Compositions, systems, and methods for oral administration

Abstract

The present disclosure relates to oral delivery compositions that transition from a flowable state to a hardened or semi-hardened state. The flowable hardenable composition may be delivered to oral tissues, including teeth and / or gums, directly or using a barrier strip or tray-like device. The composition may be configured as a multi-part system to keep reactive materials (e.g., catalyst and reactive resin) separate until use. Dispersing a drug in a viscous carrier within the hardened composition allows for sustained release of the desired drug and reduces or eliminates sensitivity that may be caused by certain drugs (e.g., dental whitening agents). The hardened delivery composition may include an inverse image of the oral tissue, allowing for multiple removals and repositionings during a single use, giving the user versatility during treatment.

Description

[Technical field]

[0001] The present disclosure relates to compositions for oral delivery, and related systems and methods. The compositions may include a hardenable material in combination with a functional agent in a carrier, and may be introduced to any oral tissue, including teeth, gums, and / or cheek tissue, in a flowable state prior to hardening to a hardened state. [Background technology]

[0002] Delivery of therapeutic agents to oral tissues, including soft tissues and teeth, can be accomplished using a variety of systems, including mouthwashes, toothpastes, gels, varnishes, and tablets.

[0003] For example, cosmetic dental whitening products are traditionally provided by flowable gels using trays or disposable strips. Such whitening gels are often sticky and typically require cleaning of the teeth after use. If reusable custom trays are used to apply the product to the teeth, the trays must also be cleaned after use. Furthermore, if the tray (custom or non-custom) fits poorly, the user may experience discomfort during the treatment process and the whitening gel may spill from the tray onto the user's gums or other soft oral tissues, exacerbating the discomfort. This discomfort may last for several days. These issues can make the product inconvenient to use and inhibit compliance for some users.

[0004] Some whitening systems, such as disposable strips, are relatively easy to apply and can be purchased over the counter. However, in many cases, these systems have a relatively low concentration of whitening ingredients and are intended for short-term, one-time use only. The use of strips brings with it drawbacks, such as the need for a longer whitening program with more use and frequency. Also, even after whitening with the whitening strips, residue may remain on the teeth, and the teeth still need to be cleaned after removing the strips. Also, disposable strips may slip during one use. This may expose the user's gums to the whitening agent (typically peroxide), which may lead to increased gum sensitivity. Also, the shedding of the strips means that the teeth are not optimally whitened, which is the purpose of using the strips.

[0005] Treatment of gum disorders such as periodontal pockets may be accomplished using mouthwashes or dissolvable intra-pocket devices that are placed in the periodontal pockets, however, mouthwashes may not reach the pockets effectively and intra-pocket devices may cause discomfort and dissolve before an effective treatment time has been reached. Summary of the Invention [Problem to be solved by the invention]

[0006] Ultimately, the main obstacle to successful delivery of drugs to oral tissues is the inability of the user to properly complete a given treatment plan. If the treatment device is uncomfortable to wear, difficult to use and wear, and / or prone to early dislodging from the user's teeth, the user may simply give up and prematurely discontinue the given treatment plan. Thus, even if a dental treatment is possible using a particular treatment device or treatment method, if the inadequacy of the treatment device or treatment method causes the user to lose interest before the desired result is obtained, the dental treatment is less likely to be properly completed. [Means for solving the problem]

[0007] The present disclosure relates to improved compositions and systems for delivering functional agents to teeth and / or oral tissues for oral delivery that overcome the aforementioned shortcomings of conventional devices and provide for simple, fast, inexpensive, uniform, and reusable application.

[0008] Typically, the composition includes a fluid or viscous carrier for the functional agent, such as a water-soluble polymeric carrier, dispersed in a hardening or curing system, such as an elastomeric impression material (e.g., polyvinyl siloxane) and a curable resin system (e.g., acrylates, methacrylates, epoxies, and polyurethanes). For example, the treatment composition may be a multi-part (e.g., two-part) composition, where one part includes one or more functional agents and one or more catalysts and / or initiators, and the other part includes a reactive component, such as, for example, a silicone-based condensation chemistry or reactive monomer.

[0009] Storing the catalyst with the functional agent (e.g., dental whitening agent, tooth desensitizing agent, and / or oral treatment agent) and isolating the catalyst or initiator from the reactive hardenable components is a new way to prevent premature hardening and thus maintain the stability of these components. For example, the compositions of the present invention can maintain stability for several months to a year or more. In some embodiments, the whitening agent is included with a viscous carrier material. Dispersing the functional agent in the carrier material facilitates the movement of the agent in the composition after hardening, thereby allowing for efficient delivery of the agent to the desired tissue. The functional agent and carrier material may be mixed before combining with the agent so that at least a portion of the agent remains dispersed in the carrier material in the composition.

[0010] In use, when the components in the hardenable material are mixed, they undergo a curing or setting process (e.g., a chemical or physical hardening process). For example, the material may include a reactive resin that crosslinks in the presence of a catalyst or initiator and / or moisture to initiate hardening. In a multi-part system, the reactive resin may be kept isolated from the catalyst. Advantageously, each part of the multi-part system may be fluid to facilitate mixing to form the hardenable treatment material. Once formed, the hardenable material may remain fluid for a sufficient time for delivery to the teeth and / or soft oral tissues. Advantageously, in this manner, the hardenable composition becomes a single solid or semi-solid coherent mass after the two parts are mixed and allowed sufficient time to cure and / or harden.

[0011] The disclosed compositions, methods, and systems provide oral and dental care products that are at least as stable and effective as conventional products, while being more convenient and comfortable to use. In some embodiments, the oral or dental compositions are formed as gels that undergo a chemical curing process after mixing and application to oral tissues, which transform into elastomeric solids. In some embodiments, the compositions can be applied directly to teeth or other oral tissues. In other embodiments, the gel may be placed in or on a support or delivery device, such as a backing strip or a tray-like device, before curing. Such a tray-like device may be a conventional dental whitening tray, which may be custom or non-custom. The delivery device with the gel placed on it may be placed on the oral tissues of the user, such as the teeth and / or dental arch. The gel may be cured into an elastomer that has an impression or impression of the portions of the user's teeth and / or dental arch that are in contact with the gel. For example, the elastomer may be a translucent or transparent film that includes a reverse image of the user's dentition and / or dental arch. Advantageously, the hardened elastomeric gel can be removed and reapplied multiple times during a single use, providing great versatility to the user during dental procedures.

[0012] For example, the curing or hardening behavior of the treatment gel may be achieved using two-part condensation cure silicone chemistry. In the presence of water and a catalyst or initiator, the reactive silicone material present in the treatment composition undergoes hydrolysis and initiates crosslinking, which transforms the gel component into an elastomeric solid.

[0013] A non-limiting exemplary formulation of a silicone-based cured delivery composition is as follows: Part A: A silanol-terminated silicone polymer (eg, a hydroxy-terminated polydimethylsiloxane), a functional silane (eg, a silicate ester), and optional additives (eg, fillers, surfactants, etc.). Part B: Condensation catalysts (e.g., organotin compounds), functional or treatment agents (e.g., dental whitening agents, desensitizing agents, and remineralizing agents, and / or periodontal treatment agents), carrier materials (e.g., polyacrylic acid, polyvinylpyrrolidone, etc.), additives (e.g., fillers, surfactants, etc.).

[0014] The blending of the multiple parts of the multi-part composition may play an important role in maintaining a viable and stable product. It has been demonstrated that isolating the reactive materials (i.e., silicone polymer and crosslinker) from the catalyst or initiator prevents premature hardening of the composition, allowing for long-term storage and subsequent use. For example, part A and part B of the exemplary blend above can be blended as a flowable composition, and the two can be easily mixed to form a flowable gel-like composition. Part A can be mixed with part B to initiate the hardening reaction, converting the flowable gel composition into a hardened treatment composition (which is advantageously still flexible and elastic). The two parts can be loaded into a delivery system that includes two chambers, such as, for example, a dual-barrel syringe (e.g., parallel or concentric). The two parts can be squeezed through a mixing tip to mix the components together and produce a gel in which the treatment and carrier materials are substantially homogenously distributed throughout the reaction chemistry.

[0015] In the uncured or partially uncured state, the mixture is flowable and may be applied directly to oral tissues or may be applied to teeth or other oral tissues using a delivery device such as a backing, oral treatment appliance, or dental treatment tray. In use, a dental tray containing the uncured or partially uncured mixture is placed over the teeth (and optionally the gum tissue) or an oral strip carrying the uncured or partially uncured mixture is placed over the teeth and / or other oral tissue areas and the gel is allowed to harden. As the reactive components in the composition cure to a cured state, the elastomeric material forms a reverse image or impression of the location where it was applied. When removed, the cured composition reflects and maintains the shape of the teeth and / or surrounding tissues in a manner similar to dental silicone impression materials. The elastomeric behavior of the cured composition allows the user to remove it easily and cleanly, leaving little residue, and subsequently reapply it to the application site to resume treatment (e.g., cosmetic tooth whitening, tooth desensitization, or gum treatment) at a later date. The cured compositions typically deform upon removal and / or reapplication, but because they are elastomeric, they return to their original molded shape once the deforming force is removed.

[0016] The hardenable or hardened treatment composition allows for the sustained release of functional or treatment agents from the combined silicone and polymer system, compared to conventional oral treatment compositions such as desensitizing or whitening gels. The sustained release of such agents allows for a reduction in sensitivity, such as sensitivity caused by dental whitening agents (such as peroxides), by reducing the amount and / or concentration of whitening agent that contacts the teeth and the surrounding soft oral tissues at a given time, while at the same time extending the time that the whitening agent remains active. The sustained release of these and other agents, such as potassium nitrate or fluoride dental desensitizing agents, provides improved results. The extended release of the agent also allows the user to temporarily remove the composition to perform activities such as eating or brushing, and then resume treatment using the same composition instead of using an additional amount of the composition.

