EA008520B1

EA008520B1 - Oral treatment devices that include a thin, flexible barrier layer and an endoskeleton treatment or adhesive composition

Info

Publication number: EA008520B1
Application number: EA200501652A
Authority: EA
Inventors: Питер М. Оллред; Дэн Э. Фишер; Нэйл Т. Джессоп; Брюс С. Маклин; Скот Н. Андерсон
Original assignee: Алтрадент Продактс, Инк.
Priority date: 2003-05-23
Filing date: 2004-05-07
Publication date: 2007-06-29
Also published as: AR044431A1; IL171855A; EA200501652A1

Abstract

Oral treatment devices (100) include a barrier layer (102) and an oral treatment composition (112), and optionally an auxiliary adhesive composition, that acts as an endoskeleton so as to at least partially contribute to maintaining the barrier layer (102) in the shape of a dental tray, or in a tray-like configuration, prior to use. The barrier layer (102) protects the oral treatment (112) and/or adhesive composition from saliva or moisture during use. The treatment and/or auxiliary adhesive compositions (112) can have a consistency ranging from a sticky, viscous gel or a solid. They preferably include a tissue adhesion agent comprising a hydrophilic polymer.

Description

The present invention relates to the field of oral treatment devices used to treat the teeth and / or gums of an individual. More specifically, the invention relates to oral treatment devices that contain a thin, flexible, moisture resistant barrier layer and an oral treatment composition and / or an auxiliary adhesive composition that acts as an internal framework to maintain the barrier layer in the desired configuration before use .

Relevant technology

Essentially, all people want their teeth to be whiter or whiter than they are. To achieve this goal, people put crowns with a porcelain topcoat on teeth or expose teeth to chemical bleaching. The usual method of bleaching involves the use of a dental impression spoon, which is tailor-made for an individual's teeth and therefore comfortable to wear. One type of custom-made impression spoon is made from an individual's plaster model. The other type is custom-made directly using the teeth of the individual as a template (for example, “boil and bite” impression spoons). Impression spoons that were not made to order were also used, which in shape and size approached a variety of dental arches. The tooth whitening composition is placed in an impression spoon, and the impression spoon is placed on top of an individual's teeth for a desired period of time.

Another method of bleaching involves direct staining of an individual's teeth with a whitening composition. The perceived advantage of whitening staining is that it eliminates the need for an impression spoon.

The main disadvantage of the whitening composition for dyeing is that it remains under the direct influence of the saliva of the individual and the destructive forces found in the oral cavity of the individual. As a result, a significant portion of the whitening composition does not remain on the teeth, whitening of which is desirable. Some or all of the composition may dissolve in the saliva of an individual and wash off with it and / or be transferred to adjacent tissues with possible irritation of the soft tissues of the oral cavity.

Another way to whiten teeth is to install a flexible whitening strip on the surface of the user's teeth. Conventional whitening strips include a flexible plastic strip with a teeth whitening gel with moderate viscosity and relatively low adhesion from the side of the strip facing the user's teeth. To install the whitening strip, part of it is placed over the front surfaces of the user's teeth, and the rest is folded around the occlusal edges of the teeth and pressed against a part of the lingual surfaces. Like the bleaching compositions applied by dyeing, this procedure does not require the use of impression trays. In contrast to staining bleaching compositions, the whitening strips include a plastic barrier that, at least theoretically, keeps the teeth whitening gel from diffusing into the user's oral cavity.

In fact, in general, due to the weak adhesion of the whitening strips to the user's teeth in combination with their essentially paper nature, it is often difficult for the user to maintain the whitening strip in the correct position for the recommended time. Conventional whitening strips tend to slip off the teeth as a result of even minimal movement of the mouth, jaw or tongue of the user. Indeed, it is recommended that the user does not eat, drink, smoke or sleep while wearing a whitening strip. In practice, it is difficult to speak or smile, and at the same time, appropriately maintain the whitening strip in the correct position.

Even if the user successfully maintains the normal whitening strip in its correct position during the recommended whitening period, the whitening gel often diffuses into the individual's saliva, which can cause an unpleasant taste in the user's mouth and possibly discomfort for the soft tissues of the mouth and throat. The tendency of the whitening gel to diffusion into the user's oral cavity can be accelerated as a result of even minimal shifts of the whitening strip in the user's teeth, with each shift potentially causing contact with the user's whitening gel saliva, which remains stuck to the user's teeth but not covered with a plastic stripe. In some cases, the whitening strip may shift or shrink so that the user has to remove it and replace it with a fresh whitening strip to complete the recommended whitening time. This several times increases the cost and difficulty of using conventional whitening strips.

From a practical point of view, the use of conventional whitening strips can greatly inhibit even the simplest forms of activity, which include the movement of the mouth or the user's language, such as talking, smiling, creating other facial expressions, or even swallowing (which usually occurs unconsciously during the day). Of course, the time when the mouth and tongue of an individual is less prone to movement is the night when the individual sleeps. Unfortunately, it is recommended not to use conventional whitening strips during sleep, apparently, to prevent accidental asphyxiation when unfastening the whitening strips due to the negligence of users.

- 1 008520 la. This confirms the tendency of conventional whitening strips to easily detach from the user's teeth.

Ultimately, the main obstacle to successful whitening is the failure of users to comply with the assigned whitening scheme. If the whitening device is difficult to install on an individual's teeth, which requires numerous repetitions to achieve the observed results or is inconvenient to wear, the user can simply refuse and prematurely stop the performance of the assigned whitening scheme. Thus, even if teeth whitening is possible using a specific whitening device or method, it is less likely to occur if the inconsistencies of the whitening device or method to certain requirements cause the user to become frustrated before the desired results are achieved.

In connection with the above, there remains a need for improved devices and methods of treatment that are simple, easy to use and which remain securely in position over the user's teeth and / or gums in order to reduce the diffusion of the therapeutic composition into the user's oral cavity. Such improvements can be expected to improve or stimulate the performance of the prescribed treatment by the user.

A brief description of the preferred embodiments

The present invention relates to oral treatment devices used to treat an individual’s teeth and / or gums, which include a thin, flexible barrier layer and oral composition and / or an auxiliary adhesive composition placed relative to the barrier layer so as to act as the inner frame, which is at least partially responsible for maintaining the barrier layer in the desired configuration before use (for example, in the form of an impression spoon or in a configuration, approved impression spoon). During use, the barrier layer protects the treatment and / or adhesive composition from saliva and moisture, keeps it / them in contact with the teeth and / or surrounding soft tissue of the individual and helps prevent, minimize or reduce their diffusion into the user's oral cavity.

The barrier layer is preferably formed from a moisture-resistant polymeric material, examples of which include polyolefins, polyesters, ethylene-vinyl acetate copolymer (BUL), polyurethane, other polymers, and mixtures thereof (for example polyethylene and polypropylene). The barrier layer is predominantly thin and flexible in order to conform to the shape of the teeth of the individual as a result of the adhesive nature of the compositions for the treatment of the oral cavity. The thickness should preferably be from 0.0001 to 0.012 inch. It can be in the form of an impression spoon, having two or more walls that limit the chute between them. Alternatively, the barrier layer may be in the form of a device, like an impression spoon, having two or more walls, at least one of which includes cutouts or gaps that help an individual to shape the barrier layer over the teeth and / or gums during installation. When one or more of the walls includes deep cuts or gaps that make up one or more intermittent walls, the tray-like treatment device may no longer have a gutter.

The barrier layer may take a specific form before use, regardless of the treatment composition, or it may be so thin and flexible as to only be able to take shape as a result of the presence of the oral treatment composition and / or an auxiliary adhesive composition adjacent to the barrier layer. In any case, the treatment and / or auxiliary adhesive composition acts as an internal framework that helps to maintain the barrier layer in the form of an impression spoon or tray-like configuration before use. Thus, the therapeutic and / or adhesive composition helps keep the walls from moving apart and / or falling together. In use, the barrier layer is securely held in place over the user's teeth for a desired period of time by the adhesion action of the treatment and / or auxiliary adhesive composition.

A composition for treating the oral cavity and / or an auxiliary adhesive composition may include a layer of beads (granules) or a continuous layer essentially covering the inner surface of the barrier layer. The therapeutic and / or adhesive composition may be in the form of a sticky, viscous gel, it may be a hard putty, or it may be hard or substantially hard. Sticky, viscous therapeutic gels can act as a high viscosity adhesive or adhesive material that helps securely hold both the therapeutic and / or adhesive composition and the barrier layer with an emphasis on the surface of the teeth and / or gums to be treated. Medicinal compositions in the form of hard putty, hard, or essentially hard, material are usually dry or drier to the touch than gel compositions, and they can become more adherent to the teeth and / or gums when wetted with saliva or water during use.

