JP2007531551A - Oral healing device and endoskeletal treatment or adhesive composition comprising a thin and flexible barrier layer - Google Patents

Abstract

The oral treatment device (100) includes a barrier layer (102) and an oral treatment composition (112), and optionally acts as an internal skeleton to place the barrier layer (102) prior to use in a dental tray. Or an auxiliary adhesive composition that contributes at least in part to maintaining in the form of or a tray-like structure. The barrier layer (102) protects the oral treatment composition (112) and / or adhesive composition in use from saliva or moisture. The consistency range of the therapeutic composition and / or the auxiliary adhesive composition (112) is from a sticky viscous gel to a solid. Preferably they comprise a tissue adhesive comprising a hydrophilic polymer.

Description

  The present invention belongs to the field of oral treatment devices used to treat human teeth and / or gums. More particularly, the present invention relates to an oral treatment device comprising a thin, flexible, moisture-resistant barrier layer, and an oral treatment composition and / or auxiliary agent that serves as an internal skeleton that maintains the barrier layer in a desired configuration prior to use. The present invention relates to an adhesive composition.

  Almost all people want white or whiter teeth. To achieve this goal, people put veneers on the teeth or chemically bleach. Common bleaching methods include the use of dental trays that are custom made to fit human teeth and are therefore comfortable to wear. One type of custom-made tray is made from a human tooth profile. Other types are custom made directly using human teeth as a template [eg, “boil-and-bit” trays]. Non-custom trays have also been used that approximate the shape and size of the user's various dental arches. The dental bleaching composition is placed in a tray, which is placed on a person's teeth for a desired period of time.

  Another bleaching method involves applying the bleaching composition directly onto a person's teeth. An advantage observed with coated bleaching is that no dental tray is required. The main disadvantage of the applyable bleaching composition is that it is constantly directly exposed to the saliva and destructive forces in a person's mouth. As a result, a significant portion of the bleaching composition does not remain where bleaching on the teeth is desired. Some or all of the composition may dissolve in the human saliva and disappear and / or be carried to adjacent oral tissue to irritate the oral soft tissue.

  Another method of tooth bleaching involves placing a soft bleaching strip on the user's tooth surface. Conventional bleaching strips include a flexible plastic strip coated with a dental bleaching gel of medium viscosity and relatively low viscosity on the side facing the user's teeth of the strip. To install the bleaching strip, a portion of the bleaching strip is placed on the front of the user's tooth and the rest is folded around the occlusal edge of the tooth and against a portion of the tongue surface. As with the coating bleach composition, this method does not require the use of a dental tray. Unlike a coated bleach composition, the bleach strip includes a plastic barrier that at least theoretically prevents the dental bleaching gel from spreading into the user's mouth.

  In practice, it is often difficult for the user to maintain the bleach strip in its proper position for the recommended time, since the bleach strip is generally thin and generally has poor adhesion to the user's teeth. Conventional bleaching strips are prone to disengagement from the teeth as a result of minimal movement of the user's mouth, jaw or tongue. In fact, it is recommended that the user not eat, drink, smoke or sleep while wearing the bleach strip. In practice, it is difficult to talk and laugh while keeping the bleach strip in place and in place.

  Even if a user successfully maintains a conventional bleaching strip in its proper position at the recommended bleaching time, bleaching gel often diffuses into the human saliva, reducing the taste of the user's mouth, And can cause discomfort in the soft tissue of the throat. The tendency of the bleaching gel to diffuse into the user's mouth is also facilitated by minimal movement of the bleaching strip over the user's teeth, which adheres to the user's teeth but is not covered with a plastic strip. The bleaching gel can be exposed to saliva in the user's mouth each time the bleaching strip moves. In some cases, the bleach strip may slip or collapse so that the user must remove it and replace it with a new bleach strip to complete the recommended bleach time. This increases the cost and difficulty of using conventional bleach strips.

  In practice, the use of conventional bleaching strips is the simplest activity related to the movement of the user's mouth or tongue, such as talking, smiling, making other facial expressions, or swallowing (usually unconsciously throughout the day Even happens). In fact, the time when the person's mouth and tongue are least likely to move is the night while the person is sleeping. Unfortunately, conventional bleach strips are recommended not to use during sleep, presumably to prevent accidental suffocation from accidental bleach strips. This confirms the tendency of the conventional bleaching strip to be easily detached from the user's teeth.

  Finally, the main obstacle to successful bleaching is that users do not implement the prescribed bleaching scheme. If it is difficult to install a bleaching appliance on a person's teeth, if multiple iterations are required to achieve a clear result, or if the fit is poor, the user should give up and give the prescribed bleaching The plan will only be interrupted early. Thus, even if teeth can be bleached using a specific bleaching instrument or method, if the bleaching instrument or method is inadequate and will disappoint the user before the desired result is obtained , The likelihood of such a result is low.

  In view of these, an improvement that is simple, easy to use, and reliably stays in place on the user's teeth and / or gingiva, reducing the spread of the therapeutic composition into the user's oral cavity. There is a need for a therapeutic device and method. Such improvements are expected to improve or facilitate prescription compliance by the user.

  The present invention is used to treat a person's teeth and / or gingiva, and is a thin and flexible barrier layer, an oral treatment composition and / or a barrier layer prior to use in a desired structure (eg, a dental tray or Relating to an oral treatment device comprising an auxiliary adhesive composition placed relative to the barrier layer so as to act as an internal skeleton that at least partly serves to maintain in the form of a tray-like structure). During use, the barrier layer protects the therapeutic and / or adhesive compositions from saliva and moisture, keeps them in contact with human teeth and / or surrounding soft tissue, and diffuses them into the user's mouth Helps to prevent, minimize or reduce

  Advantageously, the barrier layer is formed of a moisture resistant polymeric material, examples being polyolefins, polyesters, ethylene vinyl acetate copolymers (EVA), polyurethanes, other polymers and mixtures thereof (eg polyethylene and polypropylene). Advantageously, the barrier layer is thin and flexible so as to conform to the human dental mold as a result of the adhesive properties of the oral treatment composition. The thickness is preferably in the range of 0.0001 inch (0.000254 cm) to 0.012 inch (0.03048 cm). The shape may be in the form of a dental tray having two or more walls with a certain trough in between. Alternatively, the barrier layer is a tray having two or more walls, at least one of which includes a cut or discontinuity to help form a barrier layer on a person's teeth and / or gums during wearing. It may be in the form of a fixture. If one or more of the walls include deep cuts or discontinuities that provide one or more discontinuous walls, the tray-like treatment instrument can no longer have a trough.

  The barrier layer can take a specific form prior to use regardless of the therapeutic composition, or can be in a form that is only as a result of the presence of the oral therapeutic composition and / or the auxiliary adhesive composition adjacent to the barrier layer. It can be thin and flexible so that it can be taken. In any case, the therapeutic composition and / or auxiliary adhesive composition serves as an internal scaffold that maintains the barrier layer in the form of a dental tray or tray-like structure prior to use. As such, the therapeutic and / or adhesive composition serves to prevent the walls from spreading apart and / or collapsing. In use, the barrier layer is securely held in place on the user's teeth by the adhesive action of the treatment composition and / or the auxiliary adhesive composition for a desired period of time.

  The oral treatment composition and / or the auxiliary adhesive composition can include a bead or continuous layer that substantially covers the inner surface of the barrier layer. The therapeutic and / or adhesive composition may be in the form of a sticky viscous gel, may be a hard putty, and may be solid or substantially solid. An adhesive, viscous therapeutic gel is a very viscous glue that ensures that both the treatment and / or adhesive composition and the barrier layer are retained on the tooth and / or gingival surface of the person being treated. Or it can act as an adhesive. Solid putty, solid or substantially solid therapeutic compositions generally have a drier or slightly dry feel than gel compositions and tend to stick to teeth and / or gums when moistened with saliva or water during wear. Get higher.