[0017] Silicone-based chemistry is a non-limiting example of a polymer system that can be employed in the present invention. Other curable chemistries can also be used. For example, the formulation of a curable methacrylate delivery composition is as follows: Part A: Methacrylate resins, and optional additives (e.g., amine synergists, photoactivatable initiators, fillers, surfactants, etc.) Part B: Polymerization initiators (e.g., organic peroxide initiators), functional or treatment agents (e.g., dental whitening agents, desensitizing and remineralizing agents, and / or periodontal treatment agents), carrier materials (e.g., polyacrylic acid, polyvinylpyrrolidone, etc.), additives (e.g., fillers, surfactants, etc.).

[0018] Water-soluble polymers such as polyacrylic acid and / or polyvinylpyrrolidone can also be included as carrier materials. The carrier material can function as a thickener or rheology modifier and promote uniform mixing of the components of the system. Without the addition of a carrier material, the components containing both the treatment agent and the catalyst or initiator may not mix easily with the other components containing the siloxane material as desired to create a homogeneous and workable hardenable gel. Inefficient or incomplete mixing may be improved, especially when the treatment agent is a liquid, such as hydrogen peroxide. The addition of a carrier material that is more hydrophilic than the siloxane material can also improve the retention and sustained release of the treatment agent.

[0019] Advantageously, once hardened, the treatment agent is dispersed within the aggregate, providing a steady release of the agent to the tooth. To remove the hardened delivery material after a desired time, the user can simply grasp a corner or part of the applied composition or barrier material carrying the composition and pull it off the tooth. In general, the hardened delivery material typically peels off as a single cohesive piece, greatly simplifying removal compared to conventional dental treatment gels. Typically, little or no residual material is left attached to the user's teeth and tissues after removal. Also, the ability of the hardened delivery material to remain as a single cohesive piece of material allows it to be reapplied and reused.

[0020] In addition, advantageously, the multi-part composition may exhibit a lag time between initial contact and / or mixing and when the combined composition completes the setting process, such lag time providing the user with sufficient time to place the composition on the teeth and / or other oral tissues while it is in a dental tray or on a strip, while still in a flowable and manipulable state, allowing the user to press the mass against the teeth to form an impression before it fully hardens.

[0021] These and other objects 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.

[0022] This Summary is provided to introduce some concepts in a simplified form that are described later in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an indication of the scope of the claimed subject matter.

[0023] To further clarify the foregoing and other advantages and features of the present invention, the invention will now be more particularly described by reference to specific embodiments thereof which are illustrated in the accompanying drawings, it being understood that these drawings depict only exemplary embodiments of the invention and therefore are not to be considered as limiting its scope. The invention will now be described with further specificity and detail through the use of the accompanying drawings, in which: [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 is a perspective view of an embodiment of a dental delivery system including a dental tray having a hardenable whitening composition therein and configured to fit over at least a portion of an upper or lower dental arch. [Diagram 2] 2 illustrates an embodiment in which a hardenable whitening composition is applied to a dental tray to form the dental delivery system shown in FIG. 1. [Diagram 3] FIG. 1 illustrates the dental delivery system after it has been placed on the teeth of the dental arch to conform the hardenable whitening composition to the teeth. [Figure 4] FIG. 1 shows a dental delivery system utilizing a custom dental tray that has been placed over the teeth of a dental arch to conform the hardenable composition to the teeth of the dental arch. [Figure 5A] 1 is a cross-sectional view of a dental delivery system over a tooth. [Figure 5B] 1 is a cross-sectional view of a dental delivery system over a tooth. [Figure 6] FIG. 1 illustrates a dental delivery system having a hardened whitening composition. [Figure 7] FIG. 7 shows an example of a hardenable treatment composition being dispensed from a dual barrel mixing syringe onto a backing material. [Figure 8A] FIG. 13 illustrates an example of applying a hardenable treatment composition to oral tissues using a backing material to deliver one or more functional agents to the oral tissues. [Figure 8B]FIG. 13 illustrates an example of applying a hardenable treatment composition to oral tissues using a backing material to deliver one or more functional agents to the oral tissues. [Figure 8C] FIG. 13 illustrates an example of applying a hardenable treatment composition to oral tissues using a backing material to deliver one or more functional agents to the oral tissues. [Figure 9] FIG. 1 shows an example of application of the hardenable treatment composition to the gingival margin between the tooth and gum. [Figure 10] FIG. 1 illustrates examples of areas of oral soft tissue to which the hardenable treatment composition of the present disclosure may be applied. [Figure 11A] FIG. 1 illustrates an example of the hardening behavior and subsequent flexibility and resiliency of an exemplary two-component dental treatment composition. [Figure 11B] FIG. 1 illustrates an example of the hardening behavior and subsequent flexibility and resiliency of an exemplary two-component dental treatment composition. [Figure 11C] FIG. 1 illustrates an example of the hardening behavior and subsequent flexibility and resiliency of an exemplary two-component dental treatment composition. [Figure 12A] FIG. 1 illustrates an example of application of hardened whitening composition material to a user's teeth, removal, and reapplication to the user's teeth. [Figure 12B] FIG. 1 illustrates an example of application of hardened whitening composition material to a user's teeth, removal, and reapplication to the user's teeth. [Figure 12C] FIG. 1 illustrates an example of application of hardened whitening composition material to a user's teeth, removal, and reapplication to the user's teeth. [Figure 13A] FIG. 1 illustrates an example of application of hardened whitening composition material to a user's teeth, removal, and reapplication to the user's teeth. [Figure 13B] FIG. 1 illustrates an example of application of hardened whitening composition material to a user's teeth, removal, and reapplication to the user's teeth. [Figure 13C] FIG. 1 illustrates an example of application of hardened whitening composition material to a user's teeth, removal, and reapplication to the user's teeth. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] The present disclosure relates to hardening or curable oral treatment compositions suitable for use in delivering functional agents to oral tissues. The compositions may, for example, comprise a hardenable composition including at least one functional agent dispersed in a carrier material. The carrier material may be a polymer, a solvent, or a combination thereof. The hardening material used in the composition may be a curable or setting material, while the carrier material may be a material that maintains viscosity.

[0026] The disclosed compositions, methods, and systems provide versatile and convenient delivery of agents to oral tissues. As used herein, "oral tissue" means and includes tissues of the oral cavity, pharynx, and throat, including, but not limited to, teeth, gingiva (or gums), buccal tissue (e.g., cheek tissue), tongue, bone, blood vessels, nerves, and salivary glands. As a non-limiting example, the hardenable composition may be a chemically hardenable composition that includes multiple (e.g., two) parts, where the first part includes the functional agent(s) along with the catalyst, and the other part includes the remaining hardening chemicals. In some embodiments, storing the catalyst or initiator in combination with the functional agent and isolating the catalyst from the reactive materials and / or crosslinking agents is one example of an improved approach to maintain the stability of the components prior to mixing and hardening. In some embodiments, the treating agent is combined with a carrier material, such as a water-soluble polymer.

[0027] For example, the hardening or curing composition can be a cosmetic tooth whitening composition, oral desensitizing composition, or periodontal treatment composition that is at least as stable and effective as conventional products, while at the same time being more versatile and convenient. Specifically, the disclosed hardenable compositions improve ease of use by reducing or eliminating cleanup and user errors, providing a more comfortable use experience, and allowing reuse of the composition once hardened. Such advantages promote compliance with a prescribed treatment regimen. In comparison, conventional whitening, desensitizing, and periodontal treatment agents are generally non-curable, non-hardening gels that include a treatment agent dispersed in a viscous carrier. In contrast, the invention disclosed herein relates to treatment compositions that undergo a curing or setting process to transform into a solid or semi-solid material after mixing and application to teeth and / or other oral tissue(s). The treatment composition can be directly contacted to the oral tissue or teeth as such, or can be contacted by a carrier such as a tray-like device before hardening. The hardened treatment composition also allows for removal and reapplication one or more times during a single use cycle, providing the user with versatility during dental treatment without wasting treatment material and having to reposition new treatment composition, as is the case when using conventional treatment gels.

[0028] As used herein, the terms "harden" and "hardening" may indicate that a viscous and / or flowable material or composition transitions to an at least partially solidified or hardened material or composition to form a "hard" or "hardened" material or composition. Such a hardened material or hardened composition may be a substantially non-flowable or solid material and / or may substantially retain its three-dimensional shape without the need for external support. For example, a hardenable material or hardenable composition may be any material that can be cured or set to a hardened state (while still remaining flexible and elastic).

[0029] A hardenable material is a curable material or resin, such as a crosslinkable or polymerizable monomer, oligomer, polymer, or solidifiable material. A hardenable material may be hardened (cured or set) by physical action (e.g., light, heat, or pressure) or chemical action (e.g., catalyst, initiator, or solvent). Examples of crosslinkable or polymerizable materials include, but are not limited to, siloxanes and polysiloxanes (e.g., polyvinylsiloxane ("PVS"), hydroxypolydialkylsiloxanes), acrylates, methacrylates, acrylic acid, methacrylic acid, acrylamides, methacrylamides, aldehydes, vinyl acetate, methyl vinyl ether maleate, aziridines, vinyl ethers, epoxides, polyols, polyamines, diisocyanates and polyisocyanates, cyanoacrylates, polyethers, polyether-PVS hybrids, polysulfides, glass ionomer fillers, glass ionomer cements, zinc phosphate cements, carboxylic acid cements, cyclic amides, cyclic esters, silicate cements, silicophosphate cements, silicones, silicone rubbers, and combinations thereof. Elastomeric materials such as polysulfides, polyethers, condensation cure silicones (e.g., α-ω-hydroxyl terminated polydimethylsiloxanes), and addition cure silicones (e.g., polyvinylsiloxane (PVS) or vinylpolysiloxane (VPS)) are particularly useful as the curable material. Examples of solidifying materials include, but are not limited to, alginates, alginic acid, agar, curdlan, gelatin, konjac glucomannan, methylcellulose, hydroxypropylmethylcellulose, pectin, starch, carrageenan, Portland cement, and other hydrocolloids, gels and cements, and combinations thereof.

