WO2014055674A2

WO2014055674A2 - Non-custom dental treatment device having thickened occlusal wall

Info

Publication number: WO2014055674A2
Application number: PCT/US2013/063106
Authority: WO
Inventors: Dan E. Fischer; Lynn W. PEASLEE
Original assignee: Ultradent Products, Inc.
Priority date: 2012-10-02
Filing date: 2013-10-02
Publication date: 2014-04-10
Also published as: WO2014055674A3

Abstract

Dental treatment devices for treating a person's teeth and/or gums include a barrier layer with a thickened occlusal wall that is at least about 10%, 20%, 30%, 40%, or 50% thicker than the labial and lingual walls. The thickened occlusal wall assists the user when installing the treatment device and helps retain the treatment device over the teeth during use. The barrier layer has a generally horseshoe-shaped and is devoid of structures corresponding to the size and shape of a person's unique dentition so as be adaptable and conformable over a plurality of differently-sized dental arches corresponding to different people. The dental treatment device may be initially separate from the dental treatment composition or pre-filled within the composition. Kits include one or more dental treatment devices and one or more treatment compositions. Methods include positioning a barrier layer and treatment composition over a person's teeth for a desired time period.

Description

NON-CUSTOM DENTAL TREATMENT DEVICE

HAVING THICKENED OCCLUSAL WALL

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention is in the field of dental trays and treatment devices used to provide a desired dental treatment to a person's teeth (e.g., bleaching, administration of fluoride, or application of medicaments).

2. The Relevant Technology

A common method for applying a dental treatment composition to teeth involves using a dental tray that has been custom-fitted to a person's teeth. One type of customized tray is made from a stone cast of a person's teeth. Another is customized directly using a person's teeth as a template (e.g., "boil-and-bite" trays). Non-customized trays that approximate the shapes and sizes of a variety of users' dental arches have also been used. A dental treatment composition is placed into the tray and the tray is placed over the person's teeth for a desired period of time.

Another treatment method involves placing a treatment composition directly onto a person's teeth. A perceived advantage of paint-on treatment compositions is that it eliminates the need for a dental tray. A disadvantage is that the treatment composition is directly exposed to saliva and disruptive forces found in a person's mouth. As a result, a significant portion of the treatment composition may not remain on the teeth during treatment. Some or all of the composition may dissolve away or diffuse into the person's saliva and/or be transferred to adjacent oral tissues, potentially irritating soft oral tissues.

Another treatment method involves placing a flexible strip over a user's tooth surfaces. Conventional treatment strips comprise flexible plastic strips coated with dental treatment gels of moderate viscosity and relatively low stickiness on the side of the strip facing the user's teeth. To install the treatment strip, a portion of the treatment strip is placed over the front surface of a user's teeth, and the remainder is folded around the occlusal edges of the teeth and against the lingual surface. Sometimes this process is difficult and must be repeated, resulting in the waste of one or more treatment strips.

Because of the generally poor adhesion of treatment strips to the user's teeth, coupled with their generally flimsy nature, it is often difficult for the strip to remain in its proper position for the recommended time. Treatment strips easily slip off the teeth as a result of even minimal movement of the user's mouth, jaw or tongue. Indeed, it is recommended that the user not eat, drink, smoke or sleep while wearing strips. In practice, it is difficult to talk or smile while properly maintaining the strip in the correct position. In many cases, unless the user is completely immobilized, there will be some slippage of the strip out of proper position during use.

Even if the treatment strip is maintained in its proper position during treatment, the treatment composition can easily diffuse into the person's saliva, potentially causing a bad taste in the user's mouth and possibly discomfort to soft oral and throat tissues. This tendency of the treatment composition to diffuse into the user's mouth can be accelerated through even minimal shifts of the treatment strip over the user's teeth, with each shift potentially causing treatment composition that remains adhered to the user's teeth, but no longer covered by the plastic strip, to be directly exposed to saliva in the user's mouth. In some cases, the treatment strip can become so dislodged or mangled before the end of a treatment session that it must be removed and replaced with a fresh strip to complete the recommended treatment time. This multiplies the cost and hassle of using treatment strips.

In practical terms, the use of treatment strips can greatly inhibit even the simplest of activities that involve movement of the user's mouth or tongue, such as talking, smiling, making other facial expressions, or even swallowing (which normally occurs subconsciously throughout the day). Indeed, the time when a person's mouth and tongue are the least prone to move is at night while the person is sleeping. Unfortunately, it is recommended that conventional treatment strips not be used while sleeping, presumably to prevent accidental choking on an inadvertently dislodged bleaching strip. This confirms the tendency of conventional treatment strips to easily dislodge from a user's teeth. Ultimately, the main impediment to successful treatment is the failure of users to properly install the treatment devices and complete the prescribed treatment regimen. If the treatment device is difficult to install over a person's teeth, requires numerous repetitions to achieve observable results, or is uncomfortable to wear, the user may simply give up and prematurely abort the prescribed treatment regimen. Thus, even if treatment is possible using a particular treatment apparatus or method, it is less likely to occur if the inadequacies of the treatment apparatus or method cause a user to become discouraged before desired results are attained.

In view of the foregoing, there is an ongoing need for improved dental treatment devices that are easy to install and which reliably remain in proper position over the user's teeth so as to reduce diffusion of the dental treatment composition into the user's oral cavity. Such improvements would be expected to improve or encourage compliance by the user.

SUMMARY OF THE INVENTION

The present invention generally relates to improved dental treatment devices, kits and methods for treating a person's teeth and/or gums. According to one aspect, dental treatment devices may include a barrier layer with a thickened occlusal wall that can be used together with a dental treatment composition. Alternatively, dental treatment devices may be pre-filled with a dental treatment composition. Kits as disclosed herein include one or more dental treatment devices and one or more dental treatment compositions for use with the one or more dental treatment devices. Methods as disclosed herein include providing a barrier layer and dental treatment composition, positioning the barrier layer and treatment composition over a person's dental arch for a desired time period, and removing the barrier layer and treatment composition following treatment.

According to one embodiment, a non-custom dental treatment device for placement over at least a portion of a person's dental arch during treatment of a person's teeth and/or gums comprising a non-customized barrier layer formed from a moisture-resistant material. Alternatively, the barrier layer can be "semi-moisture resistant" as that term is defined herein. The barrier layer has a generally horseshoe- shaped configuration so as to substantially correspond to the curvature of a person's dental arch and is substantially devoid of structures corresponding to the size and shape of a person's unique dentition so as to be adaptable to and comfortably fit over a plurality of differently-sized dental arches corresponding to different people. The barrier layer further includes a labial wall configured to lie adjacent to labial tooth surfaces when the dental treatment device is placed over a person's dental arch, the labial wall having a wall thickness in a range of about 0.001 " to about 0.015". The barrier layer also includes an occlusal wall that extends laterally from the labial wall and is configured to lie adjacent to occlusal tooth surfaces when the dental treatment device is placed over a person's dental arch, the occlusal wall having a wall thickness in a range of about 0.002" to about 0.04". The occlusal wall thickness is at least about 10%, 20%, 30%, 40%, or 50% greater than the labial wall thickness (e.g., about 1.5 to about 3 times greater).

