Compositions containing iodide or thiocyanate and methods for treating teeth

Abstract

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

Description

Technical Field

[0001] The present invention generally relates to compositions and methods for removing or reducing the appearance of dental stains. The compositions and methods are useful, for example, for removing stains resulting from treatment of teeth with silver-containing compounds. DETAILED DESCRIPTION

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

[0003] There are two mechanisms by which SDF (and other silver-containing compounds) cause dark or black staining of teeth. The first is light-induced silver oxide, which occurs when the compound reacts with the tooth to form a silver phosphate precipitate. When exposed to light, this silver phosphate precipitate converts to silver oxide (black in color). The second is microbially induced silver sulfide, which occurs when sulfur compounds produced by some microbial species in the mouth react with the silver phosphate precipitate to form silver sulfide (which turns black over time).

[0004] Therefore, there may be a need for compositions and methods for reversing, eliminating, or reducing dark spots caused by oral use of SDF (or other silver-containing compounds).

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

[0006] The term "or" is generally employed in its ordinary sense including "and / or" unless the content clearly 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] In addition, all numbers herein are assumed to be modified by the term "about". As used herein, with respect to a measured amount, the term "about" refers to the deviation in the measured amount that would be expected by a skilled artisan who, with a certain degree of care, performs the measurement commensurate with the objective of the measurement and the precision of the measuring equipment used. As used herein, "at most" a number (e.g., at most 50) includes 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 (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," "certain embodiments," or "some embodiments" mean that a particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, configurations, compositions, or characteristics may be combined in any suitable manner in one or more embodiments.

[0011] Generally speaking, the present disclosure relates to methods for removing or reducing the presence of tooth staining caused by the use of silver-containing compounds in the oral cavity. Surprisingly, it has been discovered that such stains can be removed or substantially reduced by an oxidative treatment followed by the introduction of a source of iodide or thiocyanate 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). Generally speaking, the oxidizing composition (or solution) can 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, crude benzene peroxide, peracetic acid and related salts, peresters, potassium persulfate, ammonium persulfate, calcium persulfate, sodium persulfate or a combination thereof. In some embodiments, the compound (or peroxide) containing peroxide groups 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 comprise contacting the tooth or 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 mouth with a fluid (eg, water) to facilitate removal of any undesirable matter or debris from the tooth surfaces or the oral cavity.

[0015] In some embodiments, after (or simultaneously or nearly simultaneously with) the oxidation step (and optionally rinsing with water), the methods of the present disclosure may include introducing an oral care composition (or solution) comprising an iodide (or iodide ion) or a thiocyanate (or thiocyanate ion) into the oral cavity. For example, the iodide may be present in the oral care composition as potassium iodide, ammonium iodide, sodium iodide, silver iodide, calcium iodide, or a combination thereof. The thiocyanate may be present as ammonium thiocyanate, sodium thiocyanate, potassium thiocyanate, guanidine thiocyanate, or a combination thereof.

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

[0017] In some embodiments, the step of introducing an iodide source can include introducing a composition that, in addition to providing an iodide source, can also help address tooth hypersensitivity and prevent dental caries. In such embodiments, the iodide-containing oral care composition can be an aqueous iodide-containing composition (e.g., a solution) comprising silver cations, iodide anions, fluoride anions, and water.

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

[0019] In some embodiments, silver ions (also referred to herein as silver cations) can 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 wt% is based on the total weight of the composition (e.g., solution). In some embodiments, silver cations can be present in the composition in an amount of at most 20 wt%, at most 19 wt%, at most 18 wt%, or at most 17 wt%, where the wt% is based on the total weight of the composition (e.g., solution).