  Oral therapeutic compositions according to the present invention typically include certain active agents, tissue adhesives, liquid or gel solvents or carriers, and optionally other active agents, inactive ingredients or adjuvants. The auxiliary adhesive composition can optionally exclude one or more active agents contained in the oral treatment composition. Whether the therapeutic or adhesive composition is in the form of a sticky, viscous gel, hard putty or solid depends primarily on the relative concentrations of the tissue adhesive and the solvent or carrier. Increasing the solvent or carrier ratio compared to the tissue adhesive generally reduces the viscosity of the composition, but decreasing the solvent or carrier ratio compared to the tissue adhesive yield results in a more viscous bleaching composition Things are generated. When the concentration of the solvent or carrier is reduced to a certain point, the composition becomes viscous enough to be considered a putty or even a solid. In one embodiment, a hard but plastically deformable putty is prepared by first forming a therapeutic gel with a substantial amount of solvent and then removing a significant portion of the solvent by evaporation. The In other embodiments, the solid composition is made by removing additional solvent. Some residual moisture or solvent may remain in the putty-like solid composition after evaporation.

  The size and shape of the oral treatment device according to the present invention can be adjusted to more easily fit the person's upper or lower dental arch. They can also be adjusted to suit people with different sized or shaped dental arches. The treatment device is advantageously flexible and sticky to fit a wide variety of teeth and dental arches of different sizes. In one embodiment, the treatment device is designed to substantially cover the front and lingual surfaces of the tooth and / or gingiva to be treated. Treating both surfaces helps to penetrate the therapeutic composition into the interdental space between adjacent teeth.

  The oral treatment device according to the present invention can be designed to be worn for any desired period. In general, increasing the concentration of the active agent within the therapeutic composition reduces the time required to provide the desired treatment. Nevertheless, for a comfortable fit and secure adhesion between the inventive treatment device and a person's teeth, wearing such a device for a long time to ensure a uniform and perfect treatment Is possible. The therapeutic device according to the invention can be worn, for example, during conversation, sleeping, eating, drinking, smiling, frowning, frowning, yawning, coughing, smoking, or virtually any facial expression or mouth movement Can be designed. This greatly increases the inconvenience of daily activities compared to invasive treatment devices such as conventional bleach strips that do not reliably adhere to teeth or large and bulky dental bleaching devices. Reduce.

  The oral treatment device of the present invention can be designed to be worn in just a few minutes or even a long time of several hours. By way of example, but not limitation, a typical short treatment session lasts from about 10 minutes to about 30 minutes. The intermediate time treatment session lasts from about 30 minutes to about 2 hours. Long treatment sessions, including professional treatment or overnight treatment during sleep, last from about 2 hours to about 12 hours. The treatment session can be repeated as many times as necessary to obtain the desired therapeutic effect. A typical treatment plan comprises preferably 1-20 treatment sessions, more preferably 2-15 treatment sessions, most preferably 3-10 treatment sessions.

  For convenience in use, multiple oral treatment devices can be packaged together and sold as a kit. In one embodiment, the number of oral treatment devices provided with each kit can be equal to the number of sessions reflecting the prescribed treatment plan. In order to effectively utilize the space within the kit package, multiple treatment devices may be stacked, nested within each other, or placed together in a package. The therapeutic devices can be sealed together or individually as desired. They can include a removable protective layer on the inner surface to protect the bleaching composition from contamination or moisture.

  These and other advantages and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by practice of the invention as set forth hereinafter.

  In order to further clarify the above and other advantages and features of the present invention, a more detailed description of the invention will be given by reference to specific embodiments thereof illustrated in the accompanying drawings. . It should be appreciated that these figures depict only typical embodiments of the invention and are therefore not intended to limit its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

I. INTRODUCTION AND DEFINITIONS The present invention relates to an improved oral treatment device used to treat human teeth and / or gingiva. The therapeutic device of the present invention includes a thin and flexible barrier layer and an internal skeleton containing an oral treatment composition and / or an auxiliary adhesive composition. During use, the barrier layer protects the therapeutic and adhesive compositions from saliva or moisture in the oral cavity, keeps them in contact with the human teeth and / or surrounding soft tissue, and into their mouths Helps prevent or minimize spread.

  The treatment device of the present invention is more tacky to teeth and / or gums than conventional dental bleaching strips and is less bothersome than commercially bulky, ready-made or boil-and-bite dental trays. In some cases, they may have a confidence in holding the therapeutic composition against a person's teeth and / or gums that is comparable or higher than a custom dental tray. Depending on the person, they may be at least as comfortable as custom trays.

  As used herein, the term “barrier layer” refers to a substance that protects the therapeutic composition and optional adhesive composition from ambient moisture and saliva when the therapeutic device is worn on a person's teeth. Of one or more layers. The barrier layer can also serve to protect the therapeutic and / or adhesive composition from moisture and contaminants during storage and use. The barrier layer may maintain itself in the desired shape independent of the adjacent internal skeleton composition, or may be thin and flexible so that it does not take a predetermined shape when no internal skeleton is present.

  The term “internal scaffold” when placed adjacent to a barrier layer, any oral treatment composition and / or auxiliary adhesive that helps maintain the barrier layer in the form of a dental tray or tray-like structure prior to use. Refers to the composition. If the barrier layer is at least partially compatible with the shape of the dental tray, or has a tray-like structure, regardless of the inner skeleton, the inner skeleton is in the form of a dental tray or tray-like structure before use. It becomes a further support to help maintain. If the barrier layer does not have a predetermined shape, the internal skeleton determines and maintains the shape of the barrier layer prior to use. The viscosity of the “internal skeleton” can have a range from sticky, viscous gel to solid composition.

  The term “sticky, viscous gel” is formulated to have a viscosity that does not flow easily by gravity but can be squeezed out of a syringe hole or other dispensing means known in the art. It is intended to refer to the processed therapeutic composition and / or auxiliary adhesive composition.

  At some point when the viscosity of the highly viscous gel becomes so high that a substantially solid but plastically deformable composition is produced, it can be considered to be a “stiff putty”. The difference between "sticky, viscous gel" and "hard putty" is a matter of degree. Similarly, a “hard putty” can be so hard or stiff that it is “solid”.

  As used herein, the term “substantially solid” refers to a therapeutic or auxiliary adhesive composition that is in a solid or semi-solid state. In one aspect, a “substantially solid” composition is characterized by a sticky object that does not flow or separate easily when subjected to gravity, and is a syringe outlet or other similarly sized opening. It cannot be easily squeezed through a part or hole. Thus, the term “substantially solid” can flow when subjected to flowable viscous liquids, viscous viscous liquids, and even gravity, and / or a syringe outlet or similar sized opening. It also eliminates thick, sticky gels that can be easily squeezed through a hole or hole. When used in the context of a therapeutic or adhesive composition, the term “substantially solid” also excludes dry particulate compositions or powders because dry microparticles and powders have been subjected to gravity. Sometimes it flows easily and / or easily separates (ie the particles as a whole have little or no tackiness). Furthermore, when viewed as a whole, the powder or particulate is neither sticky nor solid.

