RELATED APPLICATION:

[0001 ] The present disclosure claims priority to U.S. Provisional Patent Application No. 63/377,794, filed September 30, 2023, the entire content of which is herein incorporated by reference.

TECHNICAL FIELD:

[0002] The present disclosure relates dental devices. More particularly, the present disclosure relates to vibratory devices for dental applications and related methods and kits.

BACKGROUND:

[0003] Orthodontic aligners, such as clear aligners, apply mechanical forces to tooth crowns to reposition the teeth to a desired position and correct malocclusions (misalignment of teeth). When the mechanical forces are applied by the aligners to the crowns, the alveolar bone surrounding the teeth roots will remodel to allow the repositioning of the teeth.

[0004] Once all the orthodontic tooth movements are completed, the user will typically wear retainers (fixed or removable) to maintain the position of the teeth and prevent relapse (i.e., the teeth moving in an undesired position). Removable retainers include two trays: one for the mandible dental arch and one for the maxilla dental arch. The removable retainer trays are similar to orthodontic clear aligners in terms of construction and appearance, only that they are not designed to move teeth but to maintain the teeth positioning unchanged.

[0005] However, for both clear aligners and removable retainers to work properly, it is important that they fit well over the crowns and maintain an accurate contact with the crowns. [0006] Proper and consistent aligner fit over the crowns ensures that orthodontic tooth movements occur as planned in terms of tooth repositioning and the duration of the movements. Poor aligner fit may result in the planned tooth movements of the aligner sequence not being achieved, which may necessitate further refinements. Refinements, including replanning of the orthodontic tooth movements and manufacturing of new sets of aligners, can lead to delayed orthodontic treatment and additional costs.

[0007] Similarly, proper and consistent removable retainer fit ensures that the teeth are maintained in the desired position. Poor removable retainer fit may result in relapse, which may require the user to undergo orthodontic treatment again at a later time, incurring additional costs for the new treatment and causing user inconvenience.

[0008] Intra-oral vibratory devices have been developed to facilitate the proper seating of orthodontic clear aligners and removable retainers over a user’s teeth. Conventional vibratory devices rely on the weight of the device as mechanical leverage to deliver the vibrations to the aligners or retainers located over the teeth. One example of a vibratory seating device is described in U.S. Patent No. 8,500,446 to Lowe. The Lowe device comprises a flat, c-shaped bite plate connected to an external module containing a vibration mechanism. The bite plate is received into the user’s mouth for the user to bite down upon (with the clear aligner trays or removable retainer trays located over their teeth), with the external module located extra-orally in front of the mouth. Vibrations are transmitted from the external module to the bite plate to assist with the seating of the trays. Vibratory seating devices may also include a “chewie” component such as the device described in U.S. Patent No. 10,695,148 to Florman et al. The Florman device comprises a chewie at the end of an external handle containing the vibration mechanism. The user bites on the chewie end of the device while holding the handle in their hand and vibrations are transmitted from the handle to the chewie to assist with tray seating.

[0009] In conventional vibratory devices, the external module/handle and the bite plate/chewie vibrate together as a single unit. Thus, the amplitude of the vibrations (and therefore the amount of vibrational energy that is transferred to the aligner or removable retainer trays) will be affected by: a) the weight of the external module/handle; b) the position of the external module/handle’s center of mass relative to the teeth; and c) how hard the bite plate or chewie is bit by the user (more specifically, the amount of bite force and direction of the bite force relative to the direction of the vibrations).

[0010] For example, if the user holds the external module/handle by hand, their hand will absorb some of the vibrations, thereby reducing the vibrational energy transferred to the aligner or retainer trays. If the device is used hands-free, the vibrational energy delivered to the trays is dependent on the weight of the external module/handle and its center of mass’ location relative to the position of the teeth, which may be limited by the practical size and shape of the device. Furthermore, using such devices handsfree will rely on the bite force of the user to keep the entire device in the desired position for the duration of each usage, which can tire the user’s mouth muscles or cause TMJ (temporomandibular joints) pain, making it difficult to use and resulting in low usage compliance and poor results.

[0011 ] Moreover, a challenge for both handheld and hands-free devices is the dependence of the deliverance of vibration energy on how hard the user bites the bite plate or chewie. The user may apply a different or varying bite force every time they use the device, which results in inconsistent application of vibrational energy. In addition, vibration devices with c-shaped bite plates typically only deliver vibrations in a plane parallel to the occlusal plane, which only helps seat the trays sideways, and relies on the patient bite force to push the trays in/over the crowns.

