Iodide or thiocyanate-containing compositions and methods for treating teeth - Patents.com

Abstract

A method of treating a patient's teeth includes introducing an oxidizing composition into the patient's oral cavity such that the oxidizing composition contacts the teeth. The method further includes introducing an oral care composition into the oral cavity such that the oral care composition contacts the teeth, the oral care composition comprising an iodide or thiocyanate.

Description

[Technical field]

[0001] The present invention relates generally to compositions and methods for removing or reducing the appearance of stains on teeth. The compositions and methods may be used, for example, to remove stains resulting from the use of silver-containing compounds to treat teeth. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0002] Silver diamine fluoride (SDF) has been proven to be an effective treatment for addressing tooth sensitivity and inhibiting dental caries. However, use of SDF is associated with dark staining of the teeth.

[0003] There are two mechanisms by which SDF (and other silver-containing compounds) result in dark or black tooth staining. First, light-induced silver oxide results when the compounds react with teeth to form silver phosphate deposits that are converted to silver oxide (which is black) when exposed to light. Second, microbiologically-induced silver sulfide results when sulfide compounds produced by some microbial species in the oral cavity react with silver phosphate deposits to form silver sulfide (which turns black over time).

[0004] Therefore, compositions and methods for reversing, removing, or reducing the dark staining caused from the oral use of SDF (or other silver-containing compounds) may be desirable.

[0005] In this application, terms such as "a," "an," and "the" are not intended to refer to only a singular entity, but include general classes, specific examples of which may be used for illustration. The terms "a," "an," and "the" are used interchangeably with the phrases "at least one" and "one or more." The phrases "at least one of" and "including at least one of" following a list refer to any one of the items in the list, as well as any combination of two or more items in the list.

[0006] The term "or" is generally used in its ordinary sense including "and / or" unless the context specifically dictates otherwise.

[0007] The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements.

[0008] Also, all numbers herein are deemed to be modified by the term "about." As used herein, in the context of a measured quantity, the term "about" refers to the variation in the measured quantity as would be expected by one of ordinary skill in the art making the measurement and exercising a level of care commensurate with the purpose of the measurement and the precision of the measuring device used. As used herein, a number "up to" (e.g., up to 50) is inclusive of that number (e.g., 50).

[0009] Also herein, the recitations of numerical ranges by endpoints include all numbers subsumed within that range, as well as the endpoints thereof (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0010] References throughout this specification to "one embodiment," "an embodiment," "particular embodiment," or "some embodiments" mean that the particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of such phrases in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, the particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0011] Generally, the present disclosure relates to a method for eliminating or reducing the presence of tooth staining resulting from the use of silver-containing compounds in the oral cavity. It has surprisingly been found that such staining can be eliminated or substantially reduced by administering an oxidative treatment followed by the introduction of an iodide or thiocyanate source into the oral cavity.

[0012] In some embodiments, the method of the present disclosure may include introducing an oxidizing composition into the oral cavity (such that the composition contacts one or more teeth to be treated). In general, the oxidizing composition (or solution) may be any composition capable of oxidizing silver sulfide present on the tooth surface. In some embodiments, the oxidizing solution may include any organic or inorganic compound having one or more peroxide groups. Such compounds may include hydrogen peroxide, calcium peroxide, sodium peroxide, benzol peroxide, peracetic acid and related salts, peresters, potassium persulfate, ammonium persulfate, calcium persulfate, sodium persulfate, or combinations thereof. In some embodiments, the peroxide group-containing compound (or peroxide) may be present in the oxidizing composition in an amount of at least 0.1 wt%, at least 0.5 wt%, or at least 1.0 wt%, based on the total weight of the oxidizing composition. In some embodiments, the oxidizing composition may be an aqueous solution comprising at least 30 wt%, at least 40 wt%, or at least 50 wt% water, based on the total weight of the oxidizing composition.

[0013] In some embodiments, the step of introducing the oxidizing composition may include contacting the one or more teeth to be treated with the oxidizing composition for at least 5 seconds, at least 10 seconds, at least 30 seconds, at least 1 minute, at least 5 minutes, at least 15 minutes, at least 30 minutes, at least 1 hour, at least 2 hours, or at least 5 hours.

[0014] In some embodiments, following the oxidation step, the method may include rinsing the oral cavity with a fluid (e.g., water) to facilitate removal of any undesirable material or residue from the tooth surfaces or oral cavity.

[0015] In some embodiments, following the oxidation step (or simultaneously or nearly simultaneously with the oxidation step) (and optionally following a water rinse), the method of the present disclosure may include introducing into the oral cavity an oral care composition (or solution) that includes iodide (or iodide ions) or thiocyanate (or thiocyanate ions). For example, iodide may be present in the oral care composition as potassium iodide, ammonium iodide, sodium iodide, silver iodide, calcium iodide, combinations thereof. Thiocyanate may be present as ammonium thiocyanate, sodium thiocyanate, potassium thiocyanate, guanidinium thiocyanate, or combinations thereof.

