Patent Application
20070298380
To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by references to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:
The present invention relates to improved dental treatment devices used to treat a person's teeth and/or gums. The treatment devices include a moisture-resistant barrier layer, a treatment gel positioned so as to contact a person's tooth surfaces, and an adhesive composition that is advantageously hydrophilic positioned near a lingual edge of the barrier layer in order to reliably maintain the barrier layer against lingual tooth surfaces during use. The barrier layer protects the treatment composition and adhesive composition from saliva or moisture within a person's mouth during use, which keeps them in contact with the person's teeth and/or surrounding soft tissue and helps prevent or minimize their diffusion into the user's oral cavity. The hydrophilic adhesive region reliably adheres to moist oral tissue and helps keep the barrier layer from pealing away from lingual tooth surfaces as a result of mechanically disruptive forces typically caused by a person's tongue brushing against the lingual side of the barrier layer during use.
The inventive treatment devices are more adhesive to teeth than conventional dental treatment strips and are less intrusive than bulky, over-the-counter, non-custom or boil-and-bite dental trays. In some cases they may be as reliable as, or even more reliable than, custom-fitted dental trays in maintaining a treatment composition against a person's teeth. To some people they may be at least as comfortable as custom-fitted trays.
The term “barrier layer”, as used herein, refers to one or more layers of a material that protects the treatment gel and adhesive region from ambient moisture and saliva found within a person's mouth when the dental treatment device is placed over the person's teeth. The barrier layer may also serve to protect the treatment and adhesive compositions from moisture and contaminants during storage and prior to use. The barrier layer may be in any desired form including, but not limited to, a dental tray, a tray-like shape, a strip or a patch. The terms “strip” and “patch” are essentially synonymous and refer to barrier layers and treatment devices that are essentially flat or formless prior to placing the treatment device over a person's teeth.
The term “gel” shall refer to treatment and/or adhesive compositions that have been formulated or processed so as to be flowable, either by the force of gravity (i.e., having no yield stress) or that do not flow by the force of gravity but which are viscous or plastic such that they can be shaped or manipulated (e.g., they can be expressed from a syringe orifice or other dispensing means known in the art). The term “gel” broadly encompasses a wide range of compositions having greatly varying viscosities, although treatment and adhesive gels according to the invention are preferably sufficiently thick or viscous that they will not run out or off of a dental tray, tray-like device or other barrier layer by gravity alone. In one embodiment, the treatment and/or adhesive gel may be rubbery or highly viscous. At some point, when the viscosity becomes so great as to yield a composition that is substantially solid (e.g., a stiff or highly viscous putty), the composition may be considered to be “substantially solid”.
The term “substantially solid”, as used herein, refers to a treatment composition or adhesive composition or region that is in a solid or semi-solid condition. In one aspect, a “substantially solid” composition or region can be characterized as a cohesive mass that does not readily flow or separate when subjected to gravitational forces and which cannot be readily expressed through a syringe outlet or other similarly-sized opening or orifice. Thus, the term “substantially solid” excludes runny adhesive liquids, viscous adhesive liquids, and even thick adhesive gels that are able to flow when subjected to gravity and/or which can be readily expressed through a syringe outlet or other similarly-sized opening or orifice. The term “substantially solid”, when used in the context of a treatment composition or adhesive composition, also excludes dry particulate compositions or powders because dry particulates and powders readily flow when subjected to gravity and/or are readily separated (i.e., the particles as a whole have little or no internal cohesion). Moreover, powders or particulates, when viewed as a whole, are not coherent or solid.
In one embodiment, the “substantially solid” compositions or regions become more adhesive when moistened with saliva or water. When moistened, the surface of the substantially solid composition or region turns into a sticky material that is able to more strongly adhere to teeth compared to a substantially solid composition or region that has not been moistened. The substantially solid composition may, at least on the surface, become a viscous liquid, paste or gel, at least temporarily, depending on the amount of moisture that is applied to the surface of the “substantially solid” composition or region. The consistency of the moistened surface can remain “substantially solid” depending on the degree of initial moistening, or it can stiffen and even revert back to being “substantially solid” as the initial quantity of surface moisture diffuses into a remaining portion of the “substantially solid” composition or region over time (e.g., during a treatment procedure in which the composition is protected from saliva and ambient moisture in a person's mouth by a moisture-resistant barrier layer).
The term “dental tray”, as used herein, refers to a treatment device having a tray-like shape so as to facilitate placement of the device over at least a portion of a person's dental arch. A “dental tray” or “tray-like” device includes a front side wall configured to engage front surfaces of a person's teeth when in use, a rear side wall extending laterally from the front side wall, either abruptly by one or more distinct angles or non-abruptly by a bottom wall or curved transition portion, configured to engage lingual surfaces of the person's teeth, and a trough between said front and rear side walls. A “dental tray” may be configured so that a portion of the front side wall, rear side wall, or transition portion (e.g., a bottom wall), engages the incisal or occlusal edges of the person's teeth when in use. The dental tray may be curved or straight in a longitudinal dimension.
