Compositions containing iodide or thiocyanate, and methods for treating teeth.

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 generally relates to compositions and methods for removing or reducing the appearance of staining on teeth. The compositions and methods can be used, for example, to remove staining resulting from the use of silver-containing compounds for treating teeth.

Best Mode for Carrying Out the Invention

[0002] Silver diamine fluoride (SDF) has been proven to be an effective treatment for addressing tooth hypersensitivity and arresting 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. First, photo-induced silver oxide occurs because the compound reacts with the tooth to form silver phosphate precipitates, which are converted to silver oxide (which is black) when exposed to light. Second, microbially-induced silver sulfide occurs because sulfide compounds produced by some microbial species in the oral cavity react with the silver phosphate precipitates to form silver sulfide (which turns black over time).

[0004] Therefore, there may be a desire for compositions and methods to reverse, remove, or reduce the dark staining caused by the oral use of SDF (or other silver-containing compounds).

[0005] In this application, terms such as "a," "an," and "the" are not intended to refer only to singular entities but include general classifications, and specific examples of those general classifications 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 "comprising at least one of" following an enumeration refer to any one of the items in the enumeration and any combination of two or more of the items in the enumeration.

[0006] The term "or" is generally used in its usual sense, including "and / or," unless otherwise specified in the context.

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

[0008] Furthermore, in this specification, all numbers are considered to be modified by the term “approximately.” When used herein, in relation to a measured quantity, the term “approximately” refers to the variation in the measured quantity that can be predicted by a person skilled in the art who performs the measurement and exercises a level of care commensurate with the purpose of the measurement and the precision of the measuring instrument used. In this specification, the “maximum” digit (e.g., maximum 50) includes that number (e.g., 50).

[0009] Furthermore, in this specification, the description of a numerical range by endpoints includes all numbers and their endpoints that are included within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0010] Throughout this specification, references to “one embodiment,” “a certain embodiment,” “a particular embodiment,” or “several embodiments” mean that any specific feature, configuration, composition, or characteristic described in relation to an embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of such phrases in various places throughout this specification does not necessarily refer to the same embodiment of this disclosure. Furthermore, specific features, configurations, compositions, or characteristics may be combined in any preferred manner in one or more embodiments.

[0011] In general, this disclosure relates to methods for removing or reducing tooth discoloration resulting from the use of silver-containing compounds in the oral cavity. Surprisingly, it has been found that such discoloration can be removed or substantially reduced by performing an oxidation treatment followed by introducing 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 (so that the composition comes into contact with one or more teeth being treated). Generally, 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 include hydrogen peroxide, calcium peroxide, sodium peroxide, benzene peroxide, peracetic acid, and related salts, peracid esters, 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% by weight, at least 0.5% by weight, or at least 1.0% by weight, based on the total weight of the oxidizing composition. In some embodiments, the oxidizing composition may be an aqueous solution containing at least 30% by weight, at least 40% by weight, or at least 50% by weight of water, based on the total weight of the oxidizing composition.

[0013] In some embodiments, the step of introducing the oxidizing composition may include bringing one or more teeth to be treated into contact 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 (e.g., water) to facilitate the removal of any undesirable substances or residues from the tooth surface or the oral cavity.

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

[0016] In some embodiments, iodide or thiocyanate may be present in the oral care composition in an amount of at least 5% by weight, at least 10% by weight, at least 30% by weight, 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 representing 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 may include, in addition to providing an iodide source, introducing a composition that can contribute to addressing tooth hypersensitivity and preventing tooth decay. In such embodiments, the iodide-containing oral care composition may be an iodide-containing aqueous 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 iodide-containing aqueous composition may be selected from silver fluoride, silver chloride, silver nitrate, silver iodide, diamminesilver 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 amounts of at least 12.2% by weight (wt%), at least 13% by weight, or at least 13.5% by weight, where the weight percentage is based on the total weight of the composition (e.g., solution). In some embodiments, silver cations may be present in the composition in amounts of up to 20% by weight, up to 19% by weight, up to 18% by weight, or up to 17% by weight, where the weight percentage is 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, diamminesilver fluoride, sodium fluoride, ammonium fluoride, potassium fluoride, fluorine amines, and combinations thereof.