[0016] In some embodiments, the iodide or thiocyanate may be present in the oral care composition in an amount of at least 5%, at least 10%, at least 30%, or at least 50% by weight based on the total weight of the oral care composition. In some embodiments, the oral care composition may be saturated with iodide or thiocyanate (i.e., the iodide or thiocyanate may be present in an amount that represents the maximum amount that iodide or thiocyanate may be present in a particular solution).

[0017] In some embodiments, the step of introducing a source of iodide may include introducing a composition that may contribute to addressing dental sensitivity and inhibiting dental caries in addition to providing a source of iodide. In such embodiments, the iodide-containing oral care composition may be an iodide-containing aqueous composition (e.g., a solution) that includes silver cations, iodide anions, fluoride anions, and water.

[0018] In some embodiments, the source of silver cations in the iodide-containing aqueous composition may be selected from silver fluoride, silver chloride, silver nitrate, silver iodide, silver diammine fluoride, and combinations thereof.

[0019] In some embodiments, silver ions (also referred to herein as silver cations) may be present in the iodide-containing aqueous composition in an amount of at least 12.2 weight percent (wt%), at least 13 wt%, or at least 13.5 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution). In some embodiments, silver cations may be present in the composition in an amount of up to 20 wt%, up to 19 wt%, up to 18 wt%, or up to 17 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution).

[0020] In some embodiments, the source of fluoride anions in the iodide-containing aqueous composition may be selected from silver fluoride, silver diammine fluoride, sodium fluoride, ammonium fluoride, potassium fluoride, amine fluorides, and combinations thereof.

[0021] In some embodiments, the fluoride ions (also referred to herein as fluoride anions) in the iodide-containing aqueous composition may be present in an amount of at least 2.0 wt%, at least 2.1 wt%, at least 2.2 wt%, or at least 2.25 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution). In some embodiments, the fluoride anions may be present in an amount of up to 4.0 wt%, up to 3.9 wt%, up to 3.8 wt%, up to 3.5 wt%, or up to 3.0 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution).

[0022] In some embodiments, the source of iodide ions (also referred to herein as iodide anions) may be selected from ammonium iodide, sodium iodide, potassium iodide, silver iodide, and combinations thereof. In some embodiments, the source of iodide ions may include ammonium iodide and, optionally, a secondary source of iodide ions selected from sodium iodide, potassium iodide, silver iodide, and combinations thereof. In some embodiments, the source of iodide ions may include ammonium iodide and, optionally, a secondary source of iodide ions selected from sodium iodide, potassium iodide, silver iodide, and combinations thereof.

[0023] In some embodiments, the molar ratio of silver ions to iodide ions in the composition may be less than 0.42: 1. In some embodiments, the molar ratio of silver ions to iodide ions in the composition may be at least 0.09: 1.

[0024] In some embodiments, the iodide-containing aqueous composition (e.g., solution) may comprise 12.25% to 20% by weight silver cations and 2.0% to 4.0% by weight fluoride anions; or 13% to 17% by weight silver cations and 2.25% to 3.0% by weight fluoride anions, where the weight percentages are based on the total weight of the composition (e.g., solution).

[0025] In some embodiments, the iodide-containing aqueous composition (e.g., solution) may include water in an amount of at least 20% by weight, based on the total weight of the composition (e.g., solution). In some embodiments, the amount of water in the aqueous composition (e.g., solution) may be less than 41.5% by weight, based on the total weight of the composition (e.g., solution).

[0026] In some embodiments, the aqueous oral care solution comprises silver cations, thiocyanate anions, fluoride anions, and water.

[0027] In some embodiments, silver ions (also referred to herein as silver cations) may be present in the thiocyanate-containing aqueous composition in an amount of at least 12.25 weight percent (wt%), at least 13 wt%, or at least 13.5 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution). In some embodiments, silver cations may be present in the thiocyanate-containing composition in an amount of up to 20 wt%, up to 19 wt%, up to 18 wt%, or up to 17 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution).

[0028] In some embodiments, the source of silver cations in the thiocyanate-containing aqueous composition may be selected from silver fluoride, silver chloride, silver nitrate, silver iodide, silver diammine fluoride, and combinations thereof.

[0029] In some embodiments, the source of fluoride anion in the thiocyanate-containing aqueous composition may be selected from silver fluoride, silver diammine fluoride, sodium fluoride, ammonium fluoride, potassium fluoride, amine fluorides, and combinations thereof.

[0030] In some embodiments, the fluoride ions (also referred to herein as fluoride anions) in the thiocyanate-containing aqueous composition may be present in an amount of at least 2.0 wt%, at least 2.1 wt%, at least 2.2 wt%, or at least 2.25 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution). In some embodiments, the fluoride anions may be present in an amount of up to 4.0 wt%, up to 3.9 wt%, up to 3.8 wt%, up to 3.5 wt%, or up to 3.0 wt%, where the weight percentages are based on the total weight of the composition (e.g., solution).