  In one embodiment, “hard putty” and “substantially solid” compositions become more tacky when moistened with saliva or water. When moistened, the surface of the substantially solid or putty-like composition turns into a sticky substance that can adhere more strongly to the teeth compared to the non-moistened substantially solid or putty-like composition. . The substantially solid or putty composition is at least temporarily in a viscous liquid, paste or gel at least on the outer surface, depending on the amount of moisture applied to the surface of the “substantially solid” or putty composition. Can be. The consistency of the dampened surface remains “substantially solid” or putty-like depending on the initial degree of humidification, or the initial application amount of surface water is “substantially solid” or As it sequentially diffuses into the rest of the putty-like composition (eg, during an oral treatment procedure where the composition is protected from saliva in the mouth and surrounding moisture by a moisture resistant barrier layer), It even returns to a “substantially solid” or putty state.

  As used herein, the term “dental tray” refers to an instrument having a tray-like shape that facilitates attachment of the instrument to at least a portion of a human dental arch. In one embodiment, the “dental tray” is a front wall of a structure that engages the front surface of a person's teeth in use, abruptly at one or more different angles from the front wall, or by a curved transition. And a trough between the front side wall and the rear side wall that extends laterally and engages the lingual side of the person's teeth. A “dental tray” can be structured such that, in use, the front side wall, the rear side wall, or a portion of its transition (eg, the bottom wall) engages with a person's dental incision or occlusal edge. The dental tray may be curved or straight on the vertical axis.

  As used herein, the term “trough” refers to a front side wall, a rear side wall, and a region that is at least partially surrounded by a planar or imaginary curved domed sphere extending from the front side wall upper edge and the rear side wall upper edge. Point to. Thus, a “trough” is theoretically present whenever successive front and back sidewalls have a space between them and are laterally offset by less than 180 degrees. In practice, the front and back side walls are preferably separated by an angle of less than about 150 degrees, more preferably less than about 120 degrees, and most preferably less than about 90 degrees.

  When the front and rear side walls are connected by a transition (eg, in the case of a trough having a U-shaped or rectangular cross section), at least a portion of the front and rear side walls are substantially parallel (ie, approximately 0 degrees). Separated by an angle) or very small angles. For troughs having a V-shaped or trapezoidal cross section, at least a portion of the front and rear side walls may be separated by an acute angle (ie, an angle of 0-90 degrees). For troughs having an L-shaped cross section, at least a portion of the front and back side walls may be separated by an angle centered at about 90 degrees (eg, an angle of about 70 degrees to about 110 degrees). Thus, a trough with an L-shaped cross section is a subset or a slight deformation of a trough with a V-shaped cross section.

  The terms “longitudinal”, “vertical axis” and “longitudinal section” as used herein when referring to a dental tray or treatment instrument shall refer to the longitudinal dimension of the tray or instrument. The tray or instrument may be straight on the "vertical axis", or the longitudinal axis is horseshoe-shaped to approximate the curvature of the human dental arch, or at least to facilitate the mounting of the tray or instrument on the dental arch Alternatively, it may be “vertically curved”.

  If the treatment device includes one or more walls containing cuts or other discontinuities and the walls are not continuous, the individual flaps or segments of the discontinuous walls There is one or more sufficient spaces in between, so that a “trough” no longer exists between the front side wall and the bottom side wall or flap. Thus, the term “trough” should be understood as a region between two or more consecutive walls that define an internal region within which a liquid or gel can be held or contained. If one of the walls is fairly discontinuous enough to create a device that allows liquid to flow through or out of the cut or discontinuity, the space or area between the side walls is not "trough" and simply It is the interior area between the walls.

  The term “molecular weight” as used herein refers to the number average molecular weight expressed in daltons unless otherwise specified.

II. Oral Treatment Device The oral treatment device according to the present invention comprises a thin and flexible barrier layer that protects the surrounding moisture in the oral cavity during use of the therapeutic composition and optionally the auxiliary adhesive composition. The therapeutic composition and / or adhesive composition serves as an internal scaffold to at least partially maintain the barrier in the desired shape of the tray or tray-like structure prior to use. The therapeutic and / or adhesive compositions range from sticky viscous gels to solid compositions that become more sticky when moistened with saliva or water. The following are preferred examples of barrier layers, therapeutic compositions and auxiliary adhesive compositions according to the present invention, as well as the properties of therapeutic devices made therefrom.

A. Barrier layer The barrier layer is preferably moisture resistant to protect the therapeutic composition and / or auxiliary adhesive composition from moisture around the oral cavity. According to one embodiment, the barrier layer comprises a thin and flexible membrane formed from a moisture resistant polymeric material. The thin and flexible barrier layer preferably ranges from about 0.0001 inch (0.000254 cm) to about 0.012 inch (0.03048 cm), more preferably from about 0.001 inch (0.00254 cm) to about 0.001. The thickness is in the range of 01 inches (0.0254 cm). The barrier layer can form a dental tray or tray-like instrument without an internal skeleton, or is unshaped and requires an internal skeleton.

  Examples of materials that can be used to form the barrier layer include, but are not limited to, polyolefins, waxes, metal foils, paraffins, ethylene vinyl acetate copolymers (EVA), ethylene vinyl alcohol copolymers (EVAL), polycaprolactones. (PCL), polyvinyl chloride (PVC), polyester, polycarbonate, polyamide, polyurethane or polyesteramide. Examples of suitable polyolefins that can be used 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), There are polypropylene (PP) and polytetrafluoroethylene (PTFE) (eg Teflon®). Examples of suitable polyesters used to make the barrier layer include, but are not limited to, polyethylene terephthalate (PET), such as MYLAR sold by DuPont. An example of a suitable polyurethane barrier material is a polyurethane film manufactured by ArgoTech located in Greenfield, Massachusetts. The barrier layer can include a polymer blend and / or multiple layers that include two or more of the aforementioned materials. Plasticizers, flow additives and fillers known in the art can be used if desired to modify the properties of any of the aforementioned 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 about 5% to about 35% PP, more preferably about 10% to about 30%. PP, more particularly preferably about 15% to about 25% PP, most preferably about 20% PP, with the remainder like ethylene vinyl acetate (EVA) and optionally other polymers and / or plasticizers Small amount of additives.

  Other materials that can serve as a barrier layer include cellulose ether, cellulose acetate, polyvinyl acetate, polyvinyl alcohol, shellac, and chemical or photocured products (eg, methacrylate or acrylate resins). Examples of useful cellulose ethers that can be used to form the barrier layer include, but are not limited to, ethyl cellulose, propyl cellulose, isopropyl cellulose, butyl cellulose, t-butyl cellulose, and the like.

B. Oral Treatment Composition The viscosity of the oral treatment composition according to the present invention ranges from an adhesive viscous gel to a solid. A substantially solid or putty-like composition preferably becomes more sticky and adhesive to the teeth and / or gums when moistened with water or saliva. The therapeutic composition can include a bead or continuous layer placed to cover one or more of a person's tooth surface and / or gingiva. The therapeutic composition can be placed directly adjacent to the barrier layer, or at least some of the therapeutic composition can be placed adjacent to the auxiliary adhesive composition.

  In general, sticky viscous therapeutic gels include at least one active agent, at least one tissue adhesion (or thickening) agent, a liquid or gel in which the active agent and tissue adhesive are dispersed, a solvent, a carrier or a medium ( vehicle), and optionally other ingredients and adjuvants. The main difference between a composition that is a “gel” and one that is “putty” or “solid” is the level of solvent or carrier within the composition. In general, the greater the concentration of solvent or carrier compared to the tissue adhesive, the more gelled the composition. The lower the concentration of solvent or carrier compared to the tissue adhesive, the more putty or solid the composition will be. At some point, the ratio of solvent or carrier to tissue adhesive is low enough for the gel composition to transition to a hard or highly viscous putty, or for the putty to transition to a solid.

