Oral care compositions and methods

Abstract

The disclosure includes an oral care composition comprising an orally acceptable carrier and a mixture of plant materials, wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract. Methods of the disclosure comprise treating or preventing periodontitis by promoting osteoblast cell mineralization with the oral care composition.

Description

13344-00- WO-Ol-OCORAL CARE COMPOSITIONS AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority from U.S. Provisional Application No.63 / 763,615, filed 26 February 2025, the contents of which are hereby incorporated by reference in their entirety.BACKGROUND

[0002] Periodontitis is a chronic infection that affects the gums and the bones that support the teeth. The condition is caused by a build-up of bacterial plaque as a biofilm that accumulates on the teeth and around the gum line. The bacteria irritate and inflame the gums, which causes sore, bleeding gums typically associated with gingivitis. Failure to remove the plaque, such as through regular brushing or flossing, can lead to periodontitis. In periodontitis, gum inflammation spreads to the deeper connective tissues, including the bone, that support the teeth.

[0003] Periodontitis negatively impacts the bone remodeling process and causes the bone and connective tissue that hold teeth in place to irreversibly break down. Bone remodeling involves the removal of mineralized bone by osteoclasts followed by the formation of bone matrix through the osteoblasts that subsequently become mineralized. In periodontitis, the bacteria-initiated inflammatory cascade disrupts the remodeling balance such that bone resorption is greater than bone formation, leading to bone loss. Periodontitis may eventually cause teeth to become loose or to fall out, and may require removing affected teeth in a dental procedure.

[0004] The effects of periodontitis can go beyond the mouth and may lead to other systemic diseases. Some common health problems potentially linked to periodontitis include heart disease, diabetes, respiratory disease, chronic kidney disease, increased risk of stroke, and premature birth, among others.

[0005] It would therefore be beneficial to develop oral care compositions that promote osteoblast cell mineralization and thereby offer a treatment option for periodontitis and other related diseases and disorders.BRIEF SUMMARY

[0006] This summary is intended merely to introduce a simplified summary of some embodiments of one or more implementations of the present disclosure. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. This13344-00- WO-Ol-OCsummary is not an extensive overview, nor is it intended to identify all elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description below.

[0007] One embodiment of the disclosure includes an oral care composition, which comprises:an orally acceptable carrier; anda mixture of plant materials,wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract; andwherein the mixture of plant materials is present in the oral care composition in an amount ranging from about 0.001 wt% to about 0.09 wt%, such as from about 0.01 wt% to about 0.08 wt%, or such as from about 0.03 wt% to about 0.07 wt%, based on the total weight of the oral care composition.

[0008] In some embodiments, thymol is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials. In further embodiments, peppermint oil is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials. In additional embodiments, oregano oil is present in the mixture of plant materials in an amount ranging from about 1 wt% to about 20 wt%, such as from about 5 wt% to about 15 wt%, based on the total weight of the mixture of plant materials. In further embodiments, rosemary oil is present in the mixture of plant materials in an amount ranging from about 0.01 wt% to about 5 wt%, such as from about 0.1 wt% to about 4 wt%, based on the total weight of the mixture of plant materials.

[0009] The lavender oil. natural cinnamic aldehyde, lemon oil. cinnamon bark oil, golden seal root extract and olive leaf extract can each independently be present in the mixture of plant materials in an amount ranging from, for example, about 0.0001 wt% to about 5 wt%, such as from about 0.01 wt% to about 2 wt%, based on the total weight of the mixture of plant materials.

[0010] The oral care composition may comprise additional active or inactive ingredients, such as a fluoride ion source or a metal ion source. The oral care composition may also be in any13344-00- WO-Ol-OCappropriate form for oral administration, such as in the form of a mouthwash, a mouth rinse, a toothpaste, a gel, a patch or a solid film.

