard that have similar material properties can be defined as regions. Portions of the mouthguard that have similar material properties may provide similar functions. Different regions of the mouthguard can be defined by one or more material properties.

[0126] The impact protection region 10 primarily functions to protect the teeth from projectile damage. The impact protection region 10 may dissipate the impact force. For example, the impact protection region 10 may distribute the load force, i.e., the impact protection region 10 may distribute the direct / focused impact force over a wide area / volume. Optionally, the impact protection region 10 transfers a portion of the load force to another region of the mouthguard. For example, the impact protection region 10 may transfer a portion of the impact force to the intermediate region 30 and / or the occlusal cushion region 20. Optionally, the impact protection region 10 may dissipate the impact force throughout the entire impact protection region 10. Optionally, the impact protection region 10 dissipates the impact force through irreversible deformation of its polymer network, such as destruction of the impact protection region 10.

[0127] The material properties of the mouthguard can be precisely tailored to provide a defined function. For example, specific locations on the mouthguard can have distinct attributes that can be tailored to a specific function. Preferably, the material properties of the mouthguard at a specific location are optimized for the primary function of the mouthguard at that location. For example, the material properties of a region of the mouthguard can be tailored to the function of that region.

[0128] The impact protection area can be configured to protect against direct damage during impact by dispersing focal impact loads, thus protecting against traumatic impact to the anterior teeth (e.g., the vulnerable incisors).

[0129] The impact protection region 10 primarily functions to protect the teeth from damage caused by projectiles. For example, the impact protection region 10 distributes load forces to other regions of the mouthguard. For example, the impact protection region 10 can transmit a portion of the load force to other regions of the mouthguard. For example, the impact protection region 10 can transmit a portion of the impact force to the intermediate region 30. Preferably, the impact force transmitted to other regions of the mouthguard is less than the proportion of the impact force absorbed by the impact protection region 10.

[0130] Optionally, the impact protection area 10 may also dissipate a load force, such as an impact force. Optionally, the impact protection area 10 may also dissipate an impact force throughout the impact protection area 10.

[0131] The material properties of the impact protection region 10 can be selected to provide one or more desired functions. For example, the impact protection region 10 may include a hard and / or tough and / or rigid material. A tough impact protection region 10 can withstand large deformations. A brittle and / or hard impact protection region 10 can undergo irreversible deformation, such as fracture or cracking, optionally at a specific impact energy, to dissipate the transmitted load. The impact protection region 10 may include a hard material. The impact protection region 10 may include a material with plastic properties. Preferably, the impact protection region 10 is a hard insert on the mouth guard. In this manner, the material of the impact protection region 10 provides the region with shock-absorbing properties.

[0132] It will be appreciated that, depending on the particular function of the impact protection region 10, the impact protection region may comprise a different material (i.e., a different material compound / composition) than other regions of the mouthguard. Specifically, the impact protection region may comprise a first material, and the intermediate region 30 and the bite cushion region 20 may not comprise the (first) material of the impact protection region. The impact protection region may be the only portion of the mouthguard that comprises the (first) material of the impact protection region.

[0133] The Young's modulus of the impact protection region 10 may be 0.5 to 5 GPa. The Young's modulus of the impact protection region 10 may be 1 GPa or more. Preferably, the Young's modulus of the impact protection region 10 is 2 to 3 GPa. The hardness of the impact protection region 10 may be 60 or more on the Shore D scale. For example, the hardness of the impact protection region 10 may be 80 to 90 on the Shore D scale. Preferably, the impact protection region 10 may have a Shore hardness greater than that of other regions of the mouth guard. For example, the Shore hardness of the impact protection region 10 may be greater than that of the occlusion cushion region 20 and / or the intermediate region 30.

[0134] The impact protection area 10 can include a material having desired material properties. For example, the material of the impact protection area 10 can provide desired mechanical properties. Optionally, the impact protection area 10 can include a hard plastic material. Preferably, the impact protection area 10 includes a thermoplastic material and / or a thermosetting material.

[0135] The impact protection area 10 can have material properties that are optimized and / or tailored for use in the human body. For example, the impact protection area 10 can include a biocompatible material and / or a material with improved biocompatibility. In this way, the impact protection area 10 can have material properties that are optimized for contact with human tissue.

[0136] The impact protection area 10 may include a material with improved tear and / or impact resistance. In this manner, the material properties of the impact protection area 10 may improve the lifespan of the mouthguard.

[0137] The impact protection region 10 may comprise a 3D printable material, such as a resin and / or filament. The impact protection region 10 may comprise a commercially available photosensitive resin, such as for stereolithography (SLA), digital light processing (DLP), light-emitting diode (LED), digital light synthesis (DLS), and / or polyjet printing. The impact protection region 10 may comprise a commercially available filament, such as for fused deposition modeling (FDM) printing. For example, the impact protection region 10 may include Ultracur3D ST1400 and / or Ultrafuse PLAPro1 (BASF), and / or KeyPrint Keysplint Soft and / or Keysplint Hard (Keystone), and / or MED610, MED620 and / or PC-ABS (Stratasys), and / or FLSGAM01 and / or FLBMDU-01 (Formlabs), and / or M2R-TN / GRY / WT / CL (3D Systems), and / or GR-22 Flex and / or GR-10 Guide (printodent), and / or similar 3D printable materials from known suppliers such as DETAX, Dreve, and / or Carbon. The impact protection region 10 may also include custom 3D printable materials. 3D printable biocompatible materials can impart desired material properties to the impact protection region 10. For example, the impact protection region 10 may comprise a 3D printable biocompatible material. Preferably, the impact protection region 10 may comprise a 3D printable biocompatible hard resin.

[0138] The shape of the impact protection region 10 can impart one or more desired characteristics to the impact protection region 10. For example, the impact protection region 10 can include contours that correspond to the user's anatomy, such as the oral and / or dental anatomy. Preferably, the impact protection region 10 can include contours that correspond to the contours of the underlying mouth guard region, such as the partial tooth contour and / or the full tooth contour and / or the tooth-engaging contour of the intermediate region 30. In this manner, the shape of the impact protection region 10 can be customized to the user's anatomy.

[0139] The impact protection region 10 may include a stress concentration feature 15. For example, the impact protection region 10 may incorporate a predetermined groove or crack line. Figures 5D and 5E show an impact protection region 10 including a stress concentration feature 15. The stress concentration feature is shown as a generally vertical groove on the front side of the impact protection region 10. As shown, the stress concentration feature 15 may be located in the center of the impact protection region 10. Other orientations and locations of the stress concentration feature 15 are also possible.

[0140] Stress concentration feature 15 may be configured to deform and / or break when impact protection region 10 is subjected to an impact force. In this manner, stress concentration feature 15 may assist in dissipating the impact force and improve the protection provided by impact protection region 10. For example, stress concentration feature 15 may be configured to reduce the amount of force transmitted from impact protection region 10 to other regions of the mouth guard.

[0141] The stress concentration feature 15 may, for example, be a partial region of the impact protection region 10 that has a different thickness than the remainder of the impact protection region 10. For example, the stress concentration feature 15 may have a thickness that is less than the thickness of the remainder of the impact protection region 10. Preferably, the stress concentration feature 15 is a recess in the surface of the impact protection region 10.

[0142] The dimensions of the impact protection area 10 can impart one or more desired characteristics to the impact protection area 10. For example, the thickness of the impact protection area 10 can be configured to provide a desired level of protection from trauma. Furthermore, the thickness of the impact protection area 10 can provide a desired level of comfort to the user. Preferably, the thickness of the impact protection area 10 is a compromise between the level of impact protection and the level of comfort for the user. Preferably, the thickness of the impact protection area 10 is 0.8 to 4.0 mm, more preferably 0.9 to 2.0 mm, and even more preferably 1.0 to 1.5 mm.

[0143] It can be appreciated that customizing the shape and / or thickness and / or material properties of the impact protection area 10 facilitates customizing the protective performance of the mouthguard. For example, by increasing the thickness and / or hardness of the impact protection area 10, the degree of protection of the impact protection area 10 and / or the mouthguard can be increased. In this way, the degree of protection of the mouthguard can be tailored to the needs of the user, for example, to suit different sports.

[0144] The impact protection region 10 may be configured to be removable from the mouth guard. For example, the impact protection region 10 may be configured to be removable from the intermediate region 30 and / or the bite cushion region 20. The mouth guard 100 of Figures 5A to 5C includes a removable impact protection region 10. Figures 5A and 5B show the removable impact protection region 10 in an attached state, whereby the removable impact protection region 10 is attached to the intermediate region 30. Figure 5C shows the removable impact protection region 10 removed from the intermediate region 30.

[0145] It will be appreciated that the impact protection region 10 may be slid into the installation position. For example, in Figures 5A-5C, one or more interlocking features 41 of the impact protection region 10 may slide along (i.e., parallel / longitudinal to its long axis) one or more interlocking features 41 of the intermediate region 30. In this way, the interlocking features 41 may act as rails to guide the removable mouth guard pieces into the installation position.

[0146] Additionally or alternatively, one or more interlocking features 41 of the impact protection region 10 can be pressed into (i.e., perpendicular / lateral to its long axis) one or more interlocking features 41 of the intermediate region 30 (see, e.g., FIGS. 6A-6B). In this manner, the interlocking features 41 can act to "snap" the removable mouth guard pieces into their attached position.

[0147] The impact protection areas 10 may be configured to be replaceable. For example, a first impact protection area 10 may be removed from the mouth guard and replaced with a second impact protection area 10. Optionally, the mouth guard may have multiple replaceable impact protection areas 10.

[0148] Optionally, the impact protection region 10 may be configured to be removable after the impact protection region 10 is subjected to an impact force. For example, the impact protection region 10 may be configured to be removable only after the impact protection region 10 is subjected to a load force. In this manner, a deformed and / or broken impact protection region 10 may be removed from the mouth guard and replaced with a new and / or undamaged impact protection region 10. Thus, the mouth guard can be reused even after the mouth guard and / or impact protection region 10 is subjected to an impact force. In this manner, the protection level of the mouth guard and / or impact protection region 10 can be restored after the mouth guard and / or impact protection region 10 is subjected to an impact force.

[0149] The impact protection region 10 can be configured to be removed from the mouthguard when no impact force is received. For example, a first impact protection region 10 having a first characteristic can be removed from the mouthguard. Optionally, the first impact protection region 10 can be replaced with a second impact protection region 10. The second impact protection region 10 may have different characteristics from those of the first impact protection region 10. For example, the second impact protection region 10 can have a different surface design and / or appearance and / or Young's modulus and / or hardness and / or dissipation ability than the first impact protection region 10. In this manner, different material properties can be imparted to the mouthguard. For example, different material properties can be imparted to the mouthguard without the need to replace the mouthguard and / or fabricate a new mouthguard. Thus, the mouthguard can be adapted for different sports. For example, the mouthguard can be adapted for different sports in which impact forces of different natures and / or magnitudes are expected.