  Hard putties and solids preferably become more adhesive to the teeth when moistened with water or saliva. Lowering the solvent or carrier of the solid or putty composition provides a dry feel and is initially non-adhesive, but when moistened with water or saliva, becomes more sticky to the teeth and / or gums. A substantially solid composition or putty-like composition may initially contain a very small amount of solvent or carrier and / or initially form a gel, which is then dried to obtain a significant amount of solvent or carrier. Can be made by removing parts.

  The following are exemplary active agents, tissue adhesives, solvents or carriers, and other ingredients that can be used to make an oral treatment composition according to the present invention.

1. Active Agents Examples of active agents that can be used in the oral therapeutic composition according to the present invention include dental bleaching agents, desensitizing agents, recalcifying agents, antibacterial agents, anti-plaque agents, anti-calculus agents, and painless gums. There are chemicals, anesthetics, antioxidants and mouth refreshers. Examples of dental bleaching agents include, but are not limited to, hydrogen peroxide, carbamide peroxide, metal perborate (eg, sodium perborate), metal percarbonate (eg, sodium percarbonate), There are metal peroxides (eg, calcium peroxide), metal chlorites and hypochlorites, peroxoacids (eg, peroxyacetic acid), and peroxoacid salts.

  The bleaching agent in the dental bleaching composition according to the invention can have any desired concentration, for example 1 to 90% by weight of the dental bleaching composition. The concentration of dental bleach can be adjusted according to the intended treatment time of each bleaching session. In general, the shorter the treatment time, the faster the teeth are bleached by adding more bleach to bring about bleaching in a shorter time. Preferably the one or more bleaching agents are in an amount from about 1% to about 60%, more preferably from about 5% to about 40%, most preferably from about 10% to about 30% by weight of the dental bleaching composition. Included.

  Examples of other active agents that can be included in addition to or in place of dental bleaching agents include desensitisers (eg, potassium nitrate, other potassium salts, citric acid, citrate and sodium fluoride), Stone agents (eg sodium fluoride, tin fluoride, sodium monofluorophosphate and other fluoride salts), antibacterial agents and preservatives (eg chlorhexidine, triclosan, sodium benzoate, parabens, tetracycline, phenol and cetylpyridinium chloride) Anti-plaque agents, anticalculus agents (eg pyrophosphate), gum soothing agents (eg aloe vera, mild potassium nitrate, isotonic salts), anesthetics (eg benzocaine, lidocaine etc.), antioxidants ( Eg vitamin A, vitamin C, vitamin E, other vitamins and carotene) and Freshener is [e.g. camphor and methyl salicylate (winter green)].

2. Tissue adhesives Useful tissue adhesives (or tackifiers) include a wide variety of hydrophilic polymers. Examples of hydrophilic polymer tissue adhesives include, but are not limited to, polyvinylpyrrolidone (PVP), PVP-vinyl acetate copolymer, carboxypolymethylene (eg, sold by CARBOPOL, Novean, Inc.), polyethylene oxide (eg, POLYOX, manufactured by Union Carbide), polyacrylic acid polymer or copolymer (sold by, for example, PEMULEN, Novean, Inc.), polyacrylate, polyacrylamide, polyacrylic acid and polyacrylamide copolymer, carboxymethylcellulose, carboxypropylcellulose, cellulose There are ethers, polysaccharide gums and proteins.

  Non-limiting examples of polyvinylpyrrolidone polymers used in the formulation of oral treatment compositions according to the present invention include Kollidon 30, a 50,000 molecular weight polyvinylpyrrolidone polymer sold by BASF, having a molecular weight of 60,000. There is Kollidon VA 60, a polyvinyl pyrrolidone polymer, and Kollidon 90 F, a polyvinyl pyrrolidone polymer with a molecular weight of 1,300,000.

  When the oral treatment composition is a gel, preferably the one or more tissue adhesives are from about 1% to about 50%, more preferably from about 3% to about 30%, most preferably from the treatment gel. It is included in an amount of about 5% to about 20% by weight.

  Where the oral therapeutic composition is substantially solid, preferably the one or more tissue adhesives are from about 10% to about 90%, more preferably about 20%, of the substantially solid therapeutic composition. To about 80% by weight, most preferably from about 40% to about 75% by weight.

3. Carriers and Media Adhesive viscous oral treatment gels typically include one or more liquids or gels, solvents, carriers or media in which the active agent, tissue adhesive and other components are dissolved or dispersed. Examples of liquid or gel solvents, carriers or media include, but are not limited to, water, alcohols (eg, ethyl alcohol), and polyols (eg, glycerin, sorbitol, mannitol, other sugar alcohols, propylene glycol, 1, 3-propanediol, polyethylene glycol, polyethylene oxide and polypropylene glycol).

  In the case of a substantially solid or hard putty composition, the concentration of the solvent, carrier or vehicle is generally lower compared to the therapeutic gel. If it is desired to form a therapeutic gel that is later converted to a putty or solid composition, one or more volatile solvents (eg, water, alcohols, acetone and other organics) that can be removed by evaporation. It is advantageous to include a solvent. Due to the affinity of the hydrophilic polymer for water, even a solid-state therapeutic composition can contain a significant amount of bound water (eg, up to about 10% by weight or more of the therapeutic composition). Where the therapeutic composition has a very viscous or hard putty consistency, the composition typically includes a solvent, carrier or vehicle that acts as a plasticizer or softener.

4). Other Components The oral treatment composition can optionally include other components as desired to obtain a therapeutic composition having the desired properties. Examples include bleach stabilizers (eg EDTA, salts of EDTA, citric acid and salts thereof, phosphoric acid and salts thereof, phenolphosphonic acid and salts thereof, gluconic acid and salts thereof, alkali metal pyrophosphates, alkali metal polyphosphorus Acid salts, and alkyl sulfates), neutralizing agents (eg, sodium hydroxide and triethanolamine), inorganic thickeners (eg, fumed silica), colorants, flavors, sweeteners, and the like.

C. Auxiliary Adhesive Composition When used optionally in the manufacture of an oral treatment device according to the present invention, the auxiliary adhesive composition cannot contain an active agent, or a considerably smaller amount compared to the oral treatment composition. An active agent or a different active agent can be included. Alternatively, they can include any of the ingredients described above with respect to the oral treatment composition. The auxiliary adhesive composition can be located between the therapeutic composition and the barrier layer. Alternatively, the auxiliary adhesive composition may be a therapeutic composition that, for example, protects a person's gingiva or periodontal tissue from the bleaching composition during use, thereby limiting the bleach to an area adjacent to the person's tooth surface to be bleached. It can be located adjacent to or surrounding an object.

  Similar to the therapeutic composition, the auxiliary adhesive composition varies from sticky viscous gels to solids. It can be a bead or a layer. When the therapeutic device is in use, the adhesive composition can be placed in a limited area near the edge or edge of the barrier layer closest to the person's gingiva, or a portion of the adhesive composition can be under the therapeutic composition. May extend. Alternatively, the bead of adhesive composition can be placed on top of a portion of the therapeutic composition.

  In general, at least in the case of a gel and / or during the production of a substantially solid adhesive composition, the auxiliary adhesive composition comprises at least one tissue adhesive (or tackifier) and a liquid in which the tissue adhesive is dispersed or Contains gel solvent, carrier or medium. The tissue adhesive preferably comprises a hydrophilic polymer (eg, one or more of the hydrophilic polymers discussed above with respect to the dental bleaching composition). The relative amount of tissue adhesive relative to the liquid solvent, carrier or medium can be varied to obtain either a sticky viscous gel or a solid adhesive composition as indicated above. The solvent, carrier or medium can include any of the solvents, carriers or media discussed above with respect to the bleaching composition.