The term “trough”, as used herein, refers to the region that is at least partially bounded by the front side wall, the rear side wall, and a plane or imaginary curved dome extending from an upper edge of the front side wall and an upper edge of the rear side wall. Thus, a “trough” can theoretically exist whenever the front and rear side walls have a space therebetween and are laterally offset by an angle of less than 180°. In practice, the front and rear side walls will be offset by an angle that is preferably less than about 150°, more preferably less than about 120°, and most preferably less than about 90°.
In the case where the front and rear side walls are connected by a transition portion (e.g., a trough having a U-shaped or rectangular cross section), at least a portion of the front and rear side walls may be substantially parallel (i.e., be offset by an angle of approximately 0°) or offset by a very small angle. In the case of a trough having a V-shaped or trapezoidal cross section, at least a portion of the front and rear side walls may be offset by an acute angle (i.e., by an angle between 0-90°). In the case of a trough having an L-shaped cross section, at least a portion of the front and rear side walls may be offset by an angle centered around approximately 90° (e.g., by an angle in a range of about 70° to about 110°). Thus, a trough having an L-shaped cross section can be a subset or slight variation of a trough having a V-shaped cross section.
The terms “longitudinal”, “longitudinal dimension” and “longitudinal profile”, as used herein when referring to a dental tray or treatment device, shall refer to the lengthwise dimension of the tray or device. The tray or device may be straight in the “longitudinal dimension” or it may be horseshoe-shaped or otherwise “longitudinally curved” in the longitudinal dimension so as to approximate the curvature of a person's dental arch, or at least facilitate placement of the tray or device over the dental arch.
The terms “strip” or “patch” are used interchangeably and shall refer to any barrier layer or treatment device that is substantially flat, or that only has a slight curvature or bend but that does not constitute a “dental tray”, as that term is understood in the art. A “strip” or “patch”, includes an inner surface or region generally oriented toward the front and/or rear surfaces of a person's teeth and/or gums when in use and an outer surface that is generally oriented away from the person's teeth and/or gums. A “strip” or “patch” may be configured so that a portion of the inner surface is oriented toward the incisal or occlusal edges of the person's teeth during use. The strip or patch may be curved or straight in one or both of the lengthwise and widthwise directions in order to fit over a user's teeth and/or gums in a desired manner.
The term “molecular weight”, as used herein, shall refer to number average molecular weight expressed in Daltons, unless otherwise specified.
Dental treatment devices according to the invention include a barrier layer that protects a treatment gel and adhesive composition from ambient moisture within a person's mouth during use. The treatment gel is positioned adjacent to the barrier layer in a manner so as to contact both tooth surfaces to be treated, and the adhesive composition is positioned adjacent to the barrier layer near the lingual rim or edge of a treatment tray or strip so as to reliably maintain the barrier layer against lingual tooth surfaces (e.g., so as to overcome the tendency of the lingual portion of the barrier layer from peeling away from lingual tooth surfaces as a result of disruptive mechanical forces caused by a person's tongue during use). The treatment composition is in gel form, and the adhesive composition can be a gel or substantially solid. Following are preferred examples of barrier layers, treatment compositions, and adhesive compositions according to the invention, as well as characteristics of treatment devices made therefrom.
A. Barrier Layers
The barrier layer can have any desired shape or thickness. It is preferably moisture-resistant in order to protect the treatment and adhesive compositions from ambient moisture found in a person's mouth. According to one embodiment, the barrier layer comprises a thin, flexible membrane formed from a moisture-resistant polymer material. The barrier layer may comprise a conventional dental tray, examples of which include both customized and non-custom dental trays, or it may initially be a strip or patch, or have some other configuration.
Examples of materials that can be used to form the barrier layer include, but are not limited to, polyolefins, wax, metal foil, paraffin, ethylene-vinyl acetate copolymer (EVA), ethylene-vinyl alcohol copolymer (EVAL), polycaprolactone (PCL), polyvinyl chloride (PVC), polyesters, polycarbonates, polyamides, polyurethanes, or polyesteramides. Examples of suitable polyolefins that can be uses to make the barrier layer include, but are not limited to, polyethylene (PE), high density polyethylene (HDPE), low density polyethylene (LDPE), ultra low density polyethylene (ULDPE), polypropylene (PP), and polytetrafluoroethylene (PTFE) (e.g., TEFLON). An example of a suitable polyester for use in making the barrier layer includes, but is not limited to, polyethylene terephthalate (PET), an example of which is MYLAR, sold by DuPont. An example of a suitable polyurethane barrier material is a polyurethane film manufactured by ArgoTech, which is located in Greenfield, Mass. The barrier layer may comprise a polymeric blend and/or multiple layers comprising two or more of the foregoing materials. Plasticizers, flow additives, and fillers known in the art can be used as desired to modify the properties of any of the foregoing polymers used to form the barrier layer.