[0150] The original impact protection area 10 can be replaced with a new impact protection area 10 that has a different appearance from the original impact protection area 10. For example, an impact protection area 10 of a different color or a different design. In this way, the mouth guard can be customized according to the needs or desires of the user.

[0151] As discussed above, bite cushion region 20 is configured to provide protection from indirect injury during impact by increasing head stability and / or reducing force transmission to the skull.

[0152] For example, by allowing biting on the mouth guard, the bite cushion area 20 provides jaw clenching and activation of neck muscles such as the sternocleidomastoid muscle. Thus, the bite cushion area 20 reduces rotation and improves head stability during traumatic impact, thereby protecting against rotation-induced brain injury.

[0153] Additionally or alternatively, by altering the configuration of the jaw, for example, by providing separation between the mandibular condyle of the head and the mandibular fossa of the skull, the bite cushion region 20 can reduce the transmission of force from the jaw to the skull. In this way, the brain experiences lower transmitted forces during an impact and is therefore protected from injury. Through one or more of these described mechanisms for reducing brain damage, the bite cushion region 20 can therefore provide an anti-impact effect. In this way, the mouth guard of the present invention may qualify as a medical device, for example, the mouth guard of the present invention may qualify as a Class I medical device.

[0154] The mouthguard may include a single bite cushion region 20. For example, the mouthguard may include a bite cushion region 20 on only one side of the mouthguard. The mouthguard may include multiple bite cushion regions 20. For example, the mouthguard may include bite cushion regions 20 on both sides of the mouthguard. Preferably, the mouthguard may include a first bite cushion region 20 and a second bite cushion region 20. For example, the mouthguard may include a right bite cushion region 20 and a left bite cushion region 20. The mouthguard 100 of FIGS. 1-4 includes a first bite cushion region 20 and a second bite cushion region 20.

[0155] The material properties of the bite cushion region 20 can be selected to impart one or more desired functions. For example, the bite cushion region 20 may comprise a flexible material and / or a soft material and / or a low hardness material.

[0156] Optionally, the bite cushion region 20 may be a soft insert on the mouth guard. For example, the mouth guard 100 of Figures 2A and 2B may include a bite cushion region 20 that is a soft insert on the intermediate region 30. In this manner, the bite cushion region 20 may be supported by the intermediate region 30.

[0157] The occlusal cushion region 20 may comprise a material having elastic properties. Optionally, the occlusal cushion region 20 may be viscoelastic and / or exhibit nonlinear behavior after deformation. For example, the occlusal cushion region 20 may comprise a rubber-like material and / or an elastomeric material and / or a polymeric material. The occlusal cushion region 20 may comprise a material capable of withstanding a tensile strain of at least 50%, e.g., 50-70%, more preferably at least 70%, or 70% or more. The occlusal cushion region 20 may have a lower Shore hardness. For example, the hardness of the occlusal cushion region 20 may be 40-80 on the Shore A scale, preferably 60-80 on the Shore A scale. More preferably, the hardness of the occlusal cushion region 20 is 55-75 on the Shore A scale, preferably 65-75 on the Shore A scale. The occlusal cushion region 20 may have a Young's modulus that is smaller than that of other regions of the mouthguard. For example, the Young's modulus of the occlusal cushion region 20 may be less than that of the impact protection region 10 and / or the intermediate region 30. Preferably, the occlusal cushion region 20 has a compressive Young's modulus that is less than that of other regions of the mouthguard. For example, the occlusal cushion region 20 may have a compressive Young's modulus of 10-25 MPa near the 20% strain range, or 8-25 MPa near the 20% strain range.

[0158] It will be appreciated that customizing the material properties of the occlusal cushion region 20 allows for customization of the protective performance of the mouthguard. For example, decreasing the hardness and / or changing the Young's modulus of the occlusal cushion region 20 can increase the degree of bite and / or jaw clenching and / or neck muscle engagement and / or head stability. In this manner, the degree of protection of the mouthguard can be tailored to the needs of the user, for example, to suit different sports.

[0159] The occlusal cushion region 20 may include a material that imparts one or more desired material properties. For example, the material of the occlusal cushion region 20 may impart desired mechanical properties. Optionally, the occlusal cushion region 20 may include a resilient and / or hyperviscoelastic material, optionally a thermoplastic and / or thermoset material. Preferably, the occlusal cushion region 20 may include an elastomeric material and / or a flexible polymeric material.

[0160] The occlusal cushion region 20 may have material properties that are optimized for use with the human body. For example, the occlusal cushion region 20 may include a biocompatible material and / or a material with improved biocompatibility. In this manner, the material properties of the occlusal cushion region 20 can be optimized for contact with human tissue.

[0161] Optionally, the bite cushion region 20 may include a material with improved tear resistance. In this manner, the material properties of the bite cushion region 20 may improve the longevity of the mouthguard.

[0162] The occlusal cushion region 20 may comprise a 3D printable material, such as a resin and / or a filament. The occlusal cushion region 20 may comprise a commercially available resin for 3D printing, such as for stereolithography (SLA), digital light processing (DLP), light-emitting diodes (LED), digital light synthesis (DLS), and / or polyjet printing. The occlusal cushion region 20 may comprise a commercially available filament for fused deposition modeling (FDM) printing. For example, the occlusal cushion region 20 may comprise Ultracur3D EL 150 and / or Ultrafuse TPU 85a (BASF), and / or EPU40 (Carbon), and / or NinjaFlex (Ninjatech), and / or Visijet M2E / BK70 (3D Systems), and / or GR-15.1 Gingiva (printodent), and / or similar 3D-printable materials from known suppliers, such as Dreve and / or DETAX. The occlusal cushion region 20 may also comprise custom 3D-printable materials. The 3D-printable biocompatible materials can impart any desired material properties to the occlusal cushion region 20. For example, the occlusal cushion region 20 may comprise a 3D-printable biocompatible material. Preferably, the occlusal cushion region 20 may comprise a 3D-printable biocompatible fatigue-resistant resin.

[0163] The shape of the bite cushion region 20 can impart one or more desired characteristics to the bite cushion region 20. For example, the bite cushion region 20 can include contours that correspond to the user's anatomy, such as the oral and / or dental anatomy. Preferably, the bite cushion region 20 can include partial and / or complete teeth-engaging contours. In this manner, the shape of the bite cushion region 20 can be customized to the user's anatomy.

[0164] The dimensions of the occlusal cushion region 20 can impart one or more desired characteristics to the occlusal cushion region 20. For example, a sufficient thickness of the occlusal cushion region 20 can provide sufficient cushioning during clenching, thereby providing a sufficient degree of neck muscle activity for effective head stabilization. A sufficient thickness of the occlusal cushion region 20 can provide sufficient separation between the mandibular condyle and the mandibular fossa, thereby reducing the transmission of impact forces from the jaw to the skull to effectively protect against brain injury in jaw impacts.

[0165] Customizing the thickness of the occlusal cushion region 20 allows for customization of the degree of protection provided. For example, increasing the thickness of the occlusal cushion region 20 increases the degree of possible tooth occlusion and / or clenching, and therefore increases the degree of muscle activation. In this manner, the degree of head stabilization can be customized. As a further example, increasing the thickness of the occlusal cushion region 20 increases the separation between the mandibular condyles and the mandibular fossa, thereby reducing the transmission of impact forces from the jaw to the skull. However, increasing the thickness of the occlusal cushion region 20 may further reduce the level of user comfort. Preferably, the thickness of the occlusal cushion region 20 is customized to provide a compromise between the degree of protection and the level of user comfort. Preferably, the thickness of the occlusal cushion region 20 is 1.5 to 6.0 mm, more preferably 2.0 to 5.0 mm, and even more preferably 2.5 to 4.0 mm.

[0166] The internal structure of the occlusal cushion region 20 can impart one or more desired material properties to the occlusal cushion region 20. For example, by altering the internal structure of the occlusal cushion region 20, the effective material properties of the material of the occlusal cushion region 20 can be altered.

[0167] For example, increasing the porosity of the occlusal cushion region 20 decreases the stiffness of the occlusal cushion region 20. Thus, the overall material properties of the occlusal cushion region 20 can be altered in a simple and efficient manner. In a mouthguard that includes an occlusal cushion region 20 and an intermediate region 30 that preferably include the same material (i.e., the same material compound / composition) having the same inherent material properties, altering the internal structure of the occlusal cushion region 20 can impart different overall and / or apparent material properties to the occlusal cushion region 20 compared to the intermediate region 30.

[0168] It can be appreciated that the degree of change to the effective material properties of a region can be customized by the degree of change to the internal structure of the region. In this manner, the stiffness of the occlusal cushion region 20 can be adjusted by adjusting the internal structure, such as adjusting the degree of porosity and / or perforation. The stiffness of the occlusal cushion region 20 can be decreased to a desired degree by increasing the porosity and / or perforation of the occlusal cushion region 20.

[0169] By adjusting the hardness of the intermediate region and / or bite cushion region, the degree of bite-induced neck muscle activity can be adjusted.

[0170] In the mouthguard of Figures 3 and 4, the bite cushion area 20 has a porous structure. The porous bite cushion region 20 may be provided only on the occlusal surface. For example, in Figure 4, the bite cushion region 20 has a porous structure. The bite cushion region 20 of the mouth guard 100 of Figure 4 is located on the occlusal surface of the mouth guard. The bite cushion region 20 of the mouth guard 100 of Figure 4 is located within a tooth-engaging contour.

[0171] The porous bite cushion region 20 may be internally and / or externally exposed. For example, the bite cushion region 20 in both Figures 3 and 4 is both internally and externally exposed, i.e., the porous structure is on the interior and exterior surfaces of the mouthguard. The porous bite cushion region 20 may be on the occlusal surface portion and / or the labial surface portion and / or the proximal-gingival surface portion. For example, the porous bite cushion region 20 in Figure 3 includes an occlusal surface portion, a labial surface portion, and a proximal-gingival surface portion.

[0172] The bite cushion region 20 may include two materials. For example, the bite cushion region 20 may include a porous material with a gel-like material injected therein. In the mouth guard of FIG. 4, the pores of the porous bite cushion region 20 are filled with a gel-like material. The gel-like material may have different material properties than the porous material of the bite cushion region 20. Injecting a gel-like material can thus provide customization of the overall material properties of the bite cushion region 20. For example, the gel-like material can improve the shock absorption of the bite cushion region 20. In this way, the overall material properties of the bite cushion region can be tailored to the end user's needs.

[0173] The intermediate region 30 can assist in dissipating impact (i.e., load) forces. For example, the intermediate region 30 may dissipate impact forces throughout the intermediate region 30 due to deformation of the intermediate region 30. Optionally, the intermediate region 30 may distribute load forces. In this manner, the intermediate region 30 may be a shock absorbing component.