[0030] Examples of catalysts and initiators that may be used include metal salts (e.g., carboxylates of platinum and tin, such as dibutyltin carboxylate), organometallic compounds (e.g., organotitanates), amines (e.g., tertiary amines), dimorpholine diethyl ether, radical initiators (e.g., peroxides having the general structure RO-OR, such as benzoyl peroxide, diisopropylbenzene monohydroperoxide, camphorquinone).

[0031] The functional agent may be any substance that is desirable to deliver to oral tissues, such as a substance that has a treatment, therapeutic, and / or cosmetic benefit. For example, the functional agent may be a dental whitening agent, a tooth mineralizing or treatment agent (e.g., desensitizing and remineralizing agents), a therapeutic agent (e.g., a chemotherapeutic agent), a caries inhibitor (e.g., urea, calcium glycerophosphate, sodium trimetaphosphate, silicone polymers, plant extracts, etc.), a chelating agent (e.g., EDTA, citric acid, alkali metal pyrophosphate, polyphosphonic acid, hydrochloric acid, phosphonates, etc.), an anesthetic agent (e.g., benzocaine, lidocaine, etc.), a cosmetic agent, an antibiotic, an antifungal agent (e.g., itraconazole, terbinafine, fluconazole, etc.), an antibacterial agent (e.g., tetracycline, triclosan, chlorhexidine, zinc nitrate, silver nitrate, copper, limonene, Antimicrobial peptides (AMPs), cetylpyridinium salts, methyl benzoate, propyl benzoate, etc.), antiplaque and antitartar agents (pyrophosphates, antioxidants, quaternary ammonium compounds, phenols, copper salts, strontium salts, magnesium salts, zinc salts, anionic polymers, etc.), analgesics (e.g., ibuprofen, acetaminophen, epinephrine, menthol, or other analgesics), antioxidants and vitamins (e.g., vitamin A, vitamin E, vitamin C, etc.), breath fresheners (e.g., zinc gluconate, zinc citrate, alpha-ionone, etc.), essential oils (e.g., eucalyptol, menthol, methyl salicylate, thymol, etc.).

[0032] The hardenable composition may be a tooth whitening composition that includes one or more dental whitening agents (e.g., for providing cosmetic tooth whitening). Examples of useful dental whitening agents include, but are not limited to, peroxides, chlorine dioxide, chlorites and hypochlorites, percarbonates, metal chlorites, persulfates, perborates, and the like. Examples of suitable peroxides include, but are not limited to, hydrogen peroxide, carbamide peroxide, alkali and alkaline earth metal peroxides (e.g., lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, and barium peroxide), organic peroxides, peroxyacids and their salts, and polymer-peroxide complexes (e.g., polyvinylpyrrolidone-hydrogen peroxide complexes such as Peroxydone™ complexes). Organic peroxides include, for example, carbamide peroxide (also known as urea hydrogen peroxide), glyceryl hydrogen peroxide, alkyl hydrogen peroxide, dialkyl peroxide, alkyl peroxyacids, peroxyesters, diacyl peroxides, benzoyl peroxide, monoperoxyphthalates, and the like. Peroxyacids and their salts include organic peroxyacids, such as alkyl peroxyacids and monoperoxyphthalates, and inorganic peroxyacid salts, including persulfates, dipersulfates, percarbonates, perphosphates, perborates, and persilicates of alkali and alkaline earth metals, such as lithium, potassium, sodium, magnesium, calcium, barium. Another useful peroxy compound is sodium pyrophosphate peroxyhydrate. In some embodiments, the whitening agent may be included as a complex with a carrier material. For example, a complex of polyvinylpyrrolidone and hydrogen peroxide (e.g., Peroxydone™ complex) may be used in the hardenable composition.

[0033] In some embodiments, the hardenable dental whitening composition may be formulated as a multi-part (e.g., two-part) dental treatment system that includes a dental whitening agent in a polyvinylsiloxane elastomer matrix. Such dental treatment compositions may include a first part that includes the whitening agent and / or desensitizing agent(s) along with a catalyst(s) and a second part that includes the remaining condensation chemical components. As used herein, "residual condensation chemical components" refers to reactive silicone polymers, such as silanol-terminated siloxanes or hydroxy-terminated siloxanes (e.g., hydroxy-terminated polydimethylsiloxanes), crosslinkers (e.g., polyfunctional silanes and / or silicate esters), and / or other suitable components.

[0034] One or more desensitizing or remineralizing agents may further be included in the dental whitening composition.Suitable desensitizing and remineralizing agents include, but are not limited to, nitrate ion sources (e.g., potassium nitrate and silver nitrate), fluoride ion sources (e.g., sodium fluoride, tin(II) fluoride, potassium fluoride, sodium fluorosilicate, ammonium fluorosilicate, and sodium monofluorophosphate), calcium ion sources and salts (e.g., calcium phosphate, calcium chloride, calcium carbonate), potassium ion sources and salts (potassium nitrate and potassium citrate), phosphorus ion sources and salts (e.g., triethyl phosphate, calcium phosphate, and sodium phosphate), hydroxyapatite, fluoroapatite, glutaraldehyde, zinc chloride, strontium chloride hexahydrate, strontium chloride, citrate, potassium oxalate, bioactive glass, and combinations thereof. Some desensitizing agents, such as fluoride, calcium, and phosphate, can help strengthen teeth and counteract the potentially corrosive effects of peroxide on tooth enamel. In two-part compositions, the desensitizing agent may be included in one part in an amount ranging from about 85% by weight, preferably about 50% by weight, and more preferably about 20% by weight, for example, from about 0.001% to about 10% by weight of the composition.

[0035] The hardening or curing behavior can be accomplished, for example, using condensation cure silicone chemistry. In the presence of water and a catalyst or initiator, the reactive silicone polymer undergoes hydrolysis and initiates crosslinking. This converts the liquid gel whitening material into an at least partially cured or set elastomeric material (i.e., an elastomeric solid). For example, the treatment material may be a curable polyvinyl siloxane composition that includes a silanol- or hydroxy-terminated siloxane, a crosslinker, a catalyst, and a treatment component.

[0036] Suitable silanol or hydroxy terminated siloxanes may include polydimethylsiloxane, diphenylsiloxane, polydiphenylsiloxane, polytrifluoropropylmethylsiloxane, vinylmethylsiloxane copolymers, and combinations thereof. In a multi-part (e.g., two-part) composition, the siloxane material may be included in one part in an amount ranging from about 20% to about 95%, preferably from about 40% to about 95%, and more particularly from about 70% to about 90%, by weight of the composition.

[0037] Suitable crosslinkers may include, for example, vinyl-functional silanes, hydride-functional silanes, polyfunctional silanes such as alkoxy, acetoxy, ester, enoxy, or oxime silanes, and / or silicate esters. Examples of crosslinkers that may be used in the whitening material include, but are not limited to, vinylisopropenoxysilane (e.g., vinyltriisopropenoxysilane, vinylmethyldiisopropenoxysilane, and their partial hydrolysis condensation products such as vinyltriisopropenoxypolysiloxane), methyltriacetoxysilane, methyltrioximesilane, ethyltriacetoxysilane, methyltriacetoxysilane, bis(triethoxysilyl)ethane, vinyltriacetoxysilane, vinyltrimethylsilane, methyltriethoxysilane, methyltrimethoxysilane, tetraethoxysilane, tetra-n-propoxysilane, methyltris(methylethylketoxyimino)silane, and combinations thereof. In a two-part composition, the crosslinker may be included in one part in an amount of up to about 50% by weight, preferably up to about 20% by weight, more preferably up to about 10% by weight, for example in an amount ranging from about 3% to about 15% by weight, and more particularly from about 5% to about 10% by weight.

[0038] Suitable catalysts or initiators include tin compounds, platinum compounds, and organometallics such as organotin complexes, platinum complexes, peroxide initiators, and titanates. As non-limiting examples, the catalyst or initiator may include one or more of dimethyltin dineodecanoate, tin bis(neodecanoate), tin(II) octoate (tin bis(2-ethylhexanoate)), di-n-butyl dilauryl tin, dimethyltin hydroxy(oleate), di-n-butyltin bis(2-ethylhexylmaleate), di-n-butylbutoxychlorotin, dibutyltin diacetate (di-n-butyl diacetoxytin), di-n-butyltin bis(2,4-pentanedionate), dibutyltin dilaurate (di-n-butyl dilauryl tin), dibutyltin dioctoate, dioctyltin dilaurate, tin(II) acetate, di-octyltin-bis, di-octyltin-bis, and combinations thereof. Other silicone catalysts include chloride, ammonium, iodonium, palladium, or peroxide. Still other catalysts may include lead, antimony, iron, cadmium, barium, manganese, zinc, chromium, cobalt, nickel, aluminum, gallium, germanium, titanium, or zirconium, which may be provided as compounds or complexes to provide metal-containing catalysts. Such catalysts may be used in moisture-curable compositions that include silicones. In multi-part (e.g., two-part) compositions, the catalyst or initiator may be included in one part in an amount ranging from about 0.001% to about 10% by weight, preferably in the range of about 0.1% to about 10% by weight, and more preferably in the range of about 1% to about 6% by weight. The minimum concentration of catalyst is typically about 500 ppm, and in some cases an amount ranging from about 0.05% to about 0.5% is suitable.

[0039] The compositions disclosed herein exhibit efficient curing in the presence of peroxide whitening agents, thus solving the problem of cure inhibition associated with incorporating peroxide compounds into polymer systems. Suitable whitening agents may include peroxide compounds and peroxide complexes. Examples of whitening agents that can be used in the whitening material include, but are not limited to, hydrogen peroxide, carbamide peroxide, sodium perborate, sodium percarbonate, and combinations thereof. In a two-part composition, the whitening agent may be included in one part in an amount up to about 90% by weight, preferably in the range of about 5% to about 70% by weight, more preferably in the range of about 10% to about 50% by weight.