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

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

[0022] In some embodiments, the iodide ion source (also referred to herein as iodide anion) can be selected from ammonium iodide, sodium iodide, potassium iodide, silver iodide, and combinations thereof. In some embodiments, the iodide ion source can include ammonium iodide and an optional second iodide ion source selected from sodium iodide, potassium iodide, silver iodide, and combinations thereof. In some embodiments, the iodide ion source can include ammonium iodide and an optional second iodide ion source 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, an aqueous iodide-containing composition (e.g., a solution) can comprise: 12.25 to 20 weight percent silver cations and 2.0 to 4.0 weight percent fluoride anions; or 13 to 17 weight percent silver cations; and 2.25 to 3.0 weight percent 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) can comprise water in an amount of at least 20 wt % 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) can be less than 41.5 wt % based on the total weight of the composition (e.g., solution).

[0026] In some embodiments, an aqueous oral care solution comprises: a silver cation; a thiocyanate anion; a fluoride anion; and water.

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

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

[0029] In some embodiments, the source of fluoride anions in the aqueous thiocyanate-containing composition can be selected from the group consisting of silver fluoride, silver ammonium fluoride, sodium fluoride, ammonium fluoride, potassium fluoride, amine fluoride, and combinations thereof.

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

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

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

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

[0035] In some embodiments, an aqueous thiocyanate-containing oral care solution comprises: 12.2% to 20% by weight silver cations; and 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, wherein the molar ratio of silver ions to thiocyanate ions is at least 0.1:1 and less than 0.37:1; wherein the oral care solution forms a precipitate upon contact with additional water or saliva.

[0036] In some embodiments, the step of introducing an iodide or thiocyanate source may comprise 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 an iodide or thiocyanate source may occur within 1 second, within 5 seconds, within 10 seconds, within 20 seconds, within 30 seconds, within 1 minute, within 10 minutes, within 30 minutes, or within 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 mouth with a fluid (eg, water) to facilitate removal of any undesirable material or debris from the tooth surfaces or oral cavity.

[0038] As described above, the methods of the present disclosure can be used to address both light-induced silver oxide and microbial-induced silver sulfide. In some embodiments, the treatment mechanism of each of these can be understood as follows:

[0039] Photoinduced silver oxide

[0040]

[0041] Microbially induced silver sulfide

[0042]

[0043] In general, it is believed that the silver iodide product (which may be in the form of a precipitate) produced by some methods of the present disclosure, along with any fluoride ions and any excess iodide ions, can complex with calcium in the teeth and thereby avoid discoloration (even when exposed to light treatment). Notably, such products do not convert (discolor) to a dark color such as black, brown, or gray after being precipitated and exposed to light treatment.

[0044] In some embodiments, as described above, some compositions containing iodide or thiocyanate of the present disclosure can be aqueous compositions (e.g., solutions). Such aqueous compositions can also include a certain amount (e.g., a small amount) of one or more organic solvents. Examples of suitable organic solvents include ethanol, isopropyl alcohol, dimethyl sulfoxide (DMSO), isoprene sulfone (IS), butadiene sulfone (BS), piperyl sulfone (PS), ethyl acetate, methyl acetate, isopropyl acetate, acetone, methyl ethyl ketone (MEK), methyl isobutyl ketone (MIBK), and combinations thereof.

[0045] In some embodiments, any of the iodide- or thiocyanate-containing compositions described above may include one or more additional active agents. When included, the one or more additional active agents may include one or more active agents that are effective in the oral cavity for disorders, diseases, or conditions of the teeth, gums, cheeks, tongue, palate, and the like.

[0046] Examples of additional active agents that may be employed include one or more fluorine-containing compounds such as sodium monofluorophosphate, stannous fluoride, calcium fluoride, strontium fluoride, zinc fluoride, potassium zinc fluoride, ammonium fluoride, potassium magnesium fluoride, and combinations thereof.

[0047] The example of the additional active agent that can be adopted comprises one or more whitening agents, anticalculus agent, remineralizing agent, stannous source, antimicrobial agent, antioxidant, saliva stimulating agent, breath freshener, antiplaque agent, anti-inflammatory agent, H2 antagonist, desensitizing agent, nutrient and protein.If desired, various combinations of this type of additional active agent can be used.When adopting, one or more additional active agents will be used usually with the amount that is enough to reach its expected effect.