According to one embodiment, the barrier layer is formed of a mixture of ethylene-vinyl acetate copolymer (EVA) and polypropylene (PP), preferably comprising about 5% to about 35% PP, more preferably about 10% to about 30% PP, more especially preferably about 15% to about 25% PP, and most preferably about 20% PP, with the balance comprising ethylene-vinyl acetate (EVA), and optionally other polymers and/or small quantities of additives such as plasticizers.
Other materials that can act as a barrier layer include cellulosic ethers, cellulose acetate, polyvinyl acetate, polyvinyl alcohol, shellac, and chemical or light-cure materials (e.g., methacrylate or acrylate resins). Examples of useful cellulosic ethers that can be used to form a barrier layer include, but are not limited to, ethyl cellulose, propyl cellulose, isopropyl cellulose, butyl cellulose, t-butyl cellulose, and the like.
In general, the thickness of the barrier layer can be selected to yield a dental treatment device having a desired level of strength, rigidity, resilience, and flexibility. In order for the barrier layer to be sufficiently flexible so as to conform to a person's teeth as result of adhesive action by the treatment composition and/or adhesive composition, the barrier layer will preferably have a thickness ranging from about 0.025 mm to about 1.5 mm, more preferably in a range of about 0.05 mm to about 1 mm, and most preferably in a range of about 0.1 mm to about 0.75 mm.
The treatment compositions within the treatment devices according to the invention may comprise any treatment composition known in the art. Preferred treatment gels are those that are substantially viscous and tacky in order to assist the adhesive composition region in retaining the treatment device against a person's teeth during use. The treatment compositions may comprise a continuous layer or bead positioned so as to cover a person's front tooth surfaces, rear tooth surfaces, or both, or they may comprise separate beads, layers or islands separated by one or more spaces. The treatment composition is advantageously positioned directly adjacent to the barrier layer.
In general, dental treatment gels will include at least one dental treatment agent, at least one tissue adhesion (or thickening) agent, and a liquid or gel, solvent, carrier or vehicle into which the dental treatment agent and tissue adhesivion agent are dispersed. The treatment gel may optionally include other active agents (e.g., desensitizing agents, remineralizing agents, antimicrobial agents, and the like), as well as inert ingredients (e.g., plasticizers, humectants, neutralizing agents, thickening agents, flavorants, sweeteners, and the like).
Exemplary dental treatment gels, and methods for making such gels, which may be used to manufacture the treatment compositions and devices according to the invention are disclosed in U.S. Pat. No. 5,376,006; U.S. Pat. No. 5,785,527; U.S. Pat. No. 5,851,512; U.S. Pat. No. 5,858,332; U.S. Pat. No. 5,985,249; U.S. Pat. No. 6,306,370; U.S. Pat. No. 6,309,625; U.S. Pat. No. 6,312,671; U.S. Pat. No. 6,322,774; U.S. Pat. No. 6,368,576; U.S. Pat. No. 6,387,353; U.S. Pat. No. 6,500,408; and U.S. Pat. No. 6,503,485. For purposes of disclosing dental treatment gels, and methods of making such gels, the foregoing patents are incorporated herein by reference.
Following are preferred treatment agents, tissue adhesion agents, solvents or carriers, and other components within preferred treatment compositions used to manufacture dental treatment devices according to the invention.
1. Treatment Agents
Any treatment agent capable of treatment teeth can be used. Examples include dental bleaching agents, desensitizing agents, antimicrobial agents, anticariogenic agents, and the like. A common dental bleaching agent that is known to bleach teeth and that has been found to be safe for oral use is hydrogen peroxide. However, stable hydrogen peroxide does not itself exist free in nature, but as an aqueous solution or a complex. Aqueous hydrogen peroxide is an acceptable dental treatment agent to the extent that an anhydrous treatment composition is not desired. Non-limiting examples of hydrogen peroxide complexes include carbamide peroxide and metal perborates (e.g., sodium perborate). Other bleaching agents that can be used to bleach teeth include, but are not limited to, metal percarbonates (e.g., sodium percarbonate), metal peroxides (e.g., calcium peroxide), metal chlorites and hypochlorites, peroxy acids (e.g., peroxyacetic acid), and peroxy acid salts.
The bleaching agent can have any desired concentration, e.g., between 1-90% by weight of the treatment composition. The concentration of the dental bleaching agent can be adjusted depending on the intended treatment time for each treatment session. In general, the shorter the treatment time, the more bleaching agent will be added to accelerate dental bleaching so as to effect treatment in a shorter time period. The one or more bleaching agents are preferably included in an amount in a range of about 1% to about 60% by weight of the dental bleaching composition, more preferably in a range of about 5% to about 40% by weight, and most preferably in a range of about 10% to about 30% by weight.
The treatment gel may include one or more other active agents instead of, or in addition to, the bleaching agent to yield treatment compositions having desired properties. Examples of other active agents include, but are not limited to, desensitizing agents (e.g., potassium nitrate, other potassium salts, citric acid, citrates, and sodium fluoride), remineralizing agents (e.g., sodium fluoride, stannous fluoride, sodium monofluorophosphate, and other fluoride salts), antimicrobial agents (e.g., chlorhexidine, troclosan, and tetracycline), antiplaque agents, anti-tartar agents (e.g., pyrophosphates salts), and other medicaments. Such active agents may be includes in amounts customary in the art of dental treatments.