[0040] In addition to the treating agent, catalyst or initiator, and reactive components, the hardenable composition also includes a carrier material, which acts as a thickener or diluent for the treating agent (which may be liquid or solid) and facilitates the dispersion of the components of the treating material upon mixing. In some embodiments, the carrier material remains uncured, fluid or flowable within the composition after the hardenable material in the composition is set or cured. Thus, the carrier material can form a fluid or flowable passive network throughout the hardenable composition. The carrier material may include one or more water-soluble polymers or viscosity adjusting / thickening agents. Water-soluble polymers or viscosity adjusting / thickening agents include, but are not limited to, polyacrylic acid, poly(N-vinyl lactams) (e.g., polyvinylpyrrolidone (crosslinked or uncrosslinked)), polyacrylates, polyacrylamides, polyethylene glycols, waxes, propylene glycol, polar solvents (e.g., water), fillers (e.g., fumed silica or fumed alumina), cellulose derivatives (e.g., carboxymethyl cellulose), alginates, starches, starch derivatives, polyurethane thickeners, or polyacrylic acid and polyacrylamide copolymers, polyvinylpyrrolidone-vinyl acetate copolymers, polyvinyl alcohols, polyethylene oxides (e.g., POLYOX™ resins), polyvinyl caprolactams, glycerin, and / or polyoxazoline copolymers (e.g., poly(2-ethyl-2-oxazoline)). The carrier material may also be a complex of such water-soluble polymers with a peroxide compound. In two-part compositions, the carrier material may be present in one part in an amount up to about 90% by weight, preferably up to about 50% by weight, more preferably in the range of about 1% to about 40% by weight, and most particularly preferably in the range of about 2% to about 25% by weight.

[0041] For example, the treatment composition may be formed as a two-part elastomeric system including a first part (Part A) containing a silanol- or hydroxy-terminated siloxane and a crosslinker, and a separate second part (Part B) containing a catalyst or initiator, a treatment agent, and a carrier material. As will be described in more detail below, the arrangement of ingredients within Parts A and B can play an important role in maintaining a viable and stable product.

[0042] As another example, the treatment composition may be formed as a two-part resin system that includes a first part (Part A) that includes a methacrylate resin and a separate second part (Part B) that includes an initiator, a treatment agent, and a carrier material. If the methacrylate system is a light-curing system, the light-activated initiator can be included in either Part A or Part B of the system.

[0043] Optionally, the treatment composition may include additional additives such as fillers, surfactants, buffers, thickeners, colorants, flavors, and other additives. For example, viscosity modifying ingredients such as carrier materials and / or fillers may be added to Part B to aid in storage and mixing. Such carrier materials and / or fillers protect the fluid treatment agent from shearing during mixing, allowing for the production of a uniformly mixed composition.

[0044] The two components (Part A and Part B) may be stored separately until they are mixed to form a hardenable treatment composition, which may be applied to teeth and / or other oral tissues before the hardenable treatment composition is fully hardened. As a non-limiting example, the treatment composition may be loaded into a storage and delivery system including multiple (e.g., two) chambers, such as a dual-barrel or coaxial syringe. In some embodiments, the components are squeezed through a mixing tip and mixed to produce a substantially homogenous mixture. The mixture may be applied directly to the oral tissues, or may be applied to a delivery device, such as a dental whitening tray or a flexible barrier material (such as a dental treatment strip), to facilitate application to the oral tissues. The delivery device with the hardenable composition is placed on the teeth and / or other oral tissues, and the composition is allowed to cure and harden. Alternatively, the parts may be mixed and deposited on the teeth or delivery device manually or using other known methods of mixing and / or dispensing.

[0045] Because the chemistry of the treatment composition includes a hardenable material such as an elastomeric material, the composition hardens with an inverse image of the tooth and / or oral tissue to which it is applied. That is, the treatment composition is customized to the unique shape of the user's teeth and dental arch during the hardening process in a manner similar to conventional dental silicone impression materials. The hardening behavior allows the hardened or partially hardened treatment material to be cleanly and easily removed (often in one or a few chunks) without leaving a sticky gel residue or residue on the teeth and oral tissue as is the case with conventional whitening and / or desensitizing gels. In addition, if desired, the hardened treatment material can be reused by simply repositioning it over the teeth at the application site so that the dentition rests within the impression formed in the hardenable treatment material during the hardening process.

[0046] The carrier material may act as a viscosity modifying additive (e.g., thickener), binder, and / or dispersant for the components in the system to promote uniform mixing between the components and improve ease of use and consistency. In a two-component system, the component containing both the treating agent and the condensation catalyst may be too fluid to easily mix with the other component to create a homogeneous and functional hardenable composition. Incorporating the components into a carrier material prior to mixing can significantly improve the homogeneity and consistency of the final mixed product.

[0047] The treatment composition contains a treatment agent, such as a dental whitening agent (e.g., a peroxide whitening agent) and / or a desensitizing agent (e.g., potassium nitrate), which is time-released from a combined silicone and polymer (e.g., polyacrylic acid) system. The time-release of the peroxide whitening agent not only reduces the amount and / or concentration of whitening agent exposed to the teeth and / or soft oral tissues at a given time, thereby reducing sensitivity that may be caused by conventional whitening, but also allows the user to temporarily remove the hardened treatment composition from the teeth and, if desired, subsequently reinsert and resume treatment using the same composition.

[0048] Without being bound by any particular theory, it is believed that the incorporation of a carrier material prior to curing inhibits the silicone reaction in a manner that reduces the degree of crosslinking compared to a pure silicone system without a carrier material. In comparative samples that contain only silicone without a carrier material, the migration of active agents (e.g., peroxides or desensitizing agents) is reduced or eliminated. Thus, the compositions of the present invention allow peroxides and desensitizing agents to physically migrate more easily from the composition in a manner not observed in a pure silicone system, allowing for effective treatment.

[0049] The composition may further comprise one or more fillers. Fillers include, but are not limited to, silica materials (e.g., fumed silica), alumina materials (e.g., fumed alumina), quartz, cristobalite, calcium silicate, zirconium silicate, montmorillonite, bentonite, zeolite, sodium aluminum silicate, metal oxide powders (e.g., aluminum or zinc oxides or mixed oxides thereof), barium sulfate, calcium carbonate, gypsum, diatomaceous earth, and / or glass materials (e.g., silanized glass). The use of hydrophobic fillers, such as fumed silica or alumina particles or powders, can further facilitate the incorporation of the whitening agent into the hardenable polymer system. The filler may be included in the composition in an amount ranging up to about 85% by weight, preferably up to about 50% by weight, most preferably up to about 20% by weight, for example, from about 0.5% to about 15% by weight, more particularly from about 3% to about 10% by weight.

[0050] The composition may contain other dental treatment agents, additives, and adjuvants, examples of which include plasticizers and humectants (e.g., glycerin and sorbitol), stabilizers (e.g., EDTA, acrylate copolymers, and polyvinylpyrrolidone), neutralizing agents (e.g., potassium hydroxide, sodium hydroxide, triethylamine, and triethanolamine), buffers (e.g., sodium hydroxide, sodium phosphate, and citric acid), solvents (e.g., water), surfactants (e.g., polyethylene glycol), thickeners (e.g., polyacrylate thickeners, xanthan gum, gellan gum, guar flour, alginates, Carrageenan, carboxymethylcellulose, bentonite, welan gum, locust bean flour, agar, tragacanth, gum arabic, pectin, polyose, starch, dextrin, gelatin, and casein, ethylene oxide / propylene oxide copolymers (polyoxamers), and sodium lauryl sulfate), preservatives (e.g., dipotassium phosphate and sodium benzoate), other medicinal agents, flavors, colors, sweeteners (e.g., sorbitol, xylitol, and sucralose), and the like.

[0051] In some embodiments, the whitening agent may be incorporated into the whitening composition of the present invention as a premixed whitening gel formulation. For example, the premixed gel composition may be combined with a catalyst or initiator and optional additives to form a catalyst-containing component of a two-part whitening composition. For example, the premixed whitening gel formulation may include a whitening agent and a carrier material (e.g., a water-soluble polymer), and optionally one or more desensitizing and / or remineralizing agents, a polar solvent (e.g., water), a buffer, a humectant, a sweetener, and / or a flavoring agent. As a non-limiting example, the formulation may include a mixture of hydrogen peroxide and / or carbamide peroxide, polyacrylic acid, glycerin, water, silica, sorbitol, xylitol, flavoring, ethylene oxide / propylene oxide copolymer (e.g., poloxamer), sodium lauryl sulfate, sodium benzoate, sodium hydroxide, sucralose, xanthan gum, and coloring agents. As another non-limiting example, the premix formulation may include hydrogen polyvinylpyrrolidone, high molecular weight polyethylene glycol (eg, PEG-8 and PEG-6), water, acrylate copolymer, sodium hydroxide, and sodium saccharin.

[0052] Advantageously, the whitening agent is dispersed within a cohesive polymer mass once hardened, providing a steady and sustained supply of the treatment agent to the desired site (e.g., teeth for whitening). To remove the hardened dental treatment composition after the desired time, the user simply grasps a corner or portion of the applied composition and pulls it away from the tooth. Generally, the composition is pulled off as a single mass, making removal very easy.

[0053] In addition, advantageously, the multi-part hardenable composition may exhibit a delay time between initial contact and / or mixing and the time when the combined composition has completed hardening. Such a delay time allows the user time to place the composition on the teeth while still in a flowable and manipulable state to conform to the user's teeth and dental arch. If the composition is provided in a tray or on a strip, the teeth can be pressed into a mass before it is fully hardened. For example, the length of time for the composition to harden can vary from 10 seconds to a time depending on the desired application, which may range from about 10 minutes to about 24 hours. The time may be predetermined and may range, for example, from about 30 minutes to about 10 hours, from about 1 hour to about 5 hours, or from about 2 hours to about 4 hours.