SUMMARY:

[0012] In one aspect, there is provided a vibratory dental device, comprising: a main body comprising an outer housing; a bite element; and a vibration element comprising an outer casing that contains a vibration mechanism therein that vibrates the outer casing, the outer casing having a first end connected to the bite element and a second end connected to the main body, wherein the outer housing of the main body is vibrationally insulated from the outer casing of the vibration element. [0013] In some embodiments, the outer housing defines an internal cavity and wherein the second end of the outer casing is received within the internal cavity without directly contacting the outer housing.

[0014] In some embodiments, the outer housing comprises an annular shoulder, the annular shoulder defining an opening to the internal cavity through which the outer casing is received, and wherein a gap is provided between the outer casing and the annular shoulder that allows movement of the outer casing with respect to the outer housing.

[0015] In some embodiments, the device further comprises vibrationally insulating material positioned in the internal cavity between the outer casing of the vibration element and the outer housing of the main body.

[0016] In some embodiments, the outer casing of the vibration element comprises an extended base at the second end, and wherein the extended base is sandwiched between a first layer and a second layer of the vibrationally insulating material.

[0017] In some embodiments, the main body further comprises an inner shelf positioned below the extended base, wherein the inner shelf is pushed towards the extended base to compress the first and second layers of the vibrationally insulating material between the extended base and the outer housing.

[0018] In some embodiments, the vibrationally insulating material comprises a closed cell foam.

[0019] In some embodiments, the vibration mechanism comprises a vibration motor and at least one eccentric weight.

[0020] In some embodiments, the bite element comprises a tubular body having an inner layer and an outer layer.

[0021 ] In some embodiments, the outer layer has greater compressibility than the inner layer. [0022] In some embodiments, the inner layer is made of a first material and the outer layer is made of a second material, the first material having a higher hardness than the second material.

[0023] In some embodiments, the inner layer is a continuous layer of material and the outer layer is a non-continuous layer.

[0024] In some embodiments, the non-continuous layer comprises a plurality of pores or gaps around a circumferential surface thereof.

[0025] In some embodiments, the non-continuous layer comprises a plurality of projections around the circumferential surface thereof.

[0026] In some embodiments, the bite element is doped with a dental agent.

[0027] In some embodiments, the dental agent comprises xylitol.

[0028] In another aspect, there is provided a method for assembling a vibratory dental device, comprising: providing a main body comprising an outer housing; providing a vibration element comprising an outer casing that contains a vibration mechanism therein; and connecting the vibration element to the main body such that the outer housing of the main body is vibrationally insulated from the outer casing of the vibration element.

[0029] In some embodiments, the method further comprises providing a bite element and connecting the bite element to the vibration element.

[0030] In another aspect, there is provide a kit for dental applications, comprising: a vibratory dental device comprising: a main body comprising an outer housing; and a vibration element comprising an outer casing that contains a vibration mechanism therein that vibrates the outer casing, the outer casing having a first end comprising a tip and a second end connected to the main body, wherein the outer housing of the main body is vibrationally insulated from the outer casing of the vibration element; and a bite element connectable to the tip of the outer casing of the vibration element. [0031] In some embodiments, the bite element comprises a tubular body having an inner layer and an outer layer, and wherein the outer layer has greater compressibility than the inner layer.

[0032] Other aspects and features of the present disclosure will become apparent, to those ordinarily skilled in the art, upon review of the following description of specific embodiments of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS:

[0033] Some aspects of the disclosure will now be described in greater detail with reference to the accompanying drawings. In the drawings:

[0034] Figure 1 is a side view of an example vibratory dental device, according to some embodiments;

[0035] Figure 2 is a side view of the device of Figure 1 , shown with a cover;

[0036] Figure 3 is a partial, side, cross-sectional view of the device of Figure 1 ;

[0037] Figure 4A is a perspective view of a bite element of the device of Figure 1 ;

[0038] Figure 4B is a cross-sectional view of an alternative embodiment of a bite element;

[0039] Figure 4C is a cross-sectional view of another alternative embodiment of a bite element;

[0040] Figure 5 is a top view schematic of an orthodontic appliance tray showing the positioning of a vibratory dental device in use; and

[0041] Figure 6 is a flowchart of an example method for assembling a vibratory dental device, according to some embodiments. DETAILED DESCRIPTION:

[0042] Generally, the present disclosure provides vibratory devices for dental applications. The vibratory dental device may comprise: a main body comprising an outer housing; a bite element; and a vibration element comprising an outer casing that contains a vibration mechanism therein that vibrates the outer casing, the outer casing having a first end connected to the bite element and a second end connected to the main body, wherein the outer housing of the main body is vibrationally insulated from the outer casing of the vibration element. Related methods and kits are also provided.