[0021] In some embodiments, fluoride ions (also referred to herein as fluoride anions) in the iodide-containing aqueous composition may be present in amounts of at least 2.0% by weight, at least 2.1% by weight, at least 2.2% by weight, or at least 2.25% by weight, where the weight percentage is based on the total weight of the composition (e.g., solution). In some embodiments, fluoride anions may be present in amounts of up to 4.0% by weight, up to 3.9% by weight, up to 3.8% by weight, up to 3.5% by weight, or up to 3.0% by weight, where the weight percentage is 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 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 contain 12.25% to 20% by weight of silver cations and 2.0% to 4.0% by weight of fluoride anions; or 13% to 17% by weight of silver cations and 2.25% to 3.0% by weight of 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 contain at least 20% by weight of water 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 a silver cation, a thiocyanate anion, a fluoride anion, 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 can be selected from silver fluoride, silver chloride, silver nitrate, silver iodide, diamminesilver fluoride, and combinations thereof.

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

[0030] In some embodiments, 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, 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 contains 12.2% to 20% by weight of silver cations and 2.0% to 4.0% by weight of 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 contains 12.2% to 20% by weight of silver cations and 2.2% to 3.5% by weight of fluoride an fluoride 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, guanidinium thiocyanate, and combinations thereof.

[0033] In certain embodiments, the thiocyanate-containing aqueous oral care solution contains 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 can form a precipitate (i.e., a solid formed from the solution). For the thiocyanate-containing aqueous oral care solution, the precipitate contains AgSCN. The resulting silver compound provides an antibacterial effect. Without being bound by theory, it is believed that AgSCN, fluoride ions, and excess thiocyanate ions form complexes with calcium in the teeth.

[0035] In some embodiments, the thiocyanate-containing aqueous oral care solution comprises 12.2% to 20% by weight of silver cations, 2.0% to 4.0% by weight (or 2.2% to 3.5% by weight) of fluoride anions (where 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 precipitates upon contact with additional water or saliva.

[0036] In some embodiments, the step of introducing a source of iodide or thiocyanate may include bringing one or more teeth to be treated into contact 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 a source of iodide or thiocyanate may be performed within 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, 1 minute, 10 minutes, 30 minutes, or 60 minutes from the step of introducing the oxidizing composition.

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

[0038] As described above, the methods of this disclosure may be useful in addressing both photo-induced silver oxide and microorganism-induced silver sulfide. In some embodiments, the mechanism of treatment for each of these can be understood as follows:

[0039] Photo-induced silver oxide [ka] Microbial-induced silver sulfide [ka] [ka]

[0040] In general, silver iodide products obtained from some of the methods of this disclosure (which may be in the form of precipitates) are thought to complex with calcium in teeth, along with any fluoride ions and any excess iodide ions, thereby preventing discoloration (even when exposed to light). Importantly, such products do not change (discolor) to dark colors such as black, brown, or gray after precipitation and exposure to light.

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

[0042] In some embodiments, either of the above iodide or thiocyanate-containing compositions may contain one or more further active agents. If included, one or more further active agents may be one or more active agents that are active in the oral cavity against disorders, diseases, or conditions of the teeth, gums, cheeks, tongue, palate, etc.

[0043] Further examples of 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, potassium zinc fluoride, ammonium fluoride, magnesium potassium fluoride, and combinations thereof.

[0044] Examples of further active agents that may be used include one or more whitening agents, antilithotripsy agents, remineralizing agents, stannous sources, antibacterial agents, antioxidants, salivary stimulants, breath fresheners, antiplaque agents, anti-inflammatory agents, H2 antagonists, desensitizers, nutrients, and proteins. Various combinations of such further active agents may be used if desired. If used, one or more further active agents will typically be used in amounts sufficient to achieve their intended effects.