[0054] FIG. 1 is a perspective view showing a schematic embodiment of a dental whitening system 100. The dental whitening system 100 includes a hardening or curable dental whitening composition 102 that is delivered using a dental treatment tray 104 configured to fit at least a portion of an upper or lower dental arch (not shown). The embodiment shown in FIGS. 1-6 illustrates delivery using a dental tray. However, it should be understood that any method or device for delivering a dental or oral composition may be used in accordance with the present invention as well. For example, the delivery device may include a strip of material as utilized in conventional dental whitening strips. In addition, the material 102 referred to in the following embodiments may additionally or alternatively be a desensitizing composition that includes one or more desensitizing agents. Alternatively, the composition may be applied directly to teeth or other oral tissues without the use of a tray or strip.

[0055] Optionally, the dental treatment tray 104 includes an exoskeleton support tray 106 having a handle 108. The support tray 106 may have a curved shape that approximates the shape of a human dental arch. A barrier material, shown in the form of a liner 110, is placed on the exoskeleton support tray 106. In some embodiments, the liner 110 may be a flexible or flimsy material that has a shape provided by the support tray 106. For example, the liner 110 may have a thickness of less than about 2 mm, e.g., between about 0.3 mm and about 1 mm, to allow the support tray 106 to conform to the teeth and oral tissue. In other embodiments, the liner 110 may have an arch shape that fits within the support tray 106. The support tray 106 (if present) is configured to be removed from the liner 110 using the handle 108, e.g., after an impression layer (not shown) has been formed.

[0056] A delivery device such as the liner 110 may be formed from a polymeric material, a thermoplastic elastomer, a wax, or a combination thereof. For example, the liner 110 may be a material that is substantially impermeable to water, saliva, and / or one or more materials in the whitening material 102 (e.g., a peroxide activator). As a non-limiting example, the liner 110 may be formed from a wax-based composition that includes a combination of one or more waxes and one or more polymers (such as thermoplastic elastomer polymers). Suitable waxes include, but are not limited to, petroleum-based waxes, such as microcrystalline waxes, paraffin waxes, and / or intermediate waxes. Suitable polymers include, but are not limited to, polyolefins, polyesters, polyurethanes, thermoset elastomers, and mixtures thereof, such as high density polyethylene, low density polyethylene, very low density polyethylene, polypropylene, polytetrafluoroethylene, thermoplastic polyolefins, propylene-based elastomers, ethylene-vinyl acetate copolymers, ethylene-vinyl alcohol copolymers, polyvinyl acetate, polyvinyl alcohol, polyesters, polycarbonates, methacrylates, acrylates, polyamides, polyurethanes, polyvinyl chloride, synthetic rubbers, phenol formaldehyde resins, neoprene, polystyrene, polyacrylonitrile, polyvinyl butyral (PVB), silicone elastomers, thermoplastic elastomers (e.g., olefin-based elastomers such as ethylene-based, propylene-based, and butylene-based elastomers).

[0057] The liner 110 has a trough or channel 114 that defines an inner impression-receiving surface 112 configured to receive an oral treatment composition, such as the whitening composition 102. The whitening composition 102 may be disposed on the impression-receiving surface 112 to allow the whitening composition 102 to directly contact the teeth at the application site. As shown in FIG. 1, the whitening composition 102 may be dispensed as granules or columns in an amount sufficient to cover the areas of the teeth where whitening (e.g., cosmetic) is desired and / or to obtain a mirror image or impression of the teeth or dentition as the whitening composition 102 hardens and cures.

[0058] In some embodiments, the whitening composition 102 is a two-part silicone-based whitening composition, where the first part contains the whitening agent(s) along with a condensation catalyst, and the second part (separate from the first part) contains the remaining condensation chemicals. In some embodiments, the dental whitening composition 102 may be a two-part curable polyvinyl siloxane system as follows: Part A: silanol terminated siloxanes, polyfunctional silanes (eg, silicate esters), optional additives (eg, fillers, surfactants, etc.). Part B: A condensation catalyst (e.g., an organotin compound), a carrier material (e.g., polyacrylic acid), a whitening agent (e.g., hydrogen peroxide, carbamide peroxide) and / or a desensitizing agent, a carrier material (e.g., polyacrylic acid, polyvinylpyrrolidone, etc.), and optional additives (e.g., fillers, surfactants, etc.).

[0059] In such a two-part system, a first part (eg, Part A) and a second part (eg, Part B) are mixed to form the hardenable whitening composition 102 .

[0060] Part A may include a siloxane material in an amount ranging from about 0% to about 100% by weight, more particularly about 25% to about 90% by weight, and a crosslinker in an amount ranging from about 0.5% to about 40% by weight, more particularly about 2% to about 25% by weight. The concentrations of the siloxane and crosslinker materials can be adjusted to achieve desired material properties such as viscosity, set behavior, and hardness of the set material. Part B may include a catalyst in an amount ranging from about 0.001% to about 20% by weight, more particularly about 0.05% to about 10% by weight, a whitening agent (and / or desensitizing agent) in an amount ranging from about 1% to about 70% by weight, more particularly about 10% to about 60% by weight, and a carrier material in an amount ranging from about 1% to about 100% by weight, more particularly about 1% to about 25% by weight.

[0061] Optional additives that may be included in Part A or Part B include carriers / fillers, dental treatment agents, additives, and adjuvants, as described herein above. For example, additives may include carrier materials, fillers, surfactants, and / or other thickening agents, as well as buffers, colorants, flavors, and other additives. For example, fillers may be included in one or both of Part A and / or Part B in an amount ranging from about 2.5% to about 5% by weight, while carrier materials may be included in an amount ranging from about 5% to about 20% by weight.

[0062] For example, as shown in FIG. 2, part A (102a) and part B (102b) may be loaded separately into separate barrels 202a and 202b of a dual barrel syringe 200 and then squeezed through a mixing tip 204 to mix them before being dispensed into a dental tray 104. Upon squeezing parts A and B from the compartments of the barrels 202a and 202b through the mixing tip 204 of the syringe 200, the components of parts A and B are mixed together to produce a substantially homogenous whitening material 102. The whitening composition 102 may be placed into the tray 104 as desired. For example, it may be dispensed onto the inner surface 112 of the tray 104 as shown, as a string-like or beaded structure as shown in FIG. 1, or to substantially fill at least a portion of the tray 104.

[0063] The separate parts, Part A and Part B, can be mixed in various ratios depending on the desired material properties. For example, Part A and Part B may be combined in ratios ranging from 1:10 to 10:1, such as 1:1, 1:2, 1:3, 3:1, or 2:1.

[0064] Once mixed, the whitening composition 102 placed in the tray 104 begins to harden and cure. For example, in a polyvinyl siloxane system, in the presence of moisture and the catalyst from Part B, the reactive silicone material from Part A undergoes hydrolysis and begins to form siloxane crosslinks. The curing reaction is not so rapid as to prevent a user from pressing the whitening material 102 against their teeth. For example, the whitening composition 102 may remain in a fluid or semi-fluid state that allows the teeth to be contacted or submerged therein for a period of time ranging from about 10 seconds to about 1 hour.

[0065] As shown in FIG. 3, the dental tray 104 containing the dispensed whitening composition 102 is placed over the teeth in the user's mouth. The whitening composition 102 may be brought into direct contact with the tooth surface, such as by pressing the underside of the tray 104 against the teeth to contact at least a portion of the teeth with the uncured or partially uncured whitening composition 102. If present, the exoskeleton support tray (not shown) may be removed from the inner tray or liner 110. The liner 110 containing the whitening composition 102 remains placed over or connected to the whitening composition 102 to provide support for the whitening composition 102 and prevent the whitening composition 102 from contacting the surrounding oral tissues. FIG. 3 shows a non-custom dental tray 104 placed over the upper teeth. However, it should be understood that a custom dental tray having a customized contour or barrier material may alternatively be employed for the upper teeth, and that this method may be used for the lower teeth as well. The dental tray 104 is shown as being transparent for purposes of illustrating the whitening composition 102 and teeth underneath.

[0066] By placing the dental tray 104 on the dental arch so that the teeth are in contact, the unhardened or partially hardened whitening composition 102 conforms to the shape and contours of the teeth while the whitening composition 102 is in a flowable state. The whitening composition 102 in the dental tray 100 continues to harden after being placed on the dental arch and teeth. As the whitening composition 102 undergoes hardening, a reverse image of the user's teeth and portions of the dental arch is captured due to the nature of the silicone-based material in the whitening composition 102. Thus, the dental whitening composition 102 is customized to the teeth that are contacted with the whitening composition 102. As the whitening composition 102 continues to harden, the whitening agent is continuously released from the whitening composition 102 to the teeth.

[0067] As shown in Figure 4, the dental treatment system 400 may use a custom dental tray 404 having a shape and contours corresponding to a user's teeth and dental arch. As described with respect to Figures 1-3, the whitening composition 102 may be mixed and placed in the custom dental tray 404 prior to placement on the teeth.

[0068] 5A and 5B show cross-sectional views of a dental whitening system 100 including a dental whitening composition 102 in a dental tray 104 that has been molded by placement on a tooth 500. For example, upon hardening, the whitening composition 102 may form a cohesive elastomeric material that conforms to the tooth 500 and act as a network or film 116 that adheres to and remains in contact with the tooth 500. The film 116 of hardened material may behave as a unit or aggregate that is no longer in a fluid or flowable state. As shown in FIGS. 5A and 5B, the film 116 overlaps and conforms to the shape of the tooth 500, such as over the occlusal surface 502 and incisal surface 504 of the tooth 500.