[0043] As used herein the terms "a", "an", and "the" may include plural referents unless the context clearly dictates otherwise.

[0044] The vibratory dental devices disclosed herein may be used with an orthodontic appliance that comprises at least one tray. In some embodiments, the appliance comprises an upper tray for the user’s maxillary teeth and a lower tray for the user’s mandibular teeth. Suitable orthodontic appliances include orthodontic aligners, such as clear aligners, and orthodontic removable retainers. The vibratory devices assist in “seating” the orthodontic appliance, that is, securing the trays over the user’s teeth in contact with the tooth crowns. However, embodiments are not limited to only seating of aligners and removable retainers and the devices disclosed herein may be used with any intra-oral apparatus that fits closely over the user’s teeth.

[0045] An example vibratory dental device 100 will be discussed with reference to Figures 1 to 3.

[0046] Referring to Figure 1 , the device 100 in this embodiment comprises a main body 102, a bite element 104 (also referred to as a chewable element or a “chewie”), and a vibration element 106 therebetween. Optionally, as shown in Figure 2, the device 100 may further comprise a removable cover 108 that protects the bite element 104, the vibration element 106 and the user interface 122 when the device 100 is not in use. The cover may comprise one or more orifices (not shown) at its top end 109 for venting/drying any liquid retained on the device 100 after use. [0047] The main body 102 may comprise an outer housing 110. The outer housing 110 may be approximately cylindrical or any other suitable shape. In this embodiment, the outer housing 110 functions as a handle to be hand held by a user during use of the device 100, as discussed in more detail below. However, handsfree embodiments are also contemplated and the size and shape of the outer housing 110 can be adapted accordingly.

[0048] Referring to Figure 3, the outer housing 110 has an inner surface 111 and an outer surface 113. The inner surface 111 of the outer housing 110 defines an internal cavity 112 therein and an opening 114 to the internal cavity 112. In this embodiment, the opening 114 is defined by an annular shoulder 115 of the outer housing 110. An inner shelf 116 is positioned in the internal cavity 112, spaced from the annular shoulder 115. The inner shelf 116 may be coupled to the outer housing 110 or may be integral therewith. In some embodiments, the inner shelf 116 is a single unit, such as a cap or ring, with a central hole 117 therethrough. In other embodiments, the inner shelf 116 may comprise a pair of brackets on opposed sides of the outer casing with a gap 117 therebetween. As noted below, the hole or gap 117 allow wires 118 to extend between the main body 102 and the vibration element 106.

[0049] The internal cavity 112 may house control electronics and a power source (not shown). The power source and the control electronics are operatively connected to a vibration mechanism 132 (discussed in more detail below). In this embodiment, the power source and control electronics are connected to the vibration mechanism 132 via one or more electrical wires 118 extending through the hole 117 in the inner shelf 116. The power source may comprise, for example, one or more batteries. In this embodiment, the outer housing 110 further comprises a removable cap 120 (visible in Figures 1 and 2) to allow the battery to be removed and replaced. An O-ring (not shown) may seal the removable cap 120 to prevent water entry into the internal cavity 112. In other embodiments, the main body 102 may further comprise a charging coil to re-charge the battery via inductive charging means as needed. [0050] A user interface 122 may be positioned in or on the outer housing 110 to allow a user to control the operation of the vibration mechanism 132 via the control electronics. In this embodiment, the user interface 122 comprises an on/off button 123 (visible in Figure 1 ) positioned on the exterior of the outer housing 110. In other embodiments, the user interface 122 may be a more complex interface, for example, to allow the user to set the vibrational mechanism 132 to run for a specific period of time.