[0011] A further embodiment of the disclosure includes a method of treating or preventing periodontitis in a subject in need thereof, which comprises applying an oral care composition to the oral cavity of the subject suffering from periodontitis or at risk of developing periodontitis to promote osteoblast cell mineralization, wherein the oral care composition comprises:an orally acceptable carrier; anda mixture of plant materials,wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract.

[0012] The oral care compositions for use in methods of the disclosure can include, for example, any of the oral care compositions described above.

[0013] Methods of the disclosure can include inhibiting the growth of one or more periodontal pathogens in the oral cavity of the subject selected from Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Fusobacterium nucleatum. In certain embodiments, the subject suffering from periodontitis or at risk of developing periodontitis also suffers from one or more of diabetes, obesity, leukemia, HIV / AIDS, cardiovascular disease, osteoporosis, rheumatoid arthritis and Crohn's disease. In further embodiments, the subject suffering from periodontitis or at risk of developing periodontitis is a tobacco user, is undergoing cancer treatment, and / or is 65 years or older.

[0014] Some embodiments of methods of the disclosure include applying the oral care composition to the oral cavity of the subject for about 5 seconds to about 30 minutes, such as for about 10 seconds to about 20 minutes, or such as for about 30 seconds to about 2 minutes. The methods of the disclosure may also include applying the oral care composition to the oral cavity of the subject at least once a day, such as at least twice a day, or such as at least three times a day.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The features and advantages of the disclosure will be apparent from the following more detailed description of certain embodiments and as illustrated in the accompanying Figure in which:

[0016] FIG. 1 is a bar graph illustrating the dose-dependent effect of SUPRAPEIN® (A6) on13344-00- WO-Ol-OCosteoblast cell mineralization.

[0017] It should be understood that the disclosure is not limited to the particular compositions and results shown in the Figure.DETAILED DESCRIPTION

[0018] For illustrative purposes, the principles of the present disclosure are described by referencing various exemplary embodiments thereof. Although certain embodiments of the disclosure are specifically described herein, one of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be employed in, other compositions and methods. Before explaining various embodiments of the present disclosure in detail, it is to be understood that the disclosure is not limited in its application to the details of any particular embodiments disclosed herein. The terminology used herein is for the purpose of description and not of limitation.

[0019] As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural references unless the context dictates otherwise. The singular form of any class of the ingredients refers not only to one chemical species within that class, but also to a mixture of those chemical species. The terms “a” (or “an”), “one or more” and “at least one” may be used interchangeably herein. The terms “comprising”, “including”, and “having” may be used interchangeably. The term “include” should be interpreted as “include, but are not limited to”. The term “including” should be interpreted as “including, but are not limited to”.

[0020] As used throughout, ranges are used as shorthand for describing each and every value that is within the range. It should be appreciated and understood that the description in a range format is merely for convenience and brevity, and should not be construed as an inflexible limitation on the scope of any embodiments or implementations disclosed herein. Accordingly, the disclosed range should be construed to have specifically disclosed all the possible subranges as well as individual numerical values within that range. Any value within the range can be selected as the terminus of the range. Thus, a range from 1-5, includes specifically 1, 2, 3, 4 and 5, as well as subranges such as 2-5, 3-5, 2-3, 2-4, 1-4, etc.

[0021] The term “about” when referring to a number means any number within a range of 10% of the number. For example, the phrase “about 2 wt%” refers to a number between and including 1.8 wt% and 2.2 wt%.

[0022] The abbreviations and symbols as used herein, unless indicated otherwise, take their ordinary meaning. The abbreviation “wt%” means percent by weight. The symbol “°” refers to a temperature degree. The symbols “mM”, “pg”, “pg” and “ml” refer to milli moles, micro grams, pico grams and milliliters, respectively.

[0023] Any member in a list of species that are used to exemplify or define a genus may be mutually different from, or overlapping with, or a subset of, or equivalent to, or nearly the same as, or identical to, any other member of the list of species. Further, unless explicitly stated, such as when reciting a Markush group, the list of species that define or exemplify the genus is open, and it is given that other species may exist that define or exemplify the genus just as well as, or better than, any other species listed.