[0048] When adopted, whitening agent can be multiple suitable whitening agents. Whitening agent can comprise for example peroxide whitening agent, non-peroxide whitening agent or both. Peroxide whitening agent comprises hydrogen peroxide, alkali metal or alkaline earth metal peroxide, such as sodium peroxide, potassium peroxide, lithium peroxide, magnesium peroxide, calcium peroxide, barium peroxide etc., peroxyglyceryl hydrogen, alkyl hydrogen peroxide, dialkyl peroxide, peroxy acid or peroxy acid salt, benzoyl peroxide, urea peroxide etc. Hydrogen peroxide is the most common. Non-peroxide whitening agent comprises chlorine dioxide, chlorite and hypochlorite. Chlorite and perchlorate are usually in the form of alkali metal or alkaline earth metal salt, such as salt of lithium, potassium, sodium, magnesium, calcium or barium. Also can use coloring agent, titanium dioxide and hydroxyapatite.

[0049] When employed, the anticalculus agent may be any of a variety of suitable anticalculus agents. Anticalculus agents may 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.

[0050] When employed, the remineralizing agent can be a variety of suitable remineralizing agents. Remineralizing agents can include, for example, materials that release calcium ions, phosphorus ions, or both, such as calcium phosphate (e.g., monocalcium phosphate, dicalcium phosphate, and / or tricalcium phosphate), hydroxyapatite, calcium carbonate, etc.

[0051] Examples of materials that release calcium ions are water-soluble calcium salts, such as those selected from calcium chloride, calcium nitrate, calcium gluconate, calcium lactate gluconate, calcium acetate, their hydrates, and their combinations. In certain embodiments, the calcium salt is selected from calcium chloride, calcium nitrate, their hydrates, and their combinations.

[0052] When employed, the stannous source can be a variety of suitable stannous ion sources. Stannous ion sources can include, for example, stannous halides, organic carboxylic acid stannous salts, 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 be used as the stannous source.

[0053] When employed, the antimicrobial agent may include a variety of orally acceptable antimicrobial agents. Examples include triclosan, 8-hydroxyquinoline, zinc ions, stannous ions, copper compounds, phthalic acid and its salts, quaternary ammonium compounds, sanguinarine, salicylaniline, salicylic acid, thymol, eugenol, neomycin, kanamycin, clindamycin, amoxicillin, tetracycline, doxycycline, minocycline, metronidazole, chlorhexidine, and the like.

[0054] When employed, the antioxidant may be any of a variety of orally acceptable antioxidants. Examples include butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid or its salts, chlorophyll, melatonin, and the like.

[0055] When employed, the saliva stimulating agent can be any of a variety of orally acceptable saliva stimulating agents. Examples include citric acid, lactic acid, succinic acid, ascorbic acid, adipic acid, fumaric acid, and tartaric acid.

[0056] When employed, the breath freshener can be any of a variety of orally acceptable breath fresheners. Examples include zinc salts such as gluconate, citrate, chlorite, ionone, and the like.

[0057] When employed, the antiplaque agent can be any of a variety of orally acceptable antiplaque agents. Examples include stannous salts, salts of copper, magnesium, or strontium, dimethicone copolyols such as cetyl dimethicone copolyol, papain, glucoamylase, glucose oxidase, urea, calcium lactate, calcium glycerophosphate, strontium polyacrylate, and the like. Additional examples of antiplaque agents include biofilm inhibitors, particularly those described in U.S. Pat. No. 8,968,709 (Yang et al.).

[0058] When used, the anti-inflammatory agent can be a variety of orally acceptable anti-inflammatory agents. Examples include steroids such as flucinolone and hydrocortisone; nonsteroidal anti-inflammatory drugs such as ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, diclofenac, etodolac, indomethacin, sulindac, tomlmetin, ketoprofen, fenoprofen, piroxicam, nabdomyostat, aspirin, salicylic acid, diflunisal, meclofenamic acid, mefenamic acid, oxybutazone, phenylbutazone, etc.