Compositions for the treatment of the oral cavity in accordance with the invention, in general, include an active agent of any kind, a means for adhering to a tissue, a liquid or gel solvent or carrier and, if desired, other active agents, inert ingredients or adjuvants. Auxiliary adhesive compositions may optionally exclude one or more active agents contained in the composition for treating the oral cavity. Is curative or adge represented

- 2 008520 The effective composition in the form of a sticky, viscous gel, a hard lubricant or a solid substance largely depends on the relative concentrations of the tissue-gluing agent and the solvent or carrier. Increasing the proportion of solvent or carrier relative to the means for gluing fabrics generally reduces the viscosity of the composition, while increasing the share of solvent or carrier relative to the means for gluing fabrics gives a whitening composition having a higher viscosity. Reducing the concentration of the solvent or carrier at some point gives a composition that is so viscous that it is considered to be a putty or even a solid. In one embodiment, a hard but still plastically deformable putty is made by first forming a treatment gel having a substantial amount of solvent, and then removing a substantial part of the solvent by evaporation to obtain a putty composition. In another embodiment, the solid composition is made by removing additional solvent. Some residual water or solvent may still remain in the putty-like solid compositions after evaporation.

The size and shape of the oral treatment devices according to the invention can be selected to facilitate fitting to an individual’s upper or lower dental arch. They can also be selected for fitting in persons with dental arches of various sizes or shapes. Therapeutic devices are advantageously flexible and adhesive in order to easily fit a wide variety of teeth and dental arches of various sizes. In one embodiment, the treatment devices are designed to substantially cover the anterior and lingual surfaces of the teeth and / or gums to be treated. The treatment of both surfaces helps the penetration of the treatment composition into the interproximal spaces between adjacent teeth.

Oral treatment devices in accordance with the invention may be designed to be worn for any desired period of time. In general, increasing the concentration of the active substance within the treatment composition reduces the time required to effect the desired treatment. However, due to the comfortable fit and reliable adhesion between the therapeutic devices of the invention and the teeth of the individual, such devices can be worn for long periods of time to ensure uniform and thorough processing. The treatment devices of the invention may be designed to be worn, for example, while talking, sleeping, eating, drinking, smiling, mimicking grudging, yawning, coughing, smoking, or creating virtually any facial expression or curvature of the mouth. This greatly reduces their interference with daily activities, compared with conventional whitening strips, which loosely adhere to teeth, or with discomfort-causing medical devices, such as large, volumetric whitening dental devices. Oral curative devices can be designed to be worn only for a few minutes or up to several hours. By way of example, and not limitation, a typical treatment session of short duration can last from about 10 to about 30 minutes. A treatment session of intermediate duration can last from about 30 minutes to about 2 hours. A treatment session of long duration, including professional or night treatment during sleep, can last from about 2 to about 12 hours. Treatment sessions can be repeated as many times as necessary to obtain the desired degree of treatment. A typical treatment regimen would preferably include 1-20 treatment sessions, preferably 2-15 treatment sessions, and most preferably 3-10 treatment sessions.

For ease of use, a variety of oral treatment devices can be packaged together and sold as a set. In one embodiment, the number of oral treatment devices provided in each set may be equal to the number of sessions that represent the prescribed treatment regimen. In order to efficiently use the space inside the package set, multiple treatment devices can be stacked, tightly overlapped, or laid together inside the package. If desired, medical devices can be hermetically sealed together or separately. They may contain a removable protective layer on their inner surfaces to protect the whitening composition from contamination or moisture.

These and other advantages as well as features of the present invention will become more apparent from the following description and the appended claims, or they can be recognized as a result of the invention, which is set forth below.

Brief Description of the Drawings

To further clarify these and other advantages and features of the present invention, a more specific description of the invention will be presented with reference to certain embodiments thereof, which are illustrated in the accompanying drawings. It is clear that the drawings show only typical embodiments of the invention, and therefore should not be considered as limiting its scope.

The invention will be specifically and in detail described and explained through the use of the accompanying drawings:

FIG. 1A is a perspective view of an exemplary oral treatment device.

- 3 008520 cavity in accordance with the invention, comprising a barrier layer in the form of an impression spoon, having a groove and a composition for treating the oral cavity or an adhesive composition inside the groove in the form of a layer of balls, which at least partially contributes to the maintenance of the barrier layer in the form of a tray;

FIG. 1B is a perspective view of an exemplary oral treatment device in accordance with the invention, comprising a barrier layer in the form of an impression spoon, having a groove and a composition for treating the oral cavity inside the groove in the form of a continuous layer that at least partially contributes to the maintenance of the barrier layer in the form of impression spoons;

FIG. 2A and 2B are perspective views of illustrative devices for treating the oral cavity in accordance with the invention, comprising a barrier layer in the form of an impression spoon, having a groove and a composition for treating the oral cavity inside the groove in the form of a layer of pellets or a continuous layer that at least , partially contributes to the maintenance of the barrier layer in the form of a tray;

FIG. 3A and 3B are sectional views of oral treatment devices shown in FIG. 1, respectively. 2A and 2B;

FIG. 4A and 4B are perspective views of illustrative devices for treating the oral cavity in accordance with the invention, including recesses in the side walls that facilitate treatment devices in accordance with dental arches of various sizes and / or shapes;

FIG. 5A and 5B are perspective views of illustrative devices for treating the oral cavity in accordance with the invention, comprising a barrier layer having a tray-like configuration with cutouts or gaps in the lower wall so as to provide a device without a gutter and an oral composition for treating cavity or adhesive composition in the form of a layer of balls or a continuous layer adjacent to the barrier layer;

FIG. 6A and 6B illustrate devices for treating the oral cavity, shown respectively in FIG. 2A and 2B contained within hermetically sealed protective packages having a peelable cover;

FIG. 7A and 7B are perspective views of illustrative devices for treating the oral cavity, having an I-shaped trench barrier layer and a layer of balls or a continuous layer of the oral treatment composition or an adhesive composition inside the trough;

FIG. 8A and 8B are perspective views of illustrative devices for treating the oral cavity, having a barrier layer in the form of a Y-shaped gutter, and a therapeutic and adhesive composition in the form of a layer of balls or a continuous layer inside the gutter;

FIG. 9 illustrates an individual placing an oral treatment device according to the invention on the upper dental arch; and

FIG. 10 illustrates an individual with oral treatment devices placed on the upper and lower dental arches.

A detailed description of the preferred embodiments

I. Introduction and definitions

The present invention relates to improved devices used to treat the teeth and / or gums of an individual. The treatment devices of the invention comprise a thin, flexible barrier layer and an inner frame comprising a composition for treating the oral cavity and / or an auxiliary adhesive composition. The barrier layer protects the treatment composition and adhesive composition from the saliva or moisture inside the individual's oral cavity during use, which keeps them in contact with the teeth and / or the surrounding soft tissue of the individual and helps prevent or minimize their diffusion into the user's oral cavity.

The treatment devices of the invention interfere more with teeth and / or gums than ordinary dental whitening strips, and they cause less discomfort than bulk, over-the-counter, non-custom-made or impression boil-and-bite impression spoons. In some cases, they can be just as reliable or even more reliable than custom-made impression trays in keeping the treatment composition in place against the teeth and / or gums of the individual. For some people, they can be at least as comfortable as custom-made impression trays.

As used herein, the term “barrier layer” refers to one or more layers of material that protects the treatment composition and the optional adhesive composition from the surrounding moisture and saliva inside the individual’s oral cavity when the treatment device is placed on the teeth of the individual. The barrier layer may also serve to protect the treatment and / or adhesive composition from moisture and contaminants during storage and prior to use. The barrier layer may be able to be maintained in the desired shape, regardless of the composition of the adjacent inner frame, or it may be so thin and flexible that it does not have a predetermined shape that is missing in the presence of the inner frame.

The term "internal frame" refers to any composition for the treatment of the oral cavity and / or

- 4 008520 auxiliary adhesive composition which, when placed near the barrier layer, helps to maintain the barrier layer in the form of an impression spoon or in a tray-like configuration before use. In cases where the barrier layer at least partially corresponds to the shape of an impression spoon or has a tray-like configuration, regardless of the internal frame, the inner frame will provide additional support to help maintain the barrier layer in the shape of an impression spoon or tray-like configuration using. In the case when the barrier layer does not have a specified shape, the inner frame will determine and maintain the shape of the barrier layer before use. The “inner frame” may have a consistency ranging from a sticky, viscous gel to a solid composition.

The term “sticky, viscous gel” should refer to therapeutic and / or auxiliary adhesive compositions that have been formulated or processed in such a way that they do not flow under the influence of gravity, but are viscous so that they can be squeezed out of the syringe hole or other means of filing known in the field.

In some cases, when the viscosity of a high-viscosity gel becomes so high that it gives a composition that is essentially solid, but still plastically deformable, it can be considered "hard putty." The distinction between “sticky, viscous gel” and “hard putty” is a matter of viscosity grade. Similarly, a “hard putty” can become so rigid or rigid that it becomes a “solid”.