[0031] In some embodiments, the thiocyanate-containing aqueous oral care solution comprises 12.2% to 20% by weight silver cations and 2.0% to 4.0% by weight fluoride anions, where the weight percentages are based on the total weight of the solution. In some embodiments, the thiocyanate-containing aqueous oral care solution comprises 12.2% to 20% by weight silver cations and 2.2% to 3.5% by weight fluoride anions.

[0032] In some embodiments, the molar ratio of silver ions to thiocyanate ions is less than 0.37: 1. In certain embodiments, the molar ratio of silver ions to thiocyanate ions is at least 0.1: 1. In certain embodiments, the source of thiocyanate ions (also referred to herein as thiocyanate anions) is selected from ammonium thiocyanate, sodium thiocyanate, potassium thiocyanate, guanidinium thiocyanate, and combinations thereof.

[0033] In certain embodiments, the thiocyanate-containing aqueous oral care solution comprises water in an amount of at least 20% and less than 57.5% by weight, based on the total weight of the solution.

[0034] Upon contact with additional water or saliva in the oral environment, the oral care solution may form a precipitate (i.e., a solid formed from solution). For thiocyanate-containing aqueous oral care solutions, the precipitate includes AgSCN. The resulting silver compound provides the antimicrobial effect. Without being bound by theory, it is believed that the AgSCN, fluoride ions, and excess thiocyanate ions complex with calcium in the teeth.

[0035] In some embodiments, the thiocyanate-containing aqueous oral care solution comprises 12.2% to 20% by weight silver cations, 2.0% to 4.0% (or 2.2% to 3.5%) by weight fluoride anions (wherein the weight percentages are based on the total weight of the solution), and thiocyanate anions, where the molar ratio of silver ions to thiocyanate ions is at least 0.1:1 and less than 0.37:1, and the oral care solution forms a precipitate upon contact with additional water or saliva.

[0036] In some embodiments, the step of introducing the iodide or thiocyanate source may include contacting the one or more teeth to be treated with the composition for at least 10 seconds, at least 30 seconds, at least 1 minute, at least 2 minutes, or at least 5 minutes. In some embodiments, the step of introducing the iodide or thiocyanate source may occur within 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, 1 minute, 10 minutes, 30 minutes, or 60 minutes of the step of introducing the oxidizing composition.

[0037] In some embodiments, following the step of introducing the iodide or thiocyanate source, the methods of the present disclosure may optionally include rinsing the oral cavity with a fluid (e.g., water) to facilitate removal of any undesirable material or residue from the tooth surfaces or oral cavity.

[0038] As mentioned above, the methods of the present disclosure may be useful in addressing both light-induced silver oxide and microbially-induced silver sulfide. In some embodiments, the mechanism of treatment for each of these may be understood to be as follows:

[0039] Photoinduced Silver Oxide [ka] Microbially Induced Silver Sulfide [ka] [ka]

[0040] Generally, it is believed that the silver iodide product (which may be in the form of precipitate) obtained from some methods of the present disclosure, together with any fluoride ion and any excess iodide ion, can form a complex with calcium in teeth, thereby avoiding discoloration (even when exposed to light).Importantly, such products do not change (discolor) to dark colors such as black, brown or gray after being precipitated and exposed to light.

[0041] In some embodiments, as described above, certain iodide- or thiocyanate-containing compositions of the present disclosure may be aqueous compositions (e.g., solutions). Such aqueous compositions may also include a quantity (e.g., small amount) of one or more organic solvents. Examples of suitable organic solvents include ethanol, isopropanol, dimethyl sulfoxide (DMSO), isoprene sulfone (IS), butadiene sulfone (BS), piperylene sulfone (PS), ethyl acetate, methyl acetate, isopropyl acetate, acetone, methyl ethyl ketone (MEK), methyl isobutyl ketone (MIBK), and combinations thereof.

[0042] In some embodiments, any of the above iodide- or thiocyanate-containing compositions may include one or more additional active agents, if included, which may include one or more active agents active in the oral cavity against disorders, diseases, or conditions of the teeth, gums, cheeks, tongue, palate, etc.

[0043] Examples of additional active agents that may be used include one or more fluorine-containing compounds, such as sodium monofluorophosphate, stannous fluoride, calcium fluoride, strontium fluoride, zinc fluoride, zinc potassium fluoride, ammonium fluoride, potassium magnesium fluoride, and combinations thereof.

[0044] Examples of additional active agents that can be used include one or more of whitening agents, anti-calculus agents, remineralization agents, stannous sources, antibacterial agents, antioxidants, saliva stimulants, breath fresheners, antiplaque agents, anti-inflammatory agents, H2 antagonists, desensitizers, nutrients, and proteins.If desired, various combinations of such additional active agents can be used.When used, one or more additional active agents will typically be used in an amount sufficient to achieve their intended effect.