According to one variation, the barrier layer may also include a lingual wall that extends laterally from the occlusal wall and is configured to lie adjacent to lingual tooth surfaces when the dental treatment device is placed over a person's dental arch, the lingual wall having a wall thickness in a range of about 0.001 " to about 0.015". In this variation, the occlusal wall thickness is at least about 10% greater than the lingual wall thickness. In some cases, the lingual wall thickness will be substantially equal to the labial wall thickness.

It has found that providing a barrier layer with an occlusal wall that is thicker than the labial wall and optional lingual wall yields a comfortable fitting dental treatment device having several advantages compared to a barrier layer having constant thickness. A first advantage is that the disclosed barrier layers are significantly easier to install over a person's dental arch. The thickened occlusal wall provides a location that can be more easily grasped without deforming the tray-like shape of the barrier layer. A second advantage is that the disclosed barrier layers are more likely to remain in proper position during use. The thickened occlusal wall reduces the tendency of the barrier layer to deform and become dislodged as a person bites down or otherwise brings his/her teeth together during use. Nevertheless, a high level of comfort and adaptability are maintained by providing a thinner labial wall and optional lingual wall. Thus, providing a barrier layer with a thickened occlusal wall and a thinner labial wall and optional lingual wall maximizes the performance of the overall barrier layer relative to ease of installation, reliability during use, comfort, and adaptability.

The barrier layer material is advantageously selected in order for the barrier layer to be thin, flexible, highly adaptable, and readily conformable to a plurality of differently-sized dental arches corresponding to different people when worn. According to one embodiment, the barrier layer material comprises a polymeric material, wax, metal, or slowly erodible material. Examples of polymeric materials include polyolefins, polyesters, and the like. The polymeric material, wax or slowly erodible material may be combined with at least one of a plasticizer, flow additive, or filler selected to modify a property of the polymeric material or wax. In addition, one or more polyolefins can be used to modify a wax barrier layer (e.g.. , to increase flexibility and elongation).

According to one embodiment, the occlusal wall includes at least one V- shaped or U-shaped protrusion configured to fit into depressions in a plurality of adjacent posterior teeth so as to improve fit between the dental treatment device and a person's dental arch when worn. For example, the occlusal wall may include a non- customized V-shaped or U-shaped protrusion in each hemisphere of the horseshoe- shaped barrier layer that extends continuously along a length of the hemisphere and spans a plurality of depressions in adjacent posterior teeth during use. According to another embodiment, the labial wall can have a curvature corresponding to a facial curvature of labial tooth surfaces and/or skeletal maxilla or alveolar ridge so as to improve fit between the dental treatment device and a person's dental arch during use.

According to one embodiment, the dental treatment device is provided as a barrier layer so that a dental treatment composition is placed on a tooth-facing surface of the barrier layer just prior to use. In other embodiments, the dental treatment device is pre-filled so as to include a dental treatment composition positioned on a tooth-facing surface of the barrier layer. In addition, an oral treatment composition may be positioned on an exterior surface of the barrier layer to provide treatment to, e.g., surrounding oral tissue, such as labial or buccal tissue. The pre-filled dental treatment device may be contained in a sealed package prior to use.

According to one embodiment, the dental treatment composition includes at least one active agent, at least one tissue adhesion agent, and one or more other components as desired. Examples of active agents include dental bleaching agents, desensitizing agents, remineralizing agents, antimicrobial agents, antiplaque agents, and anti-tartar agents. If the active agent includes a dental bleaching agent, the treatment composition will be a dental bleaching composition.

Examples of tissue adhesion agents comprising at least one member selected from the group comprising polyvinyl pyrrolidones, carboxypolymethylene, polyethylene oxides, polyacrylic acids, copolymers of polyacrylic acid, polyacrylates, polyacrylamides, copolymers of polyacrylic acid, polysaccharide gums, proteins, PVP-vinyl acetate copolymers, carboxymethylcellulose, carboxypropylcellulose, and polyacrylamide.

Examples of other components include plasticizers and humectants (e.g. , glycerin, sorbitol, and polyethylene glycol), volatile solvents (e.g., water and alcohols), bleaching agent stabilizers (e.g., EDTA and alkyl sulfates), bleaching agent activators (e.g., metals and metal compounds), neutralizing agents, thickening agents (e.g., fumed silica), flavorants, sweeteners, and the like.

According to one embodiment, the dental treatment composition is a sticky viscous gel. In another embodiment, the dental treatment composition is a highly viscous putty. In yet another embodiment, the dental treatment composition is substantially solid prior to use but have increased adhesive to teeth when contacted with water or saliva. The substantially solid composition may be essentially dry to the touch prior to contact with water or saliva.

Exemplary kits as disclosed herein include at least one non-customized dental treatment device and at least one dental treatment composition initially separate from the at least one non-custom dental treatment device. The kits may include a first dental treatment device configured for placement over a person's upper dental arch and a second dental treatment device configured for placement over a person's lower dental arch. In one embodiinent, the number of dental treatment devices provided with each kit can equal the number of sessions that represent a prescribed treatment regimen.

According to one embodiment, a method of treating a person's teeth and/or gums includes the steps of: (1) providing a dental treatment device as disclosed herein; (2) placing a dental treatment composition adjacent to a tooth-facing surface of the barrier layer (e.g., by a dental practitioner or patient); (3) positioning the dental treatment device over a person's dental arch in order for the dental treatment composition to contact at least one of a person's teeth or gums for a desired period of time; and (4) removing the dental treatment device after treatment.

The size and shape of dental treatment devices can be tailored to readily fit a person's upper or lower dental arch. The dental treatment devices are advantageously designed so as to substantially cover the labial and lingual surfaces of the teeth and/or gums to be treated. The treatment devices are advantageously highly adaptable and flexible so as to readily conform to a wide variety of differently-sized teeth and dental arches.

The dental treatment devices can be designed to be worn for any desired time period. Increasing the concentration of active agent generally reduces the required treatment time. Nevertheless, due to the extremely comfortable fit between the disclosed dental treatment devices and a person's teeth, such devices can be worn for extended periods of time if desired. Treatment devices according to the invention can be designed to be worn while, e.g., talking, sleeping, eating, drinking, smiling, frowning, grimacing, yawning, coughing, smoking, and/or making virtually any facial expression or mouth contortion. This greatly decreases their intrusiveness into everyday activities compared to bleaching strips, which do not reliably adhere to teeth, or intrusive bleaching devices such as large, bulky bleaching dental appliances.