2. Tissue Adhesion Agents
Useful tissue adhesion agents (or tackifying agents), which can also act as thickening agents that increase the viscosity of the dental treatment gel, include a wide variety of hydrophilic polymers. Examples of hydrophilic polymer tissue adhesion agents include, but are not limited to, polyvinyl pyrrolidone (PVP), PVP-vinyl acetate copolymers, carboxypolymethylene (e.g., CARBOPOL, sold by Novean, Inc.), polyethylene oxide (e.g., POLYOX, made by Union Carbide), polyacrylic acid polymers or copolymers (e.g., PEMULEN, sold by Novean, Inc.), polyacrylates, polyacrylamides, copolymers of polyacrylic acid and polyacrylamide, carboxymethylcellulose, carboxypropylcellulose, cellulosic ethers, polysaccharide gums, proteins, and the like.
Non-limiting examples of polyvinyl pyrrolidone polymers that have been used in formulating dental treatment compositions according to the invention include Kollidon 30, a polyvinyl pyrrolidone polymer sold by BASF having a molecular weight of 50,000, Kollidon VA 60, a polyvinyl pyrrolidone polymer having a molecular weight of 60,000, and Kollidon 90 F, a polyvinyl pyrrolidone polymer having a molecular weight of 1.3 million.
To form a gel having a desired rheology, the one or more tissue adhesion agents are preferably included in an amount in a range of about 1% to about 50% by weight of the dental treatment gel, more preferably in a range of about 3% to about 30% by weight, and most preferably in a range of about 5% to about 20% by weight.
3. Carriers and Vehicles
Dental treatment gels for use in making dental treatment devices according to the invention will typically include one or more liquid or gel, solvents, carriers or vehicles into which the dental treatment agent, tissue adhesion agent, and other components are dissolved or dispersed. The solvent, carrier or vehicle will typically comprise the balance of components in the dental treatment gel in addition to the treatment agent, tissue adhesion agent, and other components.
Examples of liquid or gel solvents, carriers or vehicles include, but are not limited to, water, alcohols (e.g., ethyl alcohol), and polyols (e.g., glycerin, sorbitol, mannitol, other sugar alcohols, propylene glycol, 1,3-propanediol, polyethylene glycol, polyethylene oxide, and polypropylene glycol).
4. Other Components
The treatment compositions may optionally include other components as desired to yield treatment compositions having desired properties. Examples include bleaching agent stabilizers (e.g., EDTA, salts of EDTA, citric acid and its salts, phosphoric acid and its salts, phenolphosphonic acid and its salts, gluconic acid and its salts, alkali metal pyrophosphates, alkali metal pyrophosphates, alkyl sulfates, such as sodium lauryl sulfate, tin salts, such as sodium stannate, and tartrates), neutralizing agents (e.g., sodium hydroxide and triethanolamine), inorganic thickening agents (e.g., fumed silica), humectants, flavorants, sweeteners, and the like.
C. Adhesive Compositions
The adhesive compositions used in manufacturing dental treatment devices according to the invention are characterized as having no treatment agent, or significantly less treatment agent, than the treatment gel. Aside from that, they may include any of the components set forth above with respect to the dental treatment gel. The adhesive composition is positioned near a lingual rim of the barrier layer so as to reliably maintain the barrier layer to lingual tooth surfaces during use, thereby better confining the treatment gel to an area adjacent to the person's tooth surfaces to be treated. The adhesive composition is preferably hydrophilic in order to more reliably adhere to moist oral tissues, such as teeth and/or gums.
The adhesive composition can be a gel or substantially solid. It is preferably a continuous bead or layer to provide continuous adhesion of the lingual edge of the barrier layer. The main difference between an adhesive composition that is a “gel” or “substantially solid” is the level of solvent or carrier within the composition. In general, the greater the concentration of solvent or carrier relative to the tissue adhesive agent, the less viscous the gel. The lower the concentration of solvent or carrier relative to the tissue adhesion agent, the more viscous the gel. At some point, the ratio of solvent or carrier to tissue adhesion agent is low enough so that the composition is or becomes a stiff or highly viscous putty, which may be characterized as being “substantially solid”. Stiff putties preferably become more adhesive to teeth when moistened with water or saliva. Substantially solid adhesive compositions can have so little solvent or carrier as to feel dry to the touch and be initially non-adhesive but then become adhesive to teeth when moistened with water or saliva. Substantially solid adhesive compositions can be made by initially including a very small amount of solvent or carrier and/or by first forming an adhesive gel that is later dried to remove a substantial portion of the solvent or carrier.