[0045] When used, whitening agents can be a variety of suitable whitening agents. Examples of whitening agents include peroxide whitening agents, non-peroxide whitening agents, or both. Examples of peroxide whitening agents 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, as well as hydrogen peroxide glyceryl, hydrogen peroxide alkyl, dialkyl peroxide, peracid or perate, benzoyl peroxide, and urea peroxide. Hydrogen peroxide is the most common. Examples of non-peroxide whitening agents include chlorine dioxide, chlorous acid, and hypochlorous acid. Chlorous acid and hypochlorous acid are typically in the form of alkali metal salts or alkaline earth metal salts, such as salts of lithium, potassium, sodium, magnesium, calcium, or barium. Colorants, titanium dioxide, and hydroxyapatite can also be used.

[0046] When used, anticalculus agents can be a variety of suitable anticalculus agents. Examples of anticalculus agents include phosphates, polyphosphates, such as pyrophosphates, polyolefin sulfons, polyolefin phosphates, diphosphonates, phosphonoalkanecarboxylic acids, and salts thereof, typically alkali metal salts or ammonium salts.

[0047] When used, remineralizing agents can be a variety of suitable ones. Examples of remineralizing agents include substances that release calcium ions, phosphorus-containing ions, or both, such as calcium phosphate (e.g., monocalcium phosphate, dicalcium phosphate, and / or tricalcium phosphate), hydroxyapatite, and calcium carbonate.

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

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

[0050] When used, a variety of orally acceptable antimicrobial agents can be listed. Examples include triclosan, 8-hydroxyquinoline, zinc ions, stannous ions, cupric compounds, phthalates and their salts, quaternary ammonium compounds, sanguinalin, salicylanilide, salicylic acid, thymol, eugenol, neomycin, kanamycin, clindamycin, amoxicillin, tetracycline, doxycycline, minocycline, metronidazole, and chlorohexidine.

[0051] When used, antioxidants can be a variety of orally acceptable antioxidants. Examples include butylated hydroxyanisone, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid or its salts, chlorophyll, and melatonin.

[0052] When used, salivary stimulants can be a variety of orally acceptable ones. Examples include citrate, lactic acid, succinic acid, ascorbic acid, adipic acid, fumaric acid, and tartaric acid.

[0053] When used, breath fresheners can be a variety of orally acceptable ones. Examples include zinc salts, such as gluconic acid, citric acid, chlorite, and α-ionone.

[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, e.g., cetyl dimethicone copolyol, papain, glucoamylase, glucose oxidase, urea, calcium lactate, calcium glycerophosphate, and strontium polyacrylate. Further examples of antiplaque agents include biofilm inhibitors, particularly those described in U.S. Patent No. 8,968,709 (Yang et al.).

[0055] When used, anti-inflammatory agents can be a variety of orally acceptable anti-inflammatory agents. Examples include steroids, such as flucinolone and hydrocortisone; and 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, meclofenamete, mefenamic acid, oxyfenbutazone, and phenylbutazone.

[0056] When used, H2 antagonists can be a variety of orally acceptable H2 antagonists. Examples include cimetidine, ethinidine, ranitidine, thiotidine, lupitidine, denethidine, famotidine, roxatidine, pifatidine, lamutidine, zaltidine, nizatidine, mifentidine, lamixotidine, roxytidine, bisfentidine, safotidine, ebrotidine, and impromdine.

[0057] When used, desensitizers can be a variety of orally tolerable desensitizers. 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, and acetaminophen.

[0058] When used, nutrients can be a diverse range of orally acceptable nutrients. Examples include vitamins such as vitamin C, vitamin D, thiamine, riboflavin, folic acid, nicotinamide, niacin, pyridoxine, and bioflavonoids, and supplements such as amino acids, fat agonists, fish oil, polyunsaturated fatty acids, eicosapentanoic acid, docosahexaenoic acid, coenzyme Q10, ubiquinone, and minerals such as potassium.