[0174] Optionally, intermediate region 30 transfers load forces to and / or from other regions of the mouthguard. For example, intermediate region 30 may transfer a portion of an impact force from impact protection region 10 to intermediate region 30 and / or to bite cushion region 20.

[0175] The material properties of the intermediate region 30 can be selected to optimize one or more desired functions of the intermediate region 30. For example, the intermediate region 30 may comprise a flexible material and / or a soft or tough material. For example, the intermediate region 30 may be softer than the impact protection region 10. The intermediate region 30 may comprise a tough material and / or a less soft material. For example, the intermediate region 30 may be harder than the bite cushion region 20.

[0176] The intermediate region 30 may include a material with hyperviscoelastic properties. For example, the intermediate region 30 may behave differently at different load levels and / or may exhibit nonlinear behavior after deformation. Optionally, the intermediate region 30 may include a rubber-like material and / or an elastomeric material and / or a polymeric material. The material of the intermediate region 30 can withstand large deformations. The intermediate region 30 may include a material that can withstand a tensile strain of at least 50%, for example, a tensile strain of 50-70%, more preferably at least 70%, or even 70% or more. The hardness of the intermediate region 30 may be 60-95 on the Shore A scale, for example, 70-95 on the Shore A scale. Preferably, the hardness of the intermediate region 30 is 75-85 on the Shore A scale.

[0177] The intermediate region 30 may have a Young's modulus that is different from the Young's modulus of the other regions of the mouthguard. For example, the Young's modulus of the intermediate region 30 may be greater than the Young's modulus of the bite cushion region 20. The intermediate region 30 may have a Young's modulus that is smaller than the Young's modulus of the other regions of the mouthguard. For example, the Young's modulus of the intermediate region 30 may be smaller than the Young's modulus of the impact protection region 10. Preferably, the intermediate region 30 has a compressive Young's modulus that is different from the compressive Young's modulus of the other regions of the mouthguard. For example, the intermediate region 30 may have a compressive Young's modulus of 15 to 40 MPa around the 20% strain range.

[0178] Intermediate region 30 may comprise a material that imparts one or more desired material properties to intermediate region 30. Preferably, intermediate region 30 may comprise a thermoplastic material and / or a thermoset material.

[0179] Intermediate region 30 may have material properties optimized for use in the human body. For example, intermediate region 30 may include a biocompatible material and / or a material with improved biocompatibility. In this manner, the material properties of intermediate region 30 are optimized for contact with human tissue.

[0180] The intermediate region 30 may include a material with improved tear resistance. In this manner, the material properties of the intermediate region 30 may improve the longevity of the mouthguard.

[0181] Intermediate region 30 may include a 3D printable material, such as a resin and / or a filament. Intermediate region 30 may include a commercially available resin for stereolithography (SLA), digital light processing (DLP), light-emitting diodes (LED), digital light synthesis (DLS), and / or polyjet printing, etc. Intermediate region 30 may include a commercially available filament for fused deposition modeling (FDM) printing, etc. For example, intermediate region 30 may include Ultracur3D EL 150, and / or Ultracur3D EL 4000, and / or Ultrafuse TPU 85a (BASF), and / or EM+21, EM+23 (Luxcreo), and / or FDM TPU 92a (Stratasys), and / or NinjaFlex (Ninjatech), and / or KeyOrtho IBT (Keyprint), and / or ID2045 (Arnitel), and / or GR-18.1 IB (printodent) and / or Freeprint IBT (Detax), and / or Dreve, and / or Carbon, and similar 3D printable materials from known suppliers. Intermediate region 30 may also include custom 3D printable materials. An elastomeric custom-made photocurable G2P1 resin was formulated using, for example, 53 wt% (weight percent) aliphatic urethane diacrylate (RAHN), 26 wt% isobornyl methacrylate (Sigma-Aldrich), 13 wt% isodecyl methacrylate (Sigma-Aldrich), 7 wt% urethane dimethacrylate (Sigma-Aldrich), and 1 wt% phenylbis(2,4,6-trimethyl-benzoyl)phosphine oxide (Sigma-Aldrich). The 3D-printable biocompatible material can impart any desired material properties to the intermediate region 30. For example, the intermediate region 30 may comprise a 3D-printable biocompatible material. Preferably, the intermediate region 30 may comprise a 3D-printable biocompatible dissipative resin.

[0182] The shape of the intermediate region 30 can impart one or more desired characteristics to the intermediate region 30. For example, the intermediate region 30 can include a contour that corresponds to the user's anatomy, such as the oral and / or dental anatomy. Preferably, the intermediate region 30 can include a partial and / or complete tooth-engaging contour. In this manner, the shape of the intermediate region 30 can be customized to the user's anatomy.

[0183] Preferably, the intermediate region 30 may include a rail component. For example, the intermediate region 30 may have a U-shaped vertical cross section (see, for example, Figures 1-6). Additionally or alternatively, the intermediate region 30 may be a U-shaped component. For example, the intermediate region 30 may have a U-shaped horizontal cross section (see, for example, Figures 1-6).

[0184] The intermediate region 30 may be configured to provide a mounting surface for the impact protection region 10 and / or the bite cushion region 20. For example, the intermediate region 30 may include a recess configured to accommodate the impact protection region 10. Figures 5C and / or 6A show an exemplary intermediate region 30 including a recess configured to accommodate the impact protection region 10.

[0185] The intermediate region 30 may include a recess configured to accommodate the bite cushion region 20. For example, FIGS. 2A and 2B show the bite cushion region 20 disposed in a recess on the inner surface of the rail-shaped intermediate region 30. Optionally, the intermediate region 30 may include a first recess configured to have a shape complementary to the impact protection region 10. The intermediate region 30 may also include a second recess configured to have a shape complementary to the bite cushion region 20. The impact protection region 10 and / or the bite cushion region 20 may include a layer configured to be disposed on a portion of the intermediate region 30. In this manner, the intermediate region 30 may be configured to couple the impact protection region 10 to the bite cushion region 20.

[0186] Optionally, the intermediate region 30 can mechanically couple the impact protection region 10 to the occlusal cushion region 20. Preferably, the rear side of the intermediate region 30 may form an interface with the occlusal cushion region 20. The front side of the intermediate region 30 may form an interface with the impact protection region 10. For example, the intermediate region 30 may be disposed between the impact protection region 10 and the occlusal cushion region 20 (see, for example, FIG. 1 ).

[0187] The dimensions of the intermediate region 30 can impart one or more desired characteristics to the intermediate region 30. For example, the thickness of the intermediate region 30 can provide sufficient protection to the tooth and / or adjacent gums during a traumatic impact. The thickness of the intermediate region 30 can provide a desired level of comfort to the user. For example, the thickness of the intermediate region 30 can be a compromise between the desired level of protection and the desired level of user comfort. Preferably, the maximum thickness of the intermediate region 30 can be 2.5 to 5.0 millimeters, more preferably 3.0 to 4.5 millimeters, and even more preferably 3.2 to 4.0 millimeters. The thickness of the intermediate region 30 can vary over different portions of the intermediate region 30. For example, the thickness of the intermediate region can vary from 1 to 5 millimeters over different portions.

[0188] It can be appreciated that the intermediate region 30 and / or the bite cushion region 20 may comprise different materials (i.e., different material compounds / compositions) having different inherent material properties. For example, the bite cushion region 20 may comprise a softer rubber-like material, and the intermediate region 30 may comprise a harder rubber-like material. The material of the bite cushion region 20 may have a lower Shore hardness. The material of the intermediate region 30 may have a higher Shore hardness.

[0189] Additionally or alternatively, the intermediate region 30 and the bite cushion region 20 may comprise the same material (i.e., the same material compound / composition) having the same inherent material properties, or the intermediate region 30 and the bite cushion region 20 may have different internal structures, such as macroscopic or microscopic internal structures. For example, the bite cushion may comprise a first material having a porous or perforated structure. The intermediate region 30 may comprise a first material having a solid structure and / or a non-porous structure and / or a non-perforated structure. The different internal structure of the bite cushion region 20 compared to the intermediate region 30 may impart different properties to the bite cushion region 20 compared to the intermediate region 30. For example, a perforated bite cushion region 20 may have a lower hardness than a solid and / or non-perforated intermediate region 30. A perforated bite cushion region 20 may have a lower stiffness than a solid and / or non-perforated intermediate region 30. The perforated bite cushion region 20 may have a lower Young's modulus than the solid and / or non-perforated intermediate region 30 .

[0190] It can be appreciated that the modularity of a mouthguard, i.e., having different components corresponding to different regions of the mouthguard with different material properties, can provide for optimization of the material properties of different aspects of the mouthguard with respect to the desired function of that region. For example, the materials used in labial regions, such as impact protection region 10, and occlusal regions, such as bite cushion region 20, can be differentiated from one another. In this way, the performance of the mouthguard can be improved.

[0191] It will be appreciated that the modular nature of the mouthguard may provide for flexible customization of the properties and / or functional performance of the mouthguard. For example, the properties and / or functional performance of one region may be adjusted separately from the properties and / or functional performance of another region. For example, the properties and / or functional performance of the impact protection region 10 may be adjusted separately from the properties and / or functional performance of the bite cushion region 20 and / or the intermediate region 30. Preferably, the properties and / or functional performance of the impact protection region 10 may therefore be altered with no or minimal changes to the properties and / or functional performance of the bite cushion region 20. For example, the impact protection function of the mouthguard may be adjusted with no or minimal changes to the anti-seismic function of the mouthguard. The properties of the bite cushion region 20 may be altered with no or minimal changes to the properties and / or functionality of the impact protection region 10. The anti-seismic function of the mouthguard may be adjusted with no or minimal changes to the impact protection function of the mouthguard. In this way, different functions of the mouthguard can be separately and precisely customized to meet the needs of the end user, for example for use of the mouthguard in different sports.

[0192] The mouth guard may include an interlocking portion 40. For example, the interface between different regions of the mouth guard may include an interlocking portion 40. The interlocking portion 40 may be configured as a mechanical interlocking portion 40. Preferably, the interlocking portion 40 is configured to mechanically interlock the different regions of the mouth guard. For example, the exemplary mouth guard of FIGS. 1-7 includes an interlocking portion 40 at the interface between the different regions of the mouth guard.

[0193] The interlocking portion 40 may be configured to provide for attachment and / or fastening of different regions of the mouth guard. For example, the interlocking portion 40 may provide for attachment of one region of the mouth guard to another region of the mouth guard. Preferably, the interlocking portion 40 provides for attachment of a first mouth guard piece including a first region of the mouth guard to a second mouth guard piece including a different region of the mouth guard. In this manner, the interlocking portion 40 may facilitate more efficient assembly of the mouth guard. For example, the interlocking portion 40 may provide for the mouth guard to be assembled without the need for sealants and / or adhesives. In this manner, the number of materials and production costs of the mouth guard may be reduced, and the efficiency of manufacturing the mouth guard may be improved.