[0069] The whitening composition 102 conforms to and contacts the surface of the tooth 500, allowing the whitening agent dispersed throughout the whitening composition 102 to diffuse and directly contact the surfaces 502 and 504 to provide sustained whitening (e.g., cosmetic whitening). The whitening composition 102 may have a thickness ranging from about 0.5 mm to about 5 mm, typically 1 mm to 2 mm, and the thickness may vary. As shown in Figures 5A and 5B, the whitening composition 102 may substantially surround and at least partially contact the outer surfaces 502 and 504 of the tooth 500. Once hardened, the hardened whitening composition 102 maintains its position attached to the tooth 500. The tray 104 provides additional support for the whitening composition 102 during and after the hardening process and protects the surrounding tissue (not shown) from exposure to compounds that diffuse from the whitening composition 102, such as oxygen, the whitening agent, and / or the desensitizing agent.

[0070] As the whitening composition 102 hardens into a network or film 116 of elastomeric material, the tray 104 with the whitening composition 102 adheres closely around the teeth 500. Prior to hardening, the adherence to the teeth 500 reduces leakage or squeezing of the whitening composition 102 (and the whitening agent contained therein) from the tray 104 onto the gums and oral tissues of the user, thereby reducing the risk of potential irritation due to the whitening agent coming into direct contact with soft tissue. After hardening, the network or film 116 of the hardened whitening composition 102 is substantially immobile and remains attached in place to the teeth with or without the tray 104. Thus, the whitening composition 102 reduces or eliminates the risk of irritation or damage that may be caused by conventional non-hardening whitening gels that may leak and seep out of dental trays during treatment. By maintaining its position and reducing the risk of irritation caused by a displaced treatment, the whitening composition 102 provides increased contact with the teeth and extended wear time compared to conventional dental whitening gels.

[0071] As the whitening composition 102 undergoes condensation curing, a transition occurs between a flowable and / or fluid gel-like state and a solid and / or rubbery state. In the fluid state, the whitening composition 102 is capable of flowing into spaces, voids and contours of the contact surfaces of the teeth and dental arches, allowing the formation of a reverse image of those structures during curing. Once sufficiently cured, the whitening composition 102 transitions from the fluid gel state to a rubbery state. The rubbery state is a consolidated, unitary silicone elastomer material that mirrors and conforms to the tooth and dental arch structures, forming the film 116. As described in more detail below, the cured film 116 may include a matrix with regions of uncrosslinked material throughout the crosslinked polymeric material. For example, a carrier material having whitening agents and other ingredients dispersed therein may form regions within the cured polyvinylsiloxane material.

[0072] In some embodiments, the set time length of the whitening composition 102 ranges from 30 seconds to the length of the treatment time, where the predetermined length of treatment time may be overnight (e.g., 10 hours). In some embodiments, the set time length of the whitening material 102 ranges from 1 minute to 1 hour, more particularly 3 minutes to 45 minutes, and even more particularly 5 minutes to 30 minutes. In some embodiments, the whitening composition 102 may be configured such that the hardening process is not completed until a desired amount of the whitening agent has been slowly released from the composition. In this embodiment, the user will know that the whitening treatment is complete when the whitening composition 102 has hardened into an integrated network or solid (e.g., has reached a hardened state or is easily removable from the tooth). In some embodiments, the set time of the whitening composition 102 (i.e., the time it takes for the whitening composition 102 to cure and harden) is a function of the concentration of at least one of the whitening agent (e.g., peroxide) and / or condensation catalyst present in the whitening composition 102.

[0073] Optionally, once the whitening composition 102 has sufficiently hardened, the tray 104 can be removed, leaving only the whitening composition 102 on the teeth. However, it may be desirable to keep the tray 104 in place to help maintain the dental whitening agent on the teeth, to prevent compounds from diffusing from the whitening composition 102 into the user's mouth, and to facilitate removal and replacement of the whitening composition 102.

[0074] With reference to FIG. 6, once the whitening composition 102 is sufficiently hardened, it can be easily removed from the teeth (not shown). The hardened whitening composition 102 comprises a three-dimensional matrix in which the whitening agent and optional additives are dispersed, from which the whitening agent and optional additives gradually diffuse. In some embodiments, the matrix is ​​a polymer matrix that may include, for example, a silicone matrix having other components dispersed therein (e.g., whitening agent, additives, carrier materials, etc.). For example, the whitening agent may be a peroxide-based whitening agent and may be present in the whitening composition 102 at a concentration between about 1% and about 90%, such as, for example, between about 6% and about 60%, between about 10% and about 50%, or between about 20% and about 40%. In some embodiments, the whitening agent is a mixture of hydrogen peroxide and carbamide peroxide and is present in the whitening composition 102 at a total combined concentration ranging between 6% and 50%. The sustained release of the whitening agent allows for the incorporation of higher concentrations of the whitening agent as compared to conventional whitening gels. Such increased concentrations allow for greater whitening effects with fewer treatments. The sustained release of peroxide and molecular oxygen from the hardened whitening composition 102, particularly at increased concentrations, allows for the substantial reduction or elimination of tooth and tissue sensitivity associated with conventional peroxide tooth whitening. It also provides for extended treatment times, including one or more removals and reapplications of the elastomeric whitening material.

[0075] A matrix is ​​formed as a result of the curing process. The carrier material (e.g., polyacrylic acid) in the whitening composition 102 promotes uniform mixing of the components to promote uniform polymerization and a homogenous curable composition, thereby promoting uniform distribution of the treatment agent (e.g., whitening agent, desensitizing agent, or remineralizing agent) within the matrix. The carrier material may have increased hydrophilicity compared to silicone polymers, thereby increasing the hydrophilicity of the cured matrix of the whitening composition 102 and improving the accuracy of the impression made as the material cures. Additionally, the matrix may include regions of more hydrophilic uncrosslinked carrier material (with the whitening material disposed therein) within the more hydrophobic crosslinked polyvinylsiloxane material. It has been observed that in the absence of a carrier material such as polyacrylic acid, two-part whitening compositions formulated from curable polyvinylsiloxane materials may not efficiently release the whitening agent due to immobilization of the whitening agent within the cured polyvinylsiloxane matrix. This is especially true with solid whitening agents such as carbamide peroxide.

[0076] In the hardened matrix, the more hydrophilic nature of the carrier material can facilitate diffusion of the whitening agent from the matrix onto the teeth in the presence of water (e.g., saliva). Thus, the whitening agent of the whitening composition 102 is slowly released over time. This behavior may be present whether the bleaching agent is hydrogen peroxide, carbamide peroxide, or a combination thereof. As the whitening composition 102 hardens against the teeth, the whitening agent and / or oxygen slowly diffuse out of the matrix to contact the teeth and facilitate whitening (e.g., cosmetic whitening).

[0077] The hardened whitening composition 102 may be temporarily removed from the tooth and later replaced without discarding the treatment composition. The sustained release of the dental bleaching agent by the matrix reduces the risk of hypersensitivity that may result from the rapid release of high concentrations of peroxide in the absence of the matrix, despite the presence of high concentrations of peroxide in the hardened whitening material 102. This diffusion continues even after the hardening of the whitening composition 102 is complete, continuing until a significant portion of the bleaching agent has diffused out of the matrix of the hardened whitening composition 102. The sustained release allows the user to use the whitening composition 102 for a longer period of time before the effectiveness of the whitening material 102 begins to decrease. In some embodiments, the whitening composition 102 is configured to harden into an elastomeric solid. The hardened composition 102 remains where treatment is desired without diffusing or migrating to other parts of the oral cavity or being prematurely expelled.

[0078] The elastomeric behavior of the whitening composition 102 allows the hardened whitening composition 102 to be removed without leaving a significant amount of the composition or residue on the teeth or other oral tissue(s). Surprisingly, it has been found that the whitening composition 102 adheres well to the teeth during the procedure, but preferentially adheres to conventional trays or barrier materials, such as those formed from polymers, waxes, or combinations thereof. The whitening composition 102 preferentially adheres to dental trays, custom or non-custom. Thus, the use of a tray or barrier material, such as dental tray 104, facilitates removal of the whitening composition 102 by providing a support material to which the whitening composition 102 remains attached during removal from the teeth. The hardened whitening composition 102, including the impression of the teeth and dental arch, may be reapplied by the user to the original application site. Such reuse or reapplication of the whitening composition 102 allows a user to pause a whitening procedure (e.g., cosmetic whitening) and continue it after an interruption by simply removing the hardened whitening composition 102 and later repositioning it on the teeth.

[0079] As shown in FIG. 7, the oral delivery system 700 may be formed by applying the hardenable composition 702 described herein to a backing or strip 704 while the hardenable composition 702 is in a flowable state. The backing 704 may be formed from any material suitable for carrying the hardenable material so that it can be applied to oral tissue. For example, the backing 704 may be a material that is substantially impermeable to water, saliva, and / or one or more materials (e.g., functional agents or active ingredients) in the hardenable composition 702. Examples of suitable materials for the backing 704 include those described with respect to the liner 110 illustrated in FIG. 1. The liner 704 may be substantially flexible to allow the liner and composition to conform to oral tissue during application and hardening. For example, the backing 704 may have a thickness of less than about 2 mm, such as between about 0.3 mm and about 1 mm. The hardenable composition 702 may include a curable or hardening system having a viscous carrier and a functional agent therein. As shown in Figure 7, the hardenable composition 702 is a two-part composition that includes a catalyst in one part and a reactive polymer in the other part. The hardenable composition 702 may be mixed using any method and placed onto a barrier material 704, such as using a dual-barrel syringe 706 as described with respect to Figure 2. Once dispensed, the hardenable composition 702 may be applied to the oral tissue while remaining in a fluid or semi-fluid state. The backing material 704 may act as a support for the hardenable composition, isolating the hardenable composition 702 from certain oral tissues while simultaneously preventing leakage of the functional agent(s) into the surrounding oral tissues.