[0059] When used, the H2 antagonist can be a variety of orally acceptable H2 antagonists. Examples include cimetidine, propargyl, ranitidine, thiotidine, lupitidine, donetidine, famotidine, roxatidine, piperidin, lantidine, zotidine, nizatidine, fentidine, rafotidine, lavotidine, bifentidine, sufotidine, bromotidine, impromidine, etc.

[0060] When used, the desensitizing agent may be any of a variety of orally acceptable desensitizing agents. Examples 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.

[0061] When used, the nutrients can be a variety of orally acceptable nutrients. Examples include vitamins such as vitamin C, vitamin D, thiamine, riboflavin, folic acid, niacinamide, nicotinic acid, pyridoxine, bioflavonoids, etc.; supplements such as amino acids, anti-lipotropic agents, fish oil, polyunsaturated fatty acids, eicosapentaenoic acid, docosahexaenoic acid, coenzyme Q10, ubiquinone; and minerals such as potassium, etc.

[0062] When employed, proteins may include a variety of orally acceptable proteins. Examples include milk proteins, peroxide-generating enzymes, amylase, papain, glucoamylase, glucose oxidase, and the like.

[0063] In some embodiments, any one of the above-mentioned compositions containing iodide or thiocyanate can include a pharmaceutically acceptable buffer. The type and amount of such buffer can be selected to provide a pH of at least 5.5, at least 6 or at least 6.5 oral care compositions (e.g., solution). In certain embodiments, the type and amount of such buffer are selected to provide a pH of at most 9, at most 8.5, at most 7.5 or at most 7 oral care compositions (e.g., solution). In certain embodiments, the type and amount of such buffer are selected to provide a pH of 6.5 to 7.5 or a pH of 7.0 oral care compositions (e.g., solution). Multiple suitable pharmaceutically acceptable buffers can be included. Example includes acetate (e.g., sodium acetate), sodium carbonate, citrate (e.g., sodium citrate), tartrate, glycylglycine, histidine, glycine, lysine, arginine, sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium phosphate, tris (hydroxymethyl)-aminomethane or their mixture.

[0064] In some embodiments, the iodide- or thiocyanate-containing composition described above may include a thickener to provide a composition (e.g., solution) having a suitable viscosity to allow for the desired method of application. For example, a sufficient amount of a suitable thickener may be used to obtain a composition (e.g., solution) viscosity that is sufficient to maintain the composition (e.g., solution) in an inverted mouthpiece tray applicator for up to four minutes (a typical time for professionally applied fluoride treatments) and still be fluid enough to have handling properties acceptable to a dental practitioner (e.g., when dispensed into a dental tray applicator). Alternatively, a sufficient amount of a suitable thickener may be used to obtain a viscosity sufficient for application to the tooth surface.

[0065] In certain embodiments, the type and amount of thickener are selected to provide an oral care composition (e.g., solution) having a viscosity of at least 0.5 Pascal seconds at a shear rate of 1.0 / second. In certain embodiments, the type and amount of thickener are selected to provide an oral care composition (e.g., solution) having a viscosity of at most 500 Pascal seconds at a shear rate of 1.0 / second.

[0066] In certain embodiments, the thickener is present in the oral care composition (e.g., solution) in an amount of less than 2.5 weight % based on the total weight of the aqueous composition (e.g., solution). In certain embodiments, the thickener is present in an amount of at least 0.5 weight % based on the total weight of the aqueous composition (e.g., solution).

[0067] Suitable thickeners are generally those that are generally safe for human ingestion (approved by the U.S. Food and Drug Administration (FDA) for internal use), do not bind fluoride ions, and do not significantly affect the bioavailability of fluoride ions.

[0068] In certain embodiments, the thickening agent can be selected from natural gums, non-acidic cellulose derivatives (e.g., hydroxyethyl cellulose), inorganic fillers (e.g., colloidal silica, fumed silica, alumina, titanium dioxide, 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.