[0194] The interface between the impact protection region 10 and the intermediate region 30 may include a mechanical interlocking portion 40. FIGS. 1-7 show the interlocking portion 40 between the impact protection region 10 and the intermediate region 30. The interlocking portion 40 is for attaching the impact protection region 10 to the intermediate region 30. Additionally or alternatively, the interface between the intermediate region 30 and the occlusal cushion region 20 may include a mechanical interlocking portion 40. FIGS. 1-2 show the interlocking portion 40 between the intermediate region 30 and the occlusal cushion region 20. The interlocking portion 40 can thus provide for attachment of the occlusal cushion region 20 to the intermediate region 30.

[0195] The interlocking portion 40 may include a plurality of interlocking features 41. The interlocking feature 41 may include, for example, a male connector or a female connector. For example, the interlocking portion 40 may include a plug and socket / jack interlocking feature 41. For example, the interlocking portion 40 may include a pin and recess / hole interlocking feature 41. For example, the interlocking portion 40 may include a rail and groove interlocking feature 41. For example, the interlocking portion 40 may include a protrusion and recess interlocking feature 41. Preferably, the interlocking portion 40 may include a protrusion and a recess having complementary shapes.

[0196] 1 to 7 show the interlocking portion 40 between the impact protection region 10 and the intermediate region 30. The interlocking feature 41 of the mouth guard piece including the impact protection region 10 has a shape complementary to the interlocking feature 41 of the mouth guard piece including the intermediate region 30.

[0197] 1 to 7 show the interlocking portion 40 between the impact protection region 10 and the intermediate region 30. The interlocking feature 41 of the mouth guard piece including the impact protection region 10 has a shape complementary to the interlocking feature 41 of the mouth guard piece including the intermediate region 30.

[0198] The interlocking feature 41 may be formed from a part of the mouth guard piece including the mouth guard region. For example, the mouth guard piece including the mouth guard region may further include the interlocking feature 41. For example, the mouth guard piece including the mouth guard region may additionally include a male connector and / or a female connector and / or a plug and / or a socket and / or a jack and / or a pin and / or a protrusion and / or a recess and / or a hole and / or a rail and / or a groove.

[0199] Optionally, the hole-containing interlocking feature 41 may extend completely or partially through one or more of the guard regions and / or segments. For example, the guard of Figures 2A and 2B includes an intermediate region 30 that includes an interlocking feature that is a hole that extends completely through the intermediate region 30. In the guard of Figures 2A and 2B, the complementary interlocking feature is a protrusion in the bite cushion region 20.

[0200] The mouth guard of Figures 6A and 6B includes an interlocking feature 40 between the impact protection region 10 and the intermediate region 30. The interlocking feature 41 may be a recess that extends partially into the intermediate region 30. A complementary interlocking feature 41 may be a protrusion of the impact protection region 10. The impact protection region 10 has an outer surface. The impact protection region 10 does not have an inner surface. In this way, the comfort and / or safety of the mouth guard may be improved by having the protrusion of the impact protection region 10 cushioned by the intermediate region 30.

[0201] A mouthguard piece including a mouthguard region may include multiple interlocking features 41. A mouthguard piece including a mouthguard region may include multiple interlocking features 41 that are the same type of interlocking features 41. A mouthguard piece including a mouthguard region may include multiple interlocking features 41 that are different types of interlocking features 41.

[0202] The interlocking feature 41 may comprise a mouthguard piece separate from the mouthguard piece comprising the mouthguard region. For example, the interlocking feature 41 may comprise an interlocking piece, i.e., a separate interlocking piece. Figures 6A and 6B show a mouthguard 100 including a separate interlocking piece. The separate interlocking piece in Figures 6A and 6B is a plug that extends through complementary holes in the intermediate region 30 and the impact protection region 10.

[0203] The interlocking piece 41 may include a male connector and / or a female connector and / or a plug and / or a socket and / or a jack and / or a pin and / or a recess and / or a hole and / or a rail and / or a groove.

[0204] The interlocking feature 40 may include a portion of a guard segment that includes a guard region, or may include an interlocking piece, i.e., another interlocking piece. Preferably, an interlocking feature that includes an interlocking piece may include a portion of multiple guard segments that include a guard region. For example, the male and / or female components of the interlocking feature 41 may include multiple guard segments and / or multiple guard regions. The mouth guard 100 of FIGS. 6A and 6B includes an interlocking feature 40 that has a male portion and a female portion. The male portion is a plug / pin that is an interlocking piece. The female portion is a hole that includes a guard segment that includes the impact protection region 10 and a guard segment that includes the intermediate region 30.

[0205] Alternatively, the plug / pin may be embedded in the impact protection area 10. That is, the plug / pin in Figures 6A and 6B may be an interlocking feature 41 formed from part of the mouth guard piece that includes the impact protection area 10.

[0206] The mouth guard of FIG. 1 includes an interlocking portion 40 between the intermediate region 30 and the bite cushion region 20. The intermediate region 30 includes an interlocking feature 41 that is a female connector, and the bite cushion region 20 includes an interlocking feature 41 that is a male connector. It can be understood that the intermediate region 30 generally has a greater hardness than the bite cushion region 20. Thus, the female connector may include a region that has a greater hardness than a corresponding region of the male connector. The male connector may include a region that has a lower hardness than a corresponding region of the female connector. This can provide greater security for the interlocking portion 40 and / or greater stability for the interlocking portion 40 during deformation of the mouth guard, for example, during bruxism. In this manner, a stiffer female connector and a less stiff male connector can reduce the risk of failure of the interlocking feature 41.

[0207] The mouth guard 100 of FIG. 2A includes an interlocking portion 40 between the impact protection region 10 and the intermediate region 30. The intermediate region 30 includes an interlocking feature 41 that is a female connector, and the impact protection region 10 includes an interlocking feature 41 that is a male connector. The female connector may therefore include a region with a lower hardness than the corresponding region of the male connector. The male connector may include a region with a higher hardness than the corresponding region of the female connector. This configuration may provide greater comfort to the user. A softer female connector may reduce the risk of injury to the user, for example, injury resulting from a projectile striking an area with a higher hardness. A softer female connector may increase the security of the interlocking portion 40 and / or increase the stability of the interlocking portion 40 during deformation of the mouth guard, for example, during projectile impact. In this manner, the risk of breakage of the interlocking feature 41 may be reduced.

[0208] It is of course possible to connect the intermediate region 30 and the bite cushion region 20 with an interlocking portion 40 therebetween, such that the intermediate region 30 includes an interlocking feature that is a male connector, and the bite cushion region 20 includes an interlocking feature that is a female connector. Similarly, it is possible to connect the impact protection region 10 and the intermediate region 30 with an interlocking portion 40 therebetween, such that the impact protection region 10 includes an interlocking feature that is a female connector, and the intermediate region 30 includes an interlocking feature that is a male connector.

[0209] A region of the mouthguard may be removable. For example, a region of the mouthguard may be removable from another region of the mouthguard. Preferably, a first mouthguard piece including a region of the mouthguard is removable from a second mouthguard piece including a different region of the mouthguard. For example, the impact protection region 10 and / or the bite cushion region 20 may be removable from the mouthguard. Optionally, the impact protection region 10 and / or the bite cushion region 20 are removable from the intermediate region 30. A mouthguard piece including the impact protection region 10 may be removable from a mouthguard piece including the intermediate region 30. A mouthguard piece including the bite cushion region 20 may be removable from a mouthguard piece including the intermediate region 30.

[0210] Regions of the mouthguard may be configured to be interchangeable. For example, a first region of the mouthguard may be configured to be interchangeable with a second region of the mouthguard of the same type as the first region. Optionally, the second region may have different properties from the first region. For example, the first impact protection region 10 may be interchangeable with the second impact protection region 10. The second impact protection region 10 may have a different appearance, hardness, Young's modulus, and / or other material properties compared to the first impact protection region 10. The first bite cushion region 20 may be interchangeable with the second bite cushion region 20. The second bite cushion region 20 may have a different appearance, hardness, Young's modulus, and / or other material properties compared to the first bite cushion region 20. The material properties of the mouthguard can thus be changed without fabricating a new mouthguard as a whole. Preferably, the function of the mouthguard can be changed by fabricating a single new mouthguard piece. In this manner, the mouthguard can be more easily and efficiently adapted.

[0211] Damaged and / or worn regions of a mouthguard may be replaceable. For example, a first region of a mouthguard may be configured to be replaceable with a second region of the mouthguard that is the same type and has the same properties as the first region. For example, a damaged impact protection region 10 may be replaced with an undamaged and / or new impact protection region 10. The new impact protection region 10 may have the same appearance, hardness, Young's modulus, and / or other material properties as the damaged impact protection region 10. A damaged and / or worn occlusal cushion region 20 may be replaced with an undamaged and / or new occlusal cushion region 20. The new occlusal cushion region 20 may have the same appearance, hardness, Young's modulus, and / or other material properties as the first occlusal cushion region 20. In this manner, damaged and / or worn mouthguards can be repaired, improving the lifespan of the mouthguard. Furthermore, the efficiency of mouthguard repair may be improved. Specifically, a region of a mouthguard may be replaced without replacing the entire mouthguard.

[0212] Interlocking portion 40 may be configured to provide temporary attachment. For example, interlocking portion 40 may be configured to provide temporary mechanical interlocking of different guard segments and / or regions of the guard. Optionally, interlocking portion 40 may be configured to allow for detachment of one guard segment and / or region of the guard from another guard segment and / or region of the guard. In this manner, interlocking portion 40 may improve ease of assembly and disassembly of the guard.

[0213] The interlocking feature 41 may be configured to be positioned to reduce discomfort for the user. For example, the interlocking feature 41 may be configured to be positioned in an area on the interface between adjacent teeth. For example, in FIGS. 5A-5C , the interlocking feature 41 in the impact protection area 10 is configured to be positioned in an area between the teeth. Preferably, the interlocking feature 41 may be positioned according to various factors. To determine the position of the interlocking feature 41, factors such as the user's needs, the type of interlocking feature 41, the shape of the interlocking feature 41, the orientation of the male and female components, and / or the positions of the male and female components may be considered. In this way, the protective performance of the mouth guard may be improved, and the accuracy and / or comfort of wearing the mouth guard for the user may be improved.

[0214] The interlocking feature 41 may be configured to be positioned to reduce the risk of failure, such as unintentional removal of a portion of the mouth guard due to impact or bite.

[0215] The mouth guard may be configured to provide a gap between the mouth guard and the teeth, which provides space for the impact protective components to flex and break, allowing impact energy to be absorbed. The inclusion of a gap between the teeth and the mouth guard improves the protective performance of the mouth guard by improving control of energy absorption.