[0024] The phrases, “a mixture thereof,” “a combination thereof.” or a combination of two or more thereof’ do not require that the mixture include all of A, B, C, D, E, and F (although all of A, B, C, D, E, and F may be included). Rather, it indicates that a mixture of any two or more of A, B, C, D, E, and F can be included. In other words, it is equivalent to the phrase “one or more elements selected from the group consisting of A, B, C, D, E, F, and a mixture of any two or more of A, B, C, D, E, and F.” Likewise, the term “a salt thereof’ also relates to “salts thereof.” Thus, where the disclosure refers to “an element selected from the group consisting of A, B, C, D, E, F, a salt thereof, and a mixture thereof,” it indicates that that one or more of A, B, C, D, E and F may be included, one or more of a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included, or a mixture of any two of A, B, C, D, E, F, a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included.

[0025] All components and elements positively set forth in this disclosure can be negatively excluded from the claims. In other words, the oral care compositions of the instant disclosure can be free or essentially free of all components and elements positively recited throughout the instant disclosure. In some instances, the oral care compositions of the present disclosure may be substantially free of non-incidental amounts of the ingredient(s) or compound(s) described herein. A non-incidental amount of an ingredient or compound is the amount of that ingredient or compound that is added into the oral care composition by itself. For example, an oral care composition may be substantially free of a non-incidental amount of an ingredient or compound, although such ingredient(s) or compound(s) may be present as part of a raw material that is included as a blend of two or more compounds.13344-00- WO-Ol-OC

[0026] Some of the various categories of components identified may overlap. Tn such cases where overlap may exist and the oral care composition includes both components (or the composition includes more than two components that overlap), an overlapping compound does not represent more than one component. For example, certain compounds may be characterized as both a humectant and a sweetener. If a particular oral care composition includes both a humectant and a sweetener (e.g., xylitol), the compound will serve only as either a humectant or a sweetener — not both.

[0027] Embodiments of the disclosure include an oral care composition, which comprises:an orally acceptable carrier; anda mixture of plant materials,wherein the mixture of plant materials comprises thymol, peppermint oil. oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract; andwherein the mixture of plant materials is present in the oral care composition in an amount ranging from about 0.001 wt% to about 0.09 wt%, such as from about 0.01 wt% to about 0.08 wt%, or such as from about 0.03 wt% to about 0.07 wt%, based on the total weight of the oral care composition.

[0028] The oral care composition may be used, for example, for the treatment or prevention of periodontitis, or to ameliorate symptoms associated with periodontitis. In periodontitis, a bacteria initiated inflammatory cascade disrupts the remodeling balance such that bone resorption is greater than bone formation, leading to bone loss. As demonstrated in the Example, a mixture of plant materials as disclosed herein may be included in an oral care composition to promote osteoblast cell mineralization and thereby treat periodontitis by improving the bone remodeling balance.

[0029] A further embodiment of the disclosure therefore includes a method of treating, preventing, and / or ameliorating symptoms of periodontitis in a subject in need thereof, which comprises applying an oral care composition to the oral cavity of the subject suffering from periodontitis or at risk of developing periodontitis to promote osteoblast cell mineralization, wherein the oral care composition comprises:an orally acceptable carrier; anda mixture of plant materials,13344-00- WO-Ol-OCwherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract.

[0030] As used herein, the term “oral care composition” means a composition that is delivered to the oral surfaces. In certain embodiments, the oral care composition is further defined as a product which, during the normal course of usage, is not for the purposes of systemic administration of particular therapeutic agents, and not intentionally swallowed but rather is retained in the oral cavity for a time sufficient to contact oral tissues.

[0031] The term “orally acceptable earner” means one or more solid or liquid excipients that are suitable for oral administration. The components of the orally acceptable carrier should be capable of being commingled without interaction in a manner that would substantially reduce the composition's stability and / or efficacy. The excipients useful in embodiments of the present disclosure can include the usual and conventional components of a mouthwash, a mouth rinse, a toothpaste, a gel, a patch, or a solid film as appropriate. Examples of suitable excipients are described later herein.