[0069] In certain embodiments, the aqueous oral care compositions (e.g., solutions) of the present disclosure may include one or more optional additives, including flavorings (i.e., spices) and sweeteners. Other optional additives include surfactants. Various combinations of such additives may be used if desired.

[0070] In certain embodiments, the aqueous oral care compositions (e.g., solutions) of the present disclosure may include sweeteners. A variety of orally acceptable sweeteners can be used. Common sweeteners include xylitol, sorbitol, sucralose, aspartame, saccharin (typically saccharin sodium), etc. When present, sweeteners can be used in any suitable amount, most commonly in an amount sufficient to impart a pleasant sweet taste to the composition (e.g., solution). Suitable amounts are typically 0.5% to 15% by weight based on the gross weight of the aqueous composition (e.g., solution).

[0071] In certain embodiments, the aqueous oral care composition of the present disclosure (e.g., solution) may include flavorings. A variety of oral acceptable flavorings can be used. Common flavorings include peppermint oil, spearmint oil, cherry flavor, citric acid, orange flavor, vanilla, strawberry flavor, coconut flavor and bubble gum flavor. When present, flavorings can be used in any suitable amount, most commonly in an amount sufficient to impart desired local flavor to the composition (e.g., solution). Suitable amount is typically 1 wt % to 4 wt % based on the gross weight of the aqueous composition (e.g., solution).

[0072] In certain embodiments, the aqueous oral care composition of the present disclosure (e.g., solution) may include a surfactant. Typically, such surfactants are anionic surfactants, examples of which include polysorbates, glycerol, polyglycerol-based surfactants, or compositions thereof. When present, the surfactant can be used in any suitable amount, most commonly in 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).

[0073] In some embodiments, any of the above-mentioned 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 in the composition can be applied by providing a certain amount of the composition to the patient and instructing the patient to rinse or gargle with the composition for the recommended time. In some embodiments, any or all of the compositions in the composition can be applied by spraying the composition on the patient's teeth. In some embodiments, any or all of the compositions in the composition can be applied by smearing or brushing the composition on the patient's teeth. In some embodiments, any or all of the compositions in the composition can be applied by distributing 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 in the composition can be incorporated into a dental fluoride varnish and applied by conventional varnishing methods. Most fluoride varnishes on the market are rosin / ethanol-based preparations with hydrophobic properties. The varnish is applied to the teeth and kept in place for several hours to allow fluoride to be released from the composition. Typically, dentists use fluoride varnishes for in-office fluoride treatments. Most dental fluoride varnishes contain 5% sodium fluoride. The varnish can be dosed in amounts of about 0.5 grams.

[0074] In some embodiments, any or all of the compositions of the present disclosure may be delivered via a liquid, emulsion, paste (or gel coating), tooth whitening strips, toothpaste (with a total fluoride content not exceeding 0.15%), chewing gum, or a combination thereof.

[0075] In some embodiments of the above methods, the method may further include placing a dental restorative on the tooth surface to which the oral care composition (e.g., solution) is applied (before or after the composition (e.g., solution) is dried, rinsed off, wiped off and / or forms a deposit on the tooth surface). Examples of dental restoratives include, but are not limited to, adhesives (such as 3MSCOTCHBOND Universal Adhesive (available from 3M Company, St. Paul, MN, USA)), primers, cements (such as 3M RelyX UNICEM 2 Automatic Mixing 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 (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.

[0076] As described above, the methods of the present disclosure are intended to remove or reduce tooth stains or dark discoloration resulting from treatment of teeth with silver-containing compounds. In this regard, in some embodiments, prior to employing the methods of the present disclosure, the patient's teeth may have undergone a treatment that included subjecting the teeth to a silver-containing compound (e.g., silver ammonium fluoride). Thus, in some embodiments, prior to the steps of introducing the oxidizing composition and introducing the oral care composition, the patient's teeth may include one or more stains or dark spots resulting from treatment with the silver-containing compound.