Dental treatment devices can be worn for as little as a few minutes or as long as several hours. By way of example, not limitation, a typical treatment session of fast duration may last from about 10 to about 30 minutes. A treatment session of intermediate duration may last from about 30 minutes to about 2 hours. A treatment session of long duration, including professional or overnight treatment while a person is sleeping, may last from about 2 hours to about 12 hours. Treatment sessions may be repeated as many times as are needed to obtain a desired result. In the case of tooth bleaching, a clinical whitening effect has been observed after only 1-3 whitening sessions. A typical bleaching regimen will preferably include 1-20 bleaching sessions, more preferably 2-15 bleaching sessions, and most preferably 3- 10 bleaching sessions.

According to one embodiment, the treatment device may include a support structure, such as an exoskeleton or endoskeleton, prior to use. An exoskeleton or cndoskeleton may be useful where the barrier layer is very thin and flexible. The exoskeleton may have a similar shape as the treatment device so as to receive and support the walls of the treatment device. The exoskeleton can provide additional support and ease of placement to the treatment device when positioning the device over a person's teeth. The exoskeleton may include a handle to facilitate gripping and maneuverability during placement over the teeth. Once positioned, the exoskeleton can be removed to leave the treatment device in place over the teeth.

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 the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by references to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

Figure 1A is a perspective view illustrating a conventional non-custom dental treatment tray having a uniform wall thickness;

Figure IB is a cross-section view of the dental treatment tray of Figure 1A taken along line I B— IB showing the uniform wall thickness; Figure 2A is a perspective view illustrating an exemplary non-custom dental treatment device having a barrier layer with a thickened occlusal wall and thinner labial and lingual walls;

Figure 2B is a cross-section view of the treatment device of Figure 2A taken along line 2B— 2B schematically illustrating the thickened occlusal wall compared to the thinner labial and lingual walls;

Figure 3A is a perspective view illustrating an exemplary pre-filled noncustom dental treatment device having a barrier layer with a thickened occlusal wall, thinner labial and lingual walls, and a gel treatment composition positioned on a lingual side of the barrier layer;

Figure 3B is a cross-section view of the pre-filled non-custom dental treatment device of Figure 3 A taken along line 3B— 3B schematically illustrating the thickened occlusal wall compared to the thinner labial and lingual walls and the gel treatment composition;

Figure 4A is a perspective view illustrating an exemplary pre-filled non- custom dental treatment device having a barrier layer with a thickened occlusal wall, thinner labial and lingual walls, and a substantially solid treatment composition positioned on a lingual side of the barrier layer;

Figure 4B is a cross-section view of the pre-filled non-custom dental treatment device of Figure 4A taken along line 4B— 4B schematically illustrating the thickened occlusal wall compared to the thinner labial and lingual walls and the substantially solid treatment composition;

Figure 5A is a perspective view illustrating an exemplary non-custom dental treatment device having a thickened occlusal wall compared to the labial and lingual walls and a non-customized V-shaped protrusion in the occlusal wall configured to fit into depressions in adjacent posterior teeth and improve fit between the dental treatment device and a person's dental arch when worn;

Figure 5B is a cross-section view of the non-custom dental treatment device of Figure 5A taken along line 5B 5B schematically illustrating the thickened occlusal wall compared to the thinner labial and lingual walls and the V-shaped protrusion; Figure 6Λ is a perspective view illustrating an exemplary non-custom dental treatment device having a barrier layer with a narrow, yet thickened occlusal wall and thinner labial and lingual walls that form a generally V-shaped tray configuration;

Figure 6B is a cross-section view of the non-custom dental treatment device of Figure 6A taken along line 6B— 6B schematically illustrating the thickened occlusal wall compared to the thinner labial and lingual walls and the generally V-shaped tray configuration;

Figure 7 A is a perspective view illustrating an exemplary pre-filled noncustom dental treatment device having a thickened occlusal wall and a dental treatment composition within a sealed protective package;

Figure 7B is a perspective view illustrating an exemplary pre-filled noncustom dental treatment device having a thickened occlusal wall with a non- customized V-shaped protrusion and a dental treatment composition within a sealed protective package;

Figure 8A illustrates an exemplary non-custom dental treatment device in use in maintaining a dental treatment composition against a posterior tooth, the treatment device having a barrier layer with a thickened occlusal wall and non-customized V- shaped protrusion to enhance fit within a recess of the posterior tooth;

Figure 8B illustrates an exemplary non-custom dental treatment device in use in maintaining a dental treatment composition against an anterior tooth, the treatment device having a barrier layer with a thickened occlusal wall; and

Figure 9 is a cross-section view of an exemplary non-custom dental treatment device in use in maintaining a dental treatment composition against a tooth and having a labial wall with a curvature that corresponds to a facial surface of the tooth. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

I. INTRODUCTION AND DEFINITIONS

Disclosed herein are dental treatment devices, kits and methods for treating a person's teeth and/or gums. Exemplary dental treatment devices include a barrier layer with a thickened occlusal wall and a thinner labial wall that can be used together with a dental treatment composition. Dental treatment devices may also be pre-filled with a dental treatment composition. Kits may include at least one dental treatment device and at least one dental treatment composition for use with the dental treatment device(s). Methods include providing a barrier layer and dental treatment composition, positioning the barrier layer and treatment composition over a person's dental arch for a desired time period, and removing the barrier layer and treatment composition following treatment.

The term "barrier layer", as used herein, refers to a single layer of a moisture- resistant or semi-moisture resistant material that protects the dental treatment composition from ambient moisture and saliva within a person's mouth when the dental treatment device is worn. The barrier layer can also protect the treatment composition from moisture or contaminants during storage prior to use. The barrier layer may be in the form a dental treatment tray have a generally horseshoe-shaped configuration and a tooth-facing surface (e.g., trough) for placement of a dental treatment composition thereon.

According to one embodiment, the barrier layer material is formulated or selected so as to be readily adaptable to the shape of a person's unique dental arch. According to one embodiment, the barrier layer material can have some degree of elastic memory, although once placed over a person's teeth it may be advantageous for the barrier layer to have little or no elastic memory so that it resists the tendency to pull or spring away from the person's tooth surfaces. According to one embodiment, the barrier layer material can be a blend that enables plastic deformation with little or no elastic memory. In some cases, the barrier layer material can have decreased elastic memory when heated to body temperature compared to at room temperature.

The term "moisture-resistant" means a barrier layer material that is essentially non-dissolvable in or by water or saliva. Polymers, waxes and metals are examples of "moisture-resistant" barrier layer materials.

The term "semi moisture-resistant" means a barrier layer material that is initially resistant to dissolution in or by water or saliva but that can slowly erode over time, such as over a period of at least about 15 minutes, 30 minutes 1 hour, or 2 hours.

The term "sticky viscous gel," as used herein, refers to a composition that is sticky or tacky to the touch and that is able to hold and retain a dental treatment tray over a person's teeth for a desired time period (e.g., for at least about 1 hour) absent external support.