[0032] The oral care compositions of the disclosure comprise a mixture of plant materials, wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract.

[0033] The components of the mixture of plant materials may be extracted from any portion of the respective plants, including one or more of the leaves, flowers and stems of the plants. In some embodiments, the oils can comprise a mixture of esters, aldehydes, alcohols, ketones and terpenes obtained from the original botanical material.

[0034] The components of the mixture of plant materials can be prepared by a number of known processes. One suitable process for preparing an extract is by subjecting the respective plant material to a distillation process. In this process, the plant material is macerated and heated in an amount of water for sufficient time. The resulting mixture is then distilled with steam to remove the organic components with the steam. The steam and organic components are then condensed and collected in a suitable collection vessel. The resulting oil phase is then separated from the aqueous phase by standard separation processes. The oil component is then purified as needed.13344-00- WO-Ol-OC

[0035] Alternatively, the oils can be obtained as a tincture. The tincture can be obtained by extracting the active compounds using a solvent or extracting medium. The solvent can be an aqueous solvent, an organic solvent, or a mixture thereof. Examples of suitable organic solvents include glycerin, propylene glycol, and ethanol. In other embodiments, the extracting solvent is an aqueous / ethanol mixture that can contain about 10% to about 90% ethanol by volume. The botanical materials are generally macerated in the presence of the selected solvent. The solvent is allowed to remain in contact with the botanical materials for a suitable length of time to extract the active compounds before filtering to remove the solid materials. The filtrate is collected as the extract or tincture. The extract can be further purified and the concentration adjusted by evaporating the solvent or adding additional solvent. In one embodiment, the solvent in the tincture or extract is evaporated to obtain a residue or extract. The resulting extract can be in the form of a dry powder, oil or paste depending on the recovered fraction or compounds extracted from the botanical materials.

[0036] The extracts can also be obtained by placing the botanical materials in a column and percolating with the solvent by passing the solvent through the column. Percolation is desirable in some instances where the volume of solvent used can be minimized. The volume of solvent can be controlled by adjusting the flow rate through the column. Changing the flow rate and volume of the solvent can determine the make-up of the final extract for some plant materials that contain constituents with varying solubilities. The extraction process can be earned out in an extraction vessel with a mixture of the plant material in hot water heated to about 90 °C for several hours, typically about 5-8 hours. The liquid material is then collected and then passed through a suitable separation column to purify the active components of the extract. Examples of separation media for use in the column include polystyrene, polyacrylic acid esters, silica gel and polymethacrylic acid esters. Various components of the mixture of plant materials can also be purchased from commercial suppliers.

[0037] The oral care composition may comprise the mixture of plant materials in any proportion appropriate relative to the amount of orally acceptable carrier in the composition. For instance, in some embodiments the mixture of plant materials is present in the oral care composition in an amount ranging from about 0.001 wt% to about 0.09 wt%, such as from about 0.01 wt% to about 0.08 wt%, or such as from about 0.03 wt% to about 0.07 wt%, based on the total weight of the oral care composition.13344-00- WO-Ol-OC

[0038] The components of the mixture of plant materials may also be blended in any suitable ratio to provide the desired activity for the intended use of the oral care composition. In some embodiments, thymol is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials. In certain embodiments, peppermint oil is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials. In additional embodiments, oregano oil is present in the mixture of plant materials in an amount ranging from about 1 wt% to about 20 wt%, such as from about 5 wt% to about 15 wt%, based on the total weight of the mixture of plant materials. In further embodiments, rosemary oil is present in the mixture of plant materials in an amount ranging from about 0.01 wt% to about 5 wt%, such as from about 0.1 wt% to about 4 wt%, based on the total weight of the mixture of plant materials.