[0080] As shown in Figures 8A-8C, an oral delivery system 800 including a hardenable composition 802 disposed on a backing material 804, such as oral delivery system 700 described with respect to Figure 7, may be removably attached to oral tissues 808. With reference to Figure 8A, the hardenable material 802 may be in a flowable state in which the material therein has not fully hardened.

[0081] The backing 804 may facilitate placement of the system 800 at a desired site on the oral tissue 808. Once placed, the system 800 may optionally be held in place for a period of time sufficient for the hardenable material 802 to at least partially harden. As shown in FIG. 8B, the hardened or partially hardened composition 802 may improve adhesion to the oral tissue 808, allowing the composition 802 (and optional backing 804) to remain on the oral tissue without additional support.

[0082] 8C, oral delivery system 800 may be placed on any area(s) of oral tissue 808 while hardenable composition 802 is still at least partially flowable, and once at least partially hardened, hardened composition 802 may be easily and generally removed as one piece. Hardened composition 802 may form an impression or imprint 810 of oral tissue 808 therein. Additionally, system 800 may be removed and repositioned on the same or a different area of ​​oral tissue, allowing for delayed, intermittent, and / or different areas of delivery using a single composition 802.

[0083] 9 illustrates another example of a method for direct oral delivery application of a hardenable composition 902 described herein to gums 908 using a delivery syringe 906. After application, the composition 902 hardens to a state capable of maintaining its shape and integrity in the oral environment and remains attached to oral tissues such as the gums 906 until removed by the user. In the hardened state, the composition 902 provides improved comfort, ease, removal, and reattachment compared to compositions that remain in a viscous or flowable state.

[0084] With reference to FIG. 10, the compositions disclosed herein for oral delivery are suitable for delivery to any site on the oral tissues, including the cheek, cheek tissue, gums, lips, palate, teeth, etc.

[0085] The examples herein illustrate the delivery of a two-part hardenable composition using a mixing delivery syringe. However, it should be understood that the hardenable composition disclosed herein may be one-part and may be mixed and delivered using any suitable means. Furthermore, the hardenable composition comprising the functional material disclosed herein can be easily removed from oral tissues by simply peeling off the backing material or the hardenable material itself, and can be reapplied later.

[0086] By way of non-limiting example, Figure 10 illustrates areas of oral tissue to which the hardenable compositions of the present invention may be applied to deliver any desired functional composition. As previously described, any delivery vehicle, such as an oral tray or strip, may be used to apply the hardenable composition.

[0087] The following examples are provided to more clearly illustrate the parameters of the disclosed dental whitening materials within the scope of the present disclosure. The following examples are illustrative and should not be considered as limiting the scope of the present disclosure. EXAMPLES

[0088] Example 1 For comparative purposes, the ingredients shown in Tables 1A and 1B were combined to prepare whitening agents that did not contain a carrier material.

[0089] [Table 1]

[0090] [Table 2]

[0091] (Processing order) 1. Combine dimethyltin dodecanoate and silanol-terminated polydimethylsiloxane. 2. Add fumed silica. 3. Add 50% hydrogen peroxide in water. 4. Add vinyltriisopropenoxysilane.

[0092] (result) After sufficient curing time, the physical properties and distribution of materials within Formulation A and Formulation B were observed. Formulation A cured to a suitable cured state, but it was observed that the hydrogen peroxide was not fully incorporated into the material, resulting in a moist cured material. Formulation B cured to a cured state, but it was observed that the carbamide peroxide was not uniformly dispersed or incorporated throughout the material. Thus, it was demonstrated that in the absence of a carrier material (e.g., a hydrophilic polymer), liquid or solid active / whitening agents (i.e., aqueous hydrogen peroxide and carbamide peroxide) are not readily incorporated into curable polymer systems, such as polyvinylsiloxane systems.

[0093] Example 2 A study was conducted to investigate the compatibility of functional silane fluids (e.g., silicate esters) with condensation catalysts (e.g., tin-based compounds). Sample gels containing mixtures of silane fluids and tin-based catalysts were prepared and their direct compatibility was measured. The catalyst concentrations were included in the range of 1% to 20% by weight, and the silane concentrations ranged from 80% to 99% by weight. After mixing, the sample gels were placed at room temperature (25°C) and 40°C.

[0094] Within 96 hours, discoloration was observed in the samples containing the higher concentration of catalyst and placed at 40° C. Two samples with higher concentrations of catalyst polymerized within 96 hours. The remaining samples continued to discolor and polymerize over time.

[0095] Sample gels with higher catalyst concentrations were observed to cure more quickly. The higher the catalyst concentration, the faster the premature cure. Thus, it was demonstrated that the cure time of the composition can be a function of the concentration of the condensation catalyst.

[0096] It has been observed that compositions containing both a polymerizable material (e.g., a functional silane or siloxane) and a condensation catalyst undergo autocatalysis over time and are therefore unstable at both room temperature and at 40°C. It was concluded that storing a polymerizable material, such as a silane or siloxane material, and a catalyst together results in premature curing, which impairs commercial utility. By separating the polymerizable material and the catalyst into separate portions in accordance with the present invention, the stability of compositions containing these two components is substantially improved, resulting in compositions with commercial utility.

[0097] Example 3 Experimental formulations were made according to Table 3 to replicate the comparative two-part gel system with a peroxide whitening agent.

[0098] [Table 3]

[0099] The ingredients of Component A and Component B were combined to form two parts of a comparative gel system, and the two parts were observed over time. In Component A, the polydimethylsiloxane and water or water-based solution (e.g., hydrogen peroxide) separated from the mixture immediately after mixing the ingredients in the established manufacturing method. In Component B, the placement of a silicate ester and a condensation catalyst in the same mixture caused premature curing in the presence of moisture. This premature curing behavior was observed in the presence of a water source as small as ambient moisture or environmental humidity. It was concluded that the two-part whitening system with the experimental formula was not commercially practical. Specifically, it was demonstrated that formulations including a mixture of a curable polymer (e.g., polydimethylsiloxane) and a whitening agent were not stable in the absence of a carrier material, with the whitening agent separating from the mixture. Also, it was demonstrated that formulations including a mixture of a crosslinker (e.g., silicate ester) and a catalyst were not stable due to premature curing. Thus, both Component A and Component B of the experimental formulations failed to produce commercially viable results for separate reasons. The curable compositions of the present invention solve the demonstrated stability problems by providing a carrier material for materials that tend to separate from the mixture (e.g., whitening agents) and isolating the catalyst and polymerizable materials (e.g., crosslinkers) in separate portions until use.

[0100] Example 4 11A-11C show the curing behavior and substantially uniform mixing test of an exemplary two-part dental whitening material. Each of Component A and Component B was prepared according to the disclosed method. The ingredients of Component A and Component B are shown in Table 4.

[0101] [Table 4]

[0102] As shown in Figures 11A-11C, the individual components of the two-part dental whitening material were tested separately against a two-part mixture. The mixture was squeezed through a mixing tip, combining the two parts in a substantially homogenous manner as shown. As shown in Figure 11B, just after the start of the curing process, the individual components and the mixture were still malleable. After sufficient curing time, the mixture had changed to an elastomeric solid, as shown in Figure 11C, while the individual components were still completely malleable.

[0103] Example 5 12A-13C show examples of removal and reapplication of hardened dental whitening gel to typodonts using different tray types and materials for application. A two-part hardenable whitening gel was formulated using the ingredients shown in Table 5.

[0104] [Table 5]

[0105] One part of the dental whitening gel (Component A) was stained to allow for observation of the mixing between the two parts. The dental whitening gel was squeezed through a mixing tip into both a disposable tray (FIG. 12A) and a custom-fitted tray (FIG. 13A) at separate intervals. The disposable tray was formed from a flexible wax polymer material and included a removable outer support tray, whereas the custom tray was formed from a more rigid polymer material. As shown in FIG. 12B and FIG. 13B, the dental whitening gel was applied to each typodont by placing the disposable or custom tray containing the dental whitening gel over the typodont's teeth and leaving the whitening system on the typodont without disturbance for the prescribed setting time of 5-10 minutes.

[0106] As shown in Figures 12C and 13C, the tray was removed from the typodont after the setting time had elapsed. In both cases, no whitening gel was observed on the teeth and typodont after treatment (see Figure 12C), demonstrating that the hardened gel preferentially adheres to the tray. As shown in Figure 12C, the whitening gel remained attached to the tray material and maintained the shape of the teeth after removal. That is, the whitening gel mirrored the shape of the typodont. The tray was then repositioned in dentifrice and confirmed to be able to be placed on the dentition again. In both cases, the whitening gel was confirmed to fit back into the location where it was previously applied. It was concluded that the hardened whitening gel easily peeled off the teeth (probably due to surface moisture) and preferentially adheres to the polymer- and wax-based tray materials. It was further observed that the tray containing the hardened whitening gel could be easily removed and reapplied to the teeth, allowing for reuse of the whitening material.

[0107] Example 6 Tables 6A and 6B show one example of cosmetic whitening effect using the disclosed system. Human extracted teeth were artificially stained with a mixture of red wine, blueberry and pomegranate juice. The teeth were immersed in the mixture and stored at 40° C. for 2 and 6 weeks. After staining, the teeth were removed from the mixture and rehydrated in water for at least 1 week before applying the whitening gel. The resulting tooth stain was dark purple to brown in the dentin and gray to reddish brown in the enamel. As described below, three comparative tests were conducted to compare the effect of treating colored sample teeth with a hardenable whitening gel according to the embodiments described herein, water, and a conventional non-hardening whitening gel. To evaluate tooth whitening (cosmetic effect in shade change), the teeth were evaluated using the VITA® Shade Guide according to the instructions. The general formulations of the hardenable and non-hardening whitening gels are shown in Tables 6A and 6B below.