[0051 ] The outer housing 110 of the main body 102 can be made of a hard plastic (such as polycarbonate, acrylonitrile butadiene styrene, or a blend of hard plastics), a metal (such as aluminum or stainless steel), or any other suitable material. The on/off button 123 can be made of a flexible material, such as silicone elastomers, RTV (room temperature vulcanization) silicones, LSR (liquid silicone rubber) silicones, SBS (Poly(styrene-butadiene-styrene)) rubbers, EVA (Ethylene-vinyl acetate) plastics, a combination thereof, or any other suitable material.

[0052] Referring again to Figure 3, vibration element 106 comprises an outer casing 124 that defines an inner chamber 126 therein. The outer casing 124 has a first end 105 and a second end 107 (which are also the respective ends of the vibration element 106). The first end 105 is connectable to the bite element 104 and the second end 107 is connectable to the main body 102. The outer casing 124 has an inner surface 125 and an outer surface 127. The inner surface 125 defines the inner chamber 126.

[0053] The outer casing 124 in this embodiment is generally cylindrical or frusto- conical in shape. In other embodiments, the outer casing 124 is any other suitable shape. The outer casing 124 may be made of any of the materials listed above for the outer housing 110 of the main body 102. The outer casing 124 and the outer housing 110 may be made of the same or different materials.

[0054] The outer casing 124 in this embodiment comprises a tip 128 at the first end 105 and an extended base 130 at the second end 107. Note that the bite element 104 is shown as a simplified transparent block in Figure 3 for illustrative purposes to view the tip 128. In some embodiments, the extended base 130 may be in the form of “wings” that extend outwards on opposed sides the outer casing 124. In other embodiments, the extended base 130 may be in the form of an annular ring or flange that extends outwards around the circumference of the outer casing 124.

[0055] The vibration element 106 is configured to transmit vibrations from the vibration mechanism 132 to the bite element 104 via the tip 128. In this embodiment, the vibration mechanism 132 is housed within the inner chamber 126 of the outer casing 124. The vibration mechanism 132 may comprise a vibration motor 134 with at least one eccentric weight 136. In some embodiments, two eccentric weights 136 may be used for stronger vibrations. The vibration motor 134 may be coupled to the inner surface of the outer casing 124 via an adhesive, press-fitting, or any other suitable coupling means. In some embodiments, the motor has a rotational speed of between about 6,000 and 42,000 rotations per minute (RPM) and/or a frequency in the range of between about 100 Hz and 700 Hz. Non-limiting examples of vibration motors include: DC Motor Vibration, ERM 9000 RPM 1.3VDC (manufacturer product number 316040005), DC Motor Vibration, ERM 8500 RPM 2.3VDC (manufacturer product number VZ30C1T9870088L) or Brushed DC Motor Vibration, ERM 15000 RPM 2.7VDC (manufacturer product number VZ30C1T8460002L).

[0056] The vibration element 106 is connected to the main body 102 via a vibration insulating coupler 138 such that the outer housing 110 of the main body 102 is vibrationally insulated from the outer casing 124 of the vibration element 106. As used herein “vibrationally insulated” refers to little or no vibrations being transmitted between the vibration element 106 and the outer housing 110 of the main body 102, although it will be understood that the outer housing 110 may not be perfectly insulated and minor transmission of vibrations may still occur.

[0057] In this embodiment, the second end 107 of the vibration element 106 is received into the internal cavity 112 of the outer housing 110 via the opening 114. The diameter of the outer casing 124 is smaller than the diameter of the opening 114 such that the outer casing 124 is spaced from the annular shoulder 115, leaving a small gap 140 therebetween. The extended base 130 at the second end 107 of the outer casing 124 also has a smaller diameter/width than that of the outer housing 110 such that the extended base 130 is spaced from the inner surface of the outer housing 110 by another small gap 141 . The extended base 130 is positioned in the internal cavity 112 below the annular shoulder 115 and above the inner shelf 116. The extended base 130 is spaced from the annular shoulder 115 and the inner shelf 116 such that the extended base 130 is suspended therebetween by vibrationally insulating material, as discussed below. Thus, in this embodiment, there is no direct physical contact between the vibration element 106 and the outer housing 110 of the main body 102.