[0059] When used, the proteins can be a variety of orally acceptable proteins. Examples include milk proteins, peroxide-producing enzymes, amylase, papain, glucoamylase, and glucose oxidase.

[0060] In some embodiments, either of the above iodide or thiocyanate-containing compositions may contain a pharmaceutically 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 may be selected to provide an oral care composition (e.g., a solution) having a pH of up to 9, up to 8.5, up to 7.5, or up to 7. In certain embodiments, the type and amount of such buffer may be selected to provide an oral care composition (e.g., a solution) having a pH of 6.5 to 7.5, or 7.0. A variety of suitable pharmaceutically acceptable buffers can be listed. Examples include acetates (e.g., sodium acetate), sodium carbonate, citrates (e.g., sodium citrate), tartrates, glycylglycine, histidine, glycine, lysine, arginine, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium phosphate, tris(hydroxymethyl)-aminomethane, or mixtures thereof.

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

[0062] In certain embodiments, the type and amount of the thickening agent are selected to provide an oral care composition (e.g., a 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 the thickening agent are selected to provide an oral care composition (e.g., a solution) having a viscosity of up to 500 pascal seconds at a shear rate of 1.0 / second.

[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 thickeners are typically those that are generally safe for human ingestion (FDA approved for internal use), do not bind to fluoride ions, and do not significantly affect the bioavailability of fluoride ions.

[0065] In certain embodiments, the thickener may be selected from natural rubber, non-acidic cellulose derivatives (e.g., hydroxyethylcellulose), 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-acidic modified starch, and combinations thereof.

[0066] In certain embodiments, the aqueous oral care composition (e.g., solution) of the Disclosure may contain 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 contain sweeteners. A variety of orally acceptable sweeteners can be used. Common sweeteners include xylitol, sorbitol, sucralose, aspartame, saccharin, and usually sodium saccharin. If present, the sweetener can be used in any preferred amount, in most cases sufficient to impart a pleasant sweetness to the composition (e.g., solution). Preferred amounts are 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 contain flavoring agents. 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. If present, the flavoring agent can be used in any preferred amount, in most cases sufficient to impart the desired flavor to the composition (e.g., solution). Preferred amounts are 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 contain a surfactant. Typically, such surfactants are anionic surfactants, examples of which include polysorbates, glycerols, polyglycerol-based surfactants, or combinations thereof. If present, the surfactant can be used in any suitable amount, in most cases sufficient to impart wetting properties. Suitable amounts are 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) may 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 may 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 a recommended period of time. In some embodiments, any or all of the compositions may be applied by spraying the composition onto the patient's teeth. In some embodiments, any or all of the compositions may be applied by applying or brushing the composition onto the patient's teeth. In some embodiments, any or all of the compositions may be applied by dispensing the composition into a dental or orthodontic tray and bringing the dental or orthodontic tray into contact with the patient's teeth. In some embodiments, any or all of the compositions may be incorporated into a dental fluoride varnish and applied by conventional varnishing methods. Most fluoride varnishes on the market are rosin / ethanol-based formulations with hydrophobic properties. The varnish is applied to the teeth and remains in place for several hours, allowing the fluoride to be released from the composition. Typically, dentists use fluoride varnish for in-house fluoride treatments. Most dental fluoride varnishes contain 5% sodium fluoride. The dosage of the varnish may be about 0.5 grams.