[0045] When used, the brightener may be a variety of suitable brighteners. Brighteners may include, for example, peroxide brighteners, non-peroxide brighteners, or both. Peroxide brighteners include hydrogen peroxide, alkali metal or alkaline earth metal peroxides, such as sodium peroxide, potassium peroxide, lithium peroxide, magnesium peroxide, calcium peroxide, and barium peroxide, glyceryl hydrogen peroxide, alkyl hydrogen peroxide, dialkyl peroxide, peracids or salts, benzoyl peroxide, urea peroxide, and the like. Hydrogen peroxide is the most common. Non-peroxide brighteners include chlorine dioxide, chlorous acid, and hypochlorous acid. Chlorous acid and hypochlorous acid are typically in the form of an alkali metal salt or alkaline earth metal salt, such as lithium, potassium, sodium, magnesium, calcium, or barium salt. Colorants, titanium dioxide, and hydroxyapatite may also be used.

[0046] If used, the anticalculus agent can be a variety of suitable anticalculus agents. Anticalculus agents can include, for example, phosphates, polyphosphates, such as pyrophosphates, polyolefin sulfonates, polyolefin phosphates, diphosphonates, phosphonoalkane carboxylic acids, and salts thereof, typically alkali metal or ammonium salts.

[0047] If used, the remineralizing agent can be a variety of suitable remineralizing agents, including, for example, materials that release calcium ions, phosphorus-containing ions, or both, such as calcium phosphates (e.g., monocalcium phosphate, dicalcium phosphate, and / or tricalcium phosphate), hydroxyapatite, calcium carbonate, and the like.

[0048] Examples of materials that release calcium ions include water-soluble calcium salts, such as calcium chloride, calcium nitrate, calcium gluconate, calcium lactate gluconate, calcium acetate, hydrates thereof, and combinations thereof. In certain embodiments, the calcium salt is selected from calcium chloride, calcium nitrate, hydrates thereof, and combinations thereof.

[0049] If used, the stannous source can be a variety of suitable stannous ion sources. Stannous ion sources include, for example, stannous halides, organic stannous carboxylates such as stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, and stannous citrate. When the fluoride source is stannous fluoride, it can also function as the stannous source.

[0050] When used, antibacterial agents can include a variety of orally acceptable antibacterial agents, including, for example, triclosan, 8-hydroxyquinoline, zinc ions, stannous ions, cupric compounds, phthalic acid and its salts, quaternary ammonium compounds, sanguinarine, salicylanilide, salicylic acid, thymol, eugenol, neomycin, kanamycin, clindamycin, amoxicillin, tetracycline, doxycycline, minocycline, metronidazole, chlorhexidine, and the like.

[0051] If used, the antioxidant can be a variety of orally acceptable antioxidants, examples of which include butylated hydroxy anisone, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid or its salts, chlorophyll, melatonin, and the like.

[0052] If used, the saliva stimulant can be a variety of orally acceptable saliva stimulants, examples include citric acid, lactic acid, succinic acid, ascorbic acid, adipic acid, fumaric acid, and tartaric acid.

[0053] If used, the breath freshener can be a variety of orally acceptable breath fresheners. Examples include zinc salts, such as zinc salts of gluconate, citrate, chlorite, alpha-ionone, and the like.

[0054] When used, antiplaque agents can be a variety of orally acceptable antiplaque agents. Examples include stannous salts, copper, magnesium or strontium salts, dimethicone copolyols such as cetyl dimethicone copolyol, papain, glucoamylase, glucose oxidase, urea, calcium lactate, calcium glycerophosphate, strontium polyacrylate, and the like. Further examples of antiplaque agents include biofilm inhibitors, particularly those described in U.S. Pat. No. 8,968,709 (Yang et al.).

[0055] If used, the anti-inflammatory agent can be a variety of orally acceptable anti-inflammatory agents, including steroids such as flucinolone and hydrocortisone, non-steroidal anti-inflammatory drugs such as ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, diclofenac, etodolac, indomethacin, sulindac, tolmetin, ketoprofen, fenoprofen, piroxicam, nabumetone, acetylsalicylic acid, salicylic acid, diflunisal, meclofenamate, mefenamic acid, oxyphenbutazone, phenylbutazone, and the like.

[0056] If used, the H2 antagonist can be a variety of orally acceptable H2 antagonists, examples of which include cimetidine, ethinidine, ranitidine, tiotidine, rupitidine, denetidine, famotidine, roxatidine, pifatidine, ramutidine, zarutidine, nizatidine, mifentidine, lamixotidine, roxytidine, visfentidine, sufotidine, ebrotidine, impromdine, and the like.

[0057] If used, the desensitizing agent can be a variety of orally acceptable desensitizing agents, examples of which include potassium citrate, potassium chloride, potassium tartrate, potassium bicarbonate, potassium oxalate, potassium nitrate, strontium salts, arginine, acetylsalicylic acid or its salts, salicylic acid or its salts, codeine, acetaminophen, and the like.