As used herein, the term “substantially solid” refers to a therapeutic composition or an auxiliary adhesive composition that is in a solid or semi-solid state. In one aspect, a “substantially solid” composition can be characterized as a binding mass that does not easily flow or separate when exposed to gravity and which cannot be easily squeezed out through a syringe outlet or another channel or hole of similar size. Thus, the term “substantially solid” excludes current adhesion fluids, viscous adhesion fluids, and even thick adhesion gels that can flow when exposed to gravity and / or that can be easily squeezed out through a syringe outlet or other channel or hole of similar size. The term “substantially solid”, when used in the context of a therapeutic or adhesive composition, also excludes dry compositions in the form of particles or powders, because the solids in the form of particles and powders flow easily when exposed to gravity and / or easily separated (ie particles generally have little or no internal adhesion). In addition, powders or particulate materials, when considered as a whole, are not coherent or solid.

In one embodiment, the "hard putty" and "essentially hard" compositions become more sticky when wetted with saliva or water. When wetted, the surface of the substantially solid or putty composition turns into a sticky material that is able to adhere more strongly to the teeth, as compared to a substantially solid or putty composition that has not been moistened. The substantially solid or putty 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" or similar putty. The consistency of the wetted surface may remain “substantially hard” or similar to the putty, depending on the degree of the initial wetting, or it may become hard or even restore the “essentially hard” or putty-like condition as the initial amount of surface moisture diffuses into the remaining a portion of a “substantially solid” or putty-like composition over time (for example, during an oral treatment procedure in which the composition is protected from saliva and surrounding moisture in the oral band individual moisture-resistant barrier layer).

As used in the present description, the term “impression spoon” refers to a device that has a shape similar to a tray in order to facilitate the placement of the device over at least a part of the dental arch of an individual. In one embodiment, an “impression spoon” includes a front side wall configured to engage with the front surface of an individual’s teeth when used, the rear side extending laterally from the front side wall or steeply at one or more specific angles or not steeply curved transition piece configured to engage with the lingual surfaces of an individual's teeth, as well as a chute between said anterior and posterior side walls. The dental impression tray can be configured so that a part of the front side wall, the back side wall or its transition part (for example, the bottom wall) engages with the incisal or occlusive teeth during use. The impression tray can be curved or straight in length.

Used in the present description, the term "chute" refers to an area that is at least partially limited by the front side wall, the rear side wall and the plane or an imaginary curved dome extending from the upper edge of the front side wall and the upper edge of the rear side wall. Thus, a "gutter" can theoretically exist when adjacent

- 5 008520 front and rear side walls have a space between them and are arranged in lateral directions at an angle of less than 180 °. In practice, the front and rear side walls will extend at 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 part (for example, a chute having a ϋ-shaped or rectangular shape in section), at least a part of the front and rear side walls can be essentially parallel (i.e. move at an angle approximately 0 °) or move away at a very small angle. In the case of a groove having a Y-shaped or trapezoidal shape, at least a portion of the front and rear side walls may extend at an acute angle (for example, at an angle from 0 to 90 °). In the case where the chute in the section is L-shaped, at least part of the front and rear side walls may extend at an angle centered around about 90 ° (for example, at an angle of about 70 to about 110 °). Thus, a chute that has an L-shaped section can be a subset or a small variation of a chute that has a Y-shaped section.

Used in the present description, the terms "longitudinal", "longitudinal size" and "longitudinal profile", referring to an impression spoon or treatment device, should refer to the size of the length of the spoon or device. The spoon or device can be straight in “longitudinal size” or the spoon can have a horseshoe shape or else be “longitudinally curved” in longitudinal size in order to approach the curvature of the individual's dental arch or at least facilitate the placement of the spoon or device on dental arch.

In the case where the treatment device includes one or more walls containing cuts or other gaps so that the wall is not continuous, there may be enough space or gaps between the individual flaps or segments that make up the continuous wall, so that the “gutter” no longer exists between front and lower side walls or flaps. Thus, the term "gutter" should be understood as the area between two or more continuous walls that limit the internal area that can hold or contain a liquid or gel inside it. When one of the walls is largely intermittent and provides a device that allows the liquid to spill or pour out of the cuts or gaps, the space between the side walls does not constitute a “groove”, but is simply an internal area between the walls.

In the absence of other definitions, the term “molecular weight” as used herein shall refer to the average quantitative molecular weight expressed in Daltons.

Ii. Oral treatment devices

Oral treatment devices in accordance with the invention include a thin, flexible barrier layer that protects the treatment composition, and optionally an auxiliary adhesive composition, from the surrounding moisture inside the individual’s mouth during use. Therapeutic and / or adhesive compositions act as an inner frame so as to at least partially maintain the barrier and the desired shape of the tray or tray-like configuration before use. Therapeutic and / or adhesive compositions can range from a sticky, viscous gel to a solid composition that becomes more adhesive when wetted with saliva or water. This is followed by preferred examples of barrier layers, therapeutic compositions and auxiliary adhesive compositions in accordance with the invention, as well as the characteristics of therapeutic devices made from them.

A. Barrier layers

The barrier layer is preferably resistant to moisture to protect the therapeutic and / or auxiliary adhesive compositions from the ambient moisture found in the oral cavity of the individual. In accordance with one embodiment, the barrier layer comprises a thin, flexible membrane formed of a moisture resistant polymeric material. The thin, flexible barrier layers preferably have a thickness of from about 0.0001 to about 0.012 inch, more preferably from about 0.001 to about 0.01 inch. The barrier layer may be able to form an impression spoon or tray-like device without an inner frame, or they may be shapeless, requiring an inner frame.

Examples of materials that can be used to form a barrier layer include, but are not limited to, polyolefins, wax, metal foil, paraffin, ethylene vinyl acetate (EUA) copolymer, ethylene-vinyl alcohol copolymer (ECU), polycaprolactone (PCB), polyvinyl chloride (RUS) , polyesters, polycarbonates, polyamides, polyurethanes or polyether amides. Examples of suitable polyolefins that can be used to make a barrier layer include, but are not limited to, polyethylene (PE), high density polyethylene (HOPE), low density polyethylene (BORE), ultra low density polyethylene (HOPE), polypropylene (PP) and polytetrafluoroethylene (RTH) (for example, TEELOI). An example of a suitable polyester for use in the manufacture of a barrier layer includes, but is not limited to, polyethylene terephthalate (PET), an example of which is MUAC, sold by LiPoSC. An example of a suitable polyurethane barrier material

- 6 008520 is a polyurethane film manufactured by AgdoTei, which is located in Sygeyeia, Mazzasiejwei. The barrier layer may include a polymer mixture and / or multiple layers consisting of two or more of the above materials. Plasticizers, flowables, and fillers known in the art can be used as described to modify the properties of any of the above polymers used to form the barrier layer.

In accordance with one embodiment, the barrier layer is formed from a mixture of ethylene-vinyl acetate copolymer (EUA) and polypropylene (PP), preferably comprising from about 5 to about 35% PP, more preferably from about 10 to about 30% PP, particularly preferably from about 15 up to about 25% PP and most preferably about 20% PP, with the remainder comprising ethylene vinyl acetate (EUA) and, optionally, other polymers and / or small amounts of additives, such as plasticizers.

Other materials that can act as a barrier layer include cellulose ethers, cellulose acetate, polyvinyl acetate, polyvinyl alcohol, shellac, and chemical or lightly cured materials (for example, methacrylate or acrylate resins). Examples of useful cellulosic ethers that can be used to form the barrier layer include, but are not limited to, ethyl cellulose, propyl cellulose, isopropyl cellulose, butyl cellulose, tert-butyl cellulose, and the like.

B. Compositions for the treatment of the oral cavity

Compositions for the treatment of the oral cavity in accordance with the invention can have a consistency ranging from a sticky, viscous gel to a solid. Essentially hard or putty compositions preferably become more sticky and adhere to teeth and / or gums when wetted with water or saliva. Therapeutic compositions may include a continuous layer arranged to cover one or more surfaces of the individual’s teeth and / or gums. The therapeutic composition can be positioned immediately adjacent to the barrier layer, or at least a portion of the therapeutic composition can be located near the auxiliary adhesive composition.

In general, sticky, viscous therapeutic gels must have at least one active agent, at least one means for gluing tissues (or a thickener), a liquid or gel, a solvent, a carrier or carrier in which the active agent and the agent for gluing tissues and if desired, other components and adjuvants. The main difference between compositions that are “gel” and compositions that are “putty” or “solid material” is the level of solvent or carrier within the composition. In general, the greater the concentration of the solvent or carrier relative to the tissue bonding agent, the more the composition is similar to a gel. The lower the concentration of the solvent or carrier relative to the tissue bonding agent, the more the composition is like putty or solid material. At some point, the ratio of solvent or carrier to the means for gluing fabrics is low enough for the gel composition to become a hard or very viscous putty, or for the putty to become solid.