  The auxiliary adhesive composition optionally includes other ingredients such as colorants (eg, carotene), gum soothing agents (eg, aloe vera, mild potassium nitrate, isotonic liquid forming salts (eg, about 0.9). Sodium chloride in weight%), and anesthetics (eg benzocaine, lidocaine, etc.), antioxidants (eg vitamin A, vitamin C, vitamin E, other vitamins, chlorophyll and carotene), flavorings, antibacterial agents and storage Materials (eg sodium benzoate, parabens, triclosan, phenol, chlorhexidine and cetylpyridinium chloride), mouthwashes (eg camphor and methyl salicylate), bleach stabilizers (eg EDTA, citric acid and sodium lauryl sulfate), inorganic Sticky agents (eg fumed silica and fumed) Aluminum oxide), re-mineralization agent (e.g. sodium fluoride or other fluoride salt), antiplaque agents, anticalculus agents, other adjuvants bleach activators and optionally.

D. Oral Treatment Device Features According to one embodiment, the oral treatment device has a horseshoe-shaped longitudinal section and the trough is U-shaped in cross-section, much like a conventional bleaching tray. An exemplary treatment instrument in the form of a dental tray is shown in FIGS. 1A and 1B. FIG. 1A includes a flexible barrier layer 102 having a front side wall 104, a rear side wall 106, and a horseshoe-shaped bottom wall 108 that together define a trough 110 having a generally U-shaped cross section throughout its longitudinal dimension. 1 is a perspective view of an oral treatment device 100. FIG. Located within the trough 110 is a dental tray having at least partially a trough with a U-shaped cross-section, and an oral treatment composition 112 serving as an internal skeleton for maintaining the barrier layer 102. It is a continuous bead. The viscosity of the oral therapeutic composition 112 varies from a sticky viscous gel to a solid therapeutic composition. The bead of the oral treatment composition 112 is preferably an adhesive viscous gel having a cross-sectional diameter or thickness in the range of about 1 mm to about 5 mm, more preferably in the range of about 2 mm to about 4 mm.

  FIG. 1B represents an oral treatment device 100 'that includes a barrier layer 102 in the form of a dental tray having a substantially U-shaped cross section. The barrier layer 102 includes a front side wall 104, a rear side wall 106, and a horseshoe-shaped bottom wall 108 that together define a trough 110 having a generally U-shaped cross-section throughout its vertical dimension. Disposed within the trough 110 is a continuous layer of oral treatment composition 112 '. Oral treatment compositions 112 'vary from sticky viscous gels to solid compositions. The continuous layer of therapeutic composition 112 'is a hard putty or solid composition preferably having a thickness in the range of about 0.2 mm to about 2 mm, more preferably in the range of about 0.5 mm to about 1 mm.

  2A and 2B have a generally U-shaped trough but are narrowed to have a more V-shaped cross section near the incisors, as shown in more detail in FIGS. 3A and 3B. Represents oral treatment devices 200 and 200 ′. As shown in FIGS. 2A and 3A, the oral treatment device 200 includes a barrier layer 202 having a front side wall 204, a rear side wall 206, and a bottom wall 208 that together define a trough 210. A continuous bead of oral treatment composition 212 is placed in trough 210 and formulated to serve as an internal skeleton that at least partially serves to maintain barrier layer 202 in the form of a dental tray. .

  As shown in FIGS. 2B and 3B, the oral treatment device 200 ′ has a trough 210 that, when combined, has a substantially U-shaped cross section that narrows near the incisor and becomes a substantially V-shaped cross section. A barrier layer 202 having a front side wall 204, a rear side wall 206, and a bottom wall 208. A continuous layer of oral treatment composition 212 'is placed in trough 210 and formulated to act as an internal skeleton that at least partially helps maintain barrier layer 202 in the form of a dental tray.

  4A and 4B represent oral treatment devices 400 and 400 ′, each of which is put together with a bead of treatment composition 412 (FIG. 4A) or a continuous layer of treatment composition 412 ′ (FIG. 4B). A barrier layer 402 having a front sidewall 404 defining a trough 410, a rear sidewall 406, and a bottom wall 408. In addition, oral treatment devices 400 and 400 ′ include a first notch 414 on the front side wall 404 and a second notch 416 on the rear side wall 406. Notches 414 and 416 help in adapting oral treatment devices 400 and 400 'to dental arches of various sizes and shapes.

  Figures 5A and 5B represent oral treatment devices 500 and 500 'structured to be a discontinuous bottom or posterior wall. In this method, oral treatment instruments 500 and 500 ′ do not include “troughs”, although the term is usually understood in the context of a conventional dental tray having continuous walls that together define the troughs. Because it is.

  Instead of a continuous side wall, each oral treatment device 500 and 500 ′ includes a front side wall 504, a first bottom flap 506a separated by a first cut or discontinuity 507, and a second cut or discontinuity. 509 includes a barrier layer 502 having a second bottom flap 506b separated from the first bottom flap 506a by 509. The size and structure of the first bottom flap 506a is adapted to cover and adjacent to the inner surface of a person's incisor and canine in use. The size and structure of the second bottom flap 506d is adapted to cover and contact the human premolars and optionally the inner surface of one or more molars.

  The cut or discontinuity 509 between the first flap 506a and the second flap 506b improves the adhesion of the first bottom flap 506a to the person's incisor and canine, particularly the canine and premolar joint. The cut or discontinuity 509 compensates for the steep difference in width between the human premolar adjacent to the second bottom flap 506b and the canine adjacent to the first bottom flap 506a. The discontinuities or cuts 507 separating the first bottom flaps 506a from one another further help in fitting the flaps 506a to the inner surface of a person's incisor and canine.

  FIG. 5A further shows a continuous bead of oral treatment composition 512 placed in the inner region defined by the front side wall 504 and bottom flaps 506a and 506b. FIG. 5B instead shows a substantially continuous layer of oral treatment composition 512 'placed within the inner region defined by the front sidewall 504 and bottom flaps 506a and 506b.

  In order to protect the oral treatment device according to the invention from contaminants during storage and before use, the treatment device can be enclosed in a sealed container or package. As illustrated in FIGS. 6A and 6B, exemplary oral treatment devices 200 and 200 'can be sealed within a protective package 600 or 600' that includes a rigid support layer 632 and a peelable cover 634. If it is desired to use the oral treatment device 200 or 200 ′, the peelable cover 634 is removed and the treatment device 200 or 200 ′ is removed from or detached from the support layer 632.

  In one embodiment, the support layer 632 includes a shaped portion that serves as an exoskeleton to further assist in maintaining the treatment device 200 or 200 ′ in the shape of a dental tray prior to use. . In use, both the therapeutic device 200 or 200 'and the support layer 632 can be placed in a person's mouth such that the therapeutic device 200 or 200' is first placed on the person's teeth and / or gums. Thereafter, the support layer 632 is removed, leaving only the therapeutic device 200 or 200 'in the person's mouth. This allows the barrier layer 202 to be further manipulated so that the treatment device 200 or 200 'better conforms to the shape and irregularity of the person's teeth.

  In addition to or instead of the protective package, the therapeutic device or alternatively a removable protective layer (not shown) that is temporarily placed in the trough or inner region adjacent to the therapeutic composition and / or the auxiliary adhesive composition. Can be included). When it is desired to use the therapeutic device, the removable protective layer is removed to expose the therapeutic composition and / or the auxiliary adhesive composition.

  7A and 7B represent an alternative embodiment of an oral treatment device 700 or 700 'that is a U-shaped trough but has a substantially linear or straight longitudinal section. More particularly, oral treatment devices 700 and 700 ′ include a front side wall 704, a rear side wall that together define a U-shaped trough 710 on which a bead of treatment composition 712 or a continuous layer of treatment composition 712 ′ is placed. 706 and a barrier layer 702 having a bottom wall 708.