Examples of substantially solid adhesive compositions that can be used to reliably maintain a barrier layer against a person's lingual tooth surfaces are disclosed in U.S. application Ser. No. 10/637,237, filed Aug. 8, 2003; U.S. application Ser. No. 10/646,484, filed Aug. 22, 2003; and U.S. application Ser. No. 10/646,443, filed Aug. 22, 2003. For purposes of disclosing substantially solid adhesive compositions, the foregoing applications are incorporated herein by reference. Examples of adhesive gel compositions are disclosed in U.S. Pat. No. 5,770,182; U.S. Pat. No. 5,855,870; U.S. Pat. No. 5,851,512; U.S. Pat. No. 5,5,985,249; and U.S. Pat. No. 6,036,943. For purposes of disclosing adhesive gel compositions, the foregoing patents are incorporated herein by reference.
In the case where the adhesive composition is a gel, the concentration of tissue adhesion agent can fall within the ranges set forth above relative to the treatment gels. In the case where the adhesive composition is substantially solid, the one or more tissue adhesion agents are preferably included in an amount in a range of about 10% to about 90% by weight of the substantially solid adhesive composition, more preferably in a range of about 20% to about 80% by weight, and most preferably in a range of about 40% to about 75% by weight.
In adhesive compositions that are substantially solid, the concentration of solvent, carrier or vehicle will typically be attenuated compared to adhesive gels. Where it is desired to form an adhesive gel that is later converted into a substantially solid adhesive composition, it may be advantageous to include one or more volatile solvents that can be removed by evaporation (e.g., water, alcohols, acetone, and other organic solvents). Because of the affinity of hydrophilic polymers for water, even treatment compositions that appear to be solid may include a significant amount of bound water (e.g., up to about 10% or more by weight of the treatment composition). In the case where the treatment composition has the consistency of a highly viscous or stiff putty, the composition will generally include a solvent, carrier or vehicle that acts as a plasticizer or softening agent.
In general, adhesive compositions will include at least one tissue adhesion (or tackifying) agent and a liquid or gel solvent, carrier or vehicle into which the tissue adhesion agent is dispersed, at least in the case of a gel and/or during the manufacture of a substantially solid adhesive composition. The tissue adhesion agent preferably comprises a hydrophilic polymer (e.g., one or more of the hydrophilic polymers discussed above with respect to the dental treatment composition). The relative amount of tissue adhesion agent to liquid solvent, carrier or vehicle can be varied to yield either a gel or a substantially solid adhesive composition, as discussed above.
The solvent, carrier or vehicle may comprise any of the solvents, carriers or vehicles discussed above with respect to the treatment composition. The amount can be varied to yield either a gel or a substantially solid adhesive composition. An adhesive gel can be heated or otherwise processed to remove a substantially quantity of solvent or carrier to yield a substantially solid adhesive composition. In one embodiment, the substantially solid adhesive composition is initially non-adhesive or less adhesive but becomes more adhesive to teeth and soft oral tissues when moistened with saliva or water.
The adhesive composition may include a dental treatment agent, but typically in a lesser amount than the dental treatment gel. In that way, the portion of the tooth, if any, that contacts the adhesive composition rather than the treatment gel can still be subjected to tooth treatment. In addition, peroxide treatment agents are known to have an antimicrobial effect, thus potentially acting as a disinfecting and freshening agent to gums and periodontal tissue. The adhesive compositions may include a dental treatment agent in a range of 0% to about 10% by weight of the adhesive composition, preferably in a range of about 1% to about 10%, and more preferably in a range of about 5% to about 10% by weight.
The adhesive composition may include other components as desired, including colorants (e.g., carotene), gingival soothing agents (e.g., aloe vera, mild potassium nitrate, isotonic solution-forming. salts (e.g., sodium chloride in an amount of about 0.9% by weight), and anesthetics (e.g., benzocaine, lidocain and the like), antioxidants (e.g., vitamin A, vitamin C, vitamin E, other vitamins, chlorophyll and carotene), flavoring agents, antimicrobial agents and preservatives (e.g., sodium benzoate, parabens, triclosan, phenols, chlorhexidine, and cetylpyridinium chloride), mouth freshening agents (e.g., camphor and wintergreen), inorganic thickening agents (e.g., fumed silica and fumed aluminum oxide), remineralizing agents (e.g., sodium fluoride or other fluoride salts), treatment agent stabilizers, antiplaque agents, anti-tartar agents, and other adjuvents as desired.
The adhesive composition may optionally a bleaching agent activator that is released when the treatment device is moistened with saliva and/or mixed with the dental treatment gel upon placing the treatment device over the person's teeth. When peroxides are destabilized they more rapidly release oxygen radicals that cause tooth whitening. The treatment agent activator is advantageously retained within the adhesive composition prior to use (e.g., is locked within a substantially solid or gel matrix), but diffuses, leaches, or otherwise contacts, mixes or reacts with the bleaching gel upon moistening the bleaching and/or adhesive composition with saliva or water. The bleaching composition is initially substantially anhydrous and/or does not initially touch the adhesive composition in order to prevent diffusion or leaching of the bleaching agent activator into the bleaching composition prior to use.