[0058] At least one layer of vibrationally insulating material may be provided within the internal cavity 112, between the outer casing 124 of the vibration element 106 and the outer housing 110 of the main body 102. In this embodiment, the extended base 130 is sandwiched between two layers of a vibrationally insulating material. As shown in Figure 3, a first layer 142 of vibrationally insulating material may be positioned between the extended base 130 and the annular shoulder 115. The first layer 142 may be in the form of a ring that fits around the outer casing 124. A second layer 144 of vibrationally insulating material may be positioned between the extended base 130 and the inner shelf 116. The second layer 144 may be in the form of a ring with a hole 145 therethrough that aligns with the hole 117 of the inner shelf 116 to allow wires 118 to pass through. The shelf 116 may be pushed towards the extended base 130 (i.e., upwards in Figure 3) against the first and second layers 142, 144 to compress the insulating material. The compressed insulating material may thereby fill the gap 141 between the extended base 130 and the outer housing 110.

[0059] The first and second layers 142, 144 may form a “quasi” airgap to reduce or prevent transmission of vibrations between outer casing 124 of the vibration element 106 and the outer housing 110 of the main body 102, thereby insulating the outer housing 110 from the vibrations generating by the vibration mechanism 132. The first and second layers 142, 144 may also help to waterproof the device 100 by preventing the passage of water through the opening 114 and into the inner chamber 126 of the vibration element 106 or into the internal cavity 112 below the shelf 116 where the power source and control electronics are housed. Moreover, by securing the extended base 130 between the two layers 142, 144 (instead of through a mechanical connection to the outer housing 110), the vibration element 106 may have flexibility of (lateral) movement within the gap 140 between the outer casing 124 and the annular shoulder 115.

[0060] The vibrationally insulating material may comprise closed cell foam or any other suitable material that reduces or prevents transmission of vibrations therethrough. Closed cell foam is mostly air, which allows it to provide the quasi-airgap noted above. Non-limiting examples of closed cell foam materials include nylon-based foam, polyurethane foam, or silicone foam. The thickness, hardness, and flexibility of the foam may be varied to achieve a desired level of vibration insulation as well as a desired movement flexibility of the vibration element 106 with respect to the outer housing 110. The first layer 142 and the second layer 144 can be made of the same material or different materials and may have the same thickness or different thicknesses. In some embodiments, the first and second layer 142, 144 each have a thickness of between about 1 and about 4 mm.

[0061 ] Optionally, the first and second layer 142, 144 may further comprises a waterproofing layer on one or both sides thereof. In some embodiments, the waterproofing layer comprises adhesive transfer tape including, but not limited to, an acrylic-based adhesive, such as 3M 467MP or 3M 468MP. The waterproofing layer may reduce or prevent water infiltration into the insulating material, the internal cavity 112 and/or inner chamber 126.

[0062] The bite element 104 will be discussed in more detail with reference to Figure 4A. The bite element 104 may comprise a tubular body 146. In this embodiment, the tubular body 146 is approximately cylindrical in shape. In other embodiments, the tubular body 146 may be rectangular, pyramidal, or any other suitable shape. The tubular body 146 may have an inner orifice 148 extending at least partially therethrough. The inner orifice 148 may receive the tip 128 of the outer casing 124 therein to couple the bite element 104 to the vibration element 106. In some embodiments, the inner orifice 148 has an inner diameter smaller than the outer diameter of the tip 128 to provide a tight fit (i.e. , an interference fit) and facilitate propagation of the vibrations from the tip 128 to the bite element 104. In some embodiments, the bite element 104 is only coupled to the tip 128 by the tight fit therebetween, and the bite element 104 is removable, allowing it to be easily replaced when needed. In other embodiments, the bite element 104 may be coupled to the vibration element 106 by an adhesive or some other coupling means and may or may not be removable. In other embodiments, the bite element 104 may be omitted and the tip 128 of the vibration element 106 may instead function as the bite element for the device 100.

[0063] The bite element 104 is configured to be bit and/or chewed by the user. The thickness of the tubular body 146 wall can be in the order of about 2 to about 4 mm to allow both comfort and delivery/propagation of vibrations to the trays of the orthodontic appliance located on the user’s teeth. In addition, the outer diameter of the tubular body 146 diameter may be less than or equal to about 10 to about 12mm, in order to easily be inserted and bit between the teeth without requiring excessive opening of the mouth. In other embodiments, the bite element 104 may be any suitable dimensions.