  8A and 8D represent another alternative embodiment of an oral treatment device 800 or 800 'having a V-shaped trough. More particularly, oral treatment devices 800 and 800 ′ include a front side wall 804 and a rear side wall 806 that together define a V-shaped trough 810 on which a bead of oral composition 812 or a layer of oral composition 812 ′ is placed. A barrier layer 802 having

III. Method of Making an Oral Treatment Device The various components that make up the inventive oral treatment device according to the present invention can be assembled and assembled in any desired order. If the barrier layer can maintain its shape as a dental tray or tray-like structure, the oral treatment composition and optional auxiliary adhesive composition are simply within the trough or inner region of the dental tray or tray-like instrument. Can be put in. The oral treatment device can then be further manipulated, modified or packaged as desired to obtain the desired oral treatment device.

  There are various options when the barrier layer is thin and flexible and cannot maintain itself in the desired structure regardless of the internal skeletal composition. When the oral treatment composition and / or the auxiliary adhesive composition is a sticky viscous gel, the barrier layer is placed in the exoskeleton or template to form a dental tray or a device having a tray-like structure. It is advantageous to place. The gel composition can then act as an internal skeleton, allowing the barrier layer to be maintained in the form of a tray or tray-like structure even in the absence of an external support or exoskeleton.

  In other embodiments, the gel composition can be placed adjacent to a substantially flat barrier layer that is subsequently formed to provide a therapeutic device having a desired structure. This flat barrier layer may be the size of a single oral treatment device, or it can include a large sheet from which multiple oral treatment devices can be cut, stamped, or otherwise formed.

  If the oral treatment composition and / or auxiliary adhesive composition is substantially solid (eg, a hard putty or solid), the oral treatment composition and / or auxiliary adhesive composition is previously in the form of a dental tray or tray-like structure. Can be placed in the barrier layer. Alternatively, the substantially solid composition can be formed into the desired shape, and then a barrier layer can be applied to the outer surface of the composition.

  Notwithstanding the foregoing, it will be appreciated that other manufacturing sequences or methods may be used to commercialize oral treatment devices in accordance with the present invention.

IV. Method of Use of Oral Treatment Device A dental bleaching device according to the present invention can be designed to be worn for any desired time. In general, increasing the concentration of the active agent reduces the time required to achieve treatment. Nevertheless, due to the extremely comfortable fit and secure adhesion between the oral treatment device of the present invention and a person's teeth, such a device is worn for a long time to ensure a more uniform treatment Is possible. The therapeutic device according to the present invention can be used for virtually any facial expression or mouth during normal daily activities such as conversation, eating, drinking, smoking, coughing, smiling, frowning, distorting the face, yawning etc. It can be designed to be worn during operation or even during sleep. This greatly reduces the inconvenience of daily activities compared to invasive treatment devices such as conventional bleaching strips that do not reliably adhere to the teeth, or large and bulky dental bleaching devices.

  The oral treatment device according to the present invention can be simultaneously worn on a person's upper dental arch, lower dental arch, or both. Other characteristics that are different from bleaching strips that are not recommended to be used to bleach the upper and lower dental arches at the same time, ensuring that oral appliances can be worn comfortably at the same time on the upper and lower dental arches It is.

  FIG. 9 shows a person 900 wearing an oral treatment device 902 over the upper dental arch. The treatment instrument 902 may be in the form of a dental tray having a trough, or may be an instrument having a tray-like structure having one or more discontinuous walls that define an interior region that is not a trough. FIG. 10 shows a person 900 having an oral treatment device 902 on a person's upper dental arch and a treatment device 904 on a lower dental arch. It will be appreciated that oral treatment devices 902 and 904 can be placed in any desired order on a person's upper and lower dental arches.

  To remove the oral treatment device, the user can pry off the corners of the barrier layer with a fingernail or a hard tool to remove the rest. Any remaining therapeutic and / or auxiliary adhesive compositions that remain adhered to the person's teeth can be removed by washing or rinsing on the teeth and / or brushing. The inventive therapeutic and auxiliary adhesive compositions are very sticky to the teeth when protected from excessive moisture, but they are rinsed with excess water and / or weakly mechanically affected (eg brushing) Can be formulated so as to be quickly destroyed and dissolved.

  The dental treatment instrument can be worn for as little as a few minutes or as long as hours. By way of example, but not limitation, a typical tolerable duration treatment session lasts from about 10 minutes to about 30 minutes. Medium duration treatment sessions last from about 30 minutes to about 2 hours. Long treatment sessions, including professional treatment or overnight treatment during sleep, last from about 2 hours to about 12 hours.

  The treatment session according to the invention can be repeated as many times as necessary to obtain the desired therapeutic effect. In the case of bleaching equipment, clinical bleaching effects were observed after only 1 to 3 bleaching sessions. A typical treatment plan comprises preferably 1-20 treatment sessions, more preferably 2-15 treatment sessions, most preferably 3-10 treatment sessions.

V. Dental care kit For convenience in use, multiple oral care devices can be packaged together and sold as a kit. In one embodiment, the number of oral treatment devices provided with each kit can be equal to the number of sessions reflecting the prescribed treatment plan. Because it is easy to place the inventive oral treatment device on a person's teeth, and because the adhesion to the teeth is certain, certain treatment devices may be damaged or otherwise not function as intended. The possibility is much lower compared to conventional bleach strips.

  Multiple treatment devices may be stacked or nested together to effectively utilize the space within the kit package. The therapeutic devices can be sealed together or individually as desired. The protective packages 600 and 600 'are represented in FIGS. 6A and 6B. The therapeutic device can optionally include a removable protective layer on the inner surface to protect the therapeutic composition and the auxiliary adhesive composition from contamination or moisture.

  It is within the scope of the present invention to provide barrier layers, therapeutic compositions and auxiliary adhesive compositions that are initially separate but brought together by the end user. For example, a gel or putty-like therapeutic composition can be expressed or placed adjacent to the barrier layer. The resulting therapeutic device can be used as is, or the therapeutic composition can be dried to a solid.

Examples of preferred embodiments The following are some examples of therapeutic and auxiliary adhesive compositions that can be used in the manufacture of a therapeutic device according to the present invention. Examples of formulations and manufacturing conditions are provided by way of example and not limitation, and are intended to illustrate therapeutic devices found to be useful for treating human teeth and / or gums. Unless otherwise noted, all ratios are weight percent.

  Examples 1-21 are directed to the manufacture of a dental bleaching gel composition that is processed to obtain a substantially solid bleaching composition that is used to manufacture a therapeutic device according to the present invention. Examples 22-26 are directed to the manufacture of a dental desensitization composition that is processed to obtain a substantially solid desensitization composition that is used to manufacture a therapeutic device according to the present invention. . Examples 27-29 are directed to the manufacture of medicinal compositions that are processed to obtain a substantially solid medicinal composition that is used to produce a therapeutic device according to the present invention. Examples 30-37 are directed to the production of auxiliary adhesive compositions that do not contain any active agent. Examples 38-43 are directed to an adhesive viscous dental bleaching gel suitable for use in the manufacture of an oral treatment device according to the present invention. Examples 44-49 describe further variations of exemplary compositions and devices according to the present invention.

  The dental bleaching composition was formed by mixing the following ingredients.

  The dental bleaching composition was spread in the form of a gel on a flexible polymer sheet using a spatula and then heated in a forced air oven heated to a temperature of 50-70 ° C. for about 1 hour. The coated sheet was removed from the oven and inspected. The bleaching gel was sufficiently dry so that a substantially solid, coherent bleaching composition formed on the surface of the polymer sheet. The coated sheet was returned to the oven overnight to remove further water.