An exemplary bleaching agent activator is a base, examples of which include oxides, hydroxides, carbonates, and bicarbonates of alkali metals and alkaline earth metals, and amines. Examples include sodium oxide, sodium hydroxide, potassium oxide, potassium hydroxide, sodium carbonate, sodium bicarbonate, ammonium hydroxide, magnesium hydroxide, sodium phosphate tribasic, and ethanolamine. Bases, when used as treatment agent activators, are preferably included in an amount in a range of about 0.1% to about 20% by weight of the adhesive composition, more, preferably in a range of about 1% to about 10% by weight, and most preferably about 7% by weight.
Another class of bleaching agent activator includes metals and metal compounds, such as transition metals (e.g., powders or fine particulates of iron, cobalt, nickel, copper, zinc, manganese, chromium, and the like) or metal compounds (e.g., halides or sulfates of iron, cobalt, nickel, copper, zinc, manganese, chromium, and the like). More specific examples include iron and manganese metal, manganese chloride, manganese citrate, ferrous sulfate, and manganese sulfate.
Another class of bleaching agent activator includes enzymes, particularly organo-metallic enzymes containing transition metals, such as iron. One example is “catalase”, which is described more particularly in U.S. Pat. No. 6,485,709 to Banerjee et al.
Metals, metal compounds, and organo-metallic enzymes, when used as a bleaching agent activator, are preferably included in an amount in a range of about 0.01% to about 20% by weight of the adhesive composition, more preferably in a range of about 0.05% to about 10% by weight, and most preferably in a range of about 0.1% to about 5% by weight.
In one embodiment, the adhesive composition includes both a bleaching agent activator and bleaching agent stabilizer. Where the bleaching composition directly contacts the adhesive composition, the effects of the bleaching agent stabilizer may predominate prior to moistening the adhesive composition and/or treatment gel with water or saliva. Thereafter, upon moistening the adhesive composition and/or treatment gel with water or saliva the effects of the bleaching agent activator may predominate. Many chemical reactions, including activating a peroxide bleaching agent, have a threshold activation energy requirement. The bleaching agent stabilizer can act to raise the activation energy requirement just enough to prevent or inhibit activation of the bleaching agent prior to moistening the adhesive composition or treatment gel with water or saliva but not so much as to prevent or inhibit activation after moistening occurs. This careful balance can be determined and optimized by testing adhesive compositions having varying concentrations of bleaching agent activator and bleaching agent stabilizer. Alternatively, the bleaching agent activator can be concentrated within the interior of the adhesive composition and/or the bleaching agent stabilizer can be concentrated at the surface of the adhesive composition.
D. Characteristics of Dental Treatment Devices
In one embodiment, the dental treatment devices according to the invention are in the shape of a dental tray having a front side wall, a rear side wall, and a trough between the front and rear side walls. Having the shape of a dental tray facilitates placement of the dental treatment device over a person's teeth by reducing the amount of manipulation necessary to obtain a good fit between the device and the person's teeth. They are substantially devoid of structures corresponding to the size and shape of a person's unique dentition so that the treatment devices are designed to comfortably fit over a plurality of differently-sized dental arches corresponding to different people. In another embodiment, the treatment devices are in the shape of a patch or strip. It is within the scope of the invention for the treatment devices to have any desired shape or configuration. In contrast to conventional treatment strips, which are not recommended for use while a person eats, drinks, smokes or sleeps, dental treatment devices according to the invention can be designed so as to be worn while talking, sleeping, eating, drinking, smiling, frowning, grimacing, yawning, coughing, smoking, or making virtually any facial expression or mouth contortion.
According to one embodiment, the dental treatment devices have a horseshoe shaped longitudinal profile and a trough with a U-shaped cross section, much like a conventional bleaching tray. An exemplary dental treatment device in the form of a dental tray is depicted in
The dental treatment device 10 further includes a barrier layer 18, preferably comprising a moisture-resistant material, which has a front rim 20 and a back rim 22. In one embodiment, one or both of the front and back rims 20, 22 of the barrier layer are designed so as to terminate at or slightly beyond the gingival margin when the dental treatment device 10 is in use. A dental treatment composition 24 is positioned adjacent to the barrier layer and is included in an amount so as to contact both labial and lingual tooth surfaces during use. An adhesive composition or region 26 is positioned adjacent to the lingual rim 22 of the barrier layer 18 in order to reliably maintain the rear side wall adjacent to lingual tooth surfaces during use. The adhesive composition or region 26 also confines the treatment composition 24 so as to primarily or exclusively contact the lingual tooth surfaces of the teeth to be treated.
In order to protect dental treatment devices from contaminants during storage and prior to use, the treatment devices can be packaged within a sealed container or package. As illustrated in
In one embodiment, the support layer 32 includes a shaped portion that acts as exoskeleton to hold or maintain the treatment device 10 in the shape of a dental tray, or within a tray-like configuration, prior to use. In use, both the treatment device 10 and support layer 32 are placed into a person's mouth so as to initially position the treatment device over the person's teeth. Thereafter, the support layer 32 is removed, leaving only the treatment device 10 within the person's mouth. This permits further manipulation of the barrier layer 18 in order for the treatment device 10 to better conform to the shape and irregularities of the person's teeth.