Hard putties and hard materials preferably become more adherent to the teeth when wetted with water or saliva. Solid or putty compositions may have so little solvent or carrier as to cause a feeling of dryness when touched, and to be initially non-adherent, but to become more adherent with teeth and / or gums when wetted with water or saliva. Essentially solid or putty compositions can be made by initially incorporating a very small amount of solvent or carrier and / or first forming a gel, which later dries to remove a substantial portion of the solvent or carrier.

Illustrative active substances, tissue bonding agents, solvents or carriers, and other ingredients that can be used to make oral compositions according to the invention are presented below.

1. Active substances

Examples of active substances that can be used inside oral treatment compositions in accordance with the invention include teeth whitening agents, desensitizing agents, remineralizing agents, antimicrobial agents, antiplaque agents, anti-tartar agents, emollient gums, anesthetics, antioxidants and mouth fresheners. Examples of teeth whitening products include, but are not limited to, aqueous hydrogen peroxide, carbamide peroxide, metal perborates (for example sodium perborate), metal percarbonates (for example sodium percarbonate), metal peroxides (for example calcium peroxide), chlorites and metal hypochlorites, peroxyacids (for example peroxyacetic acid) and peroxyacid salts.

Bleaching agents within the teeth whitening compositions according to the invention may have any desired concentration, for example, 1-90% by weight. The concentration of the tooth whitener can be adjusted depending on the expected treatment time for each whitening session. In general, the shorter the treatment time, the more bleaching agent will be added to speed up the teeth whitening in order to make the bleaching more shortly.

- 7 008520 time period. One or more bleaching agents are preferably included in an amount of from about 1 to about 60 wt.% Of the composition for whitening teeth, preferably from about 5 to about 40 wt.% And most preferably from about 10 to about 30 wt.%

Examples of other active agents that can be included in addition to, or instead of, a tooth whitening agent, include desensitizing agents (for example, potassium nitrate, other potassium salts, citric acid, citrates and sodium fluoride), remineralizing agents (for example, sodium fluoride, divalent tin, sodium monofluorophosphate and other fluorides), antimicrobial agents and preservatives (for example, chlorhexidine, triclosan, sodium benzoate, parabens, tetracycline, phenols and cetylpyridinium chloride), anti-dental summer, anti-tartar agents, gum softening agents (for example, aloe, weak potassium nitrate, isotonic salts forming salts), anesthetics (for example benzocaine, lidocaine and the like), antioxidants (for example vitamin A, vitamin C, vitamin E, others vitamins and carotene), and mouthwash (eg camphor and wintergreen).

2. Means for bonding fabrics

Useful agents for bonding fabrics (or tackifying agents) include a wide variety of hydrophilic polymers. Examples of hydrophilic polymeric tissue bonding agents include, but are not limited to, polyvinylpyrrolidone (Ruhr), copolymers of Ruhr-vinyl acetate, carboxypolymethylene (for example SAEVORA, sold by Νονοαη.1 ps.), Polyethylene oxide (for example, ROUOX, manufactured by synthetics, 1pc.), And synthesized chitmas. acids (for example REMPEAH, sold by NNP, 1ps.), polyacrylates, polyacrylamides, copolymers of polyacrylic acid and polyacrylamide, carboxymethylcellulose, carboxypropylcellulose, cellulose ethers, polysaccharides dnye resins, fibers and the like.

Non-limiting examples of polyvinylpyrrolidone polymers that have been used in formulating compositions for treating the oral cavity in accordance with iridum include Cochbop 30, a polyvinylpyrrolidone polymer sold by BA8P, having a molecular weight of 50,000, Cochbop UA 60, a polyvinylpyrrolidone polymer having a molecular weight of 60000, 30000 io. P, polyvinylpyrrolidone polymer having a molecular weight of 1.3 million.

In the case when the composition for treating the oral cavity is a gel, one or more means for gluing tissues is preferably included in an amount of from about 1 to about 50 wt.%, A therapeutic gel, preferably from about 3 to about 30 wt.% And most preferably from about 5 to about 20 wt.%

In the case where the composition for treating the oral cavity is essentially a solid, one or more means for gluing tissues is preferably included in an amount of from about 10 to about 90% by weight of an essentially solid therapeutic composition, preferably from about 20 up to about 80 wt.% and most preferably from about 40 to about 75 wt.%

3. Carriers and fillers

Sticky, viscous gels for treating the oral cavity usually must include one or more ingredients from a liquid, gel, solvents, carriers, or excipients, in which the active agent, the agent for gluing fabrics and other components dissolve or disperse. Examples of liquid or gel solvents, carriers, or fillers include, but are not limited to, water, alcohols (for example ethyl alcohol) and polyols (for example glycerin, sorbitol, mannitol, other sugar alcohols, propylene glycol, 1,3-propanediol, polyethylene glycol, polyethylene oxide and polypropylene glycol).

In the case of compositions that are essentially hard or hard putty, the concentration of solvent, carrier or filler will usually be reduced as compared to therapeutic gels. When it is desirable to form a therapeutic gel that later turns into a putty or solid composition, it may be preferable to include one or more volatile solvents that can be removed by evaporation (for example, water, alcohols, acetone, and other organic solvents). Due to the affinity of hydrophilic polymers for water, even therapeutic compositions that appear to be solid may include a significant amount of bound water (for example, up to about 10% by weight of a therapeutic composition or more). In the case where the treatment composition has a very viscous or hard putty consistency, the composition as a whole will include a solvent, carrier or filler, which act as a plasticizer or emollient.

4. Other components

Compositions for treating the oral cavity may optionally include other components, if desired, to obtain therapeutic compositions having the desired properties. Examples include bleaching agent stabilizers (for example, соли or salts ΕΌΤΑ, citric acid and its salts, phosphoric acid and its salts, phenol-phosphoric acid and its salts, gluconic acid and its salts, alkali metal pyrophosphates, alkali metal polyphosphates and alkyl sulfates), neutralizing agents ( for example, sodium hydroxide and triethanolamine), inorganic thickeners (for example, white carbon) coloring agents, flavoring agents, sweeteners, and the like.

- 8 008520

C. Auxiliary adhesive compositions

Auxiliary adhesive compositions with optional use in the manufacture of devices for treating the oral cavity in accordance with the invention may not include active agents, or they may include significantly less active agent or other active agent compared to the composition for treating the oral cavity. In addition, they may include any of the components presented above with respect to the composition for treating the oral cavity. The auxiliary adhesive composition may be located between the treatment composition and the barrier layer, or it may be located adjacent to or surrounding the treatment composition, for example, so as to protect the gums or periodontal tissue of the individual from the whitening composition during use, limiting the bleaching agent to the area adjacent to the surfaces of the teeth of the individual to be bleached.

Like a therapeutic composition, the auxiliary adhesive composition can be a material from a sticky, viscous gel to a solid material or layer. The adhesive composition may be located in a limited area: near the edge (s) or edges (s) of the barrier layer closest to the gums of an individual when a therapeutic agent is used, or a part may extend under the therapeutic composition. Alternatively, the adhesive composition layer may be located on top of a portion of the treatment composition.

In general, ancillary adhesive compositions should include at least one tissue adhesive (or tackifier) and a liquid or gel solvent, carrier or filler in which the tissue adhesive is dispersed, at least in the case of gel and / or production time essentially solid adhesive composition. The fabric bonding agent preferably contains a hydrophilic polymer (for example, one or more of the hydrophilic polymers discussed above in relation to a tooth whitening composition). The amount of the agent for bonding fabrics with respect to a liquid solvent, carrier or filler may vary to obtain either a sticky, viscous gel or a solid adhesive composition, as discussed above. The solvent, carrier, or vehicle may include any of the solvents, carriers, or excipients discussed above in relation to the whitening composition.

The auxiliary adhesive composition may, if desired, contain other components, including dyes (for example, carotene), softening agents (for example, aloe), weak potassium nitrate, salts that form isotonic solutions (for example, sodium chloride in an amount of about 0.9 wt.%) And anesthetics (for example lidocaine and others like it), antioxidants (for example vitamin A, vitamin C, vitamin E, other vitamins, chlorophyll and carotene), flavoring agents, antimicrobial agents and preservatives (for example sodium benzoate, parabens, triclosan, phenols, chlorhexidine and cetylperidinium chloride), means for freshening the oral cavity (for example, camphor and wintergreen), stabilizers of bleaching agents (for example, ΕΌΤΑ citric acid and sodium lauryl sulfate), inorganic thickeners (for example, white soot and fumigated aluminum oxide), remineralizing agents (for example, fouling agents (for example, white carbon black and fumigated aluminum oxide), remineralizing agents (for example, fouling agents (for example, white soot and fumigated alumina), remineralizing agents (for example, fouling) other fluorides), anti-plaque agents, bleach activators and, if desired, other adjuvants.