[0216] Preferably, the anterior surface of the interface between the mouth guard and the teeth is configured to include a gap. For example, the anterior surface of the interface between the mouth guard and the teeth may be configured to include a forward offset 50 between the teeth and the mouth guard. For example, the shape of the mouth guard may be such that the anterior surface of the mouth guard does not directly contact / contact the teeth. For example, the mouth guard 100 of FIG. 7 is configured to provide a forward offset 50 between the teeth and the mouth guard. In this manner, the inner surface of the anterior surface of the mouth guard may be offset from the teeth. For example, the inner surface of the intermediate region 30 may be configured to be offset forward from the teeth. This gap provides space for the forward-located impact protection region 10 to flex upon impact, thereby improving energy absorption of the impact protection region 10. In this manner, the protective performance of a mouth guard configured to provide a gap between the teeth and the mouth guard is greater than the protective performance of a mouth guard configured to completely contact the teeth. In this manner, the forward offset can improve the protective performance of the mouth guard.

[0217] Optionally, the region of the mouthguard configured to be offset anteriorly from the teeth may correspond to the region of the mouthguard underlying the impact protection region 10. Preferably, a portion of the intermediate region 30 underlying the impact protection region 10 is configured to be offset anteriorly from the teeth. The inclusion of a gap between the teeth and a mouthguard including a hard insert such as the impact protection region 10 further enhances the protective performance of the mouthguard due to the combined dissipative effect of the anterior offset 50 and the impact protection region 10.

[0218] Optionally, the mouth guard may be configured to be offset from the front teeth. Preferably, the mouth guard may be configured to be offset anteriorly from the front teeth by at least 1 millimeter. For example, the mouth guard may be configured to be offset anteriorly from the front teeth by 1 to 2 millimeters. The mouth guard may be configured to be offset anteriorly from the front teeth by 2 millimeters or more. The mouth guard may be configured to be offset anteriorly from the central incisors and / or lateral incisors and / or canines. Preferably, the mouth guard is configured to be offset anteriorly from multiple front teeth. For example, the mouth guard may be configured to be offset anteriorly from one canine to the other canine. For example, the mouth guard may be configured to be offset anteriorly from the right canine, right incisor, right central incisor, left central incisor, left incisor, and left canine.

[0219] The distance of the offset may vary across the width of the anterior offset 50. For example, the mouth guard may be configured to provide a greater anterior offset 50 distance at the anterior lateral portion of the anterior offset 50 and / or a lesser anterior offset 50 distance at the lateral lateral portion of the anterior offset 50.

[0220] Additionally or alternatively, the front portion of the mouth guard may include a gap within the mouth guard. For example, the front portion of the mouth guard may include a gap region 60. The gap region 60 may be at an interface between other regions of the mouth guard. Preferably, the gap region 60 is between the impact protection region 10 and the intermediate region 30. In FIG. 1 , the gap region 60 is between the intermediate region 30 and the impact protection region 10. The gap region 60 may be surrounded by other regions of the mouth guard. For example, the gap region 60 may be surrounded by the intermediate region 30. The gap region 60 may be surrounded by the impact protection region 10.

[0221] It will be appreciated that the front portion of the mouth guard may include multiple layers. The front portion of the mouth guard may include multiple layers, including the gap region 60. The front portion of the mouth guard may include layers including the gap region 60 and / or the impact protection region 10 and / or the intermediate region 30. If the gap region 60 is at the interface between regions, the front portion of the mouth guard may include three layers. The front portion of the mouth guard 100 in FIG. 1 includes three layers: the impact protection region 10 layer, the gap region 60 layer, and the intermediate region 30 layer. The front portion of the mouth guard 100 in FIG. 7 includes three layers: the impact protection region 10 layer, the intermediate region 30 layer, and the front offset 50 layer. If the gap region 60 is surrounded by other regions, the front portion of the mouth guard may include four layers.

[0222] The portion of the mouth guard including the gap region 60 may correspond to the portion of the mouth guard below the impact protection region 10. Preferably, the gap region 60 is posterior to the portion of the impact protection region 10. Additionally or alternatively, the gap region 60 may be configured to cover an anterior tooth. The gap region 60 may be configured to cover a central incisor and / or a lateral incisor and / or a canine. Preferably, the gap region 60 is configured to cover multiple anterior teeth. For example, the gap region 60 may be configured over a right canine, a right lateral incisor, a right central incisor, a left central incisor, a left lateral incisor, and / or a left canine.

[0223] Preferably, the gap region 60 may have a thickness of at least 0.7 millimeters. For example, the gap region 60 may include a gap of 1-2 millimeters. The gap region 60 may have a thickness of 2 millimeters or more. The thickness of the gap region 60 may vary over the length of the gap region 60. For example, the mouth guard may be configured to have a greater thickness at the anterior lateral portions of the gap region 60 and / or a lesser thickness at the lateral lateral portions of the gap region 60.

[0224] Similar to the above-mentioned feature of forward offset 50, the inclusion of gap region 60 improves the protective performance of the mouthguard by improving the absorption of impact energy by the impact protection region. By including gap region 60 between the teeth and a rigid insert of the mouthguard, such as impact protection region 10, the combined dissipative effect of gap region 60 and the rigid impact protection region 10 further enhances the protective performance of the mouthguard.

[0225] 8 and / or 9 illustrate methods 1000, 2000 for making a mouth guard, preferably according to any of the embodiments disclosed above. It can be appreciated that one or more method steps of method 1000 of FIG. 8 can be performed in combination with one or more steps of method 2000 of FIG. 9.

[0226] The mouthguard produced by this method may include the impact protection region 10 and / or bite cushion region 20 and / or intermediate region 30 disclosed above. The mouthguard produced by this method may include any of the features disclosed above.

[0227] 8, a method 1000 of making a mouth guard according to the present disclosure is provided. The method 1000 may optionally include capturing 1010 anatomical features, obtaining 1020 a digital model of the anatomical features, generating 1030 a customized digital model of the mouth guard, and / or producing 1040 the customized mouth guard.

[0228] The capturing of anatomical features 1010 may include obtaining a scan of the anatomical features, preferably in digital form. The scan may include any image, such as an image obtained by exposing the anatomical features to radiation. Additionally or alternatively, the capturing of anatomical features 1010 may include obtaining an impression of the anatomical features and obtaining a scan of the impression. The scan may include any image, such as an image obtained by exposing the impression to radiation. For example, the scan may include an oral scan, an X-ray scan, a CT (computer tomography) scan, and / or an US (ultrasound) scan. Preferably, the scan is a 3D scan. This method may allow for more accurate, precise, complete, and / or reliable capturing of anatomical features. For example, the shape of the anatomical features may be more accurately captured.

[0229] The anatomical feature may be a tooth shape. The anatomical feature may include maxillary teeth and / or mandibular teeth and / or maxillary proximal gingiva and / or mandibular proximal gingiva. The method for fabricating a mouthguard may include obtaining 1020 a digital model of anatomical features. For example, a scan of the anatomical features may be converted into the digital model. A 3D scan of a dental impression may be converted into the digital model. Preferably, the digital model may be in STL format.

[0230] The method for making a mouthguard may include generating 1030 a customized digital model of the mouthguard. Preferably, the customized digital model of the mouthguard may be generated based on a digital model of anatomical features, such as a digital model of dental impressions. Optionally, generating the customized digital model of the mouthguard may include subtracting the digital model of dental impressions from the digital mouthguard model. For example, a standard / generic digital mouthguard model may be customized by subtracting the digital model of anatomical features. This method allows the mouthguard model to be more precisely and / or accurately customized to the supplemented anatomical features.

[0231] The method of making the mouthguard may include providing an anterior offset 50 from the front teeth of the mouthguard. Additionally or alternatively, the method of making the mouthguard may include providing a gap region 60 in the front portion of the mouthguard. For example, generating a customized digital model of the mouthguard may include providing an anterior offset 50 from the front teeth of the mouthguard and / or providing a gap region 60 in the front portion of the mouthguard.

[0232] Preferably, providing an anterior offset 50 from the anterior teeth of the mouth guard may be based on a digital model of anatomical features, such as a tooth profile. The modified digital model of the anatomical features may be generated by applying the anterior offset 50 to the digital model of the anatomical features. For example, an offset may be applied to the anterior teeth of the digital model of the tooth profile to generate the modified digital model of the tooth profile. Preferably, the offset is 1 to 2 millimeters. Optionally, the anterior offset 50 may be applied to the central incisors and / or lateral incisors and / or canines. Preferably, the anterior offset 50 may be applied from one canine to the other canine. For example, the anterior offset 50 may be applied from the right canine, right lateral incisor, right central incisor, left central incisor, left lateral incisor, and left canine.

[0233] Providing the anterior offset 50 may include digital lamination of a portion of the mouthguard model. For example, a portion of the mouthguard model corresponding to the mid-region 30 of the mouthguard may be digitally laminated. A portion of the mouthguard model corresponding to the U-shaped rail component of the mouthguard may be digitally laminated. The digital lamination may include lamination at a preferred thickness. The preferred thickness may be 1 to 2 millimeters. The digital lamination may include lamination of a preferred embodiment of the mouthguard based on the supplemented anatomical features. For example, the preferred embodiment of the mouthguard may include an embodiment of the mouthguard that overlaps the central incisors and / or lateral incisors and / or canines of the digital model of the dental impression. The modified digital model of the dental impression may be subtracted from the digitally laminated portion of the mouthguard model, optionally creating a space of the anterior offset 50 between the lateral portion of the mouthguard and the lateral portion of the anatomical feature. For example, the space of the anterior offset 50 may be between the mid-region 30 of the mouthguard and the anterior teeth.

[0234] The method for making a mouthguard may include providing a gap region 60 in the anterior portion of the mouthguard. Providing the gap region may include digitally laminating a portion of the mouthguard model. For example, a portion of the mouthguard model corresponding to the intermediate region 30 of the mouthguard may be digitally laminated, and an anterior layer behind the impact protection region 10 may be removed from the digital model of the intermediate region 30. Optionally, the gap region 60 may be applied between the intermediate region 30 and the impact protection region 10, and / or to a region of the mouthguard configured to be placed over the central incisors and / or lateral incisors and / or canines. Preferably, the gap region 60 may be applied from one canine to the other canine. For example, the gap region 60 may be applied from the right canine, right lateral incisor, right central incisor, left central incisor, left lateral incisor, and left canine. The preferred width of the gap region 60 (i.e., gap thickness) may be 1 to 2 millimeters.

[0235] The method can provide a space between the teeth and at least a portion of the mouth guard and / or a gap between components of the mouth guard. The inclusion of a space between the teeth and at least a portion of the mouth guard and / or a gap between components of the mouth guard can improve the protective performance of the mouth guard. The inclusion of a space between the teeth and a portion of the mouth guard and / or a gap between components of the mouth guard that comprise a hard insert, such as impact protection region 10, can improve the protective performance of the mouth guard. For example, the protective performance of a mouth guard configured to provide an anterior offset from the teeth may be greater than the protective performance of a mouth guard configured to completely contact the teeth.