[0058] If used, the nutrients can be a variety of orally acceptable nutrients, including vitamins such as vitamin C, vitamin D, thiamine, riboflavin, folic acid, nicotinamide, niacin, pyridoxine, and bioflavonoids, supplements such as amino acids, lipoactive agents, fish oils, polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, coenzyme Q10, ubiquinone, minerals such as potassium, and the like.

[0059] If used, proteins can include a variety of orally acceptable proteins, including milk proteins, peroxide generating enzymes, amylase, papain, glucoamylase, glucose oxidase, and the like.

[0060] In some embodiments, any of the iodide- or thiocyanate-containing compositions described above may include a pharma- ceutically acceptable buffer. The type and amount of such buffer may be selected to provide an oral care composition (e.g., a solution) having a pH of at least 5.5, at least 6, or at least 6.5. In certain embodiments, the type and amount of such buffer is selected to provide an oral care composition (e.g., a solution) having a pH of at most 9, at most 8.5, at most 7.5, or at most 7. In certain embodiments, the type and amount of such buffer is selected to provide an oral care composition (e.g., a solution) having a pH of 6.5 to 7.5, or a pH of 7.0. A variety of suitable pharma- ceutically acceptable buffers may be included. Examples include acetate (e.g., sodium acetate), sodium carbonate, citrate (e.g., sodium citrate), tartrate, glycylglycine, histidine, glycine, lysine, arginine, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium phosphate, tris(hydroxymethyl)-aminomethane, or mixtures thereof.

[0061] In some embodiments, any of the above iodide- or thiocyanate-containing compositions may include a thickener to provide a composition (e.g., solution) with a suitable viscosity that allows for the desired application method. For example, a suitable thickener may be used in an amount sufficient to achieve a composition (e.g., solution) viscosity that is suitable for maintaining the composition (e.g., solution) in an inverted mouthpiece tray applicator for up to 4 minutes (a time typical of professionally applied fluoride treatments), but is sufficiently fluid (e.g., when dispensed into a dental tray applicator) to have acceptable handling characteristics for a dental technician. Alternatively, a suitable thickener may be used in an amount sufficient to achieve a suitable viscosity for application onto a tooth surface.

[0062] In certain embodiments, the type and amount of thickener is selected to provide an oral care composition (e.g., a solution) with a viscosity of at least 0.5 Pascal-second at a shear rate of 1.0 / sec. In certain embodiments, the type and amount of thickener is selected to provide an oral care composition (e.g., a solution) with a viscosity of up to 500 Pascal-second at a shear rate of 1.0 / sec.

[0063] In certain embodiments, the thickening agent is present in the oral care composition (e.g., solution) in an amount of less than 2.5% by weight based on the total weight of the aqueous composition (e.g., solution). In certain embodiments, the thickening agent is present in an amount of at least 0.5% by weight based on the total weight of the aqueous composition (e.g., solution).

[0064] Suitable thickening agents are typically those that are generally safe for human consumption (FDA approved for internal use), that do not bind fluoride ions, and that do not significantly affect the bioavailability of fluoride ions.

[0065] In certain embodiments, the thickening agent may be selected from natural gums, non-acid cellulose derivatives (e.g., hydroxyethyl cellulose), inorganic fillers (e.g., colloidal silica, fumed silica, alumina, titania, and zinc oxide), alkylene oxide polymers (e.g., polyethylene glycol, polypropylene glycol, and copolymers of polyethylene glycol and polypropylene glycol), non-acid modified starches, and combinations thereof.

[0066] In certain embodiments, the aqueous oral care compositions (e.g., solutions) of the present disclosure may include one or more optional additives, including flavoring agents (i.e., flavorants) and sweeteners. Other optional additives include surfactants. Various combinations of such additives may be used, if desired.

[0067] In certain embodiments, the aqueous oral care compositions (e.g., solutions) of the present disclosure may include a sweetener. A variety of orally acceptable sweeteners can be used. Common sweeteners include xylitol, sorbitol, sucralose, aspartame, saccharin, usually sodium saccharin, and the like. When present, the sweetener can be used in any suitable amount, most often in an amount sufficient to impart a pleasant sweetness to the composition (e.g., solution). A suitable amount is typically 0.5% to 15% by weight based on the total weight of the aqueous composition (e.g., solution).

[0068] In certain embodiments, the aqueous oral care compositions (e.g., solutions) of the present disclosure may include a flavoring agent. A variety of orally acceptable flavoring agents can be used. Common flavoring agents include peppermint oil, spearmint oil, cherry flavor, citric acid, orange flavor, vanilla, strawberry flavor, coconut flavor, and bubble gum flavor. When present, the flavoring agent can be used in any suitable amount, most often in an amount sufficient to impart the desired flavor to the composition (e.g., solution). A suitable amount is typically 1% to 4% by weight based on the total weight of the aqueous composition (e.g., solution).