The term "substantially solid," as used herein, refers to a composition that is in a solid or semi-solid condition. A characteristic of "substantially solid" composition according is that it may be initially dry or relatively non-adhesive to the touch (e.g., does not stick on its own to a dry surface) but becomes more adhesive (e.g. , highly adhesive) when moistened with saliva or water (e.g. , on a person's teeth). When moistened, a surface of the substantially solid composition turns into a sticky material that is able to more strongly adhere to teeth compared to a substantially solid composition that has not been moistened. The composition at the surface may become a viscous liquid, paste or gel, at least temporarily, depending on the amount of moisture that is applied to the surface. Nevertheless, the consistency of the moistened surface can remain "substantially solid" depending on the degree of initial moistening, or it can stiffen and even revert back to being "substantially solid" as the initial quantity of surface moisture diffuses into a remaining portion of the "substantially solid" composition over time (e.g. , during treatment where the moisture-resistant barrier layer protects the composition from ambient moisture in a person's mouth).

The term "viscous putty," as used herein, refers to a composition that is highly viscous but not solid. In some cases, a viscous putty composition may be less adhesive, or even non-adhesive, to the touch initially and become more adhesive (e.g., highly adhesive) when moistened with saliva or water (e.g., on a person's teeth). When moistened, a surface of the viscous putty composition may turn into a sticky material that is able to more strongly adhere to teeth compared to a substantially solid composition that has not been moistened.

The term "molecular weight", as used herein, refers to number average molecular weight expressed in Daltons unless otherwise specified.

π· DENTAL TREATMENT DEVICES

A. Barrier Layers

The dental treatment devices include a moisture-resistant barrier layer that protects the dental treatment composition from ambient moisture in a person's mouth during use. According to one embodiment of the invention, the barrier layer comprises a thin, flexible, moisture-resistant polymer material or similarly moisture- resistant material, such as wax or thin metal foil. Alternatively, the barrier layer may comprise a thin, flexible, semi moisture-resistant material (e.g., a slowly erodible material).

Exemplary polymers used to make the barrier layer include, but are not limited to, ethylene-vinyl acetate copolymer (EVA), ethylene-vinyl alcohol copolymer (EVAL), polyolefms, polypropylene (PP), polyethylene (PE), high density polyethylene (HDPE), low density polyethylene (LDPE), ultra low density polyethylene (ULDPE), polytetrafluoroethylene (PTFE) (e.g. , TEFLON), polyvinyl chloride (PVC), polycaprolactone (PCL), polyesters, polyethylene terephthalate (PET) (e. g., MYLAR) polycarbonates, polyamides, polyurethanes or polyesteramides. Plasticizers, flow additives, and fillers known in the art can be used as desired to modify the properties of any of the foregoing polymers used to form the barrier layer.

Blends of wax and polyolefin can also be used to form a barrier layer within the scope of the invention. For example, Parafilm® is a proprietary blend of paraffin wax, polyolefin, and plasticizer. Other waxes that may be used herein are bees wax and microcrystalline wax, alone or combined with one or more polymers, plasticizers or other additives to enhance the flexibility and elasticity of the wax blend.

Examples of semi moisture-resistant (e.g., erodible) materials include hydrophilic polymers or oligomers (e.g., microcrystalline cellulose, pullulan, cellulosic ethers, proteins, and polysaccharides), often mixed with a plasticizer (e.g. , glycerol, sorbitol, propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives such as dimethyl, diethyl and dibutyl phthalate, citrate derivatives such as tributyl, triethyl, and acetyl citrate, triacetin, polysorbate, and castor oil) and/or particulate thickeners (e.g., fumed silica).

B. Dental Treatment Compositions

Dental treatment compositions are used in combination with barrier layers to provide a desired treatment to teeth and/or gums. They typically include one or more tissue adhesion agents, one or more active agents, and one or more auxiliary components. .According to one embodiment, the treatment composition is a single continuous bead or layer adjacent to a tooth-facing surface of the barrier layer (e.g., the lingual side of the labial wall and/or the labial side of the lingual wall). Alternatively, one or more treatment compositions may comprise a plurality of beads or regions applied to the tooth-facing of the barrier layer. In addition, an oral treatment composition may be applied to an exterior surface of the barrier layer (e.g., labial surface of labial wall and/or lingual surface of lingual wall) to provide treatment to surrounding oral tissues, such as labial tissue, buccal tissue and/or lingual tissue. The treatment composition may be a sticky viscous gel, viscous putty, or substantially solid composition.

1. Tissue Adhesion Agents

The tissue adhesion agent may comprise any known material that is adhesive to teeth. Examples of tissue adhesion agents include polyvinyl pyrrolidone (PVP) (molecular weight greater than at least about 90,000, preferably at least about 200,000, more preferably at least about 500,000, and most preferably at least about 1 ,000,000), PVP-vinyl acetate copolymers, carboxypolymethylene (e.g., CARBOPOL, sold by Novean, Inc.), polyethylene oxide (e.g. , POLYOX, made by Union Carbide), polyacrylic acid polymers or copolymers (e.g. , PEMULEN, sold by Novean, Inc.), polyacrylates, polyacrylamides, copolymers of polyacrylic acid and polyacrylamide, carboxymethylcellulose, carboxypropylcellulose, polysaccharide gums, proteins, and the like.

The amount of tissue adhesion agent in the dental treatment composition often depends on whether the composition is a gel, putty, or substantially solid. According to one embodiment, the one or more tissue adhesion agents are included in an amount in a range of about 10% to about 90% by weight of the treatment composition (exclusive of any bound water or other solvent), preferably in a range of about 15% to about 80% by weight, more preferably in a range of about 21% to about 75% by weight, and most preferably in a range of about 25% to about 70% by weight.

2. Active Agents

Examples of active agents include dental bleaching agents, desensitizing agents, remineralizing agents, antimicrobial agents, antiplaque agents, anti-tartar agents, or other medicaments. Examples of dental bleaching agents include, but are not limited to, hydrogen peroxide (e.g., aqueous or complexed), carbamide peroxide, perborates, percarbonates, peroxides, chlorites, hypochlorites, peroxy acids, and peroxy acid salts.

If present, the bleaching agent is typically included in an amount in a range of about 5% to about 80% by weight of the treatment composition, preferably in a range of about 10% to about 70% by weight, more preferably in a range of about 15% to about 60% by weight, and most preferably in a range of about 20% to about 50% by weight.

Examples of desensitizing agents include potassium nitrate, other potassium salts, citric acid, citrates, and sodium fluoride. Examples of remineralizing agents include sodium fluoride, stannous fluoride, sodium monofluorophosphate, and other fluoride salts. Examples of antimicrobial agents include chlorhexidine, triclosan, and tetracycline. Examples of antiplaque and anti-tartar agents include pyrophosphate salts.

3. Other Components

The dental treatment composition may include other components as desired to yield a final composition having desired properties. Examples of other components include, but are not limited to, plasticizers, humectants and non- volatile solvents (e.g., glycerin, sorbitol, and polyethylene glycol), volatile solvents (e.g., water and alcohols, such as ethanol), bleaching agent stabilizers (e.g., EDTA and alkyl sulfates), bleaching agent activators (e.g., metals and metal compounds) neutralizing agents (e.g., sodium hydroxide and triethanolamine), particulate thickening agents (e.g. , fumed silica, aluminum oxide), flavorants, sweeteners, and the like.