Ό. Characteristics of the device for the treatment of the oral cavity

In accordance with one embodiment, the oral treatment devices have a horseshoe-shaped longitudinal profile and an I-shaped groove in section, very similar to a conventional whitening impression spoon. Illustrative medical devices in the form of an impression spoon are depicted in FIG. 1A and 1B. FIG. 1A is a perspective view of an oral treatment device 100 comprising a flexible barrier layer 102, having a front side wall 104, a back side wall 106, and a horseshoe-shaped bottom wall 108, which together limit the chute 110, generally having an I-shape in section throughout the longitudinal size. Inside the groove 110, there is a continuous layer of beads of the oral treatment composition 112, which acts as an inner frame so as to at least partially maintain the barrier layer 102 in the form of an impression spoon having a groove having an overall I-shaped cross section. The oral treatment composition 112 may have a consistency ranging from a sticky, viscous gel to a solid therapeutic composition. The layer of beads of the oral treatment composition 112 is preferably a sticky, viscous gel having a cross-sectional diameter or thickness from about 1 to about 5 mm, more preferably from about 2 to about 4 mm.

FIG. 1B, an apparatus for treating the oral cavity 100 ′ is shown, which comprises a barrier layer 102 in the form of an impression spoon, which is essentially I-shaped in section. The barrier layer 102 includes a front side wall 104, a rear side wall 106, and a horseshoe-shaped bottom wall 108, which together define the chute 110, which is generally I-shaped in section across the entire longitudinal dimension. Inside the groove 110 is a continuous layer of balls of the composition for the treatment of the oral cavity 112 '. The oral treatment composition 112 ′ may range from a sticky, viscous gel to a solid composition. The continuous layer of the treatment composition 112 ′ is preferably a rigid putty or solid composition having

- 9 008520 thickness from about 0.2 to about 2 mm, preferably from about 0.5 to about 1 mm.

FIG. 2A and 2B depict devices for treating the oral cavity 200 and 200 ', having a generally I-shaped groove, but which tapers in order to have a more-shaped shape in the section near the incisors, as shown more specifically in FIG. FOR and 3B. As shown in FIG. 2A and 3A, the oral treatment device 200 includes a barrier layer 202 having a front side wall 204, a back side wall 206, and a bottom wall 208, which together limit the chute 210. A continuous layer of balls of the treatment composition 212 is located inside the chute 210 and is thus composed in order to act as an internal frame, which at least partially helps to maintain the barrier layer 202 in the form of an impression spoon.

As shown in FIG. FOR and SV, the oral treatment device 200 'includes a barrier layer 202 having a front side wall 204, a back side wall 206 and a bottom wall 208, which together define a chute 210, having a substantially ϋ-shaped section, which narrows along essentially in a Y-shape in the cut near the incisors. The continuous layer of the oral treatment composition 212 ′ is located inside the chute 210 and is designed to act as an internal frame that at least partially helps to maintain the barrier layer 202 in the shape of an impression spoon.

FIG. 4A and 4B show devices for treating the oral cavity 400 and 400 ′. Each of these devices contains a barrier layer 402, having a front side wall 404, a back side wall 406, and a bottom wall 408, which together define a groove 410 in which either a layer of balls of treatment composition 412 is located (FIG. 4A) or a continuous layer of treatment composition 412 '(Fig. 4B). In addition, the oral treatment devices 400 and 400 'include a first notch 414 on the front side wall 404 and a second notch 416 on the back side wall 406. The notches 414 and 416 assist the oral treatment devices 400 and 400' according to different dental arches size and shape.

FIG. 5A and 5B depict oral treatment devices 500 and 500 ', which are configured to have non-interlocking lower or back wall. However, oral treatment devices 500 and 500 'do not include a “gutter”, as this term is commonly understood in the context of conventional impression trays with interlocking walls that are joined together to restrict the gutter.

Instead of interlocking side walls, each of the oral treatment devices 500 and 500 'includes a barrier layer 502, having a front side wall 504, front lower flaps 506a separated by a first cut or gap 507, and second lower flaps 506b separated from the first lower flaps 506a second cuts or gaps 509. The size and configuration of the first lower flaps 506a are such that they wrap up the internal surfaces of the incisors and canines of the individual during use and lie snugly against them. The size and configuration of the second lower flaps 506b are such that they wrap the inner surfaces of the premolars, and optionally one or more molars, and are in contact with them.

The cutouts or gaps 509 between the first flaps 506a and the second flaps 506b facilitate reliable adhesion of the first lower flaps 506a to the incisors and canines of the individual, especially at the junction of canines and premolars. The cuts or gaps 509 compensate for the dramatic difference in width between individual premolars adjacent to the second lower flaps 506b and to the canines adjacent to the first lower flaps 506a. A gap or cutout 507 separating the first lower flaps 506a from each other further contributes to the fit of the flaps 506a to the internal surfaces of the incisors and canines of the individual.

FIG. 5A is furthermore shown a continuous layer of beads of the composition for treating the oral cavity 512, located within the inner region bounded by the front side wall 504 and the lower flaps 506a and 506b. FIG. 5B alternatively depicts a substantially continuous layer of the oral treatment composition 512 ′, located within the inner region bounded by the front side wall 504 and the lower flaps 506a and 506b.

In order to protect the oral treatment devices of the invention against contamination during storage and prior to use, the treatment devices can be packed inside a sealed container or package. As shown in FIG. 6 A and 6B, illustrative devices for treating the oral cavity 200 and 200 'can be hermetically sealed inside a protective package 600 or 600', which includes a hard support layer 632 and a peelable coating 634. When it is desirable to use a device for treating the oral cavity 200 or 200 ' , peelable coating 634 is removed, and the oral treatment device 200 or 200 'is removed or separated from support layer 632.

In one embodiment, the support layer 632 includes a shaped portion that may act as an inner frame to further assist in maintaining the shape of the treatment device 200 or 200 '. In use, both the treatment device 200 or 200 ', and the support layer 632 can be placed in the mouth of the individual in order to initially place the treatment device 200 or 200' on top of the individual's teeth and / or gums. After that the reference

- 10 008520 layer 632 is removed, leaving only the treatment device 200 or 200 'inside the individual's oral cavity. This provides the possibility of further manipulation of the barrier layer 202 so that the treatment device 200 or 200 'better matches the shape and irregularities of the teeth of the individual.

In addition to, or instead of, the protective package, the treatment device may alternatively include a removable protective layer (not shown), which is temporarily placed inside the gutter or the inner region adjacent to the treatment composition and / or the auxiliary adhesive composition. When it is desired to use a medical device, the removable protective layer is removed in order to expose the treatment composition and / or the auxiliary adhesive composition.

FIG. 7A and 7B depict an alternative embodiment of a device for treating the oral cavity 700 or 700 ', having a жел-shaped groove, but a substantially linear or straight longitudinal profile. More specifically, treatment devices 700 or 700 ′ include a barrier layer 702, having a front side wall 704, a back side wall 706 and a bottom side wall 708, which together define a образ-shaped groove 710, in which a layer of balls of the oral treatment composition 712 or continuous layer of therapeutic composition 712 '.

FIG. 8A and 8B depict another alternative embodiment of a device for treating the oral cavity 800 or 800 ', having a Y-shaped groove. More specifically, oral treatment devices 800 or 800 ′ include a barrier layer 802 having a front side wall 804 and a rear side wall 806, which together define a Y-shaped groove 810, inside of which there is a layer of balls of the composition for treating the oral cavity 812 or Oral cavity treatment 812 '.

Iii. Methods for the manufacture of devices for the treatment of the oral cavity

The various components that make up the proposed oral treatment devices according to the invention can be assembled or combined in any desired order. In the case where the barrier layer is able to maintain its shape in an impression spoon or tray-like configuration, the oral treatment composition and the optional auxiliary adhesive composition can simply be placed inside the gutter or interior of the impression spoon or similar tray device. Thereafter, the oral treatment device can, if desired, be further manipulated, modified, or packaged to produce the desired oral treatment device.

In the case when the barrier layer is so thin and flexible that it alone cannot support the desired configuration, the configuration, regardless of the composition of the inner frame, there are various options. In the case when the composition for treating the oral cavity and / or the auxiliary adhesive composition are sticky, viscous gels, it may be advantageous to place the barrier layer inside the outer frame or template to form an impression spoon having a tray-like configuration. The gel composition can then act as an inner frame so that it can support the barrier layer in the form of a tray or tray-like configuration in the absence of an outer support or outer frame.