In addition to, or instead of, the protective package 30, the treatment device may alternatively include a removable protective layer (not shown) that is temporarily placed within the trough adjacent to the dental treatment composition and adhesive composition. When it is desired to use the treatment device, the removable protective layer is removed so as to expose the treatment composition and adhesive composition.
In the case of the dental treatment device 40 having an L-shaped cross section, it may be more correct to say that the rear side wall 44 extending laterally from the front side wall 42 is really a bottom wall rather than a rear side wall. Nevertheless, because this erstwhile “bottom wall” of an L-shaped treatment device is folded back against the lingual tooth surfaces during use, it can be readily seen that a treatment device having an L-shaped trough is merely a variation of a treatment device having a V-shaped trough. Thus, for purposes of this disclosure and the appended claims, the side wall 44 shall constitute, and fall within the definition of, a “rear side wall”.
To facilitate the ability of a dental treatment device to conform to the varying shapes and sizes among dental arches, the dental treatment device may include mechanical features such as one or more notches within the front or rear side walls. As shown in
Alternative embodiments of dental treatment compositions and devices in the form of a strip or patch are depicted in
In order to protect treatment strips or patches according to the invention from contaminants during storage and prior to use, they can be packaged within a sealed container or package. As illustrated in
Notwithstanding the foregoing examples, it will be appreciated that dental treatment devices according to the invention can have any profile and longitudinal shape (e.g., they can be flat or have a 3-dimensional shape; they can have a straight or curved longitudinal profile from one end to the other). The front and rear side walls of a tray may define a trough of any desired cross-sectional shape (e.g., the trough can be trapezoidal, rectangular, or any other desired geometric shape).
The size and shape of dental treatment devices according to the invention can be tailored to more readily fit either a person's upper dental arch or lower dental arch. They can be sized so as to bleach all or merely a subset of a person's teeth. The dental treatment devices may be sufficiently adhesive and flexible so as to readily conform to a wide variety of differently-sized teeth and dental arches. The dental treatment devices may be designed so as to substantially cover the front and lingual surfaces of the teeth to treated. Treating the front and lingual surfaces helps to treat interproximal spaces between a person's teeth, although it is certainly within the scope of the invention to bleach more of one surface than another.
The various components that make up the inventive dental treatment devices according to the invention can be assembled or brought together in any desired order. In the case where both the dental treatment composition and adhesive composition are a gel, one or both compositions can be placed directly adjacent to the barrier layer, whether in the shape of a dental tray, a strip or patch, or some other configuration, to yield the final dental treatment device. The treatment and adhesive compositions can be placed on the barrier layer simultaneously or sequentially. Alternatively, the adhesive composition can be placed against the barrier layer in gel form and then processed to remove at least a portion of the solvent or carrier. Thereafter, the treatment gel is placed adjacent to the barrier layer.
The barrier layer can have a desired shape prior to placing the treatment and protective adhesive compositions as desired to yield the finished treatment device. Alternatively, the barrier can be in the form of a sheet, the treatment and protective adhesive compositions are placed as desired, and the resulting intermediate product cut, shaped or otherwise reconfigured into a desired shape of the dental treatment device.
The dental treatment devices according to the invention can be designed to be worn for any desired time period. Increasing the concentration of dental treatment agent generally reduces the time required to effect treatment. Nevertheless, due to the extremely comfortable fit and reliable adhesion between the inventive dental treatment devices and the person's teeth, it is possible to wear such devices for extended periods of time in order to ensure more uniform treatment. They may be designed to be worn while performing normal daily activities, such as talking, eating, drinking, smoking, coughing, smiling, frowning, grimacing, or while sleeping. This greatly decreases their intrusiveness into everyday activities compared to conventional treatment strips, which do not reliably adhere to teeth, or intrusive treatment devices such as large, bulky treatment dental appliances.
The dental treatment devices according to the invention may be worn over a person's upper dental arch, lower dental arch, or both simultaneously. The ability to reliably and comfortably wear dental treatment devices over the upper and lower dental arches simultaneously is another departure from treatment strips, which are not recommended for use in treatment the upper and lower dental arches at the same time.
As illustrated in
Whereas previously filed U.S. application Ser. No. 10/783,750, filed Feb. 14, 2004, discloses that it may be acceptable or desirable to omit the protective adhesive composition in the lingual region of the treatment device, while only including the protective adhesive composition in the lingual region, it has now been found that it is preferable to do just the opposite: omit an adhesive composition in the lingual region and include a strip of an adhesive composition in the lingual region to offset disruptive lingual forces typically caused by a person's tongue while the treatment device is in use over the person's teeth. The bleaching composition, when properly formulated, does not irritate the gums as previously taught. Thus, there is often no need to protect the gums from the bleaching gel. On the other hand, the tendency of user's to dislodge the lingual side of a barrier layer using their tongue is ubiquitous. Including an adhesive strip on the lingual side greatly enhances adhesion of the barrier layer against tooth and/or soft oral tissues, thereby improving the ability to reliably maintain the barrier layer over lingual tooth surfaces.