[0077] In some embodiments, the present disclosure relates to a kit comprising any one or both of the above-mentioned oxidizing composition and oral care composition and an applicator. The applicator may comprise a toothbrush, a cotton-tipped swab, or the like. In some embodiments, the applicator may be integrated into a container having any of the above-mentioned compositions therein. The kit may also comprise one or more of a dental restorative, a tray, a dish, a well, or a tray. Examples of dental restoratives include adhesives, primers, cements, liners, sealants, amalgams, resins, resin composites, glass ionomers, resin-modified glass ionomers, glass ceramics, ceramics, metals, plastics, or combinations thereof.

[0078] The compositions of the present disclosure (e.g., oral care compositions) can be prepared using any technique known to those skilled in the art. In some embodiments, the components are added together to water and dissolved in no particular order. Alternatively, the order of addition may be important in obtaining a composition (e.g., a solution). For example, in an embodiment using an aqueous oral care composition, silver and a fluoride source (e.g., AgF) may be dissolved in water first, and then an iodide or thiocyanate source may be added. Alternatively, each component may be dissolved separately in water and then combined to form an aqueous oral care composition (e.g., a solution).

[0079] Example

[0080] Although the objects and advantages of the present disclosure are further illustrated by the following examples, the specific materials and amounts thereof and other conditions and details recited in these examples should not be construed as unduly limiting the present disclosure. These examples are for illustrative purposes only and are not intended to limit the scope of the appended claims.

[0081] Table 1. Materials

[0082]

[0083]

[0084] Preparation of test surfaces for stain removal

[0085] (teeth stained by treatment with a solution containing silver)

[0086] Prior to treatment with silver compounds, extracted human teeth were disinfected and stored in water. These teeth were human decayed teeth with varying sizes of decayed lesions. The teeth were first rinsed with water, then rinsed with artificial saliva, rinsed with water again, and air-dried to remove excess surface water. The 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 ammonium fluoride solution (SDF) as described in Table 1 above. To simulate the period of time that dental patients experience after their teeth are treated with silver-containing solutions, the following procedure was followed. The treated teeth were first stored in artificial saliva at 37°C for 3 days, then in a lactic acid-based demineralization solution at 37°C for 1 day, and finally in artificial saliva at 37°C for 3 days. This series was repeated three times. After this series of treatments, all human decayed teeth showed some degree of black staining, although the degree of staining varied somewhat between the different silver-containing solutions and between individual teeth. In all cases, the amount of staining was greater with the teeth treated with SDF. These stained human teeth were then used in the post-treatment method described below, which is the claimed subject of the present disclosure, to demonstrate the removal of the black stain.

[0087] Prepare solutions :

[0088] Formulation F1 (silver iodide fluoride complex solution): An aqueous oral care composition of a silver iodide fluoride complex solution was prepared by mixing 31.0 grams of silver iodide (AgI), 31.4 grams of ammonium iodide (NH4I), 4.9 grams of ammonium fluoride (NH4F), and 32.7 grams of water to obtain a total weight of 100 grams of Formulation F1 solution.

[0089] Concentrated aqueous NH4I solution: A concentrated ammonium iodide solution was prepared by dissolving 172 g of ammonium iodide in 100 g of water at room temperature, which was a saturated solution at room temperature.

[0090] Concentrated KI solution: Prepare concentrated potassium iodide solution by dissolving 140 g of KI in 100 g of water at room temperature, which is a saturated solution at room temperature.

[0091] Mixture #1: 4 grams of concentrated aqueous NH4I solution was mixed with 1 gram of silver iodide fluoride complex solution (Formulation F1) to form a solution.

[0092] Mixture #2: 4 grams of concentrated aqueous KI solution was mixed with 1 gram of silver iodide fluoride complex solution (Formulation F1) to form a solution.

[0093] Diluted Hydrogen Peroxide Solution: Mix 2 grams of a 3% H2O2 solution with 4 grams of water to prepare a 1% (diluted) H2O2 solution.

[0094] Example 1A: Treatment with 3% H2O2 followed by concentrated KI solution .