C. Characteristics of Dental Treatment Devices

Dental treatment devices as disclosed herein have a thickened occlusal wall, a thinner labial wall, and optionally a thinner lingual wall. In generally, the occlusal wall extends laterally from the labial wall, and the optional lingual wall extends laterally from the occlusal wall. Dental treatment devices include a barrier layer having a labial wall configured to lie adjacent to labial tooth surfaces, an occlusal wall configured to lie adjacent to occlusal tooth surfaces, and optionally a lingual wall configured to lie adjacent to lingual tooth surfaces when the dental treatment device is placed over a person's dental arch.

The labial wall has a labial wall thickness that is preferably in a range of about 0.001 " to about 0.015", more preferably in a range of about 0.002" to about 0.01 ", and most preferably in a range of about 0.004" to about 0.008".

The occlusal wall has an occlusal wall thickness that is preferably in a range of about 0.002" to about 0.04", more preferably in a range of about 0.005" to about 0.025", and most preferably in a range of about 0.008" to about 0.015".

When included, the optional lingual wall has a lingual wall thickness that is preferably in a range of about 0.001 " to about 0.015", more preferably in a range of about 0.002" to about 0.01 ", and most preferably in a range of about 0.004" to about 0.008".

The occlusal wall has an occlusal wall thickness that is at least about 10% greater than the labial wall thickness and/or the lingual wall thickness (when included), preferably at least about 20% greater, more preferably at least about 30% greater, even more preferably at least about 40% greater, and most preferably at least about 50% greater (e.g., preferably about 1.5-3 times greater, more preferably about 1.5-3 times greater). In some cases, the occlusal wall thickness may be at least about 75% or even 100% greater than the labial and/or lingual wall thicknesses.

Dental treatment devices may also include one or more anatomical features that help enhance fit over a person's dental arch: (1 ) the bottom wall includes at least one V-shaped or U-shaped protrusion configured to be inserted into depressions typically found along the surfaces of a person's posterior teeth (e.g., bicuspids and molars); (2) the labial wall has a curvature that corresponds or is exaggerated relative to the curvature of the facial surfaces of at least a portion of a person's teeth and/or skeletal maxilla or alveolar ridge; (3) a plurality of slots or cuts in the bottom wall better to account for and better conform to abrupt changes in the diameters of a person's teeth, particularly where the bicuspids and canines meet; and (4) radii of curvature that account for typical flaring of a patient's incisors.

Notwithstanding the inclusion of one or more anatomical features that approximate the shape of a person's dental arch, the dental treatment devices shown in the Figures are non-customized so as to be devoid of structures corresponding to the specific size and shape of a person's unique dentition so that the dental trays are designed to fit over a plurality of differently-sized dental arches corresponding to different people. The treatment devices are advantageously flexible and highly adaptable so as to readily conform to a wide variety of differently-sized teeth and dental arches.

Reference is now made the drawings. Figures 1 A and IB illustrate a conventional non-custom dental treatment device or tray having a substantially constant cross-sectional thickness. Figure 1A is a perspective view of a dental treatment device 100 comprising a flexible barrier layer 102 having a generally horseshoe shaped configuration defined by a labial wall 104, an occlusal wall 106 extending laterally (e.g., lingually) from labial wall 104, and a lingual wall 108 extending laterally (e.g. , occlusally-gingivally) from occlusal wall 106. Labial wall 104, occlusal wall 106, and lingual wall 108 together define a trough 110 having a generally U-shaped cross section.

Figure IB is a cross-section view of dental treatment device 100 of Figure 1A taken along line I B— I B. Labial wall 104, occlusal wall 106, and lingual wall 108 all have a substantially continuous wall thickness 1 12.

Figures 2A and 2B illustrate an exemplary non-custom dental treatment device or tray having a thickened occlusal wall and thinner labial and lingual walls. Figure 2A is a perspective view of a dental treatment device 200 comprising a flexible barrier layer 202 having a generally horseshoe shaped configuration defined by a labial wall 204, an occlusal wall 206 extending laterally (e.g., lingually) from labial wall 204, and a lingual wall 208 extending laterally (e.g., occlusally-gingivally) from occlusal wall 206. Labial wall 204, occlusal wall 206, and lingual wall 208 together define a trough 210 having a generally U-shaped cross section.

Figure 2B is a cross-section view of dental treatment device 200 of Figure 2A taken along line 2B— 2B that schematically illustrates the relative cross-sectional thicknesses 212 of labial wall 204, occlusal wall 206, and lingual wall 208. Labial wall 204 has a labial wall thickness 212a, occlusal wall 206 has an occlusal wall thickness 212b, and lingual wall 208 has a lingual wall thickness 212c. As discussed above, labial wall thickness 212a and/or lingual wall thickness 212c can be in a range of about 0.001 " to about 0.01 ", about 0.002" to about 0.008", or about 0.004" to about 0.007". Occlusal wall thickness 212b can be in a range of about 0.002" to about 0.04", about 0.005" to about 0.025", or about 0.008" to about 0.015" and be at least about 25%, 30%, 40%, 50%, 75% or 100% greater than the labial and/or lingual wall thickness 212a, 212c.

Figures 3A and 3B illustrate an exemplary pre-filled non-custom dental treatment device or tray with a barrier layer having a thickened occlusal wall and thinner labial and lingual walls. Figure 3A is a perspective view of pre-filled dental treatment device 300 including a flexible barrier layer 302 having a generally horseshoe shaped configuration defined by a labial wall 304, an occlusal wall 306 extending laterally (e.g., lingually) from labial wall 304, and a lingual wall 308 extending laterally (e.g. , occlusally-gingivally) from occlusal wall 306. Labial wall 304, occlusal wall 306, and lingual wall 308 together define a trough 310 having a generally U-shaped cross section and that holds dental treatment composition 314 therein. According to one embodiment, dental treatment composition 314 can be a bead of gel or viscous putty.

Figure 3R is a cross-section view of pre-filled dental treatment device 300 of Figure 3A taken along line 3B— 3B that schematically illustrates the relative cross- sectional thicknesses 312 of labial wall 304, occlusal wall 306, and lingual wall 308. Labial wall 304 has a labial wall thickness 312a, occlusal wall 306 has an occlusal wall thickness 312b, and lingual wall 308 has a lingual wall thickness 312c. Labial wall thickness 312a, occlusal wall thickness 312b, and lingual wall thickness 312c can be as described herein.

