APPLIANCE FOR REDUCING FACIAL AGEING AND/OR ORAL PARAFUNCTIONAL ACTIVITY

Abstract

An appliance for use in a method of reducing facial aging and/or oral parafunctional activity comprising two parts, each comprising a composite structure comprising: a first layer formed of a durable, resilient, elastomeric material comprising a cured thermoset rubber and which in use contacts the occlusal biting surfaces of the posterior teeth; and a second layer formed of a durable, non-deformable material having a softening point over 100° C. which provides a bite plate; wherein the second layer of each part is provided with a protrusion formed of durable, non-deformable material having a softening point over 100° C. which is positioned such that in use the protrusion extends from the surface above at least a part of the first and/or second molar teeth which are in contact with the first layer. A method of making the appliance, a kit of parts, and methods of use are also disclosed.

Claims

1. An appliance comprising two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition.

2. The appliance of claim 1, wherein said ambient-temperature-cured, thermoset rubber composition comprises a cured silicone rubber.

3. A method for making an appliance, wherein said appliance comprises two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition, wherein said method comprises: i) providing an appliance-preform comprising two parts, each of the two parts of the appliance-preform comprising the second layer; ii) providing an uncured rubber composition which at ambient temperature cures to form the ambient-temperature-cured thermoset rubber composition of the first layer iii) applying said uncured rubber composition on to said first surface of each of said second layers; iv) moulding the uncured rubber composition into a shape of the at least occlusal biting surfaces of the first and/or second molar teeth; and v) curing said moulded uncured rubber composition at ambient temperature, thereby forming the ambient-temperature-cured thermoset rubber composition of the first layer.

4. A kit for making an appliance, wherein said appliance comprises two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition, wherein said kit comprises: a) an appliance-preform comprising two parts, each of the two parts of the appliance-preform comprising the second layer; and b) an uncured rubber composition which at ambient temperature cures to form the ambient-temperature-cured thermoset rubber composition of the first layer; or a multipack composition comprising at least two components that when mixed together form the ambient-temperature-cured thermoset rubber composition of the first layer.

5. The kit of claim 4, further comprising instructions for making the appliance.

6. The method of claim 3, wherein said uncured rubber composition comprises a silicone rubber.

7. A method for reducing facial aging and/or oral parafunctional activity in an individual, comprising: providing an appliance comprising two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition; and fitting the appliance over at least two posterior teeth, including at least one of the at least first and/or second molar teeth on both sides of either the upper jaw or lower jaw of an individual, wherein the occlusal biting surfaces of the first and/or second molar teeth are in contact with the first layer of each of the two parts of the appliance, closing lips of the individual, and, over a specified period of time, the individual attempting to prevent involuntary jaw closures sufficient to cause upper or lower teeth to contact the protrusion of each of the two parts on the second layer of the appliance.

8. The method of claim 7, wherein said method is repeated every third day.

9. The method of claim 7, wherein said specified period of time is 5 minutes.

10. A method of reducing facial aging and/or reducing oral parafunctional activity in an individual, comprising: providing an appliance comprising two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition; and fitting the appliance over at least two posterior teeth, including at least one of the at least first and/or second molar teeth, on both sides of either the upper jaw or lower jaw of an individual, wherein the occlusal biting surfaces of the first and/or second molar teeth are in contact with the first layer of each of the two parts of the appliance, and wherein the appliance is worn by the individual for up to 1 hour, twice a day, every third day and not at night time and not while eating.

11. The method of claim 10, wherein at some point while the individual is wearing the appliance, the individual closes their lips and, over a specified period of time, attempts to prevent involuntary jaw closures sufficient to cause the upper or lower teeth to contact the protrusion of each of the two parts on the second layer of the appliance.

12. The appliance of claim 1, wherein the second layer of each of the parts comprises a plurality of orifices into which or around which the first layer is moulded to secure it to the second layer.

13. A method for reducing facial aging and/or reducing oral parafunctional activity in an individual, comprising: providing an appliance comprising two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C., wherein the second layer comprises a plurality of orifices into which or around which the first layer is moulded to secure it to the second layer, and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition, and fitting the appliance over at least two posterior teeth, including at least one of the first and/or second molar teeth, on both sides of either the upper jaw or lower jaw of an individual, wherein the occlusal biting surfaces of the first and/or second molar teeth are in contact with the first layer of each of the two parts of the appliance, closing the lips of the individual, and, over a specified period of time, the individual attempts to prevent involuntary jaw closures sufficient to cause upper or lower teeth to contact the protrusion of each of the two parts on the second layer of the appliance.

14. The method of claim 13, wherein said specified period of time is 5 minutes.

15. A method of reducing facial aging and/or reducing oral parafunctional activity in an individual, comprising: providing an appliance comprising two parts, the two parts intended in use to contact at least first and/or second molar teeth on respective opposite sides of either upper or lower jaw, each of the two parts comprising a composite structure comprising: I) a durable and resilient first layer formed of an ambient-temperature-cured thermoset silicone rubber composition, which in use contacts at least occlusal biting surfaces of the first and/or second molar teeth; and II) a second layer formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate, comprising a substantially planar first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer, a protrusion, formed of durable, non-deformable material having a softening point over 100° C., which extends from at least 2 mm up to 20 mm from said second surface away from the first layer and which is positioned such that in use the protrusion extends from said second surface away from at least a part of the at least first and/or second molar teeth which are in contact with the first layer; and one or more side walls that define borders of said first and second surfaces of the second layer, wherein the one or more side walls that border said first and second surfaces do not extend from said first surface in a direction away from said second surface; wherein the first layer of each of the two parts engages to secure itself to the first surface of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset silicone rubber composition; and fitting the appliance over at least two posterior teeth, including at least one of the first and/or second molar teeth, on both sides of the upper jaw or lower jaw of an individual, wherein the occlusal biting surfaces of the first and/or second molar teeth are in contact with the first layer of each of the two parts of the appliance, and wherein the appliance is worn by the individual for up to 1 hour, twice a day, every third day and not at night time and not while eating.