[0095] The prepared test surface, i.e., human teeth stained black due to the silver treatment and conditioning described above, was first treated with a 3% aqueous solution of H2O2 USP by rubbing H2O2 over the black stain for 30 seconds, followed by rinsing with water and wiping excess water off the tooth surface with paper. Next, the tooth was treated with concentrated potassium iodide for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with a silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with a commercially available silver ammonium 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, and then rinsing with water.

[0096] Example 1B: Treatment with 3% H2O2 followed by treatment with Formulation F1 .

[0097] The prepared test surface, i.e., human teeth stained black due to the silver treatment and conditioning described above, was first treated with a 3% aqueous solution of H2O2 USP by rubbing H2O2 over the black stain for 30 seconds, followed by rinsing with water and wiping excess water from the tooth surface with paper. Next, the tooth was treated with a silver iodide fluoride complex solution (Formulation F1) for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with a silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with a commercially available silver ammonium fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as an oxidizing agent and then treatment with a silver iodide fluoride complex solution (Formulation F1) followed by rinsing with water.

[0098] Example 2A: Treatment with carbamide peroxide gel (22%) followed by treatment with formulation F1 .

[0099] The prepared test surface, i.e., human teeth stained black due to the silver treatment and conditioning described above, was first treated with carbamide peroxide gel (22%) by rubbing the H2O2 gel on the black stain for 30 seconds, followed by rinsing with water and wiping excess water from the tooth surface with paper. Subsequently, the teeth were treated with a silver iodide fluoride complex solution (Formulation F1) for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with a silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with a commercially available silver ammonium fluoride solution (SDF), the black stain was removed after post-treatment with carbamide peroxide gel (22%) as an oxidizing agent and then treatment with a silver iodide fluoride complex solution (Formulation F1) followed by rinsing with water.

[0100] Example 2B: Treatment with carbamide peroxide gel (22%) followed by treatment with concentrated NH4I solution .

[0101] The prepared test surface, i.e., human teeth stained black due to the silver treatment and conditioning described above, was first treated with carbamide peroxide gel (22%) by rubbing the H2O2 gel on the black stain for 30 seconds, followed by rinsing with water and wiping excess water from the tooth surface with paper. Subsequently, the teeth were treated with concentrated ammonium iodide (NH4I) for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with a silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with a commercially available silver ammonium 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, and then rinsing with water.

[0102] Example 3A: Treatment with 3% H2O2 followed by Mixture #1 .

[0103] The prepared test surface, i.e., a human tooth stained black due to the silver treatment and conditioning described above, was first treated with a 3% H2O2 USP aqueous solution by rubbing H2O2 over the black stain for 30 seconds, followed by rinsing with water and wiping excess water from the tooth surface with paper. Next, the tooth was treated with Mixture #1 (ammonium iodide / silver iodide fluoride complex solution) for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with commercially available ammonium silver fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as an oxidizing agent and then treatment with Mixture #1 (ammonium iodide / silver iodide fluoride complex solution) followed by rinsing with water.

[0104] Example 3B: Treatment with 3% H2O2 followed by Mixture #2 .

[0105] The prepared test surface, i.e., a human tooth stained black due to the silver treatment and conditioning described above, was first treated with a 3% aqueous solution of H2O2 USP by rubbing H2O2 over the black stain for 30 seconds, followed by rinsing with water and wiping excess water from the tooth surface with paper. Next, the tooth was treated with Mixture #2 (potassium iodide / silver iodide fluoride complex solution) for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with a silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with a commercially available silver ammonium fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as an oxidizing agent and then treatment with Mixture #2 (potassium iodide / silver iodide fluoride complex solution) followed by rinsing with water.

[0106] Example 4: Treatment with 1% H2O2 followed by treatment with Formulation F1 .