In another embodiment, the gel composition may be placed against a substantially substantially dense barrier layer, which is then profiled so as to obtain a therapeutic device having the desired configuration. The flat barrier layer may be the size of a single oral treatment device, or it may include a large sheet from which to cut, stamp, or otherwise form a variety of oral treatment devices.

In the case when the composition for treating the oral cavity and / or the auxiliary adhesive composition are essentially solid (for example, hard putty or hard material), the composition for treating the oral cavity and / or the auxiliary adhesive composition can be placed inside the barrier layer already in the form of an impression spoon or in a tray-like configuration. Alternatively, the substantially solid composition can be formed into the desired profile, and the barrier layer is subsequently attached to the outer surface of the composition.

Notwithstanding the foregoing, it should be understood that other sequences or manufacturing procedures may be used to compose devices for treating the oral cavity in accordance with the present invention.

Iv. Ways to use devices for the treatment of the oral cavity

Teeth whitening devices in accordance with the invention can be designed to be worn for any desired period of time. Increasing the concentration of the active agent as a whole reduces the time required to effect the treatment. However, due to the extremely comfortable fit and reliable adhesion between the devices for treating the oral cavity of the invention and the teeth of an individual, such devices can be worn for long periods of time to ensure a more even treatment. They can be designed to be worn when performing normal daily activities such as talking, eating, drinking, smoking, coughing, smiling, mimicry discontent, grimacing, yawning, ultimately, with any facial expression

- 11 008520 or during the curvature of the mouth or sleep. This significantly reduces their interference with everyday types of activity, compared to conventional whitening strips that do not adhere securely to teeth, or invasive medical devices, such as large, volumetric teeth whitening devices.

Oral treatment devices according to the invention can be worn on an individual's upper and lower dental arches or both at the same time. The ability to safely and comfortably wear oral treatment devices on the upper and lower dental arches simultaneously represents another departure from the whitening strips that are not recommended for use in bleaching the upper and lower dental arches at the same time.

FIG. 9 shows 900 people placing an oral treatment device 902 on their upper dental arch. A device for treating the oral cavity 902 may be in the form of an impression spoon, having a groove or device having a tray-like configuration, having one or more intermittent walls bounding an internal region that does not constitute a groove. FIG. 10 shows 900 people with a device for treating the oral cavity 902 on the upper dental arch and with a device for treating the oral cavity 904 on the lower dental arch. It should be understood that oral treatment devices 902 and 904 can be placed on an individual's upper and lower dental arches in any desired order.

To remove the oral treatment device, the user can, by lifting, open the corner of the barrier layer using a finger nail or a hard tool, and then pull out the rest. Any residual healing and / or auxiliary adhesive composition that remains adhered to the teeth of the individual can be removed by flushing or sprinkling water on the teeth of the individual and / or brushing. Although therapeutic and / or auxiliary adhesive compositions can adhere very strongly to the teeth while protecting against excess moisture, they can be formulated for rapid destruction and dissolution when pouring excess water and / or gentle mechanical action (for example, cleaning with a toothbrush).

Dental treatment devices can be worn for as little as a few minutes or up to several hours. By way of example, and not limitation, a typical short duration treatment session can last from about 10 to about 30 minutes. An intermediate duration treatment session can last from about 30 minutes to about 2 hours. A long duration treatment session, including professional or overnight treatment, while the individual is sleeping, can last from about 2 to about 12 hours.

Treatment sessions in accordance with the invention can be repeated as many times as necessary to obtain the desired degree of treatment. In the case of whitening devices, the clinical effect of whitening was observed after only 1-3 sessions of whitening. A typical treatment regimen should preferably include 1-20 treatment sessions, preferably 2-15 treatment sessions, and most preferably 3-10 treatment sessions.

V. Dental treatment kits

For ease of use, multiple oral treatment devices can be packaged together and sold as a set. In one embodiment, the number of oral treatment devices provided by each kit may be equal to the number of sessions that the assigned treatment regimen represents. Due to the ease of placement of devices for the treatment of the oral cavity of the invention on the teeth of an individual, combined with the reliability with which they interlock with the teeth, the probability that a particular medical device will be untenable or will not work properly should be significantly reduced compared to conventional whitening strips.

To efficiently use the space inside the package package, multiple treatment devices can be stacked or stacked on top of each other. The treatment devices can optionally be hermetically sealed together or separately. Protective packages 600 and 600 'are depicted in FIG. 6 A and 6B. Treatment devices may optionally contain a removable protective layer on the inner surface to protect the treatment composition and the auxiliary adhesive composition from contamination or moisture.

It is within the scope of the invention to provide barrier layers, therapeutic compositions and auxiliary adhesive compositions that are initially separate and which are combined by the end user. For example, therapeutic compositions in the form of a gel or putty can be extruded or placed adjacent to the barrier layer. The resulting treatment device can be used as it is, or the treatment composition can be allowed to dry to form a solid.

Vi. Examples of preferred embodiments

The following are some examples of therapeutic compositions and auxiliary adhesive compositions that can be used in the manufacture of therapeutic devices in accordance with the invention. Illustrative formulations and manufacturing conditions are presented as an example, and not limitation, to illustrate therapeutic devices that have been found to be used for

- 12 008520 teeth and / or gums of an individual. While there are no other indications, all percentages are by weight.

Examples 1-21 are directed to the manufacture of compositions in the form of gel for whitening teeth, which are processed to obtain essentially solid bleaching compositions used for the manufacture of therapeutic devices in accordance with the invention. Examples 22-26 are directed to the manufacture of compositions for the sensitization of teeth, which are processed to obtain essentially solid desensitizing compositions used for the manufacture of therapeutic devices in accordance with the invention. Examples 27-29 are directed to the manufacture of compositions of drugs, which are processed to obtain essentially solid compositions of drugs used for the manufacture of therapeutic devices in accordance with the invention. Examples 30-37 are directed to the manufacture of auxiliary adhesive compositions that do not include any active agent. Examples 38-43 are directed to sticky, viscous tooth whitening gels that are suitable for use in the manufacture of devices for treating the oral cavity in accordance with the invention. Examples 44-49 describe additional embodiments of illustrative compositions and devices in accordance with the invention.

Example 1

A tooth whitening composition is formed by mixing together the following components:

Carbamide peroxide sixteen% Polyvinylpyrrolidone (molecular weight 38% 1,300,000) Water 46%

The tooth whitening composition is spread on a flexible polymer sheets in the form of a gel using a spatula and then heated in a furnace with compressed air heated to a temperature of 50-70 ° C for approximately 1 hour. The coated sheets are removed from the oven and inspected. The whitening gel dries sufficiently to form a substantially solid, coherent bleaching composition on the surface of the polymer sheets. The coated sheets are placed back into the oven overnight to remove additional water.

The coated sheets are removed from the oven a second time, cut into smaller pieces, profiled into devices like an impression spoon, suitable for placing on an individual's teeth.

Example 2

Carbamide peroxide 16%

No. 101 (molecular weight 1000000) 7%

Water 77%

The whitening composition is used to make teeth whitening devices in accordance with the procedures described in Example 1.

Example 3

Carbamide peroxide sixteen% Sagoro1 974R five% Water CaO (50%) 6% Water 73%

Example 4

Polyethylene oxide (molecular weight 100,000) 20%

Glycerin, 2.5%

Sodium percarbonate 2.4%

Water 75.1%

- 13 008520

Example 5

Carbamide peroxide ten% Water 25% Ethanol 25% Polyvinylpyrrolidone (molecular weight 38% 1,300,000) Glycerin. 73%

Example 6

Carbamide peroxide 10%

Water 21%

Ethanol 21%

Κοίϋάοη UA 64 (molecular weight 60,000) 40%

Carboxymethylcellulose 3%

PE6600 (polyethylene glycol) 5%

Example 7

Carbamide peroxide 11.6%

Ethanol 55.8%

Κοίΐίάοη UA 90 G (molecular weight 1,300,000) 24.4%

Carboxymethylcellulose 2.3%

PE0600 5.8%

Example 8

Carbamide peroxide ten% Ethanol 65% Κοίΐίάοη UA 90 g (molecular weight 1,300,000) 20% RES600. five%

Example 9

Peroxide carbamide ten% Ethanol 64% Κοίΐίάοη UA 90 E (molecular weight 1,300,000) 25% RES600 one%

- 14 008520

Example 10

Carbamide Peroxide Ethanol 10% 64% Κοίΐίάοη UA 90 K (molecular weight 1,300,000) RES600 23% 1%

AerozI 200 2%

Example 11

Composition for teeth whitening is formed by mixing together the following components: Carbamide peroxide 10%

Ethanol 66.9%

Κοίΐΐάοη UL 90 G (molecular weight 1,300,000) 20%

ΡΕΘ600 0.1%

AerozI 200 3%

Example 12

Carbamide peroxide Po1uOh I5K 101 (molecular weight 1000000) 10% 7.5% Water 75.5% Glycerol five%