[0039] In further embodiments, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract and olive leaf extract are each independently present in the mixture of plant materials in an amount ranging from about 0.0001 wt% to about 5 wt%, such as from about 0.01 wt% to about 2 wt%, based on the total weight of the mixture of plant materials.

[0040] In certain embodiments, the mixture of plant materials comprises the components listed in Table 1:Table 1: Exemplary mixture of plant materials<<<<<<<

[0041] One exemplary mixture of plant materials according to the disclosure is commercially available as SUPRAPEIN®. Embodiments of the disclosure therefore include an oral care13344-00- WO-Ol-OCcomposition comprising an orally acceptable carrier and SUPRAPEIN®, and a method of treating or preventing periodontitis in a subject in need thereof, which comprises applying an oral care composition to the oral cavity of the subject suffering from periodontitis to promote osteoblast cell mineralization, wherein the oral care composition comprises an orally acceptable carrier and SUPRAPEIN®. Additional exemplary mixtures of plant materials according to the disclosure can be found in U.S. Patent No. 7,429.396 and U.S. Patent No. 7,214,392, the entire contents of both of which are specifically incorporated by reference herein.

[0042] The oral care composition of the disclosure may be in any appropriate form. Exemplary forms of the composition include, but are not limited to, a toothpaste or a dentifrice, a mouthwash or a mouth rinse, lozenge, mint, cream, patch, strip or gum (e.g., chewing gum), a topical oral gel, a spray, a solid film and the like. In some embodiments, the oral care composition is in the form of a mouthwash, a mouth rinse, a toothpaste or a solid film. In some embodiments, the oral care composition is not in solid form; for example, in some embodiments the oral care composition is not in the form of a pill, tablet, capsule or powder.

[0043] The oral care compositions of the disclosure comprise an orally acceptable carrier and optionally any other additional ingredients as known in the art and as disclosed below. These components may include, but are not limited to, fluoride ion sources, metal ion sources, humectants, emulsifiers, flavoring agents, sweeteners, anti-calculus agents, abrasives, surfactants, anti-bacterial agents, thickening agents, whitening agents, colorants, pH adjusters, clean feel agents, foam modulators, viscosity modifiers, anti-sensitivity agents, antioxidants, calcium phosphates, water, and combinations thereof. Such ingredients would be known to those skilled in the art of oral care. However, non-limiting examples of these ingredients are provided herein. Suitable components, such as those listed herein, may be included or excluded from the formulations for the oral care compositions depending on the specific combination of other ingredients and the form of the oral care compositions. Additionally or alternatively, the oral care compositions may in some embodiments have a single phase, which contains the components and / or ingredients of the oral care composition. In other embodiments, the oral care composition may include two or more phases, such as two, three, four, or five phases. In other embodiments, the oral care composition of the disclosure does not comprise one or more of the recited additional ingredients.13344-00- WO-Ol-OC

[0044] In some embodiments, the oral care compositions further comprise one or more fluoride ion sources. The fluorides ion source may be useful, for example, as an anti-caries agent. The fluoride ion sources may be selected from any fluoride ion source known in the art, including, for example, stannous fluoride, sodium fluoride, potassium fluoride, sodium fluorosilicate, ammonium fluorosilicate, potassium monofluorophosphate, sodium monofluorophosphate, ammonium monofluorophosphate, indium fluoride, amine fluoride such as N'-octadecyltrimethylendiamine-N,N,N'-tris(2-ethanol)-dihydrofluoride (i.e., olaflur) or N-octadeca-9-enylamine hydrofluoride (i.e., dectaflur), ammonium fluoride, titanium fluoride, hexafluorosulfate, and combinations thereof.

[0045] The fluoride ion sources may be present in an amount providing a clinically efficacious amount of total soluble fluoride ion to the oral care composition. In some embodiments, the one or more other fluoride ion sources may be present in the oral care composition in an amount ranging from about 0.005 wt% to about 5 wt%, based on the total weight of the oral care composition. In certain embodiments, the total fluoride ion content of the oral care composition ranges from about 25 ppm to about 25,000 ppm.