[0069] In certain embodiments, the aqueous oral care compositions (e.g., solutions) of the present disclosure may include a surfactant. Typically, such surfactants are anionic surfactants, examples of which include polysorbates, glycerol, polyglycerol-based surfactants, or combinations thereof. When present, the surfactant can be used in any suitable amount, most often an amount sufficient to impart wettability. A suitable amount is typically 0.1% to 5.0% by weight based on the total weight of the aqueous composition (e.g., solution).

[0070] In some embodiments, any of the above compositions (e.g., oxidizing compositions, oral care compositions, aqueous oral care compositions) can be introduced into the oral cavity and applied to the teeth in any conventional manner. For example, in some embodiments, any or all of the compositions can be applied by providing a quantity of the composition to the patient and instructing the patient to rinse or gargle with the composition for a recommended period of time. In some embodiments, any or all of the compositions can be applied by spraying the composition onto the patient's teeth. In some embodiments, any or all of the compositions can be applied by painting or brushing the composition onto the patient's teeth. In some embodiments, any or all of the compositions can be applied by dispensing the composition into a dental or orthodontic tray and contacting the dental or orthodontic tray with the patient's teeth. In some embodiments, any or all of the compositions can be incorporated into a dental fluoride varnish and applied by conventional varnishing methods. Most fluoride varnishes on the market are rosin / ethanol-based formulations that are hydrophobic in nature. The varnish is applied to the teeth and left in place for several hours, allowing the fluoride to be released from the composition. Typically, dentists use fluoride varnish for in-office fluoride treatments. Most dental fluoride varnishes contain 5% sodium fluoride. The dose of the varnish can be about 0.5 grams.

[0071] In some embodiments, any or all of the compositions of the present disclosure may be in a form that is delivered via a liquid, emulsion, paste, gel (or gel coating), tooth whitening strip, toothpaste, chewing gum, or a combination thereof.

[0072] In some embodiments of the above methods, the methods may further include placing a dental restorative material over the tooth surface to which the oral care composition (e.g., solution) has been applied (either before or after the composition (e.g., solution) has been allowed to dry, rinse, wipe, and / or form a deposit on the tooth surface). Examples of dental restorative materials include, but are not limited to, adhesives (such as 3M SCOTCHBOND Universal Adhesive available from 3M Company, St. Paul, MN, USA), primers, cements (such as 3M RelyX UNICEM 2 AUTOMIX Self-Adhesive Resin Cement available from 3M Company, St. Paul, MN, USA), liners (such as 3M ESPE VITREBOND Plus Light Cure Glass Ionomer Liner / Base), sealants, amalgams, resins, resin composites (such as 3M FILTEK Z250 Universal Restorative), glass ionomers (such as 3M KETAC Universal APLICAP Glass Ionomer Restorative), resin modified glass ionomers (such as RelyX Luting Plus RMGI Cement), glass ceramics, ceramics, metals, plastics, or combinations thereof.

[0073] As mentioned above, the method of the present disclosure is intended to remove or reduce tooth stains or dark discoloration resulting from the use of silver-containing compounds to treat teeth.In this regard, in some embodiments, before using the method of the present disclosure, the patient's teeth may have already undergone treatment that includes exposing the teeth to a silver-containing compound (e.g., silver diammine fluoride).Thus, in some embodiments, before the step of introducing the oxidizing composition and the step of introducing the oral care composition, the patient's teeth may have one or more stains or dark spots caused by exposure to a silver-containing compound.

[0074] In some embodiments, the present disclosure is directed to a kit comprising either or both of the oxidizing composition and the oral care composition described above, and an applicator. The applicator may include a dental brush, a cotton swab, or the like. In some embodiments, the applicator may be incorporated into a container having any of the compositions described above. The kit may further include one or more of a dental restorative material, a tray, a dish, a well, or a pan. Examples of dental restorative materials include adhesives, primers, cements, liners, sealants, amalgams, resins, resin composites, glass ionomers, resin modified glass ionomers, glass ceramics, ceramics, metals, plastics, or combinations thereof.

[0075] The compositions (e.g., oral care compositions) of the present disclosure can be prepared using any technique known to those skilled in the art. In some embodiments, the components are added together in water and dissolved in no particular order. Alternatively, the order of addition can be important in obtaining a composition (e.g., a solution). For example, in an embodiment in which an aqueous oral care composition is used, the silver and fluoride source (e.g., AgF) can be dissolved in water first, and then the iodide or thiocyanate source can be added. Alternatively, each component can be dissolved separately in water and then combined to form an aqueous oral care composition (e.g., a solution). EXAMPLES

[0076] The objects and advantages of the present disclosure are further illustrated by the following examples, but the particular materials and amounts thereof recited in these examples, as well as other conditions and details, should not be construed to unduly limit the disclosure. These examples are merely for illustrative purposes and are not intended to limit the scope of the appended claims. [Table 1]

