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 e.g. bruxism, comprises two parts, the parts intended in use to contact the posterior teeth on respective opposite sides of either the upper or lower jaw, each part comprising a composite structure comprising: iii) a first layer ( 2 ) 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 iv) a second layer ( 3 ) formed of a durable, non-deformable material having a softening point over 100° C. and which in use provides a bite plate; wherein the second layer of each part, that has a substantially planar first surface, is provided with a protrusion ( 5 ), 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 a second surface ( 4 ) of the second layer ( 3 ) away from the first layer ( 2 ) and 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 and a kit of parts is also disclosed, as are several methods of use of the appliance.

1 . An appliance for use in a method of reducing facial aging and/or reducing oral parafunctional activity, which appliance comprises two parts, the parts intended in use to contact at least the first and/or second molar teeth on respective opposite sides of either the upper or lower jaw, each part comprising a composite structure comprising:
 I) a first layer formed of a durable, resilient, elastomeric material and which in use contacts at least the occlusal biting surfaces of the first and/or second molar teeth; and   II) a second layer, comprising a first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer and one or more side walls that define the borders of said first and second surfaces, formed from a durable, non-deformable material having a softening point over 100° C. and which in use 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 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 first and/or second molar teeth which are in contact with the first layer;   characterized in that said durable, resilient, elastomeric material is an ambient-temperature-cured, thermoset rubber composition; said first surface of said second layer is substantially planar; and said second layer is free of any side walls that border said first surface and that extend from said first surface in a direction away from said second surface.   
     
     
         2 . The appliance as claimed in  claim 1 , wherein said ambient-temperature-cured, thermoset rubber composition comprises a cured silicone rubber. 
     
     
         3 . A method for making an appliance for use in a method of reducing facial aging and/or oral parafunctional activity, wherein said appliance comprises two parts, the parts intended in use to contact at least the first and/or second molar teeth on respective opposite sides of either the upper or lower jaw, each part comprising a composite structure comprising:
 I) a first layer formed of a durable, resilient, elastomeric material and which in use contacts at least the occlusal biting surfaces of the first and/or second molar teeth; and   II) a second layer, comprising a first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer and one or more side walls that define the borders of said first and second surfaces, formed from a durable, non-deformable material having a softening point over 100° C. and which in use 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 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 first and/or second molar teeth which are in contact with the first layer,   wherein said first surface of said second layer is substantially planar, and wherein said second layer is free of any side walls that border said first surface and that extend from said first surface in a direction away from said second surface;   
       wherein said method comprises:
 i) providing an appliance-preform comprising two parts, each part comprising a said second layer; and 
 ii) providing an uncured rubber composition which at ambient temperature cures to form a cured thermoset rubber composition that is a durable, resilient, elastomeric material; 
 iii) applying said uncured rubber composition on to said first surface of each of said second layers; 
 iv) moulding the uncured rubber into the required shape; and 
 v) curing said moulded uncured rubber composition at ambient temperature. 
 
     
     
         4 . A kit of parts for making an appliance for use in a method of reducing facial aging and/or oral parafunctional activity, wherein said appliance comprises two parts, the parts intended in use to contact at least the first and/or second molar teeth on respective opposite sides of either the upper or lower jaw, each part comprising a composite structure comprising:
 I) a first layer formed of a durable, resilient, elastomeric material and which in use contacts at least the occlusal biting surfaces of the first and/or second molar teeth; and   II) a second layer, comprising a first surface that faces towards and contacts said first layer, a second surface that faces away from said first layer and one or more side walls that define the borders of said first and second surfaces, formed from a durable, non-deformable material having a softening point over 100° C. and which in use 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 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 the surface of the bite plate away from a part of the first and/or second molar teeth which are in contact with the first layer, wherein said first surface of said second layer is substantially planar, and wherein said second layer is free of any side walls that border said first surface and that extend from said first surface in a direction away from said second surface;   wherein said kit comprises:   a) an appliance-preform comprising two parts, each part comprising a said second layer; and   b) i) an uncured rubber composition which at ambient temperature cures to form a cured thermoset rubber composition that is a durable, resilient, elastomeric material; or ii) a multipack composition comprising at least two components that when mixed together form an uncured rubber which at ambient temperature cures to form a cured thermoset rubber composition that is a durable, resilient, elastomeric material.   
     
     
         5 . The kit of parts as claimed in  claim 4 , wherein the kit additionally comprises instructions for making an appliance. 
     
     
         6 . The method as claimed in  claim 3  wherein said uncured rubber composition comprises a silicone rubber. 
     
     
         7 . The method for reducing facial aging and/or oral parafunctional activity in an individual, which method comprises fitting an appliance as claimed in  claim 1  over at least two of the 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, closing the lips of the individual and, over a specified period of time, the individual attempting to prevent involuntary jaw closures sufficient to cause the upper or lower teeth, respectively, to contact the protrusions on the second layer of the appliance. 
     
     
         8 . The method as claimed in  claim 6 , wherein said method is repeated every third day. 
     
     
         9 . The method as claimed in  claim 7 , wherein said specified period of time is 5 minutes. 
     
     
         10 . The method of reducing facial aging and/or reducing oral parafunctional activity in an individual, which method comprises fitting an appliance as claimed in  claim 1  over at least the 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 appliance is worn by the individual for up to 1 hour, twice a day, every third day and not at night time and not for eating. 
     
     
         11 . The method as claimed in  claim 10 , wherein at some point during the time that the individual is wearing the appliance, the individual closes the lips and, over a specified period of time, attempts to prevent involuntary jaw closures sufficient to cause the upper or lower teeth, respectively, to contact the protrusions on the second layer of the appliance. 
     
     
         12 . The appliance as claimed in  claim 1 , wherein the second layer of each part is provided with a plurality of orifices and/or projections into which or around which the first layer is moulded to secure it to the second layer. 
     
     
         13 . The method for reducing facial aging and/or oral parafunctional activity in an individual, which method comprises fitting an appliance as claimed in  claim 2  over at least two of the 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, closing the lips of the individual and, over a specified period of time, the individual attempting to prevent involuntary jaw closures sufficient to cause the upper or lower teeth, respectively, to contact the protrusions on the second layer of the appliance. 
     
     
         14 . The method as claimed in  claim 8 , wherein said specified period of time is 5 minutes. 
     
     
         15 . The method of reducing facial aging and/or reducing oral parafunctional activity in an individual, which method comprises fitting an appliance as claimed in  claim 2  over at least the 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 appliance is worn by the individual for up to 1 hour, twice a day, every third day and not at night time and not for eating. 
     
     
         16 . The method as claimed in  claim 3  wherein the second layer of each part is provided with a plurality of orifices and/or projections into which or around which the first layer is moulded to secure it to the second layer. 
     
     
         17 . The kit as claimed in  claim 4 , wherein the second layer of each part is provided with a plurality of orifices and/or projections into which or around which the first layer is moulded to secure it to the second layer.