[0046] In some embodiments, the oral care compositions further comprise one or more metal ion sources, such as a zinc ion source, a copper ion source, or a stannous ion source. For example, in certain embodiments, the oral care composition comprises a zinc ion source selected from zinc oxide, zinc citrate, zinc lactate, zinc phosphate, and combinations thereof, or a stannous ion source selected from stannous fluoride, stannous chloride, stannous acetate, stannous tartrate, stannous oxalate, sodium stannous citrate, stannous gluconate, stannous phosphate, stannous pyrophosphate, stannous sulfate, and combinations thereof.

[0047] In some embodiments, the oral care compositions further comprise one or more humectants. A humectant keeps oral care compositions from hardening upon exposure to air by reducing evaporation and / or contributing to preservation by lowering water activity. Certain humectants can also impart desirable sweetness or flavor to oral care compositions. In certain exemplary embodiments, the one or more humectants are selected from glycerin, sorbitol, xylitol, propylene glycol, as well as other polyols and combinations thereof. The one or more humectants may be present in the oral care composition in a combined total amount of, for example, from about 10 wt% to about 40 wt%. based on the total weight of the oral care composition.13344-00- WO-Ol-OC

[0048] In some embodiments, the oral care compositions further comprise one or more emulsifiers. Any emulsifier known in the art for oral care use may be incorporated, including for example, polyglyceryl-4 caprate, polyethylene glycol (PEG), PEG-40 hydrogenated castor oil, alkyl polyglucosides, polysorbates, and combinations thereof. In certain embodiments, the emulsifier may be chosen from poloxamers (e.g., PLURONICS®) and other non-ionic emulsifiers. In certain embodiments, the emulsifier is polyglyceryl-4 caprate (TEGOSOFT® PC). The one or more emulsifiers may be present in the oral care composition in a combined total amount of, for example, from about 0.01 wt% to about 2 wt%, based on the total weight of the oral care composition.

[0049] In some embodiments, the oral care compositions further comprise one or more flavoring agents. Suitable flavoring agents include essential oils and various flavoring aldehydes, esters, alcohols, and similar materials. Examples of the essential oils include oils of spearmint, peppermint, Wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also useful are such chemicals as menthol, carvone, and anethole. Additional flavoring agents may include, but are not limited to menthol, artificial vanilla, cinnamon derivatives, and various fruit flavors, spearmint oil, peppermint oil, cinnamon oil, oil of Wintergreen (methylsalicylate), clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, and a combination of two or more thereof. The one or more flavoring agents may be present in the oral care composition in a combined total amount of, for example, from about 0.01 wt% to about 5 wt%, based on the total weight of the oral care composition.

[0050] In some embodiments, the oral care compositions further comprise one or more sweeteners useful, for example, to enhance taste of the composition. Sweeteners may include, but are not limited to, sucralose, maltodextrin, dextrose, polydextrose, sucrose, maltose, dextrin, dried invert sugar, mannose, xylose, ribose, fructose, levulose, galactose, sugar alcohols, such as sorbitol, mannitol, xylitol, maltitol, and isomalt, aspartame, neotame, saccharin and salts thereof (e.g., sodium saccharin), gum arabic, dipeptide-based intense sweeteners, cyclamates, dihydrochalcones, or the like, or combinations thereof. The one or more sweeteners may be present in the oral care composition in a combined total amount of, for example, from about 0.1 wt% to about 5 wt%. based on the total weight of the oral care composition.13344-00- WO-Ol-OC