[0108] [Table 6]

[0109] [Table 7]

[0110] In the first study, the effect on tooth shade of multiple applications of a hardenable whitening gel containing 10% by weight carbamide peroxide was compared to a water control. Hardenable whitening gel and water were applied to differently stained, rehydrated teeth (Tooth A and Tooth B, respectively) at 40° C. with 8 hour intervals for a total of 10 applications per tooth. Between each of the 10 applications, the teeth were rehydrated overnight. To ensure that the color change was not due to dehydration, the teeth were rehydrated for at least 24 hours after the final application before evaluating the shade change. The evaluation results are shown in Table 6C.

[0111] [Table 8]

[0112] As shown in Table 6C, the hardenable whitening gel of the present invention was found to be more effective at whitening than the benign water control.

[0113] In a second study, multiple applications of a hardenable whitening gel containing the same concentration of carbamide peroxide were compared to a conventional non-hardenable whitening gel. The hardenable and conventional whitening gels, both containing 35% by weight carbamide peroxide, were applied to differently stained, rehydrated teeth (tooth C and tooth D, respectively) at 40° C. with 1 hour intervals for a total of 10 applications per tooth. The teeth were rehydrated for at least 1 hour between each of the 10 applications. To ensure that color changes were not due to dehydration, the teeth were rehydrated for at least 24 hours after the final application before evaluating shade changes. The results are shown in Table 6D.

[0114] [Table 9]

[0115] As shown in Table 6D, the hardenable whitening gels were found to be equally or more effective in cosmetically whitening teeth compared to conventional non-hardenable whitening gels.

[0116] In a third study, stained rehydrated sample teeth were treated with one application of water, a hardenable gel according to embodiments described herein, and a conventional non-hardening whitening gel. The hardenable and conventional whitening gels were formulations containing 35% and 10% carbamide peroxide by weight. In this study, the teeth were exposed to each whitening gel for 24 hours at 40° C. The teeth were rehydrated for an additional 24 hours before evaluating shade change. The results are shown in Table 6E.

[0117] [Table 10]

[0118] As shown in Table 6E, the hardenable whitening gel was found to be effective in cosmetically whitening teeth compared to conventional whitening gel and water, which had no effect on tooth shade.

[0119] Example 7 The peroxide release behavior of the curable and conventional non-curable whitening compositions was characterized using a peroxide assay. The uncured compositions were added directly to a flask and the total concentration of peroxide was measured after mixing. For dissolution testing, a sample of the composition was allowed to set. Once cured, the solid composition was added to a flask and allowed to dissolve for a set period of time. The disclosed whitening gels showed sustained release of peroxide over several hours of dissolution. The peroxide release behavior was compared by measuring the rate of diffusion of peroxide from each composition.

[0120] [Table 11]

[0121] [Table 12]

[0122] [Table 13]

[0123] [Table 14]

[0124] As a result, the peroxide release behavior of silicone-only compositions shows either incomplete release or rapid release during curing.Therefore, silicone-only compositions may not be suitable for tooth whitening purposes.As disclosed herein, a slower release of both peroxides was observed in the combined silicone and polyacrylic acid curing system.Thus, the synergistic effect of combining a curable silicone system with a non-curable carrier such as polyacrylic acid may unexpectedly slow the release profile of the composition, resulting in better whitening results as well as reduced sensitivity.

[0125] Example 8 Release tests were conducted to determine whether non-whitening additives were mobilized from the polymerized matrix of the curable whitening gel of the present invention formulated according to Table 12A. Sodium fluoride (NaF), a source of fluoride ions, was used as an exemplary additive. In all test examples, the curable whitening gel was allowed to fully set before being placed in distilled water for dissolution. Fluoride ions were detected in the test solutions at all concentrations and dissolution times.

[0126] [Table 15]

[0127] [Table 16]

[0128] [Table 17]

[0129] The results demonstrate that the hardenable gel disclosed herein effectively releases fluoride ions, indicating the suitability of the gel in treating teeth with treatments such as desensitizing agents.

[0130] Example 9 Tests were conducted to determine the curing behavior of the two-part resin composition disclosed herein and the release of functional agents from the resin system after curing. Methacrylate resin was used as an exemplary curable resin and the composition was formulated according to Table 13.

[0131] [Table 18]

[0132] Equal amounts of the individual components were mixed until substantially uniform. The mixture was malleable early in the curing process and began to form a semi-solid to solid material after sufficient curing time.

[0133] Before evaluating the peroxide release behavior, the exemplary hardenable whitening composition was light-cured using a dental curing light. The mixture was malleable before being exposed to the dental curing light and turned into a solid after exposure. After curing, the solid composition was added to a container of water and allowed to dissolve for a predetermined period of time. The disclosed whitening gel sustained release of peroxide for several hours after dissolution.

[0134] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are embraced within their scope.

[0135] (Other terms and definitions) Although certain embodiments of the present disclosure have been described in detail with reference to specific configurations, parameters, components, elements, etc., this description is illustrative and is not to be construed as limiting the scope of the claimed invention.

[0136] Furthermore, unless otherwise stated implicitly or explicitly, it should be understood that for any element or component of the described embodiments, in general, any of the possible alternatives listed for that element or component can be used individually or in combination with each other.

[0137] In addition, unless otherwise indicated, numerical values ​​expressing quantities, components, distances, or other measurements used in the specification and claims are understood to be optionally modified by "about" or synonyms thereof. When the terms "about," "approximately," "substantially," and the like are used in conjunction with a stated quantity, value, or condition, it may be interpreted to mean that the quantity, value, or condition has a deviation of less than 20%, less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated quantity, value, or condition. At the very least, and without any attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be interpreted in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0138] The headings and subheadings used herein are for organizational purposes only and are not to be used to limit the scope of the specification or the claims.

[0139] Also, it should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" do not exclude plural referents unless expressly indicated otherwise. Thus, for example, an embodiment referring to a singular reference term (e.g., a "widget") may include two or more such reference terms.

[0140] It will also be understood that the embodiments described herein may include properties and / or features (e.g., components, components, members, elements, parts, and / or portions) described in one or more separate embodiments, and are not necessarily limited to the precise features explicitly described for that particular embodiment. Thus, various features of a given embodiment can be combined with and / or incorporated into other embodiments of the present disclosure. Thus, the disclosure of a particular feature with respect to a particular embodiment of the present disclosure should not be construed as limiting the application or inclusion of that feature to the particular embodiment. Rather, it will be understood that other embodiments may include such features.

Claims

1. a first part including a whitening agent and at least one of a catalyst and an initiator; a second part that is separate from the first part and includes at least one of a reactive monomer, oligomer, and polymer; A dental whitening system including

2. 2. The dental whitening system according to claim 1, wherein the whitening agent is hydrogen peroxide or carbamide peroxide.

3. The dental whitening system according to claim 1 or 2, characterized in that the first part further comprises a carrier material.

4. 4. The dental whitening system of claim 3, wherein the carrier material comprises at least one of polyacrylic acid or polyvinylpyrrolidone.

5. 4. The dental whitening system of claim 3, wherein the whitening agent and catalyst are dispersed in a carrier material.

6. 6. The dental whitening system of claim 1, wherein the first part further comprises at least one additional treatment agent.

7. 7. The dental whitening system of claim 6, wherein the at least one additional treatment agent comprises a desensitizing agent.

8. 8. The dental whitening system of claim 1, wherein the reactive polymer comprises at least one silane-terminated siloxane or hydroxy-terminated siloxane and at least one silane crosslinker.

9. 9. The dental whitening system according to claim 1, wherein the first part is disposed in one barrel of a double-barrel syringe and the second part is disposed in the other barrel of the double-barrel syringe.

10. 10. The dental whitening system according to claim 1, wherein the catalyst comprises at least one of a tin compound and a platinum compound.

11. 11. The dental whitening system of claim 1, wherein the catalyst comprises an organometallic catalyst.

12. 12. The dental whitening system of claim 11, wherein the organometallic catalyst comprises at least one of dimethyltin dineodecanoate, tin bis(neodecanoate), tin bis(2-ethylhexanoate), di-n-butyl dilauryltin, or dimethyltin hydroxy(oleate).

13. Providing a dental whitening system according to any one of claims 1 to 12; combining the first part and the second part to form a curable composition; placing a hardenable composition over at least a portion of a user's teeth; hardening the hardenable composition to form a hardened whitening composition on at least a portion of the user's teeth; wherein the hardened whitening composition provides cosmetic whitening of the teeth.

1. A method for cosmetically whitening teeth comprising:

14. removing the hardened whitening composition from the user's teeth; reapplying the hardened whitening composition to the user's teeth to resume cosmetic whitening of the teeth.

14. The method of claim 13, further comprising:

15. a first part including a whitening agent dispersed in a carrier material; a second part comprising at least one of a reactive monomer, oligomer, and polymer; a catalyst or initiator disposed in at least one of the first part and the second part; A dental whitening material comprising:

16. 16. The dental whitening material of claim 15, wherein the carrier material is a water-soluble polymer.

17. 17. The dental whitening material according to claim 15 or 16, characterized in that the carrier material comprises at least one of polyacrylic acid, polyvinylpyrrolidone, polyacrylate, polyacrylamide, copolymers of polyacrylic acid and polyacrylamide, polyvinylpyrrolidone-vinyl acetate copolymers, polyvinyl alcohol, polyethylene oxide, polyvinyl caprolactam, glycerin, and / or poly(2-ethyl-2-oxazoline).

18. a tray having an arched shape and defining a channel; A dental whitening material for placement in a tray. A dental whitening system comprising: The dental whitening material includes a first part including a condensation catalyst and a whitening agent, and a second part including a siloxane and a crosslinker. A dental whitening system comprising:

19. 20. The dental whitening system of claim 18, wherein the siloxane comprises at least one of a silanol-terminated polydimethylsiloxane or a hydroxyl-terminated polydimethylsiloxane.

20. 20. The dental whitening system according to claim 18 or 19, characterized in that the crosslinking agent comprises at least one functional silane.

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