  The coated sheet was removed from the oven again, cut into smaller pieces, and formed into a tray-like appliance suitable for placement on human teeth.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  The dental bleaching composition was formed by mixing the following ingredients.

  This bleaching composition is used to make a dental bleaching instrument by the procedure described in Example 1.

  A dental desensitization composition suitable for use in making an oral treatment composition and / or a protective auxiliary adhesive composition was formed by mixing the following ingredients.

  The desensitization composition was spread in the form of a gel on a flexible polymer sheet using a spatula and then heated in a forced air oven heated to a temperature of 50-70 ° C. for about 1 hour. The coated sheet was removed from the oven and inspected. The desensitization gel was sufficiently dry so that a substantially solid, tight desensitization composition formed on the surface of the polymer sheet. The coated sheet was cut into smaller portions and formed into a tray-like device suitable for placement on human teeth.

  The bead of the bleaching gel is substantially solid so that a portion of the desensitizing composition extends beyond the bleaching composition to near one or both edges of the tray-like device, resulting in a bleaching device according to the present invention. Placed on a portion of the desensitizing composition. A desensitizing composition that extends beyond the bleaching composition forms a protective tacky area. The bleaching equipment can be used as is or further heated to produce a substantially solid bleaching composition.

  Alternatively, the bleaching composition is placed on a portion of the first desensitization composition described above (ie, before heating in the forced air oven) and used as is or further heated to bleach composition Forming a dental bleaching appliance in which at least a portion of the article and desensitizing composition is made substantially solid. A desensitizing composition that extends beyond the bleaching composition, whether in a gel or substantially solid state, forms a protective tacky region.

  A dental desensitization composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive composition was formed by mixing the following ingredients.

  This desensitization composition is used alone or with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A dental desensitization composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive was formed by mixing the following ingredients.

  This desensitization composition is used alone or with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A dental desensitization composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive composition was formed by mixing the following ingredients.

  This desensitization composition is used alone or with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A dental desensitization composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive composition was formed by mixing the following ingredients.

  This desensitization composition is used alone or with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A medicinal composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive was formed by mixing the following ingredients.

  This medicinal composition is used alone or in conjunction with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A medicinal composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive was formed by mixing the following ingredients.

  This desensitization composition is used alone or with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A medicinal composition suitable for use in making an oral treatment composition or a protective auxiliary adhesive was formed by mixing the following ingredients.

  This desensitization composition is used alone or with a dental bleaching composition to produce a therapeutic device by the procedure described in Example 22.

  A suitable adhesive composition for use in making the auxiliary adhesive composition was formed by mixing the following ingredients.

  The adhesive composition and oral treatment composition are used to produce an oral treatment device.

  A suitable adhesive composition for use in making the auxiliary adhesive composition was formed by mixing the following ingredients.

  The adhesive composition and the oral treatment composition are used to make a therapeutic device.

  Adhesive compositions suitable for use in making protective adhesive compositions were formed by mixing the following ingredients.

  The adhesive composition and the oral treatment composition are used to make a therapeutic device.

  Adhesive compositions suitable for use in making protective adhesive compositions were formed by mixing the following ingredients.

  The adhesive composition and oral treatment composition are used to produce an oral treatment device.

  Adhesive compositions suitable for use in making protective adhesive compositions were formed by mixing the following ingredients.

  The adhesive composition and the oral treatment composition are used to make a therapeutic device.

  Adhesive compositions suitable for use in making protective adhesive compositions were formed by mixing the following ingredients.

  The adhesive composition and the oral treatment composition are used to make a therapeutic device.

  Adhesive compositions suitable for use in making protective adhesive compositions were formed by mixing the following ingredients.

  The adhesive composition and the oral treatment composition are used to make a therapeutic device.

  A desensitization composition and recalcification composition suitable for use in making a protective adhesive composition was formed by mixing the following ingredients.

  This medicinal composition is used alone or with a dental bleaching composition to produce a therapeutic device.

  A sticky viscous dental bleaching gel suitable for use in the manufacture of dental bleaching appliances according to the present invention was formed by mixing the following ingredients.

  The dental bleaching gel was placed inside a flexible wall thin dental tray. Bleaching equipment can be used as is or processed to remove some of the solvent in the bleaching gel to form a putty or solid. Alternatively, the bleaching gel is used in combination with the auxiliary adhesive composition according to any of Examples 22-37. The bleaching gel and / or auxiliary adhesive composition serves as an internal skeleton.

  A sticky viscous dental bleaching gel suitable for use in the manufacture of dental bleaching appliances according to the present invention was formed by mixing the following ingredients.

  This bleaching gel and optionally the auxiliary adhesive composition is used to make dental bleaching appliances by one or more procedures described in Examples 1, 22 and 38.

  A sticky viscous dental bleaching gel suitable for use in the manufacture of dental bleaching appliances according to the present invention was formed by mixing the following ingredients.

  This bleaching gel and optionally the auxiliary adhesive composition is used to make dental bleaching appliances by one or more procedures described in Examples 1, 22 and 38.

  A sticky viscous dental bleaching gel suitable for use in the manufacture of dental bleaching appliances according to the present invention was formed by mixing the following ingredients.

  This bleaching gel and optionally the auxiliary adhesive composition is used to make dental bleaching appliances by one or more procedures described in Examples 1, 22 and 38.

  A sticky viscous dental bleaching gel suitable for use in the manufacture of dental bleaching appliances according to the present invention was formed by mixing the following ingredients.

  This bleaching gel and optionally the auxiliary adhesive composition is used to make dental bleaching appliances by one or more procedures described in Examples 1, 22 and 38.

  A sticky viscous dental bleaching gel suitable for use in the manufacture of dental bleaching appliances according to the present invention was formed by mixing the following ingredients.

  This bleaching gel and optionally the auxiliary adhesive composition is used to make dental bleaching appliances by one or more procedures described in Examples 1, 22 and 38.

  Any of the dental bleaching compositions of Examples 1-21 and 38-43 are used with any of the therapeutic or auxiliary adhesive compositions of Examples 22-37 to form an oral treatment device according to the present invention. .

  Any of the therapeutic compositions or auxiliary adhesive compositions of Examples 22-37 used in the manufacture of the bleaching device according to Example 44 are prepared according to one or more of Examples 1-21 and 38-43. Change by adding less bleach than the amount of bleach in the product.

  Any of the dental bleaching compositions of Examples 1-21 and 38-43 used to manufacture therapeutic devices according to Examples 1-21 and 38-44 are desensitisers, recalcifiers, antibacterial agents Change by adding one or more of an anti-plaque, anti-calculus or other medicinal product.

  Any of the therapeutic or adhesive compositions of Examples 22-37 used to manufacture the therapeutic devices according to Examples 22-37 and 44 are colorants, gum soothing agents, isotonic liquid forming salts, Add one or more of anesthetics, antioxidants, flavorings, preservatives, mouth refreshers, cleaning agents, inorganic thickeners, recalcifiers, anti-plaque agents, anticalculus agents, refreshers or antioxidants Change by.

  Any of the therapeutic devices made according to Examples 1-46 are modified by providing a barrier layer in the form of a tray or tray-like device containing a mixture of ethyl vinyl acetate (80%) and polypropylene (20%). To do.

  Any of the therapeutic or adhesive compositions according to Examples 22-37 can be one or more bleach activators (eg, 5% alkali metal or alkaline earth metal base and / or 1% metal, metal compound). Or change by adding an effective amount of organometallic enzyme).