[0236] Generating 1030 a customized digital model of the mouthguard may include adjusting the shape of the digital mouthguard model. The lateral sides of the mouthguard model may correspond to the buccal and / or labial sides of the mouthguard. The shape of the digital mouthguard model may be adjusted so that the lateral sides of the mouthguard are configured to completely cover the lateral sides of the teeth. Optionally, the shape of the digital mouthguard model may be adjusted so that the lateral sides of the mouthguard are configured to only partially cover the mesial lateral sides. The medial sides of the mouthguard model may correspond to the lingual and / or palatal sides of the mouthguard. The shape of the digital mouthguard model may be adjusted so that the medial sides of the mouthguard are configured to only partially cover the medial sides of the teeth. Preferably, the medial sides of the teeth are not completely covered by the mouthguard. Adjusting the shape may provide improved protection for the corresponding mouthguard and / or improved comfort for the wearer.

[0237] Generating 1030 a customized digital model of the mouth guard may include adjusting a thickness of the mouth guard, for example, adjusting the thickness of a region of the mouth guard. The thickness of the impact protection region 10, for example, the externally exposed impact protection region 10, may be adjusted. The thickness of the intermediate region 30, for example, the internally and / or externally exposed intermediate region 30, may be adjusted. The thickness of the occlusal cushion region 20, for example, the internally exposed occlusal cushion region 20, may be adjusted.

[0238] It can be appreciated that adjusting the thickness of the mouthguard and / or the area of ​​the mouthguard can change the protective performance of the mouthguard. For example, increasing the thickness of the mouthguard and / or the area of ​​the mouthguard can increase the degree of protection of the mouthguard and / or the area of ​​the mouthguard. The degree of protection of the mouthguard can be tailored to the needs of the user, for example, for different sports. Increasing the thickness of the mouthguard and / or the area of ​​the mouthguard can decrease the comfort level of the user. The thickness of the mouthguard and / or the area of ​​the mouthguard can be a compromise between the degree of protection and the comfort of the user.

[0239] The thickness of the impact protection area 10 can be adjusted to provide sufficient protection from trauma. The thickness of the impact protection area 10 can be adjusted to provide a desired level of comfort for the user. For example, the thickness of the impact protection area 10 can be adjusted to provide a compromise between the level of impact protection and the level of comfort for the user. Preferably, the thickness of the impact protection area 10 is 0.8 to 4.0 millimeters.

[0240] The thickness of the occlusal cushion region 20 can be adjusted to provide sufficient cushioning during clenching. The thickness of the occlusal cushion region 20 can be adjusted to provide a desired level of comfort for the user. For example, the thickness of the occlusal cushion region 20 can be adjusted to provide a compromise between the level of cushioning and the level of user comfort. Preferably, the thickness of the occlusal cushion region 20 is 1.5 to 6.0 millimeters.

[0241] The thickness of the intermediate region 30 can be adjusted to provide sufficient protection from trauma. The thickness of the intermediate region 30 may also be adjusted to provide a desired level of comfort to the user. For example, the thickness of the intermediate region 30 may be adjusted to provide a compromise between the level of protection and the level of comfort to the user. Preferably, the maximum thickness of the intermediate region 30 may be 2.5 to 5.0 millimeters. The thickness of the intermediate region 30 may vary between different portions of the intermediate region 30. For example, the thickness of the intermediate region may vary between 1 to 5 millimeters across different portions.

[0242] The method for making a mouth guard may include producing a customized mouth guard 1040. Producing the customized mouth guard 1040 may include producing a customized digital model of the mouth guard by 3D printing. This method may improve the thickness uniformity and / or protective performance and / or user comfort of the mouth guard.

[0243] The mouthguard may be printed using 3D printable materials such as resin (e.g., stereolithography (SLA), digital light processing (DLP), light-emitting diode (LED), Digital Light Synthesis (DLS) and / or PolyJet printing and / or filament (e.g., fused deposition modeling (FDM) printing).

[0244] The 3D printable material may have material properties optimized for use in the human body. For example, the 3D printable material can have material properties optimized for contact with human tissue. The 3D printable material may include a biocompatible material. The 3D printable material can have improved biocompatibility.

[0245] The 3D printable material may have material properties that improve the longevity of the mouthguard. For example, the 3D printable material may include a material with improved tear resistance. The 3D printable material may include a commercially available resin. The 3D printable material may include a custom-designed 3D printable material. The 3D printable material may include a photocurable resin. The 3D printable material may include a 3D printable biocompatible resin. Preferably, the 3D printable material may include a 3D printable biocompatible dissipative resin.

[0246] Producing the customized mouthguard 1040 may include post-printing processing. For example, producing the customized mouthguard 1040 may include a washing step and / or a curing step. The printed mouthguard and / or printed components of the mouthguard may be exposed to radiation, such as UV radiation.

[0247] In some embodiments, each component of the present invention can be printed by a specific 3D printing method. For example, the impact protection region 10 of the mouthguard may be printed by a Plojet-based MJP2500 printer (3D Systems), optionally using VisiJet M2R-WT resin (3D Systems), optionally with a printing setup according to the manufacturer's instructions. The intermediate region 30 of the mouthguard may be printed by an FDM-based Pro2 printer (RAISE3D), optionally with ID2045 (Arnitel), optionally with a printing setup according to the manufacturer's instructions. The bite cushion region 20 of the mouthguard may be printed by a DLS-based printer (Carbon DLS), optionally with EPU-40 resin (Carbon), optionally with a printing setup according to the manufacturer's instructions. In some embodiments, all parts may be printed using one resin-based 3D printing method using an open material system printer such as Miicraft Prime (Miicraft), optionally using suitable resins from different suppliers or custom-made resins according to printing setup by the resin manufacturer.

[0248] For example, the impact protection area 10 of the mouthguard can be printed using GR_22 flex resin (printodent). The intermediate area 30 of the mouthguard can be printed using KeyOrtho IBT (Keyston). The bite cushion area 20 of the mouthguard can be printed using Ultracur3D EL150 resin (BASF). In another embodiment, all parts can be printed separately or simultaneously using a single 3D printing method, such as FDM or PolyJet, optionally with a printing setup according to the manufacturer's instructions. For example, the impact protection area 10 of the mouthguard can be printed using PLA Pro1 (BASF) through one nozzle on a Pro2 printer (RAISE3D). The bite cushion area 20 and the intermediate area 30 of the mouthguard can be printed using TPU 85A (BASF) through different nozzles on the same Pro2 printer (RAISE3D). Optionally, the internal structure of the bite cushion region 20 of the mouthguard may be printed with different fill patterns and / or densities to tailor the properties of the region to maximize the level of neck muscle activity induced by bite and / or minimize the impact transmitted to the skull, as needed.

[0249] It can be appreciated that fabrication parameters, such as printing and / or washing and / or curing process parameters, can be adjusted. Adjusting the fabrication parameters can change the properties of the resulting mouthguard. For example, the degree of biocompatibility and / or tear resistance and / or dissipative capacity and / or ultimate strain and / or other mechanical properties can be changed. The properties of the resulting mouthguard can be optimized and / or tailored to the needs of the user.

[0250] 9, a method 2000 of making a mouthguard according to the present disclosure is provided. Method 2000 may optionally include obtaining a digital model of anatomical features 2010, generating customized digital models of a plurality of mouthguard segments 2020, producing the plurality of mouthguard segments 2030, and / or assembling the plurality of mouthguard segments 2040.

[0251] The method may optionally include supplementing anatomical features, for example as described above in supplemental step 1010. The method may optionally include obtaining 2010 a digital model of the anatomical feature, for example as described above in the step of obtaining 1020 .

[0252] The method may optionally include generating 2020 customized digital models of the plurality of mouthguard segments. The method may optionally include generating a first customized digital model of a first mouthguard segment. The first mouthguard segment may be a mouthguard segment including the impact protection region 10 of the mouthguard. The method may optionally include generating a second customized digital model of a second mouthguard segment. The second mouthguard segment may be a mouthguard segment including the bite cushion region 20 of the mouthguard. The method may optionally include generating a third customized digital model of a third mouthguard segment. The third mouthguard segment may be a mouthguard segment including the intermediate region 30 of the mouthguard.

[0253] Preferably, the customized digital model of the mouthguard segment may be generated based on a digital model of anatomical features, such as a digital model of tooth shape. Optionally, generating the customized digital model of the mouthguard segment may include subtracting the digital model of tooth shape from the digital mouthguard segment model. For example, a standard / generic digital mouthguard segment model may be customized by subtracting the digital model of anatomical features. This method allows the mouthguard segment model to be more precisely and / or accurately customized to the supplemented anatomical features.

[0254] Generating customized digital models of the plurality of mouthguard segments 2020 may optionally include subtracting a digital model of a mouthguard segment from a digital model of another mouthguard segment. For example, one of the first customized digital model, the second customized digital model, and the third customized digital model of the mouthguard segment may be subtracted from a different one of the first customized digital model, the second customized digital model, and the third customized digital model of the mouthguard segment. For example, generating a customized digital model of a mouthguard segment including a mid-region 30 of the mouthguard may include subtracting a customized digital model of a mouthguard segment including the bite cushion region 20 of the mouthguard from a customized digital model of a mouthguard segment including the mid-region 30 of the mouthguard. Generating a customized digital model of a mouthguard segment including the mid-region 30 of the mouthguard may include subtracting a customized digital model of a mouthguard segment including the impact protection region 10 of the mouthguard from a customized digital model of a mouthguard segment including the mid-region 30 of the mouthguard. This method allows for accurate generation of complementary shapes for mouthguard segments.

[0255] By this method, a customized digital model of a mouthguard segment can be configured for production of a mouthguard segment including a mounting surface for another mouthguard segment. For example, a customized digital model of a mouthguard segment including an intermediate region 30 can be configured for production of a mouthguard segment including an intermediate region 30 that includes a mounting surface for a mouthguard segment including an impact protection region 10 and / or a mounting surface for a mouthguard segment including an occlusion cushion region 20. For example, a customized digital model of a mouthguard segment including an intermediate region 30 may include a recess configured to accommodate a customized digital model of a mouthguard segment including an impact protection region 10. A customized digital model of a mouthguard segment including an intermediate region 30 may include a recess configured to accommodate a customized digital model of a mouthguard segment including an occlusion cushion region 20. Optionally, a customized digital model of a mouthguard segment including an intermediate region 30 may include a first recess configured to have a shape complementary to a customized digital model of a mouthguard segment including an impact protection region 10. The customized digital model of the mouthguard segment including the intermediate region 30 may include a second recess configured to have a shape complementary to the customized digital model of the mouthguard segment including the bite cushion region 20.