16. The method of claim 3, wherein the second layer of each of the two parts comprises a plurality of orifices into which or around which the first layer is moulded to secure it to the second layer.

17. The kit of claim 4, wherein the second layer of each of the two parts comprises a plurality of orifices into which the or around which the first layer can be moulded to secure it to the second layer.

18. The appliance of claim 1, wherein the two parts are joined by a plastic strip or stainless steel wire.

19. The appliance of claim 1, wherein the first layer of each of the two parts engages to secure itself to the first surface, the second surface, and the one or more side walls, of the second layer of each of the two parts after moulding and curing of the ambient-temperature-cured thermoset rubber composition.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The invention in its various embodiments shall now be further described by way of exemplification with reference to the accompanying drawings, in which:

[0063] FIG. 1 is a plan view from above of an appliance-preform.

[0064] FIG. 2 is a side view of the appliance-preform shown in FIG. 1 from position A.

[0065] FIG. 3 is a plan view from below of the appliance-preform shown in FIG. 1.

[0066] FIG. 4 is a plan view from below of the appliance-preform shown in FIG. 1 after two strips of uncured rubber have been applied (i.e. after step iii) of the second aspect of the present invention).

[0067] FIG. 5 is a cross-sectional view along the line c-c of the embodiment shown in FIG. 4.

[0068] FIG. 6 is a cross-sectional view along the line c-c of the embodiment shown in FIG. 4 but after the two strips of uncured rubber composition have been moulded to the patient's teeth and second layer and cured (i.e. after steps iv) v) of the second aspect of the present invention).

DETAILED DESCRIPTION

[0069] An appliance-preform 1, as shown in FIGS. 1-6, comprises two second layers 3, each about 1.5 mm thick formed of a commercially available substantially transparent polycarbonate having a softening point of about 190° C., having a first surface 8, a second surface 4 and walls 10 between said surfaces that define their borders. The second layer 3 forms, in use, a bite plate. Extending from the second surface 4, away from the first surface 8, is a protrusion 5 which is formed integrally with the second layer 3. The protrusion extends approximately 3 mm above the second surface 4. The substantially planar first surface 8 of the second layer 3 contacts two strips of uncured rubber composition 7, as shown in FIGS. 4 and 5, which have been applied to the first surface 8 and which after curing provide a first layer 2. A stainless steel wire 9, which in another embodiment may be a plastic strip, forms a bridging means between the two second layers 3.

[0070] The second layer 3 is provided with a plurality small orifices 6 into which, as shown in FIG. 6, the first layer 2, formed after moulding and curing of the uncured rubber strips 7, engages to secure itself to the second layer 3.

[0071] The appliance-preform and two strips of uncured rubber 7, as shown in FIGS. 4 and 5, can be fitted to a patient by a method in which the patient is required to open the mouth and the uncured rubber is then placed over the teeth on the patient's lower jaw, with the uncured rubber in contact with the teeth and the protrusion 5 positioned over both first molar teeth. The patient is then required to gently raise the lower jaw until the teeth on the upper jaw contact the top of the protrusion 5. The patient then closes their lips and swallows. The pressure applied to the appliance-preform and uncured rubber composition by swallowing causes the uncured rubber composition to deform and mould itself to the shape of the teeth on the lower jaw and into and around the orifices 6 in the second layer 3. The appliance can then be carefully removed from the mouth of the patient left overnight at ambient temperature for the uncured rubber to cure. Once the rubber composition has cured, any excess rubber composition can be trimmed away with a knife or razor blade until it forms a comfortable fit in the patient's mouth.

[0072] The fitting of the appliance can readily be performed by a doctor or dentist, without the services of a dental technician or having to resort to custom moulding practices in a laboratory, or by the patient without third party assistance.

[0073] Once the uncured rubber composition has cured and any excess trimmed away, the appliance of the invention may be used by the patient for reducing facial aging.

[0074] The process for reducing facial aging and/or oral parafunctional activity can commence as soon as the uncured rubber has cured and any excess trimmed away.

[0075] In one embodiment, the patient positions the appliance of the invention in the mouth, preferably just before eating a meal. The patient then exercises the lower jaw, e.g. during eating or sleeping, by raising the lower jaw thereby to bring the teeth on the upper jaw into contact with the protrusions and then closing the teeth on the upper and lower jaw around the appliance. In so doing, the lower jaw is forced to pivot slightly about the protections and cause the facial muscles controlling the lower jaw to work harder. The muscles are then permitted to relax and the lower jaw is dropped. The exercise is preferably repeated for about 6 to 7 hours a day over a period of about 6 weeks.

[0076] The appliance-preform may be packaged as a kit of parts together with either a single pack composition, comprising an uncured rubber composition. e.g. in a syringe or blister pack, or a two-pack composition, comprising two compositions that when mixed together form an uncured rubber composition, and optionally with a set of instructions for making an appliance of the present invention.