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

[0072] In some embodiments of the above method, the method may further include placing a dental restorative material on the surface of a tooth to which an oral care composition (e.g., a solution) has been applied (either before, after, drying, wiping, and / or forming a precipitate on the tooth surface of the composition (e.g., a solution)). 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, amalgam, 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 described above, the methods of the present disclosure are intended to remove or reduce tooth discoloration or darkening resulting from the use of silver-containing compounds for treating teeth. In this regard, in some embodiments, the patient's teeth may have already undergone treatment including exposure to a silver-containing compound (e.g., diamminesilver fluoride) before using the methods of the present disclosure. Therefore, in some embodiments, the patient's teeth may have one or more discolored or dark spots caused by exposure to a silver-containing compound before the steps of introducing the oxidizing composition and introducing the oral care composition.

[0074] In some embodiments, the disclosure relates to a kit comprising either or both of the above-described oxidizing compositions and oral care compositions, as well as an applicator. The applicator may include a dental brush, a cotton swab, and the like. In some embodiments, the applicator may be incorporated into a container having one of the above-described compositions. The kit may further comprise one or more of the following: dental restorative materials, trays, dishes, wells, or pans. 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 of this disclosure (e.g., oral care compositions) can be manufactured using any technique known to those skilled in the art. In some embodiments, the components are added together and dissolved in water in no particular order. Alternatively, the order of addition may be important when obtaining a composition (e.g., a solution). For example, in embodiments in which an aqueous oral care composition is used, a source of silver and fluoride (e.g., AgF) may be dissolved in water first, and then a source of iodide or thiocyanate 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). [Examples]

[0076] The purposes and advantages of this disclosure are further illustrated by the following examples, but the specific materials and quantities thereof, as well as other conditions and details described in these examples, should not be construed as unduly limiting this disclosure. These examples are for illustrative purposes only and are not intended to limit the scope of the appended claims. [Table 1]

[0077] Preparation of a test surface for discoloration 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 carious human teeth with varying caries sizes. The teeth were first rinsed with water, then with artificial saliva, rinsed again with water, and air-dried to remove excess water from the surface. These teeth were then treated with one of two silver-containing solutions: (1) silver iodide fluoride complex solution (formulation F1 described below) or (2) commercially available diammine silver fluoride solution (SDF) as described in Table 1 above. To simulate the period that dental patients experience after their teeth are 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 stored in a lactic acid demineralization solution at 37°C for 1 day, and finally stored in artificial saliva at 37°C for 3 days. This series was repeated three times. Following this series of treatments, all human carious teeth showed some degree of black discoloration, although the degree of discoloration varied somewhat between different silver-containing solutions and between individual teeth. In all cases, the amount of discoloration was greater than that of teeth treated with SDF. These discolored human teeth were then used in the post-treatment process described below, which is the subject matter claimed in this disclosure, to demonstrate the removal of black discoloration.

[0078] Preparation solution: Formulation F1 (silver iodide fluoride complex solution): An aqueous oral care composition of silver iodide fluoride complex was prepared by combining 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 form Formulation F1 solution with a total weight of 100 grams.

[0079] A concentrated ammonium iodide aqueous 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: A solution was prepared by mixing 4 grams of concentrated NH4I aqueous solution with 1 gram of silver iodide fluoride complex solution (formulation F1).

[0082] Mixture #2: A solution was prepared by mixing 4 grams of concentrated KI aqueous solution with 1 gram of silver iodide fluoride complex solution (formulation F1).

[0083] Diluted hydrogen peroxide solution: A 1% (diluted) H2O2 solution was prepared by mixing 2 grams of 3% H2O2 solution with 4 grams of water.

[0084] Example 1A: Treatment with 3% H2O2 and subsequent treatment with concentrated KI solution. The prepared test surfaces, which were human teeth stained black for the silver treatment and pretreatment described above, were first treated with a 3% H2O2 USP aqueous solution by rubbing the black stain with H2O2 for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. Next, the teeth were treated with concentrated potassium iodide for 1 minute and rinsed with water. In both the case of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercially available diammine silver 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.