[0256] Generating 2020 customized digital models of the plurality of mouthguard segments may optionally include adjusting the thickness of the mouthguard, e.g., adjusting the thickness of the mouthguard segments. The thickness of the mouthguard segments including the impact protection regions 10, e.g., the externally exposed impact protection regions 10, may be adjusted. The thickness of the mouthguard segments including the intermediate regions 30, e.g., the internally and / or externally exposed intermediate regions 30, may be adjusted. The thickness of the mouthguard segments including the occlusal cushion regions 20, e.g., the internally exposed occlusal cushion regions 20, may be adjusted.

[0257] Optionally, the mouthguard segments are configured to mechanically interlock. For example, one of the first, second, and third mouthguard segments may be configured to mechanically interlock with a different one of the first, second, and third mouthguard segments. The mouthguard segment including the intermediate region 30 may be configured to mechanically interlock with the mouthguard segment including the impact protection region 10. The mouthguard segment including the intermediate region 30 may be configured to mechanically interlock with the mouthguard segment including the bite cushion region 20. The mouthguard segment including the impact protection region 10 may be configured to mechanically interlock with the mouthguard segment including the bite cushion region 20.

[0258] The mouthguard pieces may be configured to chemically bond together. For example, one of the first, second, and third mouthguard pieces may be configured to chemically bond with a different one of the first, second, and third mouthguard pieces. The mouthguard piece including the intermediate region 30 may be configured to chemically bond with the mouthguard piece including the impact protection region 10. The mouthguard piece including the intermediate region 30 may be configured to chemically bond with the mouthguard piece including the bite cushion region 20. The mouthguard piece including the impact protection region 10 may be configured to chemically bond with the mouthguard piece including the bite cushion region 20. The chemical bond between the two mouthguard pieces secures the two mouthguard pieces together. For example, the chemical bond between the two mouthguard pieces may prevent subsequent separation of the two bonded pieces.

[0259] Generating 2020 customized digital models of the plurality of mouthguard segments may include providing interlocking features 41. Customized digital models of mouthguard segments including a mouthguard region may include interlocking features 41. For example, customized digital models of mouthguard segments including the impact protection region 10 and / or the bite cushion region 20 and / or the intermediate region 30 may include interlocking features 41. Providing interlocking features 41 may include forming the interlocking features 41 on the customized digital models of the mouthguard segments including the mouthguard region. Additionally / or alternatively, providing the interlocking features 41 may include providing a digital model of the interlocking features 41. For example, the digital model of the interlocking features 41 that does not include the mouthguard region is a digital model of the interlocking features 41 that is separate from the customized digital model of the mouthguard segment including the mouthguard region.

[0260] Interlocking features 41 on a digital model of a mouthguard segment may be subtracted from a digital model of another mouthguard segment. For example, a male connector formed on a digital model of a mouthguard segment may be subtracted from a digital model of another mouthguard segment. A complementary female connector, i.e., a connector having a shape complementary to the male connector, may be formed on the digital model of another mouthguard segment. This method allows interlocking features 41 to be accurately formed on the digital model. For example, complementary interlocking features 41 may be formed on a digital model of mouthguard segments configured to be mechanically interlocked.

[0261] A portion of the digital model of the interlocking feature 41, e.g., another digital model of the interlocking feature 41, may be subtracted from the digital model of the mouthguard segment. A first portion of the digital model of the interlocking feature 41 may be subtracted from a first customized digital model of the mouthguard segment. A second portion of the digital model of the interlocking feature 41 may be subtracted from a second customized digital model of the mouthguard segment. For example, a distal portion of the digital model of the pin-shaped interlocking feature 41 may be subtracted from a digital model of a first mouthguard segment that includes a first region of the mouthguard. A proximal portion of the digital model of the pin-shaped interlocking feature 41 may be subtracted from a digital model of a second mouthguard segment that includes a second region of the mouthguard.

[0262] For example, a distal portion of a digital model of a pin-shaped interlocking feature 41 may be subtracted from a digital model of a mouthguard segment including the intermediate region 30 of the mouthguard. A proximal portion of a digital model of a pin-shaped interlocking feature 41 may be subtracted from a digital model of a mouthguard segment including the impact protection region 10 of the mouthguard. Holes complementary to the pin-shaped interlocking feature 41 may be formed on the digital model of the mouthguard segment including the region of the mouthguard. By this method, the interlocking feature 41 may be accurately formed on the digital model. It may be understood that the above process may be applied to interlocking features 41 of any shape. Interlocking features 41 having shapes complementary to other interlocking features 41 may also be generated.

[0263] The interlocking feature 41 can be positioned to reduce discomfort for the user. For example, the interlocking feature 41 may be positioned on a digital model of the mouth guard segment according to the user's anatomy. Preferably, the interlocking feature 41 may be configured to be positioned over an area between a first tooth and a second tooth. For example, the interlocking feature 41 may be formed on a side portion of the digital model of the mouth guard segment configured to cover the area between the two teeth.

[0264] The method may optionally include producing 2030 a plurality of mouthguard segments. Producing 2030 a plurality of mouthguard segments may include creating customized digital models of the mouthguard segments by 3D printing. Preferably, the first mouthguard segment, the second mouthguard segment, and / or the third mouthguard segment are 3D printed separately. For example, a first mouthguard segment including the impact protection region 10 of the mouthguard may be 3D printed. A second mouthguard segment including the bite cushion region 20 of the mouthguard may be 3D printed. A third mouthguard segment including the intermediate region 30 of the mouthguard may be 3D printed. The mouthguard segments may be produced according to known methods and / or methods disclosed herein. For example, the mouthguard segments may be fabricated according to the 3D printing methods disclosed herein.

[0265] Producing 2030 the plurality of mouthguard segments may include 3D printing the first mouthguard segment and / or the second mouthguard segment and / or the third mouthguard segment simultaneously. For example, the first mouthguard segment and / or the second mouthguard segment and / or the third mouthguard segment may be printed simultaneously and / or in the same process and / or using a single printer, such as a multi-jet printer. Optionally, the first mouthguard segment and / or the second mouthguard segment and / or the third mouthguard segment may be printed simultaneously using different materials.

[0266] Producing 2030 the plurality of mouthguard segments may include post-printing processing. For example, producing customized mouthguard segments may include a washing step and / or a curing step. For example, the printed mouthguard segments may be exposed to radiation, such as ultraviolet light.

[0267] Multiple mouthguard segments may be assembled 2040. Optionally, the mouthguard segments may be mechanically interlocked. For example, a mouthguard segment including intermediate region 30 may mechanically interlock with a mouthguard segment including impact protection region 10. A mouthguard segment including intermediate region 30 may mechanically interlock with a mouthguard segment including bite cushion region 20. A mouthguard segment including impact protection region 10 may mechanically interlock with a mouthguard segment including bite cushion region 20. The mechanical interlocking of the mouthguard segments may be accomplished without the need for adhesives and / or sealants.

[0268] Optionally, the mouthguard segments may be configured to be removable from one another. For example, a first mouthguard segment that is mechanically interlocked with a second mouthguard segment may be removable from the second mouthguard segment. A mouthguard segment that includes a bite cushion region 20 that is mechanically interlocked with a mouthguard segment that includes an intermediate region 30 may be removable from the mouthguard segment that includes the intermediate region 30. A mouthguard segment that includes an impact protection region 10 that is mechanically interlocked with a mouthguard segment that includes the intermediate region 30 may be removable from the mouthguard segment that includes the intermediate region 30.

[0269] The mouthguard pieces may be chemically bonded together. For example, the mouthguard piece including the intermediate region 30 may be chemically bonded to the mouthguard piece including the impact protection region 10. The mouthguard piece including the intermediate region 30 may be chemically bonded to the mouthguard piece including the bite cushion region 20. The mouthguard piece including the impact protection region 10 may be chemically bonded to the mouthguard piece including the bite cushion region 20. The chemical bonding of the two mouthguard pieces secures the two mouthguard pieces together. For example, the chemical bonding of the two mouthguard pieces may prevent subsequent separation of the two bonded pieces.

[0270] Preferably, the mouthguard according to the present disclosure is a customized, optionally 3D printed mouthguard. Preferably, the mouthguard according to the present disclosure is not a boil-and-bite or microwave-and-bite type mouthguard.

[0271] The regions of the mouthguard can be defined by the specific function of that region of the mouthguard. The regions of the mouthguard have a protective function during use, i.e., at intraoral / oral temperatures. For example, the function of the impact protection region at intraoral temperatures may be to provide protection against direct injury from traumatic contact. The function of the occlusal cushion region at intraoral temperatures may be to provide protection against rotation-induced brain injury by inducing jaw clenching or neck muscle activity. The intraoral / oral temperatures may be around 35°C, 35-40°C, or below 40°C.

[0272] The regions of the mouthguard may be defined by the material properties of the regions of the mouthguard, and the material properties of the regions of the mouthguard may be defined at test conditions at room temperature, i.e., 20-25° C. The material properties defining the regions of the mouthguard at room temperature may provide the protective function of the regions of the mouthguard in use, e.g., provide protective function at oral temperature.

[0273] The mouthguard according to the present disclosure is for a dental arch. Preferably, the mouthguard according to the present disclosure is an upper mouthguard, i.e. the arch is the upper arch. If the mouthguard is for an upper arch, the mouthguard covers the teeth of the upper arch, i.e. the teeth of the maxilla.

[0274] A mouthguard according to the present disclosure may be a lower mouthguard, i.e., the arch may be a lower arch. For example, a user may be missing teeth from the upper arch (e.g., due to previous injury to the mouth) and / or have an upper arch that is not suitable for an upper mouthguard. If the mouthguard is for a lower arch, the mouthguard covers the teeth in the lower arch, i.e., the teeth on the lower jaw.

[0275] [Experimental data] While conventional mouthguards primarily function to absorb a portion of the energy generated from a direct impact to the mouthguard, the inventors have confirmed that a specially designed mouthguard can induce jaw clenching, thereby increasing head stability through bite-induced neck muscle activity and reducing the risk of indirect brain injury caused by impact-induced head rotation.

[0276] Clenching the jaw is an instinctive response to a sudden impact. However, this response is unreliable, and the inventors have discovered that the reliability and degree of jaw clenching and head stability can be optimized by designing a mouthguard to optimize protection. In particular, the bite area of ​​the mouthguard can be designed to optimize jaw clenching and head stability, and thus impact protection.

[0277] 10A and 10B show muscle activity levels of the sternocleidomastoid (SCM) and masseter muscles, respectively, for different mouthguards of the prior art and / or the present disclosure, specifically, muscle activity data for clenching with no mouthguard, with a KeyOrtho IBT resin material (3D printed) mouthguard, with a publicly available boil and bite (mouth molded) mouthguard, with a publicly available customized (laminate) mouthguard (Flex heavy-pro, Erkodent), and with a (3D printed) mouthguard including features of the present disclosure (G2n and G2P&n).