AerozI 200 2%

Example 13

Carbamide peroxide Κοίΐίάοη νΑ 90 g (molecular weight 1,300,000) Κοίϋάοη 30 (molecular weight 50,000) 10% 10% 20% Water 53% Glycerin Aerozi 200 5% 2%

Example 14

Carbamide peroxide Κοίΐίάοη νΑ 90 G (molecular weight 1,300,000) 10% 27% Water 50% Glycerin Aerozi 200 7% 6%

- 15 008520

Example 15

Carbamide peroxide 10%

Κοίΐίάοη UA 90 G (molecular weight 1,300,000) 28%

Water 50%

Glycerin 7%

AerozI 200 5%

Example 16

Carbamide peroxide 15%

Polyvinylpyrrolidone (molecular weight

32%

1,300,000)

Water

12.8%

Ethanol

20%

Glycerol

ten%

Aogozi 200

five%

Calcium ΕϋΤΑ

0.2%

Sodium lauryl sulfate 5%

The bleaching composition is used to manufacture teeth whitening devices in accordance with the procedures described in Example 1.

co Example 17

Carbamide peroxide 15%

Polyvinylpyrrolidone (molecular weight 1,300,000) 26%

Water 16.8%

Ethanol 25%

Glycerin 15%

Calcium ΕΌΤΆ 0.2%

Sodium lauryl ether sulfate 2%

Example 18

Composition for teeth whitening is formed by mixing together the following components: Carbamide peroxide 15%

Polyvinylpyrrolidone (molecular weight 32%

1,300,000)

Water 13.8%

Ethanol 20%

Glycerin 12%

AerozI 200 5%

Calcium EOTA 0,2%

3ί1νβΐ Ь-7001 2%

- 16 008520

Example 19

Composition for teeth whitening is formed by mixing together the following components: Calcium peroxide 20%

Carbamide peroxide

Polyvinylpyrrolidone

1,300,000) (molecular weight

four%

20%

Water

Ethanol

20%

Glycerol

Aogozi 200

five%

Calcium ΕΌΤΑ

Sodium lauryl sulfate 2%

coexample 20

Carbamide peroxide ten% Κοίΐίάοη νΑ 90 G (molecular weight 1,300,000) 18.7% Water 42, 3% Ethanol 13.3% Glycerol 12% Aogozi 200 3.3% Sodium lauryl sulfate 0.33%

Example 21

Carbamide peroxide. 7.1%

Κοίΐίάοη UA 90 K (molecular weight 1,300,000) 25%

Water 10.7%

Ethanol 50.7%

Glycerin 2.9%

AerozI 200 3.6%

Example 22

Composition for desensitization of teeth, suitable for use in the manufacture of compositions for the treatment of the oral cavity and / or protective auxiliary adhesive composition is formed by mixing together the following components:

Sodium fluoride 0.25%

Polyvinylpyrrolidone (molecular weight 1,300,000) 30%

Water 69.75%

The desensitizing composition is spread as a gel on flexible polymer sheets using a spatula and then heated in an oven with compressed air heated to a temperature of 50-70 ° C for approximately 1 hour. The coated sheets are removed from the oven and inspected. The desensitizing gel dries sufficiently to form a substantially solid, coherent desensitizing composition on the surface of the polymer sheets. The coated sheets are cut into smaller pieces and profiled into devices like an impression spoon, suitable for placing on an individual's teeth.

A layer of whitening gel globules is placed on top of a portion of the substantially solid desensitizing composition so that a portion of the desensitizing composition extends beyond the whitening composition near one or both edges of an impression spoon-like device for producing a whitening device in accordance with the invention. The desensitizing composition, which passes beyond the limits of the whitening composition, forms a protective, sticky area. The bleaching device is used as it is, or it is further heated to obtain an essentially solid bleaching composition.

Alternatively, the whitening composition is placed on top of a portion of the initially described desensitizing composition (i.e. before heating in a compressed air oven) to form a tooth whitening device and a desensitizing composition so that it becomes substantially solid. The desensitizing composition, which extends beyond the whitening composition, or in gel form, or substantially in solid form, forms a protective, sticky region.

Example 23

Composition for desensitization of teeth, suitable for use in the manufacture of a composition for treating the oral cavity or a protective auxiliary adhesive composition, is formed by mixing together the following components:

Sodium citrate five% Polyvinylpyrrolidone (molecular weight 20% 1,300,000) Water 75%

The desensitizing composition is used alone or with a composition for whitening teeth for the manufacture of therapeutic devices, in accordance with the procedures described in example 22.

Example 24

Sodium nitrate 3% Polyvinylpyrrolidone (molecular weight 15% 1,300,000) Ethanol thirty% Water 52%

Example 25

Potassium nitrate 0.5% Sodium fluoride 0.25% Polyvinylpyrrolidone (molecular weight 32% 1,300,000) Ethanol thirty% Water 37.25%

The desensitizing composition is used alone or with a composition for whitening teeth for the manufacture of therapeutic devices in accordance with the procedures described in example 22.

Example 26

Potassium nitrate 0.5% 0.25% 15% 33% Sodium fluoride Carbamide peroxide weight Polyvinylpyrrolidone (molecular 1,300,000) Water 51.25%

A desensitizing composition is used alone or with a composition for whitening teeth 18 008520 for the manufacture of therapeutic devices in accordance with the procedures described in Example 22.

Example 27

Chlorhexidine gluconate 2% Polyvinylpyrrolidone (molecular weight thirty% 1,300,000) Ethanol ' 33% Water 35%

Example 28

Cetylpyridinium chloride 2% Ethanol 28% Polyvinylpyrrolidone (molecular weight 35% 1,300,000) Water 35%

Example 29

Phenol 3% Polyvinylpyrrolidone (molecular weight 35% 1,300,000) Ethanol 62%

Example 30

An adhesive composition suitable for use in the manufacture of auxiliary ad-

The nut composition is formed by mixing together the following components: Water 25% Ethanol thirty% Glycerol ten% Polyvinylpyrrolidone (molecular weight thirty% 1,300,000) Aogozi 200 five%

The adhesive composition and the composition for treating the oral cavity is used to manufacture devices for treating the oral cavity.

- 19 008520

Example 31

An adhesive composition suitable for use in the manufacture of auxiliary ad-

The nut composition is formed by mixing together the following components: Water 20% Ethanol thirty% Glycerol 15% Polyvinylpyrrolidone (molecular weight thirty% 1,300,000) Aogozi 200 five%

The adhesive composition and the composition for the treatment of the oral cavity is used for the manufacture of therapeutic devices.

Example 32

An adhesive composition suitable for use in the manufacture of a protective adhesive composition is formed by mixing together the following components:

Water 20%

Ethanol 40%

Glycerin 10%

Polyvinylpyrrolidone (molecular weight 30%

1,300,000)

Example 33

Adhesive composition suitable for use in the manufacture of protective adhesive

the composition is formed by mixing together the following components: Ethanol 60, 6% Glycerol 5.1% Polyvinylpyrrolidone (molecular weight thirty% 1,300,000) Aogozi 200 4.3%

Example 34

Adhesive composition suitable for use in the manufacture of protective adhesive

the composition is formed by mixing together the following components: Ethanol 61, 9% Glycerol 9.5% Polyvinylpyrrolidone (molecular weight 23, 8% 1,300,000) Aogozi 200 4.8%

Example 35

Ethanol 63.6%

Glycerin 9.15%

Polyvinylpyrrolidone (molecular weight 27.3%

1,300,000)

- 20 008520

Example 36

Ethanol 443

Polyvinylpyrrolidone (molecular weight

1,300,000)

Glycerol

Sodium lauryl sulfate

Sucrose

Artificial Peach Flavor

34?

143

3%

one%

four%

Example 37

A desensitizing and remineralizing composition suitable for use in making a protective adhesive composition is formed by mixing together the following components:

Ethanol 31.95% Water ten% Polyvinylpyrrolidone (molecular weight 27% > 1,000,000) Polyvinylpyrrolidone (molecular weight ten% "60000) Sodium lauryl sulfate 0, 5% Glycerol 15% Sucrose (25% solution) 0.5% Peach flavor four% Potassium nitrate 0.8% Sodium fluoride 0.25%

The drug composition is used alone or in combination with a tooth whitening composition for the manufacture of therapeutic devices.

Example 38

A sticky, viscous tooth whitening gel, suitable for use in the manufacture of teeth whitening devices in accordance with the invention, is formed by mixing together the following components:

Carboxymethylcellulose (sodium salt) 2% Carbamide peroxide 22.5% Glycerol 28% Water 16, 4% Sodium Saccharin Powder 2% Sodium EETA 0.1% SOBOZI M-5 (5Y ₂ ) 7% Peach flavor 2% Polyethylene glycol (molecular weight = 20000) 20%

Teeth whitening gel is placed inside a flexible thin-walled impression spoon. The bleaching device is used as it is, or is processed to remove some of the solvent inside the bleaching gel to form a putty or solid. Alternatively, a whitening gel is used in combination with an auxiliary adhesive composition, in accordance with any of examples 22-37. A whitening gel and / or an auxiliary adhesive composition serve as an inner scaffold.