[0085] Example 1B: Treatment with 3% H2O2 and subsequent treatment with formulation F1. The prepared test surfaces, which were human teeth stained black for the silver treatment and pretreatment described above, were first treated with a 3% H2O2 USP aqueous solution by rubbing H2O2 onto the black stain for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. Next, the teeth were treated with a silver iodide fluoride complex solution (formulation F1) for 1 minute and then rinsed with water. In both the case of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercially available diammine silver 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), and then rinsing with water.

[0086] Example 2A: Treatment with carbamide peroxide gel (22%) and subsequent formulation F1. The prepared test surfaces, which were human teeth stained black for the silver treatment and pretreatment described above, were first treated with carbamide peroxide gel (22%) by rubbing the H2O2 gel onto the black stain for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. Next, the teeth were treated with silver iodide fluoride complex solution (formulation F1) for 1 minute and then rinsed with water. In both the test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercially available diammine silver 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), and then rinsing with water.

[0087] Example 2B: Treatment with carbamide peroxide gel (22%) followed by treatment with concentrated NH4I solution. The prepared test surfaces, which were human teeth stained black for the silver treatment and pretreatment described above, were first treated with carbamide peroxide gel (22%) by rubbing the H2O2 gel onto the black stain for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. Next, the teeth were treated with concentrated ammonium iodide (NH4I) for 1 minute and rinsed with water. In both the case of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercially available diammine silver 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.

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

[0089] Example 3B: Treatment with 3% H2O2 and subsequent treatment with mixture #2. The prepared test surfaces, which were human teeth stained black for the silver treatment and pretreatment described above, were first treated with a 3% H2O2USP aqueous solution by rubbing the black stain with H2O2 for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. Next, the teeth were treated with mixture #2 (potassium iodide / silver iodide fluoride complex solution) for 1 minute and then rinsed with water. In both the case of test surfaces: (1) teeth pre-stained by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth stained with commercially available diammine silver fluoride solution (SDF), the black stain was removed after post-treatment with 3% H2O2 as an oxidizing agent, followed by treatment with mixture #2 (potassium iodide / silver iodide fluoride complex solution), and then rinsing with water.

[0090] Example 4: Treatment with 1% H2O2 and subsequent formulation F1. The prepared test surfaces, which were human teeth colored black for the silver treatment and pretreatment described above, were first treated with a 1% H2O2USP aqueous solution by rubbing the black colored areas with H2O2 for 30 seconds, then rinsed with water, and excess water on the tooth surface was wiped off with paper. Next, the teeth were treated with a silver iodide fluoride complex solution (formulation F1) for 1 minute and then rinsed with water. In both the case of test surfaces: (1) teeth pre-colored by treatment with silver iodide fluoride complex solution (formulation F1), and (2) teeth colored with commercially available diamminesilver fluoride solution (SDF), the black coloring was removed after post-treatment with 1% H2O2 as an oxidizing agent, followed by treatment with silver iodide fluoride complex solution (formulation F1), and then rinsing with water.

[0091] A substitute for formulation F1. The compositions of formulation F1 and suitable alternatives are shown in the table below. Alternative formulations F2 to F15, which contain a source of iodide and / or thiocyanate, may function similarly to formulation F1 in the process of removing discoloration caused by prior treatment with a silver solution, as shown in the above examples. [Table 2] [Table 3] [Table 4] [Table 5]