[0278] The G2P&n mouthguard includes a soft bite area (made from a custom-made G2n resin formulation having a hardness of 75 Shore A) interlocked with a mid-region U-rail made from a custom-made G2p resin formulation having a hardness of 82 Shore A. The G2n mouthguard is a mouthguard that includes features of the present disclosure, where the occlusal portion of the mouthguard (the bite cushion area in the absence of the mid-region) is made from the G2n resin formulation and has a single layer of material.

[0279] Mouthguards incorporating the features of the present disclosure (G2p&n and G2n) resulted in significantly higher levels of sternocleidomastoid muscle activation than other mouthguards. There was a statistically significant difference (p<0.1) in sternocleidomastoid muscle (SCM) activation induced by G2p&n compared to a typical boil-and-bite and a conventional customized mouthguard (Flex heavy-pro). There was a statistically significant difference (p<0.1) in sternocleidomastoid muscle (SCM) activation induced by G2n compared to a typical customized mouthguard (Flex heavy-pro). Higher levels of masseter muscle activation resulted in higher bite forces.

[0280] The mean normalized level of SCM muscle activity was 100 without a mouthguard (control standard for normalization) and approximately 200 with G2p&n. The mean normalized levels of SCM muscle activity were approximately 120, 120, and 130 with the other types of mouthguards (Key IBT, Flex heavy-pro, and Boil and Bite, respectively). There was a statistically significant difference (p<0.1) in sternocleidomastoid muscle (SCM) activity induced by G2p&n compared with the representative Boil and Bite and conventional customized mouthguards (Flex heavy-pro).

[0281] The mean normalized level of masseter muscle activity was 100 without a mouthguard (control standard for normalization) and approximately 220 with G2p&n. The mean normalized levels of masseter muscle activity were approximately 190, 195, and 190 with the other types of mouthguards (KeyOrtho IBT, Flex heavy-pro, and Boil and Bite, respectively).

[0282] The impact protection area is configured to protect against direct injury during impact by dispersing focal impact loads, thus protecting against traumatic impacts to the anterior teeth (e.g., vulnerable incisors). The mouthguard can be configured with an offset (space, gap) forward from the incisors, e.g., at least 1 mm. The hard insert can deflect toward the gap, dispersing the load and absorbing the impact energy. As observed in numerical simulations (Figure 11) and in vitro impact tests (Figure 12), the combination of a hard insert and anterior offset provides the best protection. Furthermore, the numerical simulations showed that anterior offset with a hard insert layer was most effective. Furthermore, the protective performance of a 3 mm mouthguard combined with a hard insert and anterior offset was superior to that of a single-material (EVA) mouthguard without anterior offset or a 4 mm mouthguard with a close composite placement. Therefore, the combination of a hard insert and anterior offset can further reduce the bulk of the mouthguard, providing greater comfort to the wearer.

Claims

1. 1. A mouthguard that provides impact protection for teeth in the dental arch and also provides protection against brain injury by promoting bite-induced neck muscle activity, comprising: an externally exposed impact protection region defined by a first material property and configured to cover an anterior tooth of the dental arch; and an internally exposed occlusal cushion region defined by a second material property and configured to cover a molar tooth of the dental arch; and an internally exposed intermediate region defined by a third material characteristic and configured to be positioned between the bite cushion region and the impact protection region; the first material property, the second material property, and the third material property are different; the externally exposed impact protection area is the only portion of the mouthguard that includes material of the externally exposed impact protection area; Optionally, said externally exposed impact protection area does not cover molar teeth of said dental arch; Optionally, the mouth guard wherein said internally exposed bite cushion area does not cover the anterior teeth of said dental arch.

2. 1. A mouth guard for a dental arch that protects teeth in the dental arch from impact and provides protection against brain injury by promoting bite-induced neck muscle activity, comprising: an externally exposed impact protection region defined by a first material property and configured to cover an anterior tooth of the dental arch; and an internally exposed bite cushion region defined by a second material property and configured to cover a molar tooth of the dental arch; the first material property and the second material property are different; the externally exposed impact protection area does not cover molar teeth of the dental arch; Optionally, the mouth guard further comprises an intermediate region defined by a third material characteristic and configured to be located between the bite cushion region and the impact protection region, and optionally, the third material characteristic is different from the first material characteristic and the second material characteristic.

3. The mouth guard according to claim 1 or 2, at least one interface between the regions comprises a mechanical interlock including an interlocking feature; Optionally, the interlock feature is configured to be positioned to reduce discomfort to a user; Optionally, the interlocking feature is configured to be disposed on a region between a first tooth of the dental arch and a second tooth of the dental arch; Optionally, an interface between said intermediate region and said bite cushion region comprises a plurality of said mechanical interlocks; Optionally, an interface between said intermediate region and said impact protection region comprises a plurality of said mechanical interlocks; Optionally, the dental arch is an upper dental arch or a lower dental arch.

4. The mouth guard according to any one of claims 1 to 3, the intermediate region and the bite cushion region comprise the same material; and / or The interior structure of the intermediate region is different from the interior structure of the bite cushion region, providing different material properties.

5. The mouth guard according to any one of claims 1 to 4, the intermediate region and / or the bite cushion region comprise an elastomeric material, and / or a rubber-like material, and / or a polymeric material; and / or the bite cushion region comprises a material capable of withstanding a tensile strain of at least 50%, preferably at least 70%; Optionally, the thickness of the bite cushion region is between 2.0 and 5.0 millimeters, and / or the thickness of the intermediate region is between 3.0 and 4.5 millimeters.

6. The mouth guard according to any one of claims 1 to 5, the hardness of the intermediate region is greater than the hardness of the occlusal cushion region; and / or the intermediate region has a hardness of 60 to 95 on the Shore A scale; Optionally, the hardness of the intermediate region is from 80 to 90 on the Shore A scale; and / or the bite cushion region has a hardness of 40 to 80 on the Shore A scale; Optionally, the mouthguard wherein said bite cushion region has a hardness of 55 to 75 on the Shore A scale.

7. The mouth guard according to any one of claims 1 to 6, A mouth guard in which at least one region is configured to be removable from the other regions.

8. The mouth guard according to any one of claims 1 to 7, The mouth guard includes a first material having a first inherent material property and a second material having a second inherent material property; The mouthguard, wherein the first inherent material property is different from the second inherent material property.

9. The mouth guard according to any one of claims 1 to 8, the impact protection area comprises a thermoplastic and / or thermosetting material; and / or The Young's modulus of the impact protection area is 0.5 to 5 GPa; Optionally, the Young's modulus of the impact protection region is between 2 and 3 GPa; Optionally, said impact protection area comprises a stress concentration feature; Optionally, the impact protection region is a first impact protection region configured to be removable from other regions of the mouth guard; Optionally, said first impact protection area is interchangeable with a second impact protection area; Optionally, the second impact protection area has different characteristics than the first impact protection area, or the second impact protection area has the same characteristics as the first impact protection area; Optionally, the thickness of said impact protection region is between 0.9 and 2.0 millimeters.

10. The mouth guard according to any one of claims 1 to 9, the mouth guard is configured to be offset at least 1 millimeter anteriorly from the anterior teeth of the dental arch; Optionally, the mouth guard is configured to be offset anteriorly from the anterior teeth of the dental arch, the anterior teeth of the dental arch being central incisors; and / or the mouth guard is configured to be offset anteriorly from the anterior teeth of the dental arch, the anterior teeth being central incisors, and / or lateral incisors, and / or canines; and / or The mouth guard further comprises a gap region at a front portion of the mouth guard, the gap region comprising a gap of at least 1 millimeter; Optionally, the gap region is configured to be on an anterior tooth of the dental arch; Optionally, said anterior teeth of said dental arch are central incisors; and / or A mouth guard wherein the anterior teeth of the dental arch are central incisors, and / or lateral incisors, and / or canines.

11. The mouth guard according to any one of claims 1 to 10, the bite cushion area is configured to cover one molar tooth of the dental arch; and / or the bite cushion area is configured to cover two molar teeth of the dental arch; and / or the bite cushion area is configured to cover premolars of the dental arch; and / or the impact protection area is configured to cover two incisors of the dental arch; and / or The mouth guard, wherein the impact protection area is configured to cover central incisors of the dental arch, and / or lateral incisors of the dental arch, and / or canines of the dental arch.

12. 1. A 3D printed mouth guard, comprising: a first mouthguard piece; a second mouthguard piece; the first mouth guard piece and the second mouth guard piece are configured to mechanically interlock and / or chemically bond; 1. A 3D printed mouthguard, wherein the first mouthguard piece is optionally detachable from the second mouthguard piece.

13. A method of making a mouthguard, comprising: Obtain a digital model of the dental arch, generating a customized digital model of the mouth guard based on the digital model of the dental arch, wherein generating the customized digital model of the mouth guard based on the digital model of the dental arch includes providing an anterior offset of the mouth guard from an anterior tooth of the dental arch or providing a gap region in an anterior portion of the mouth guard; 3D printing a mouthguard based on the customized digital model of the mouthguard; Optionally, the mouth guard comprises an externally exposed impact protection area, the impact protection area being defined by a first material property and configured to cover an anterior tooth of the dental arch; Optionally, the anterior offset of the mouth guard from the anterior teeth of the dental arch is an anterior offset from a central incisor of the dental arch, and / or the anterior offset of the mouth guard from the anterior teeth of the dental arch is an anterior offset from a central incisor of the dental arch, and / or a lateral incisor of the dental arch, and / or a canine of the dental arch, or A method of making a mouth guard, wherein the gap area is configured to overlie an anterior tooth of the dental arch, and optionally the anterior tooth of the dental arch is a central incisor of the dental arch, and / or a lateral incisor of the dental arch, and / or a canine of the dental arch.

14. A method of making a mouthguard, comprising: Obtain a digital model of the tooth shape, generating a first customized digital model of a first mouthguard segment; generating a second customized digital model of a second mouthguard segment; the first customized digital model and the second customized digital model are generated based on the digital model of the tooth profile; the first mouth guard piece and the second mouth guard piece are configured to mechanically interlock and / or chemically bond; separately or simultaneously 3D printing the first mouthguard piece and the second mouthguard piece based on the first customized digital model and the second customized digital model; mechanically interlocking and / or chemically bonding the first and second mouthguard pieces; A method of making a mouthguard, wherein the first mouthguard piece is optionally detachable from the second mouthguard piece.

15. A method of making a mouthguard, comprising: Obtain a digital model of the tooth shape, generating a first customized digital model of a first mouthguard segment; generating a second customized digital model of a second mouthguard segment; generating a third customized digital model of the third mouthguard segment; the first customized digital model, the second customized digital model, and the third customized digital model are generated based on the digital model of the tooth profile; one of the first mouth guard piece, the second mouth guard piece, and the third mouth guard piece configured to mechanically interlock and / or chemically bond; A method of making a mouth guard, comprising separately or simultaneously 3D printing the first mouth guard piece, the second mouth guard piece, and the third mouth guard piece based on the first customized digital model, the second customized digital model, and the third customized digital model.

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