Figures 4A and 4B illustrate an exemplary pre-filled non-custom dental treatment device or tray with a barrier layer having a thickened occlusal wall and thinner labial and lingual walls. Figure 4A is a perspective view of pre-filled dental treatment device 400 including a flexible barrier layer 402 having a generally horseshoe shaped configuration defined by a labial wall 404, an occlusal wall 406 extending laterally (e.g., lingually) from labial wall 404, and a lingual wall 408 extending laterally (e.g., occlusally-gingivally) from occlusal wall 406. Labial wall 404, occlusal wall 406, and lingual wall 408 together define a trough 410 having a generally U-shaped cross section and that holds dental treatment composition 414 therein. According to one embodiment, dental treatment composition 414 can be substantially solid and/or initially dry to the touch but become more adhesive to teeth and/or gums when moistened with saliva or water.

Figure 4B is a cross-section view of pre-filled dental treatment device 400 of

Figure 4A taken along line 4B— 4B that schematically illustrates the relative cross- sectional thicknesses 412 of labial wall 404, occlusal wall 406, and lingual wall 408. Labial wall 404 has a labial wall thickness 412a, occlusal wall 406 has an occlusal wall thickness 412b, and lingual wall 408 has a lingual wall thickness 412c. Labial wall thickness 412a, occlusal wall thickness 412b, and lingual wall thickness 412c can be as described herein.

Figures 5A and 5B illustrate an exemplary non-custom dental treatment device or tray having a thickened occlusal wall with a V-shaped protrusion and thinner labial and lingual walls. Figure 5A is a perspective view of a dental treatment device 500 comprising a flexible barrier layer 502 having a generally horseshoe shaped configuration defined by a labial wall 504, an occlusal wall 506 extending laterally (e.g., lingually) from labial wall 504, and a lingual wall 508 extending laterally (e.g. , occlusally-gingivally) from occlusal wall 506. Labial wall 504, occlusal wall 506, and lingual wall 508 together define a trough 510 for receiving a dental treatment composition. Trough is further defined by a non-customized V-shaped protrusion 516 formed in occlusal wall 506, which is included in order to enhance fit between occlusal wall 506 and indentations naturally found in posterior teeth (i.e. , bicuspids and molars).

Figure 5B is a cross-section view of dental treatment device 500 of Figure 5A taken along line 5B— 5B that schematically illustrates the relative cross-sectional thicknesses 512 of labial wall 504, occlusal wall 506, and lingual wall 508 as well as V-shaped protrusion 516 formed by occlusal wall 506. Labial wall 504 has a labial wall thickness 512a, occlusal wall 506 has an occlusal wall thickness 512b, and lingual wall 508 has a lingual wall thickness 512c. Labial wall thickness 512a and/or lingual wall thickness 512c can be in a range of about 0.001 " to about 0.01 ", about 0.002" to about 0.008", or about 0.004" to about 0.007". Occlusal wall thickness 512b can be in a range of about 0.002" to about 0.04", about 0.005" to about 0.025", or about 0.008" to about 0.015" and be at least about 25%, 30%, 40%, 50%, 75% or 100% greater than the labial and/or lingual wall thickness 512a, 512c.

Figures 6A and 6B illustrate an exemplary non-custom dental treatment device or tray having a thickened occlusal wall with thinner labial and lingual walls that define a generally V-shaped trough. Figure 6A is a perspective view of a dental treatment device 600 comprising a flexible barrier layer 602 having a generally horseshoe shaped configuration defined by a labial wall 604, an occlusal wall 606 extending laterally (e.g., lingually) from labial wall 604, and a lingual wall 608 extending laterally (e.g. , occlusally-gingivally) from occlusal wall 606. Labial wall 604, occlusal wall 606, and lingual wall 608 together define a generally V-shaped trough 610 for receiving a dental treatment composition.

Figure 6B is a cross-section view of dental treatment device 600 of Figure 6A taken along line 6B— 6B that schematically illustrates the relative cross-sectional thicknesses 612 of labial wall 604, occlusal wall 606, and lingual wall 608. Labial wall 604 has a labial wall thickness 612a, occlusal wall 706 has an occlusal wall thickness 612b, and lingual wall 608 has a lingual wall thickness 612c. Labial wall thickness 612a, occlusal wall thickness 612b, and lingual wall thickness 612c can be as described herein.

Figures 7A and 7B illustrate exemplary pre-packaged dental treatment systems

700, 710. The pre-packaged dental treatment system 700 of Figure 7A includes a pre- filled dental treatment device 702 having a dental treatment composition 704 preloaded therein. A package backing 706 supports pre-filled dental treatment device 702, and removable cover 708 seals and protects pre-filled dental treatment device 702, including dental treatment composition 704, prior to use.

The pre-packaged dental treatment system 710 of Figure 7B includes a pre- filled dental treatment device 712 having a dental treatment composition 714 preloaded therein. The dental treatment device 712 further includes a V-shaped protrusion 715 to enhance fit between the occlusal wall of treatment device 712 and indentations naturally found in posterior teeth (i.e., bicuspids arid molars). A package backing 716 supports pre-filled dental treatment device 712, and removable cover 718 seals and protects pre-filled dental treatment device 712, including dental treatment composition 714, prior to use.

Figures 8A and 8B illustrate exemplary non-custom dental treatment devices or trays having a thickened occlusal wall with thinner labial and lingual walls. Figure 8 A illustrates a dental treatment device or barrier 800 comprising a labial wall 804, a thickened occlusal wall 806 extending laterally (e.g., lingually) from labial wall 804, and a lingual wall 808 extending laterally (e.g., occlusally-gingivally) from occlusal wall 806. Dental treatment device or barrier 800 is shown installed over a tooth 820, with a dental treatment composition 814 positioned between dental treatment device or barrier 800 and tooth 820. Occlusal wall 806 includes a V-shaped protrusion 816 to better approximate the anatomy of tooth 820, particularly with respect to recess 822 in an occlusal surface 824 of tooth 820. The V-shaped protrusion 816 provides closer proximity between occlusal wall 806 and occlusal surface 824 of tooth 820. When a user closes his/her mouth and brings posterior teeth in close contact, pressure between opposing occlusal tooth surfaces of corresponding teeth is less likely to move dental treatment device or barrier 800 out of proper position relative to tooth 820 (e.g., as a result of occlusal wall 806 being pushed more deeply into recess 822 so as to pull labial wall 804 and/or lingual wall 808 downward relative to tooth 820).

Figure 8B illustrates a dental treatment device or barrier 840 comprising a labial wall 844, a thickened occlusal wall 846 extending laterally (e.g., lingually) from labial wall 844, and a lingual wall 848 extending laterally (e.g., occlusally-gingivally) from occlusal wall 846. Dental treatment device or barrier 840 is shown installed over a tooth 860, with a dental treatment composition 854 positioned between dental treatment device or barrier 840 and tooth 860. Thickened occlusal wall 846 has a thicker cross section than labial wall 844 and lingual wall 848 to provide greater stiffness and durability in the vicinity of occlusal edge or surface 864 of tooth 860. The greater stiffness and durability of occlusal wall 846 resists deformation when occlusal edge or surface 864 of tooth 860 makes contact with a secondary surface, such as an opposing occlusal edge of a corresponding tooth or an object placed in a person's mouth. When a user closes his/her mouth and brings anterior teeth in close contact, pressure between opposing occlusal tooth surfaces or edges of corresponding teeth is less likely to move dental treatment device or barrier 840 out of proper position relative to tooth 860 as a result of the greater stiffness and durability of occlusal wall 846.