[0092] All disclosures of patents, patent documents, and publications referenced herein are incorporated by reference as if each were incorporated individually. Those skilled in the art will see various modifications and changes to this disclosure that do not deviate from the scope and spirit of this disclosure. It should be understood that this disclosure is not intended to be unduly limited by the exemplary embodiments and examples described herein, and that such embodiments and examples are presented only as examples within the scope of this disclosure, which is intended to be limited only by the claims described herein as follows. Examples of embodiments of the present invention are listed in the following sections [Aspect 1] to [Aspect 16]. [Aspect 1] A method for treating a patient's teeth or a method for reducing tooth discoloration, wherein the method is The oxidizing composition is introduced into the oral cavity of the patient, and the oxidizing composition is brought into contact with the teeth. The oral care composition is introduced into the oral cavity so that it comes into contact with the teeth, A method comprising the oral care composition comprising iodide or thiocyanate. [Aspect 2] The method according to embodiment 1, wherein the oxidizing composition contains a peroxide. [Aspect 3] The method according to embodiment 2, wherein the peroxide is present in the oxidizing composition as hydrogen peroxide, persulfate, benzoyl peroxide, or carbamide peroxide. [Aspect 4] The method according to embodiment 2 or 3, wherein the peroxide is present in the oxidizing composition in an amount of at least 0.1% by weight, based on the total weight of the oxidizing composition. [Aspect 5] The method according to any one embodiment of embodiments 1 to 4, wherein the iodide is present in the oral composition as potassium iodide, ammonium iodide, sodium iodide, calcium iodide, silver iodide, or a combination thereof. [Aspect 6] The method according to any one embodiment of embodiments 1 to 5, wherein the oral care composition comprises a silver cation, an iodide anion, a fluoride anion, and water. [Aspect 7] The method according to embodiment 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. [Aspect 8] The method according to embodiment 6 or 7, wherein the molar ratio of silver ions to iodide ions in the oral care composition is less than 0.42:1, and water is present in the oral care composition in an amount of less than 41.5% by weight based on the total weight of the oral care composition. [Aspect 9] The method according to any one embodiment of embodiments 1 to 4, wherein the thiocyanate is present in the oral composition as ammonium thiocyanate, sodium thiocyanate, potassium thiocyanate, guanidinium thiocyanate, or a combination thereof. [Aspect 10] The method according to any one embodiment of embodiments 1 to 4 or 9, wherein the oral care composition comprises a silver cation, a thiocyanate anion, a fluoride anion, and water. [Aspect 11] The method according to embodiment 9 or 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. [Aspect 12] The method according to embodiment 10 or 11, wherein the molar ratio of silver ions to thiocyanate ions is at least 0.1:1 and less than 0.37:1. [Aspect 13] The method according to any one embodiment of embodiments 1 to 12, wherein the step of introducing the oral care composition includes bringing the teeth into contact with the oral care composition for at least 5 seconds. [Aspect 14] The method according to any one embodiment of embodiments 1 to 13, wherein the step of introducing the oral care composition is performed after the step of introducing the oxidizing composition. [Aspect 15] The method according to any one embodiment of embodiments 1 to 14, wherein the step of introducing the oral care composition is performed within 60 minutes from the step of introducing the oxidizing composition. [Aspect 16] The method according to any one embodiment of embodiments 1 to 15, wherein, prior to the step of introducing the oxidizing composition and the step of introducing the oral care composition, the tooth has one or more discolorations caused by exposure to a silver-containing compound.

Claims

1. A kit for at least partially removing surface discoloration of teeth, wherein the discoloration is the result of treatment with silver sulfide or otherwise with diamminesilver fluoride, and the kit is Oxidizing composition and Oral care composition, Source of iodide anions, or Sources of thiocyanate anions, Oral care composition containing, A kit that includes this.

2. The kit according to claim 1, wherein the oxidizing composition comprises a peroxide.

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

4. The kit according to claim 2, wherein the peroxide is present in the oxidizing composition in an amount of at least 0.1% by weight, based on the total weight of the oxidizing composition.

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

6. The kit according to claim 1, wherein the oral care composition comprises an iodide anion, and further comprises a silver cation, a fluoride anion, and water.

7. The kit according to 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 kit according to claim 6, wherein the silver cation and the iodide anion 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% by weight based on the total weight of the oral care composition.

9. The kit according to 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. The kit according to claim 1, wherein the oral care composition comprises a thiocyanate anion, and further comprises a silver cation, a fluoride anion, and water.

11. The kit according to 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 kit according to claim 10, wherein the silver cation and the thiocyanate anion 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.

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