[0064] The bite element 104 may be made of an elastic, flexible material that is bitable/chewable by the user. The material may be classified as biocompatible and suitable for oral use. Non-limiting examples of suitable materials are: silicone elastomers (for example MED-6033), RTV (room temperature vulcanization) silicones, LSR (liquid silicone rubber) silicones (for example MED-4950, MED-4940, and MED-4930), HCR (High Consistency Rubber) silicones, SBS (Poly(styrene-butadiene-styrene)) rubbers, EVA (Ethylene-vinyl acetate) plastics, or a combination of two or more materials.

[0065] Optionally, the material of the bite element 104 can be doped with one or more dental agents. As used herein, “doped” refers to infusing, coating, spraying, or otherwise incorporating the dental agent to the material of the bite element 104. In some embodiments, the dental agent comprises a sugar alcohol such as xylitol. Xylitol is a known dental agent that reduces the risk of cavity development by inhibiting the dental bacteria that cause cavities. During use of the device 100 in the mouth (e.g., flexing, vibrating, agitation), the bite element 104 may release the embedded xylitol compound into the user’s saliva, which will then circulate throughout the mouth, reducing the risk of cavities for the user. [0066] In use, the user would first insert the trays of their orthodontic appliance into their mouth over their teeth. The user then holds the device 100 in their hand via outer housing 110 of the main body 102 and inserts the bite element 104 between their teeth. The user may then turn the button 123 to “on” to activate the vibration mechanism. When the button 123 is turned on, the vibrating motor 134 of the vibration mechanism 132 is powered through the wires 118 and starts to rotate the eccentric weight 136 and generate vibrations. These vibrations are transmitted/coupled to the outer casing 124 of the vibration element 106 up to the tip 128 and are thereby transmitted to the bite element 104. When the user bites on the bite element 104, the vibrations are transmitted to the trays of the orthodontic appliance installed over the user’s teeth. These vibrations are also transmitted through the outer casing 124 to the extended base 130. As the base 130 is sandwiched between the first and second layers 142, 144 of insulating material, the majority of vibrations are reflected back by the insulating material and are not transmitted to the outer housing 110 or to the user’s hand.

[0067] Therefore, the device 100 provides a number of advantages over conventional vibratory dental devices. By vibrationally insulating the outer housing 110 of the main body 102 from the vibration element 106, vibration energy can be delivered to the trays of the orthodontic appliance independent of the weight or center of mass of the main body 102 relative to the teeth of the user. In addition, the outer housing 110 of the main body 102 can be held in the user’s hand as a handle without affecting the amount of vibration energy delivered to the trays. Further, mechanical flexibility is provided by the vibration insulating coupler 138 to allow the user to perform small movements of the handheld outer housing 110 with respect to the vibration element 106 when the bite element 104 is being bitten by the user. Thus, embodiments of the device 100 can provide consistent and superior seating outcomes for users.

[0068] Alternative embodiments of bite elements 204, 304 will be discussed with reference to Figures 4B and 4C, respectively. The bite elements 204 and 304 may be used in place of the bite element 104 of Figures 3 and 4A in the device 100 or in any other suitable vibratory dental device. [0069] Referring to Figure 4B, the bite element 204 comprises a tubular body 246 with an inner orifice 248. In this embodiment, the tubular body 246 is approximately cylindrical in shape. In other embodiments, the tubular body 246 may be rectangular, pyramidal, or any other suitable shape. The inner orifice 248 may have similar dimensions to the inner orifice 148 of the bite element 104 as discussed above. The tubular body 246 may comprise an inner layer 250 and an outer layer 252. Each of the layers 250, 252 may be substantially continuous, i.e. , without substantial holes, voids, or the like. The outer layer 252 may also substantially cover the inner layer 250.

[0070] The outer layer 252 may have a greater compressibility than the inner layer 250. In this embodiment, the inner layer 250 is made of a first material and the outer layer 252 is made of a second material, where the first material is of a higher hardness than the second material. For example, the first material may be of a hardness in the range of about 40 to about 70 shore A and the second material may be of a hardness in the range of about 5 to about 30 shore A.

[0071 ] The inner (harder) layer 250 may make up a larger proportion of the overall thickness of the tubular body 246 than the outer (softer) layer 252. For example, the inner layer 250 may make up about 80% or greater of the overall tubular body 246 thickness, whereas the outer layer may make up about 20% or less of the thickness.

[0072] When the user bites the two-layer bite element 204, the trays’ cuspids will first compress the softer outer layer 252 and then most of the occlusal surface of the trays will enter into contact with the bite element 204. At this moment, the user will start to feel their cuspids touching the harder surface of the inner layer 250, providing sensory feedback to the user to maintain the same bite force for the duration of the device usage.