Figure 9 illustrates a dental treatment device or barrier 900 comprising a labial wall 904, a thickened occlusal wall 906 extending laterally (e.g., lingually) from labial wall 904, and a lingual wall 908 extending laterally (e.g., occlusally-gingivally) from occlusal wall 906. Dental treatment device or barrier 900 is shown installed over a tooth 920, with a dental treatment composition 914 positioned between dental treatment device or barrier 900 and tooth 920. Labial wall 904 has an enhanced curvature that better approximates the anatomy of tooth 920, particularly with respect to the curvature of facial surface 926 of tooth 920. The enhanced curvature of labial wall 904 provides closer proximity and better fit between labial wall 904 and facial surface 926 of tooth 920. This, in turn, helps retain dental treatment device 900 in proper position relative to tooth 920 and resist dislodgement or slippage of treatment device 900 that may otherwise result from compressive and/or lateral forces applied to labial wall 904 during use (e.g., by a person's lip or cheek).

Alternatively, the non-custom dental treatment device can have the labial wall that extends beyond the gingival margin and have a curvature at least partially corresponding to a curvature of a labial surface of the skeletal maxilla or alveolar ridge so as to improve fit between the dental treatment device and a person's dental arch when worn.

HI. EXEMPLARY METHODS OF MAKING DENTAL TREATMENT DEVICES

According to an exemplary method of manufacturing a dental treatment device, an appropriate polymeric or other material is shaped in the form of a barrier layer as described herein. This may be performed by injection molding a flowable thermoplastic or thermosetting material using a mold, causing or permitting the flowable material to cool, cure or otherwise harden, and removing the molded barrier layer from the mold. Alternatively, dental treatment devices can be formed from a sheet material that is vacuum formed or otherwise pressed or formed into a desired shape of a barrier layer. In either case, the mold form can form a cavity corresponding to a thickened occlusal wall and thinner labial and/or lingual walls of desired dimensions.

In the case of a pre-filled dental treatment device, a dental treatment composition is placed on a tooth-facing surface of the barrier layer, either prior to, during, or after shaping the barrier layer in a desired shape. In the case of a sticky viscous gel or highly viscous putty, the dental treatment composition is advantageously placed adjacent to the tooth-facing surface of the barrier layer after the barrier layer has assumed the desired shape. In the case of a substantially solid composition, a flowable intermediate composition can be placed adjacent to the tooth- facing surface of the barrier layer, either before, during or after the barrier layer has assumed the desired shape and heated to remove volatile solvent, cooled to harden a thermoplastic composition, or otherwise caused to form a substantially solid composition.

IV. EXEMPLARY METHODS OF USING DENTAL TREATMENT DEVICES

Dental treatment devices as disclosed herein can be worn for any desired time period. Increasing the concentration of active agent in the treatment composition(s) generally reduces the time required to effect a desired treatment. Nevertheless, due to the comfortable and reliable fit between the dental treatment devices and the person's teeth, it may be possible to wear such devices for extended periods of time in order to ensure more complete treatment. When dental treatment devices include a substantially solid composition, they may be worn while performing normal daily activities, such as talking, eating, drinking, smoking, coughing, smiling, frowning, grimacing, or while sleeping. This greatly decreases their intrusiveness into everyday activities compared to conventional treatment strips, which do not reliably adhere to and remain over teeth, or intrusive treatment devices such as large, bulky custom- fitted dental appliances.

Dental treatment devices may be worn over a person's upper dental arch, lower dental arch, or both simultaneously. The ability to reliably and comfortably wear dental treatment devices over the upper and lower dental arches simultaneously is another departure from treatment strips, which are not recommended for use in treating the upper and lower dental arches simultaneously.

V. DENTAL TREATMENT KITS

For convenience of use, multiple dental treatment devices may be packaged together and sold as a kit. In one embodiment, the number of treatment devices provided with each kit can equal the number of sessions that represent a prescribed bleaching regimen. To efficiently utilize space within a kit package, multiple dental treatment devices can be stacked or nested together.

It is within the scope of the disclosure to provide exoskeletons, barrier layers, gel or putty treatment compositions, and/or adhesive compositions that are initially separate and then brought together by the end user. For example, one or more flowable treatment compositions can be stored in and then dispensed from one or more syringes onto a tooth- facing surface of a barrier layer by a user just prior to use.

Alternatively, kits may include multiple pre-filled dental treatment devices that are preloaded with one or more types of dental treatment composition.

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

What is claimed is:

Claims

1. A non-custom dental treatment device for placement over at least a portion of a person's dental arch during treatment of a person's teeth and/or gums, comprising:

a non-customized barrier layer formed from a moisture-resistant or semi-moisture resistant material and having a generally horseshoe-shaped configuration so as to substantially correspond to the curvature of a person's dental arch and being substantially devoid of structures corresponding to the size and shape of a person's unique dentition so as to be adaptable to and comfortably fit over a plurality of differently-sized dental arches corresponding to different people, the barrier layer comprising:

a labial wall configured to lie adjacent to labial tooth surfaces when the dental treatment device is placed over a person's dental arch, the labial wall having a wall thickness in a range of about 0.001" to about 0.015"; and

an occlusal wall, extending laterally from the labial wall, configured to lie adjacent to occlusal tooth surfaces when the dental treatment device is placed over a person's dental arch, the occlusal wall having a wall thickness in a range of about 0.002" to about 0.04" and that is at least about 10% greater than the labial wall thickness.

2. A non-custom dental treatment device as in claim 1, wherein the moisture-resistant material comprises a polymeric material.

3. A non-custom dental treatment device as in claim 2, wherein the polymeric material comprises at least one member selected from the group consisting of polyolefins, ethylene-vinyl acetate copolymer (EVA), ethylene-vinyl alcohol copolymer (EVAL), polypropylene (PP), high density polyethylene (HDPE), low density polyethylene (LDPE), ultra low density polyethylene (ULDPE), polytetrafluoroethylene (PTFE), polycaprolactone (PCL), polyvinyl chloride (PVC), polyesters, polyethylene terephthalate (PET), polycarbonates, polyamides, polyurethanes, and polyesteramides.

4. A non-custom dental treatment device as in claim 2, further comprising at least one of a plasticizer, flow additive, or filler selected so as to modify at least one property of the polymeric material.

5. A non-custom dental treatment device as in claim 1, wherein the moisture-resistant material comprises a blend of wax and polymer material that modifies the wax so as to yield a flexible and highly adaptable barrier layer.