[0077] Preparation of test surface for stain removal (Teeth stained by treatment with a silver-containing solution) Extracted human teeth were disinfected and stored in water before silver compound treatment. These teeth were human carious teeth with different caries sizes. The teeth were first rinsed with water, then with artificial saliva, rinsed again with water, and air-dried to remove excess water on the surface. These teeth were then treated with one of two silver-containing solutions: (1) a silver iodide fluoride complex solution (formulation F1 described below) or (2) a commercially available silver diamine fluoride solution (SDF) described in Table 1 above. To simulate the period that a dental patient experiences after having their teeth treated with a silver-containing solution, the following procedure was followed. The treated teeth were first stored in artificial saliva at 37°C for 3 days, then the teeth were stored in a lactic acid-based demineralization solution at 37°C for 1 day, and finally the teeth were stored in artificial saliva at 37°C for 3 days. This sequence was repeated three times. After this series of treatments, all human carious teeth showed some degree of black staining, although the degree of staining varied somewhat between different silver-containing solutions and between individual teeth. In all cases, the amount of staining was greater than that of teeth treated with SDF. These stained human teeth were then used in the post-treatment process described below, which is the claimed subject matter of the present disclosure, to demonstrate the removal of black staining.

[0078] Preparation solution: Formulation F1 (Silver iodide fluoride complex solution): An aqueous silver iodide fluoride complex oral care composition was prepared by combining 31.0 grams of silver iodide (AgI), 31.4 grams of ammonium iodide (NHI), 4.9 grams of ammonium fluoride (NHF), and 32.7 grams of water for a total weight of 100 grams of Formulation F1 solution.

[0079] Concentrated NH4I aqueous solution: A concentrated ammonium iodide solution was prepared by dissolving 172 grams of ammonium iodide in 100 grams of water at room temperature (this is a saturated solution at room temperature).

[0080] Concentrated KI solution: A concentrated potassium iodide solution was prepared by dissolving 140 grams of KI in 100 grams of water at room temperature (this is a saturated solution at room temperature).

[0081] Mixture #1: 4 grams of concentrated NH4I aqueous solution was mixed with 1 gram of silver iodide fluoride complex solution (Formulation F1) to form a solution.

[0082] Mixture #2: 4 grams of concentrated KI aqueous solution was mixed with 1 gram of silver iodide fluoride complex solution (Formulation F1) to form a solution.

[0083] Dilute Hydrogen Peroxide Solution: A 1% (dilute) H2O2 solution was prepared by mixing 2 grams of 3% H2O2 solution with 4 grams of water.

[0084] Example 1A: Treatment with 3% H2O2 followed by concentrated KI solution. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with 3% H2O2 USP aqueous solution by rubbing H2O2 on the black stain for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. The teeth were then treated with concentrated potassium iodide for 1 minute and rinsed with water. In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as an oxidizing agent, followed by treatment with concentrated potassium iodide (KI) solution, followed by rinsing with water.

[0085] Example 1B: Treatment with 3% H2O2 followed by formulation F1. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with 3% H2O2 USP aqueous solution by rubbing H2O2 on the black stain for 30 seconds, then rinsed with water, and the excess water on the tooth surface was wiped off with paper.The teeth were then treated with silver iodide fluoride complex solution (formulation F1) for 1 minute and rinsed with water.In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1) and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as an oxidizing agent, followed by treatment with silver iodide fluoride complex solution (formulation F1), followed by rinsing with water.

[0086] Example 2A: Carbamide peroxide gel (22%) followed by treatment with formulation F1. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with carbamide peroxide gel (22%) by rubbing the H2O2 gel on the black stain for 30 seconds, then rinsed with water, and the excess water on the tooth surface was wiped off with paper. The teeth were then treated with silver iodide fluoride complex solution (formulation F1) for 1 minute and rinsed with water. In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with carbamide peroxide gel (22%) as an oxidizing agent, followed by treatment with silver iodide fluoride complex solution (formulation F1), followed by rinsing with water.

[0087] Example 2B: Carbamide peroxide gel (22%) followed by treatment with concentrated NH4I solution. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with carbamide peroxide gel (22%) by rubbing the H2O2 gel on the black stain for 30 seconds, then rinsed with water, and the excess water on the tooth surface was wiped off with paper. The teeth were then treated with concentrated ammonium iodide (NH4I) for 1 minute and rinsed with water. In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with carbamide peroxide gel (22%) as an oxidizing agent, followed by treatment with concentrated ammonium iodide (NH4I) solution, followed by rinsing with water.

[0088] Example 3A: 3% H2O2 followed by treatment with Mixture #1. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with 3% H2O2 USP aqueous solution by rubbing H2O2 on the black stain for 30 seconds, then rinsed with water, and the excess water on the tooth surface was wiped off with paper.The teeth were then treated with Mixture #1 (ammonium iodide / silver iodide fluoride complex solution) for 1 minute and rinsed with water.In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as oxidizing agent, followed by treatment with Mixture #1 (ammonium iodide / silver iodide fluoride complex solution), followed by rinsing with water.