To remove the dental treatment device, a user can pry open a corner of the barrier layer using a fingernail or rigid tool and then pull the remainder off. Any residual treatment and/or adhesive composition that remains adhered to the person's teeth can be removed by washing or flushing water over the person's teeth, and/or by brushing. Although the treatment and adhesive compositions can be very adhesive to teeth when protected from excessive moisture, they can be formulated to quickly break down and dissolve when flushed with excess water and/or by gentle mechanical action (e.g., brushing).
The dental treatment devices can be worn for as little as a few minutes or as long as several hours. By way of example, not limitation, a typical treatment session of fast duration may last from about 10 to about 30 minutes. A treatment session of intermediate duration may last from about 30 minutes to about 2 hours. A treatment session of long duration, including professional treatment or overnight treatment while a person is sleeping, may last from about 2 hours to about 12 hours.
Treatment sessions according to the invention may be repeated as many times as needed to obtain a desired degree of tooth treatment. In some cases, a clinical whitening effect has been observed after only 1-3 whitening sessions. A typical treatment regimen will preferably include 1-20 treatment sessions, more preferably 2-15 treatment sessions, and most preferably 3-10 treatment sessions.
For convenience of use, multiple dental treatment devices may be packaged together and sold as a kit. In one embodiment, the number of dental treatment devices provided with each kit may equal the number of sessions that represent a prescribed treatment regimen. Because of the ease of placing the inventive dental treatment devices over a person's teeth, coupled with the reliability with which they adhere to teeth, the likelihood that a particular treatment device will fail, or otherwise not work as intended, is greatly diminished compared to conventional treatment strips.
To efficiently utilize the space within a kit package, multiple dental treatment devices can be stacked or interested together. The dental treatment devices can be sealed collectively or individually as desired. A protective package 30 is depicted in
The following are several examples' of dental treatment compositions and adhesive compositions that can used in the manufacture of dental treatment devices. The exemplary formulations and manufacturing conditions are given by way of example, not by limitation, in order to illustrate dental treatment devices that have been found to be useful for treatment a person's teeth. Unless otherwise indicated, all percentages are by weight.
Examples 1-21 are directed to the manufacture of dental bleaching compositions that can be used as the active treatment gel. Examples 22-26 are directed to the manufacture of dental desensitizing compositions that can be used as either the treatment composition or the adhesive composition. Examples 27-29 are directed to the manufacture of medicament compositions that can be used as either the treatment composition or the adhesive composition. Examples 30-37 are directed to the manufacture of adhesive compositions that do not include any active agent. Examples 38-43 are directed to exemplary dental treatment gels that are suitable for use in manufacturing dental treatment devices according to the invention. Examples 44-49 describe further variations of exemplary dental treatment compositions according to the invention.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The resulting bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The resulting bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental desensitizing composition was formed by mixing together the following components:
The desensitizing composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A dental desensitizing composition was formed by mixing together the following components:
The desensitizing composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A dental desensitizing composition was formed by mixing together the following components:
The desensitizing composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A dental desensitizing composition was formed by mixing together the following components:
The desensitizing composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A dental desensitizing composition was formed by mixing together the following components:
The desensitizing composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A medicament composition was formed by mixing together the following components:
The medicament composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A medicament composition was formed by mixing together the following components:
The medicament composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A medicament composition was formed by mixing together the following components:
The medicament composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
An adhesive composition suitable for use in making a dental treatment device was formed by mixing together the following components:
The adhesive composition can be used in gel or substantially solid form in combination with a dental treatment gel to manufacture dental treatment devices according to the invention.
A desensitizing and remineralizing composition suitable was formed by mixing together the following components:
The desensitizing and remineralizing composition can be used in gel form as a treatment composition in combination with an adhesive composition to yield a dental treatment device. Alternatively, it may be used in either gel form or substantially solid form as an adhesive composition positioned near a lingual edge of a barrier layer.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel was placed within a flexible, thin-walled dental tray. An adhesive composition is placed near the lingual rim of the tray to yield a dental treatment device according to the invention. Alternatively, the dental bleaching gel and adhesive composition are placed onto a barrier layer in the form of a strip or patch to yield a dental treatment device according to the invention.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices ng to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
A dental bleaching gel was formed by mixing together the following components:
The dental bleaching gel is suitable for use in manufacturing treatment devices according to the invention in combination with a suitable adhesive composition.
Any of the adhesive compositions of Examples 22-37 are modified by adding one or more of a colorant, gingival soothing agent, isotonic solution-forming salt, anesthetic, antioxidant, flavoring agent, preservative, mouth freshening agent, detergent, inorganic thickening agent, remineralizing agent, antiplaque agent, anti-tartar agent, freshening agent, or antioxidant.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