6. A non-custom dental treatment device as in claim 5, wherein the polymer material comprises polyolefin.

7. A non-custom dental treatment device as in claim 1 , wherein the moisture-resistant or semi-moisture resistant material comprises a blend of materials that enables plastic deformation of the barrier layer with little to no elastic memory.

8. A non-custom dental treatment device as in claim 1, the barrier layer further comprising a lingual wall, extending laterally from the occlusal wall, configured to lie adjacent to lingual tooth surfaces when the dental treatment device is placed over a person's dental arch, the lingual wall having a wall thickness in a range of about 0.001" to about 0.015".

9. A non-custom dental treatment device as in claim 1 or 8, the labial wall and/or lingual wall having a wall thickness in a range of about 0.002" to about 0.01 ".

10. A non-custom dental treatment device as in claim 1 or 8, the labial wall and/or lingual wall having a wall thickness in a range of about 0.004" to about 0.008".

11. A non-custom dental treatment device as in claim 1 or 8, the occlusal wall having a wall thickness in a range of about 0.005" to about 0.025".

12. A non-custom dental treatment device as in claim 1 or 8, the occlusal wall having a wall thickness in a range of about 0.008" to about 0.015".

13. A non-custom dental treatment device as in claim 1 or 8, wherein the occlusal wall thickness is at least about 20% greater than the labial wall thickness and/or the lingual wall thickness.

14. A non-custom dental treatment device as in claim 1 or 8, wherein the occlusal wall thickness is at least about 30% greater than the labial wall thickness and/or the lingual wall thickness.

15. A non-custom dental treatment device as in claim 1 or 8, wherein the occlusal wall thickness is at least about 40% greater than the labial wall thickness and/or the lingual wall thickness.

16. A non-custom dental treatment device as in claim 1 or 8, wherein the occlusal wall thickness is at least about 50% greater than the labial wall thickness and/ or the lingual wall thickness .

17. A non-custom dental treatment device as in claim 1 , the occlusal wall including at least one V-shaped or U-shaped protrusion configured to fit into depressions in a plurality of adjacent posterior teeth so as to improve fit between the dental treatment device and a person's dental arch when worn.

18. A non-custom dental treatment device as in claim 1 , the occlusal wall including a V-shaped or U-shaped protrusion in each hemisphere of the horseshoe- shaped barrier layer that extends continuously along a length of said hemisphere so as to span a plurality of depressions in adjacent posterior teeth when the dental treatment device is worn.

19. A non-custom dental treatment device as in claim 1 , the labial wall having a curvature at least partially corresponding to a facial curvature of labial tooth surfaces and/or to a curvature of a labial surface of the skeletal maxilla or alveolar ridge so as to improve fit between the dental treatment device and a person's dental arch when worn.

20. A non-custom dental treatment device as in claim 1, wherein the barrier layer is thin and flexible so as to be highly adaptable and readily conformable to a plurality of differently-sized dental arches corresponding to different people when worn.

21. A non-custom dental treatment device as in claim 1 , further comprising a dental treatment composition positioned on a tooth-facing surface of the barrier layer.

22. A non-custom dental treatment device as in claim 21 , further comprising an additional quantity of an oral treatment composition on an exterior surface of barrier layer.

23. A non-custom dental treatment device as in claim 21, the dental treatment composition comprising a dental bleaching composition.

24. A non-custom dental treatment device as in claim 21, the dental treatment composition comprising at least one active agent and at least one tissue adhesion agent

25. A non-custom dental treatment device as in claim 24, the at least one active agent being selected from the group consisting of bleaching agents, desensitizing agents, remineralizing agents, antimicrobial agents, antiplaque agents, anti-tartar agents, and mixtures thereof.

26. A non-custom dental treatment device as in claim 24, the tissue adhesion agent comprising at least one member selected from the group comprising polyvinyl pyrrolidones, carboxypolymethylene, polyethylene oxides, polyacrylic acids, copolymers of polyacrylic acid, polyacrylates, polyacrylamides, copolymers of polyacrylic acid, polysaccharide gums, proteins, PVP-vinyl acetate copolymers, carboxymethylcellulose, carboxypropylcellulose, and polyacrylamide.

27. A non-custom dental treatment device as in claim 24, the dental treatment composition being a sticky viscous gel.

28. A non-custom dental treatment device as in claim 24, the dental treatment composition being a highly viscous putty.

29. A non-custom dental treatment device as in claim 24, the dental treatment composition being a substantially solid composition having increased adhesiveness to teeth when contacted with water or saliva.

30. A non-custom dental treatment device as in claim 29, wherein the substantially solid composition does not stick on its own to a dry surface.

31. A non-custom dental treatment device as in any of claims 21 to 30, the dental treatment device being contained within a sealed package prior to use.

32. A non-custom dental treatment device for placement over at least a portion of a person's dental arch during treatment of a person's teeth and/or gums, comprising:

a non-customized barrier layer having a generally horseshoe-shaped configuration so as to substantially correspond to the curvature of a person's dental arch and being substantially devoid of structures corresponding to the size and shape of a person's unique dentition so as to be adaptable to and comfortably fit over a plurality of differently-sized dental arches corresponding to different people, the barrier layer comprising:

a lingual wall configured to lie adjacent to lingual tooth surfaces when the dental treatment device is placed over a person's dental arch, the lingual wall having a wall thickness in a range of about

0.001 " to about 0.015"; and

an occlusal wall, extending between the labial wall and the lingual wall, configured to lie adjacent to occlusal tooth surfaces when the dental treatment device is placed over a person's dental arch, the occlusal wall having a wall thickness in a range of about 0.002" to about 0.04" and that is at least about 10% greater than the labial wall thickness and/or the lingual wall thickness.

33. A non-custom dental treatment device as in claim 32, further comprising a dental treatment composition positioned on a tooth-facing surface of the barrier layer and optionally oral treatment composition on an exterior surface of the barrier layer.

34. A kit for use in treating a person's teeth and/or gums, comprising: at least one non-customized dental treatment device as in any one of claims 1 to 20 or 32; and

at least one dental treatment composition initially separate from the at least one non-custom dental treatment device.

35. A pre-filled dental treatment device for use in treating a person's teeth and/or gums, comprising:

a dental treatment device as in any one of claims 1 to 20 or 32; and a dental treatment composition adjacent to a lingual surface of the barrier layer.

36. A method of treating a person's teeth and/or gums, comprising:

providing a dental treatment device as in any one of claims 1 to 20 or

32;

placing a dental treatment composition adjacent to a lingual surface of the barrier layer; and

positioning the dental treatment device over a person's dental arch in order for the dental treatment composition to contact at least one of a person's teeth or gums.

37. A method as in claim 36, the dental treatment composition being placed adjacent to a lingual surface of the barrier layer by a dental practitioner.

38. A method as in claim 36, the dental treatment composition being placed adjacent to a lingual surface of the barrier layer by a patient.

39. A method of treating a person's teeth and/or gums, comprising:

providing a dental treatment device as in any one of claims 21 to 30 or

33; and