  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 that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

The invention includes a trough and a barrier layer in the form of a dental tray having a bead-shaped oral treatment composition or adhesive composition in the trough that at least partially helps in keeping the barrier layer in the form of a tray FIG. 3 is a perspective view of an exemplary oral treatment device according to FIG. In accordance with the present invention, comprising a trough and a barrier layer in the form of a dental tray having an oral treatment composition in the trough in the form of a continuous layer that at least partially serves in keeping the barrier layer in the form of a tray 1 is a perspective view of an exemplary oral treatment device. FIG. A book comprising a trough and a barrier layer in the form of a dental tray having in the trough a dental treatment composition in the form of a bead or continuous layer that at least partially serves in keeping the barrier layer in the form of a tray 1 is a perspective view of an exemplary oral treatment device according to the invention. FIG. A book comprising a trough and a barrier layer in the form of a dental tray having in the trough a dental treatment composition in the form of a bead or continuous layer that at least partially serves in keeping the barrier layer in the form of a tray 1 is a perspective view of an exemplary oral treatment device according to the invention. FIG. 2B is a cross-sectional view of the oral treatment device of FIG. 2A. FIG. 2B is a cross-sectional view of the oral treatment device of FIG. 2B. FIG. 1 is a perspective view of an exemplary oral treatment device according to the present invention that includes a notch on the side wall to help match the treatment device to various sized and / or shaped dental arches. FIG. 1 is a perspective view of an exemplary oral treatment device according to the present invention that includes a notch on the side wall that helps align the treatment device with various sized and / or shaped dental arches. FIG. Tray-like with cuts or discontinuities in the bottom wall so as to make a device with a therapeutic or adhesive composition in the form of a bead or continuous layer, without troughs and adjacent to the barrier layer 1 is a perspective view of an exemplary oral treatment device according to the present invention including a barrier layer having a structure. FIG. Tray-like with cuts or discontinuities in the bottom wall so as to make a device with a therapeutic or adhesive composition in the form of a bead or continuous layer, without troughs and adjacent to the barrier layer 1 is a perspective view of an exemplary oral treatment device according to the present invention including a barrier layer having a structure. FIG. FIG. 2B illustrates the oral treatment device of FIG. 2A included in a sealed protective package having a peelable cover. 2C illustrates the oral treatment device of FIG. 2B included in a sealed protective package having a peelable cover. FIG. 1 is a perspective view of an exemplary oral treatment device having a U-shaped trough and a barrier layer in the form of a bead or continuous layer of therapeutic or adhesive composition within the trough. FIG. 1 is a perspective view of an exemplary oral treatment device having a U-shaped trough and a barrier layer in the form of a bead or continuous layer of therapeutic or adhesive composition within the trough. FIG. 1 is a perspective view of an exemplary oral treatment device having a V-shaped trough and a barrier layer in the form of a therapeutic or adhesive composition in the form of a bead or continuous layer within the trough. FIG. 1 is a perspective view of an exemplary oral treatment device having a V-shaped trough and a barrier layer in the form of a therapeutic or adhesive composition in the form of a bead or continuous layer within the trough. FIG. It is a figure which shows the person which mounted | wore the upper dental arch with the oral treatment equipment by this invention. It is a figure which shows the person who has an oral treatment instrument mounted on the upper and lower dental arches.

Claims (24)

A thin and flexible barrier layer in the shape of a dental tray;
An oral treatment composition comprising an active agent and a tissue adhesive that is a solid composition from a sticky viscous gel in a range of consistency;
The oral treatment composition acts as an internal skeleton that contributes at least in part to maintaining the barrier layer in the shape of a dental tray prior to use;
An oral treatment device wherein the oral treatment composition is sticky and adhesive in use to at least partially match the barrier layer with the surface of a human tooth during use.   The oral treatment device according to claim 1, wherein the barrier layer is so flexible that the shape of the dental tray cannot be maintained before use in the absence of the oral treatment composition.   The oral treatment device according to claim 2, wherein the oral treatment composition prevents collapsing toge and / or spreading apart of the front and bottom walls before use.   The oral treatment device of claim 1, wherein the barrier layer has a thickness ranging from about 0.0001 inches to about 0.012 inches.   The oral treatment device of claim 1, wherein the barrier layer has a thickness in the range of about 0.001 inch (0.00254 cm) to about 0.01 inch (0.0254 cm).   The oral treatment device according to claim 1, wherein the oral treatment composition includes a bead.   The oral treatment device of claim 6, wherein the bead has a cross-sectional diameter ranging from about 1 mm to about 5 mm.   The oral treatment device of claim 6, wherein the bead has a cross-sectional diameter ranging from about 2 mm to about 4 mm.   The oral treatment device according to claim 1, wherein the oral treatment composition includes a continuous layer on an inner surface of the barrier layer.   The oral treatment device of claim 9, wherein the continuous layer has a thickness in the range of about 0.25 mm to about 2 mm.   The oral treatment device of claim 9, wherein the continuous layer has a thickness in the range of about 0.5 mm to about 1 mm.   The oral treatment device according to claim 1, wherein the oral treatment composition is an adhesive and viscous composition having a paste-like consistency.   The oral treatment composition is a hard putty that is substantially solid but flexible and becomes more sticky and more adhesive to human teeth and / or gums when moistened with saliva or water The oral treatment device according to claim 1.   The oral treatment device of claim 1, wherein the barrier layer includes a front side wall and a bottom side wall that are continuous to form a trough on which the oral treatment composition is placed prior to use.   The barrier layer includes a front side wall and a discontinuous bottom wall that includes cuts or discontinuities that form a plurality of bottom flaps that more easily conform to the inner surface of adjacent teeth having varying widths. The oral treatment device according to claim 1.   The barrier layer comprises at least one wax, metal foil, paraffin, ethylene vinyl acetate copolymer, ethylene vinyl alcohol copolymer, polycaprolactone, polyolefin, polyethylene, high density polyethylene, low density polyethylene, ultra low density polyethylene, polypropylene, polytetrafluoro The oral treatment device according to claim 1, comprising ethylene, polyester, polycarbonate, polyurethane, polyamide or polyesteramide.   The oral treatment device of claim 1, further comprising a removable external skeleton to help maintain the barrier layer in the shape of a dental tray prior to use.   The oral treatment device of claim 1, wherein the barrier layer is designed to terminate substantially at or near a human gingival margin during use.   The oral treatment device according to claim 1, wherein the barrier layer is designed to terminate at or near a human gingival margin during use.   The tissue adhesive comprises at least one polyvinylpyrrolidone (PVP), carboxypolymethylene, polyethylene oxide, polyacrylic acid, polyacrylic acid copolymer, polyacrylate, polyacrylamide, polyacrylic acid and polyacrylamide copolymer, PVP-acetic acid The oral treatment device according to claim 1, comprising a vinyl copolymer, carboxymethylcellulose, carboxypropylcellulose, polysaccharide gum or protein.   The therapeutic composition comprises a dental bleach, a dental desensitizer, an anesthetic, a gum soothing agent, a stabilizer, a recalcifying agent, an antibacterial agent, an anti-plaque agent, an anti-calculus agent, a mouth refresher and The oral treatment device according to claim 1, comprising at least one active agent selected from the group comprising antioxidants.   The oral treatment device according to claim 1, further comprising an auxiliary adhesive composition.   A kit for use in treating a person's teeth and / or gums comprising a plurality of said oral treatment devices according to claim 1. A method for treating a person's teeth and / or gingiva, comprising obtaining an oral treatment device according to claim 1 and over a desired period of time on at least a portion of the person's teeth and / or gingiva. Placing said oral treatment device.

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