[0089] Example 3B: 3% H2O2 followed by treatment with Mixture #2. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with 3% H2O2 USP aqueous solution by rubbing H2O2 on the black stain for 30 seconds, then rinsed with water, and the excess water on the tooth surface was wiped off with paper.The teeth were then treated with mixture #2 (potassium iodide / silver iodide fluoride complex solution) for 1 minute and rinsed with water.In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as oxidizing agent, followed by treatment with mixture #2 (potassium iodide / silver iodide fluoride complex solution), followed by rinsing with water.

[0090] Example 4: Treatment with 1% H2O2 followed by formulation F1. The prepared test surfaces, human teeth stained black due to the above silver treatment and pretreatment, were first treated with 1% H2O2 USP aqueous solution by rubbing H2O2 on the black stain for 30 seconds, then rinsed with water, and the excess water on the tooth surface was wiped off with paper.The teeth were then treated with silver iodide fluoride complex solution (formulation F1) for 1 minute and rinsed with water.In both cases of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1) and (2) teeth stained with commercial silver diamine fluoride solution (SDF), the black stain was removed after post-treatment with 1% H2O2 as an oxidizing agent, followed by treatment with silver iodide fluoride complex solution (formulation F1), followed by rinsing with water.

[0091] Alternative to formulation F1. The composition of formulation F1 and suitable alternatives is given in the table below. The alternative formulations F2 to F15, containing a source of iodide and / or thiocyanate, may function similarly to formulation F1 in the process of removal of the staining caused by a previous treatment with a silver solution, as shown in the examples above. [Table 2] [Table 3] [Table 4] [Table 5]

[0092] The entire disclosures of the patents, patent documents, and publications cited herein are incorporated by reference in their entirety as if each were individually incorporated. Various modifications and alterations to the present disclosure will become apparent to those skilled in the art without departing from the scope and spirit of the present disclosure. It is to be understood that the present disclosure is not intended to be unduly limited by the exemplary embodiments and examples described herein, and that such examples and embodiments are presented only as examples within the scope of the present disclosure, which is intended to be limited only by the claims set forth herein as follows.

Claims

1. A method for at least partially removing staining on the surface of a tooth, said staining containing silver sulfide or otherwise resulting from treatment with silver diammine fluoride, said method comprising: introducing an oxidizing composition into the patient's oral cavity so that the oxidizing composition contacts stains on the tooth surface; introducing an oral care composition into the oral cavity so that the oral care composition contacts stains on the tooth surfaces; Including, The oral care composition comprises: a source of iodide anions, or a source of thiocyanate anions; A method comprising:

2. The method of claim 1 , wherein the oxidizing composition comprises a peroxide.

3. 3. The method of claim 2, wherein the peroxide is present in the oxidizing composition as hydrogen peroxide, persulfate, benzoyl peroxide, or carbamide peroxide.

4. 3. The method of claim 2, wherein the peroxide is present in the oxidizing composition in an amount of at least 0.1 wt. %, based on the total weight of the oxidizing composition.

5. 10. The method of claim 1, wherein the source of iodide anions is present in the oral composition as potassium iodide, ammonium iodide, sodium iodide, calcium iodide, silver iodide, or a combination thereof.

6. 10. The method of claim 1, wherein the oral care composition comprises iodide anions and further comprises silver cations, fluoride anions, and water.

7. 7. The method of claim 6, wherein the oral care composition comprises 13% to 17% by weight of silver cations and 2.25% to 3.0% by weight of fluoride anions, based on the total weight of the oral care composition.

8. The method described in claim 6, wherein the silver cations and iodide anions are present in the oral care composition in a silver:iodide molar ratio of less than 0.42:1, and water is present in the oral care composition in an amount of less than 41.5 wt.% based on the total weight of the oral care composition.

9. 10. The method of claim 1, wherein the thiocyanate anion is present in the oral composition as ammonium thiocyanate, sodium thiocyanate, potassium thiocyanate, guanidinium thiocyanate, or a combination thereof.

10. 10. The method of claim 1, wherein the oral care composition comprises thiocyanate anions and further comprises silver cations, fluoride anions, and water.

11. 11. The method of claim 10, wherein the oral care composition comprises 12.2% to 20% by weight of silver cations and 2.0% to 4.0% by weight of fluoride anions, based on the total weight of the oral care composition.

12. The method described in claim 10, wherein the silver cations and the thiocyanate anions are present in the oral care composition in a silver:thiocyanate molar ratio of at least 0.1:1 and less than 0.37:

1.

13. 13. The method of any one of claims 1 to 12, wherein the step of introducing the oral care composition comprises contacting the teeth with the oral care composition for at least 5 seconds.

14. The method of any one of claims 1 to 12, wherein the step of introducing the oral care composition occurs after the step of introducing the oxidizing composition.

15. A kit for at least partially removing stains on the surface of teeth, said stains containing silver sulfide or otherwise resulting from treatment with silver diammine fluoride, said kit comprising: an oxidizing composition; 1. An oral care composition comprising: a source of iodide anions, or a source of thiocyanate anions; an oral care composition comprising Includes a kit.