[0107] The prepared test surface, i.e., human teeth stained black due to the silver treatment and conditioning described above, was first treated with a 1% aqueous solution of H2O2 USP by rubbing H2O2 over the black stain for 30 seconds, followed by rinsing with water and wiping excess water off the tooth surface with paper. Next, the teeth were treated with a silver iodide fluoride complex solution (Formulation F1) for 1 minute and rinsed with water. In two cases of the test surface: (1) teeth previously stained by treatment with a silver iodide fluoride complex solution (Formulation F1) and (2) teeth stained with a commercially available silver ammonium fluoride solution (SDF), the black stain was removed after post-treatment with 1% H2O2 as an oxidizing agent and then treatment with a silver iodide fluoride complex solution (Formulation F1) followed by rinsing with water.

[0108] Alternatives to Formulation F1

[0109] The composition of formulation F1 and suitable alternatives are shown in the table below.Alternative formulations F2 to F15 containing an iodide and / or thiocyanate source will function in the same manner as formulation F1 in removing stains caused by previous treatment with silver solution, as shown in the above examples.

[0110] Table 2. Formulations F1 and F2

[0111] Components F1 F2 AgI 31.0 0 AgF 0 18.5 <![CDATA[NH4I]]> 31.4 0 <![CDATA[NH4F]]> 4.9 0 Guanidine thiocyanate 0 51.9 DI water 32.7 29.6 total% 100 100 Ag% 14.3 15.7 Total iodine% 44.4 0 Total fluoride% 2.5 2.8

[0112] Table 3. Formulations F3 to F7

[0113] Components F3 F4 F5 F6 F7 AgF 22.7 20.8 19.2 17.9 16.7 <![CDATA[NH4SCN]]> 45.5 41.7 38.5 35.7 33.3 <![CDATA[H2O]]> 31.8 37.5 42.3 46.4 50.0 total(%) 100 100 100 100 100 Ag% 19.3 17.7 16.4 15.2 14.2 Fluoride% 3.4 3.1 2.9 2.7 2.5 Ag / SCN molar ratio 0.30 0.30 0.30 0.30 0.30

[0114] Table 4. Formulations F8 to F11

[0115] Components F8 F9 F10 F11 F12 AgF 19.2 17.9 16.7 15.6 17.2 <![CDATA[NH4I]]> 57.7 53.6 50.0 46.9 51.7 <![CDATA[H2O]]> 23.1 28.6 33.3 37.5 31.0 total(%) 100 100 100 100 100 Ag% 16.4 15.2 14.2 13.3 14.7 Fluoride% 2.9 2.7 2.5 2.3 2.6 Ag / I molar ratio 0.38 0.38 0.38 0.38 0.38

[0116] Table 5. Formulations F13 to F15

[0117]

[0118]

[0119] The entire disclosures of the patents, patent documents, and publications cited herein are incorporated by reference in their entirety, as if each document were cited individually. 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 should be understood that the present disclosure is not intended to be unduly limited by the exemplary embodiments and examples shown herein, and that such examples and embodiments are presented by way of example only, and the scope of the present disclosure is intended to be limited only by the claims set forth herein below.

Claims

1. A method for at least partially removing stains on a tooth surface, said stains comprising silver sulfide or caused by treatment with silver ammonium fluoride, said method comprising: contacting the stain on the tooth surface with an oxidizing composition comprising a peroxide; and contacting the stain on the tooth surface with an oral care composition, The oral care composition comprises: Iodide anion source, or Source of thiocyanate anion.

2. The method of claim 1, wherein the oxidizing composition comprises a peroxyacid, a perester, a persulfate, or a combination thereof.

3. The method of claim 1, wherein the peroxide is present in the oxidizing composition as hydrogen peroxide, persulfate, benzoyl peroxide or urea peroxide.

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

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

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

8. The method of claim 6, wherein silver cations and iodide anions are present in the oral care composition in a silver:iodine 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 weight percent, based on the total weight of the oral care composition.

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

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

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

12. The method of claim 10, wherein silver cations and 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. The method of any one of claims 1 to 12, wherein the step of introducing the oral care composition comprises contacting the tooth 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. The method of any one of claims 1 to 12, wherein the step of introducing the oral care composition occurs within 60 minutes of the step of introducing the oxidizing composition.

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