[0073] In other embodiments, the softer outer layer 252 may not be continuous, but may comprise a plurality of projections around the circumferential surface thereof. The projections may comprise bumps, ridges, etc. Compression of the projections may allow the user to feel the harder inner layer 250 underneath and provide the same feedback as to the desired bite force. [0074] Referring to Figure 4C, the bite element 304 comprises a tubular body 346 with an inner orifice 348. In this embodiment, the tubular body 346 is approximately cylindrical in shape. In other embodiments, the tubular body 346 may be rectangular, pyramidal, or any other suitable shape. The inner orifice 348 may have similar dimensions to the inner orifice 148 of the bite element 104 as discussed above. The tubular body 346 may comprise an inner layer 350 and an outer layer 352. The outer layer 352 may be more compressible than the inner layer 350. In this embodiment, the inner layer 350 and outer layer 352 are made of the same harder material (e.g., in the range of about 40 to about 70 shore A) but the inner layer 350 is continuous whereas the outer layer 352 is non-continuous. The non-continuous outer layer 352 may comprise a plurality of pores or gaps around the circumferential surface thereof. This porous structure may behave in a similar manner to a softer, continuous material, prompting the user to bite down until they feel the continuous inner layer 350 thereunder.

[0075] The bite elements 204 and 304 may be made of any of the materials described above for the bite element 104, with the materials for the individual layers selected for desired hardness. Optionally, either of the bite elements 204 and 304 may also include a dental agent such as xylitol as discussed above.

[0076] Thus, embodiments of the bite elements 204, 304 disclosed herein can be used to provide sensory feedback to the user on how much bite force to apply and to ensure that the bite force is consistent for the duration of a use session of the device 100 and repeatable every time the device 100 is used. In contrast, conventional “chewies” are typically single-layered and the user may apply a different or varying bite force every time they use the device.

[0077] By maintaining consistent bite force, embodiments may enhance seating of clear aligner and removable retainer trays for at least the reasons that follow. Another important parameter that determines the amount of vibration energy delivered to the aligner or removable retainer trays is the direction of the vibrations relative to the occlusal plane. To achieve the best tray seating effect, the direction of the vibrations is in a rotating plane perpendicular to the occlusal plane. This means that during one vibration cycle, the vibration force direction rotates (clockwise or counterclockwise depending on the electric signal polarity applied to the vibration motor) and therefore includes components of the vibration force perpendicular to the occlusal surface of the trays alternating with components of the vibration force lateral (lingual and buccal) to the trays. As a result, with the user maintaining a constant bite force (due to the sensory feedback from the bite element 204/304) the vibrations may enhance the seating of the trays over the teeth crowns by alternatively the vibrations perpendicular to the occlusal plane (which push the trays in, over the crowns) with vibrations lateral to the occlusal plane (which pushes the trays sideways). Pushing the trays both in and sideways to the crowns fully employs the elasticity feature of the trays, resulting a micro-stretching of the trays in both perpendicular and lateral directions (relative to the occlusal surface of the teeth), which results in superior and faster tray seating.

[0078] This approach is opposite to the one used by conventional vibration devices with c-shaped bite plates, where the vibrations are in a plane parallel to the occlusal plane such that the vibrations would only seat the trays sideways, and rely on the patient bite force to push the trays in.

[0079] For clarity, the amount of bite force does not affect the parameters of the vibrations (frequency and amplitude) as generated by the vibration motor 134, as such parameters are determined by the specifications of the vibration motor 134 hardware (e.g. number of rotations per minute (RPM) at a specific voltage and its eccentric weight 136 size and of-axis distance) and the vibration motor 134 encapsulation within the outer casing 124 (which are independent of the user). What is affected by the amount of user bite force is the amount of vibration energy that is delivered/transferred to the trays located over the teeth in the user’s mouth.

[0080] In some embodiments, the user can move the bite element 104/204/304 to two or more positions within their mouth to ensure the trays are fully seated. Figure 5 is a schematic showing an example clear aligner tray 400 with three positions 402A, 402B, and 402C for the bite element 104/204/304 to be placed during an individual use session for the device 100. [0081] The first position 402A is on one side of the tray 400, the second position 402B is in the middle, and the third position 402C is on the opposite side. The user may use the device 100 at each of the positions 402A, 402B, and 402C in the order indicated in Figure 5 or in any other order.