- 21 008520

Example 39

Water 19.2% Dinatrium edetate 0.1% Carbamide peroxide 18.5% Xylene s . 7% Glycerol 25.4% SAKVORO 974 5.3% NaOH (50% in water) 4.5% Carboxymethylcellulose four% Κοίϋάοη 90Е ten% Peach flavor 3% Sucralose (25% in water) 3%

A whitening gel and optionally an auxiliary adhesive composition are used to make teeth whitening devices in accordance with one or more of the procedures described in examples 1, 22 and 38.

Example 40

Water 18% Dinatrium edetate 0.1% Carbamide peroxide 18.5% Sucralose (25% in water) 3% Glycerol 41, 6% SAKVORO 974 5.3% CaON (50% in water) 4.5% Κοίΐίάοη 90Е 2% Carboxymethylcellulose four% Peach flavor 3%

Example 41

Water 18% ECTA 0.1% Carbamide peroxide 22% Sucralose (25% in water) 2% Glycerol 37.1% SAKVORO 974 5.3% CaON (50% in water) 4.5% Κοίΐίάοη 90Г 2% Carboxymethylcellulose five% Peach flavor four%

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Example 42

Glycerol

SQUORAGE 974

NaOH (50% in water)

Κοίϋάοη 90Г

40.1%

5.3%

4.5%

2%

Carboxymethylcellulose 5%

Peppermint oil 1%

Example 43

A sticky, viscous tooth whitening gel, suitable for use in the manufacture of tooth whitening devices in accordance with the invention, is formed by mixing the following components together:

Water 22.5% ΕϋΤΑ 0.1% Carbamide peroxide 18.5% Sucralose (25% in water) 0.75% Glycerol 41, 6% SQUORAGE 974 5.3% NaOH (50% in water) 2.25%

Polyvinylpyrrolidone (molecular weight> 2%

1,000,000)

Carboxymethylcellulose 4%

Taste (peach, watermelon or peppermint 3% pepper)

Example 44

Any of the teeth whitening compositions of Examples 1-21 and 38-43 are used together with any of the therapeutic or auxiliary adhesive compositions of Examples 22-37 to form devices for treating the oral cavity in accordance with the invention.

Example 45

Any of the therapeutic or auxiliary adhesive compositions in accordance with Examples 2237 used to manufacture the bleaching devices in accordance with Example 44 are modified by adding a bleaching agent in an amount less than the amount of bleaching substance inside the bleaching composition made in accordance with one or more examples. 1-21 and 38-43.

Example 46

Any of the teeth whitening compositions of Examples 1-21 and 38-43 used for the manufacture of therapeutic devices in accordance with Examples 1-21 and 38-44 are modified by adding one or more of a desensitizing agent, a remineralizing agent, an antimicrobial agent, anti-dental plaque, anti-tartar or other drug.

Example 47

Any of the therapeutic or adhesive compositions of Examples 22-37 used for the manufacture of therapeutic devices in accordance with Examples 22-37 and 44 are modified by the addition of one or

- 23 008520 several of dye, gingival agent, isotonic salt, anesthetic, antioxidant, flavoring agent, preservative, mouth freshener, detergent, inorganic thickener, remineralizing agent, antiplaque, anti-dental stone, refreshing agent or antioxidant.

Example 48

Any of the therapeutic devices made in accordance with Examples 1-46 are modified by providing a barrier layer in the form of an impression spoon or similar impression spoon of a device comprising a mixture of ethyl vinyl acetate (80%) and polypropylene (20%).

Example 49

Any of the therapeutic or adhesive compositions in accordance with Examples 22 to 37 are modified by adding an effective amount of one or more of the bleaching agent activators (for example, 5% of an alkali metal or alkaline earth metal base and / or 1% of a metal, metal compound, or organometallic enzyme).

The present invention can be implemented in other specific forms without departing from its spirit or essential characteristics. The proposed options for implementation should be considered in all respects only as illustrative and not restrictive. Therefore, the scope of the invention is defined by the attached claims, and not by the foregoing description. All changes that are within the essence and equivalence range of claims should be covered by their scope.

Claims

CLAIM

1. A device for treating the oral cavity containing a thin, flexible barrier layer in the form of an impression tray;

a composition for treating the oral cavity, comprising an active substance and a tissue adhesion substance having a consistency in the range from a sticky, viscous gel to a solid such that it acts as an inner frame so as to at least partially participate in maintaining the barrier layer in the form of an impression spoon before use, said composition for treating the oral cavity being sticky and adhesive during use in order to cause at least partially matching the barrier layer individual tooth surfaces during use.

2. A device for treating an oral cavity according to claim 1, wherein the barrier layer is so flexible as to be unable to maintain the shape of the impression tray in the absence of a treatment composition before use.

3. The device for treating the oral cavity according to claim 2, in which the composition for treating the oral cavity prevents the approach of the front side wall and the lower wall and / or bending them from each other before use.

4. A device for treating an oral cavity according to claim 1, wherein the barrier layer has a thickness of from about 0.0001 to about 0.012 inches.

5. A device for treating an oral cavity according to claim 1, wherein the barrier layer has a thickness of from about 0.001 to about 0.01 inches.

6. A device for treating an oral cavity according to claim 1, wherein the composition for treating an oral cavity includes a layer of balls.

7. A device for treating an oral cavity according to claim 6, in which the ball has a cross-sectional diameter of about 1 to about 5 mm.

8. A device for treating an oral cavity according to claim 6, in which the ball has a cross-sectional diameter of about 2 to about 4 mm.

9. The device for treating the oral cavity according to claim 1, in which the composition for treating the oral cavity includes a continuous layer on the inner surface of the barrier layer.

10. A device for treating an oral cavity according to claim 9, in which the continuous layer has a thickness of from about 0.25 to about 2 mm

11. A device for treating an oral cavity according to claim 9, in which the continuous layer has a thickness of from about 0.5 to about 1 mm.

12. A device for treating an oral cavity according to claim 1, wherein the composition for treating an oral cavity is a sticky and viscous composition having a texture similar to glue.

13. A device for treating an oral cavity according to claim 1, in which the composition for treating an oral cavity is a hard putty that is essentially solid, but plastic and which becomes more sticky and more adhered to the teeth and / or gums of an individual when wetted with saliva or water.

14. The device for treating the oral cavity according to claim 1, in which the barrier layer includes a front side wall and a lower side wall, which are adjacent to each other so as to form a gutter into which the composition for treating the oral cavity is placed before use.

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15. The device for treating the oral cavity according to claim 1, in which the barrier layer includes a front side wall and a non-adjacent lower wall, which includes cutouts or gaps so as to form a plurality of lower cusps that more easily correspond to the inner surfaces of adjacent teeth having different widths.

16. The device for treating the oral cavity according to claim 1, in which the barrier layer includes at least one substance from the group: 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, polytetrafluoroethylene, polyester, polycarbonate, polyurethane, polyamide or polyether amide.

17. The device for treating the oral cavity according to claim 1, further comprising a removable outer frame that helps maintain the barrier layer in the form of an impression tray before use.

18. The device for treating the oral cavity according to claim 1, in which the barrier layer is designed so that during use it approximately ends at or near the gingival margin of the individual.

19. The device for treating the oral cavity according to claim 1, in which the barrier layer is designed so that during use overlaps the gingival margin of the individual.

20. The device for treating the oral cavity according to claim 1, in which the coupling agent comprises at least one of the following substances: polyvinylpyrrolidone (RUR), carboxypolymethylene, polyacrylic acid polyethylene oxide, polyacrylic acid copolymer, polyacrylate, polyacrylamide, polyacrylic acid and polyacrylamide copolymer , RUR-vinyl acetate copolymer, carboxymethyl cellulose, carboxypropyl cellulose, polysaccharide resin or protein.

21. The device for treating the oral cavity according to claim 1, in which the therapeutic composition includes at least one active agent selected from the group comprising means for whitening teeth, means, desensitizing teeth, anesthetics, softening gums, stabilizing substances, remineralizing antimicrobial agents, anti-plaque agents, anti-tartar agents, oral refreshing agents, and antioxidants.

22. A device for treating an oral cavity according to claim 1, further comprising an auxiliary adhesive composition.

23. A kit for use in the treatment of teeth and / or gums of an individual, comprising a plurality of devices for treating an oral cavity according to claim 1.

24. A method of treating teeth and / or gums of an individual, comprising applying an apparatus for treating an oral cavity according to claim 1 over at least a portion of the teeth and / or gums of an individual for a desired period of time.