[0082] One example of instructions to use the device 100 are as follows:

- Use the device 100 every time the aligners or retainers are removed and reinserted over the teeth, such as after each meal, snack, or brushing;

- Use a timer or count in mind to monitor the session times while using the device 100;

- Insert the aligner/retainer trays over the teeth and turn on the device 100 via the on/off button 123;

- Insert the bite element 104 between the upper and lower trays in the mouth and gently bite on the bite element 104;

- Use for about 15 to 20 seconds in each of the positions 402A, 402B, and 402C in Figure 5 (or any other suitable time period as instructed by a dental professional);

- Turn off the device 100 by pressing the on/off button 123; and

- Clean the device 100 after each use.

[0083] In other embodiments, the device 100 may be used in any other suitable manner, including any manner recommended by a dental professional, and embodiments are not limited to only the example instructions provided above. The device 100 may be used for consumer home use or any other suitable application.

[0084] Figure 6 is a flowchart of an example method 600 for assembling a vibratory dental device, according to some embodiments. The method 600 may be used to assemble the device 100 of Figures 1 -3. [0085] At block 602, a main body is provided comprising an outer housing. The term “provide” in this context refers to making, manufacturing, receiving, acquiring, or otherwise obtaining a component described herein. The main body may comprise any of the features of the main body 102 of the device 100 as described above.

[0086] At block 604, a vibration element is provided comprising an outer casing that contains a vibration mechanism therein. The vibration element may comprise any of the features of the vibration element 106 as described above.

[0087] At block 606, the vibration element is connected to the main body such that the outer housing of the main body is vibrationally insulated from the outer casing of the vibration element. In some embodiments, the outer housing defines an internal cavity and the outer casing is partially inserted into the internal cavity such that the outer casing is suspended within the internal cavity without directly contacting the outer housing. In some embodiments, a vibrationally insulating material is provided and the outer casing is suspended in the vibrationally insulating material within the internal cavity. In some embodiments, the outer casing comprises an extended base and the extended base is sandwiched between a first layer and a second layer of the vibrationally insulating material. In some embodiments, an inner shelf is provided and the inner shelf is positioned within the outer housing below the extended base and pushed towards the extended base to compress the first and second layers of the vibrationally insulating material.

[0088] The method 600 may further comprise providing a bite element and connecting the bite element to the vibration element. The bite element may have any of the features of the bite elements 104, 204, or 304 as described above. In some embodiments, the bite element is removably coupled with the vibration element, for example, via an interference fit. In other embodiments, the bite element may be coupled to the vibration element via an adhesive or any other suitable coupling means.

[0089] Also provided herein is a kit for dental applications. The kit may be used in combination with clear aligners or removable retainers. The kit may comprise a vibratory dental device and a bite element. The vibratory dental device may comprise: a main body comprising an outer housing; and a vibration element comprising an outer casing that contains a vibration mechanism therein that vibrates the outer casing, the outer casing having a first end comprising a tip and a second end connected to the main body. The main body and the vibration element may have any of the features of the main body 102 and the vibration element 106 of the device 100 as described above and the outer housing of the main body may be vibrationally insulated from the outer casing of the vibration element in the manner discussed above. The bite element is connectable to the tip of the outer casing of the vibration element and may have any of the features of the bite elements 104, 204, or 304 as described above.

[0090] In some embodiments, the kit may further include instructions for assembling the bite element and the vibratory dental device. In some embodiments, the kit may further comprise instructions for use of the assembled device. In some embodiments, the instructions may be the example instructions for the device 100 provided above. In other embodiments, the instructions may be any other suitable instructions for use.

[0091 ] Various modifications besides those already described are possible without departing from the concepts disclosed herein. Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0092] Although particular embodiments have been shown and described, it will be appreciated by those skilled in the art that various changes and modifications might be made without departing from the scope of the disclosure. The terms and expressions used in the preceding specification have been used herein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalents of the features shown and described or portions thereof.

[0093] It is to be understood that a combination of more than one of the approaches described above may be implemented. Embodiments are not limited to any particular one or more of the approaches, methods or apparatuses disclosed herein. One skilled in the art will appreciate that variations, alterations of the embodiments described herein may be made in various implementations without departing from the scope of the claims.