[0051] In some embodiments, the oral care compositions further comprise one or more anticalculus agents. Illustrative anticalculus agents include, but are not limited to, phosphates and polyphosphates, polyaminopropane sulfonic acid (AM PS), polyolefin sulfonates, polyolefin phosphates, diphosphonates such as azacycloalkane-2, 2-diphosphonates (e.g., azacycloheptane-2,2-diphosphonic acid), N-methyl azacyclopentane-2,3-diphosphonic acid, ethane- 1 -hydroxy- 1,1-diphosphonic acid (EHDP) and ethane- 1 -amino- 1,1 -diphosphonate, and phosphonoalkane carboxylic acids. Useful inorganic phosphate and polyphosphate salts include monobasic, dibasic and tribasic sodium phosphates. Soluble pyrophosphates may be useful anti-calculus agents. The pyrophosphate salts can be any of the alkali metal pyrophosphate salts. In certain embodiments, salts include tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. The pyrophosphates may also contribute to preservation of the compositions by lowering water activity. Exemplary pyrophosphates may include tetrasodium pyrophosphate (TSPP), tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate and mixtures thereof. The salts may be useful in both their hydrated and / or unhydrated forms. An effective amount of pyrophosphate salt that may be included in the oral care compositions disclosed herein is generally enough to provide least about 0.1 wt% pyrophosphate ions, e.g., from about 0.1 wt% to about 3 wt%, based on the total weight of the oral care composition.

[0052] In some embodiments, the oral care compositions further comprise one or more abrasives that remove debris and surface stains on teeth, and which are also commonly referred to as polishing agents. Illustrative abrasives include, but are not limited to. silica, silicate, silicon, alumina (including calcined aluminum oxide), aluminosilicates, such as bentonite, zeolite, kaolin, and mica, siliceous or diatomaceous earth, pumice, calcium carbonate, cuttlebone, insoluble phosphates, composite resins, such as melamine resin, phenolic resin, and urea-formaldehyde resin, polycarbonate, silicon carbide, boron carbide, microcrystalline wax, microcrystalline cellulose, including combinations of colloidal microcrystalline cellulose and carboxymethylcellulose, and combinations and derivatives thereof. The one or more abrasives may be present in the oral care composition in a combined total amount of, for example, from about 5 wt% to about 35 wt%. based on the total weight of the oral care composition.13344-00- WO-Ol-OC

[0053] In some embodiments, the oral care compositions further comprise one or more surfactants. Exemplary surfactants include, but are not limited to, anionic, cationic, zwitterionic, and nonionic surfactants, and combinations thereof. The one or more surfactants may be present in the oral care compositions in a combined total amount of, for example, from about 0.01 wt% to about 10 wt% based on the total weight of the oral care composition.

[0054] Non-ionic surfactants are known in the art and generally include surfactants that are not electrically charged. An exemplary nonionic surfactant may be poly(oxyethylene)-poly(oxypropylene) block copolymers. Such copolymers are known commercially by the nonproprietary name of poloxamers. The name poloxamer is often used in conjunction with a numeric suffix to designate the individual identification of each copolymer. Poloxamers may have varying contents of ethylene oxide and propylene oxide which results in poloxamers that have a wide range of chemical structures and molecular weights. One poloxamer that may be mentioned is Poloxamer 407, sold under the trade name PLURONIC® F127 by BASF, Inc. (Parsippany, N.J.). In certain embodiments, the oral care compositions disclosed herein may comprise poloxamer as the at least one surfactant.

[0055] Anionic surfactants that may be used in the oral care compositions disclosed herein include, for example: (i) water-soluble salts of higher fatty acid monoglyceride monosulfates, such as the sodium salt of the monosulfated monoglyceride of hydrogenated coconut oil fatty acids such as sodium N-methyl N-cocoyl taurate, sodium cocomonoglyceride sulfate; (ii) higher alkyl sulfates, such as sodium lauryl sulfate; (iii) higher alkyl-ether sulfates, such as those of formula CH3(CH2)mCH2(OCH2CH2)iiOSO3X, wherein m is 6-16, e.g., 10, n is 1-6, e.g., 2, 3 or 4, and X is Na or K, for example sodium laureth-2 sulfate (CFb CFFhoCFF (OCFFCFbjOSOsNa): (iv) higher alkyl aryl sulfonates such as sodium dodecyl benzene sulfonate (sodium lauryl benzene sulfonate); and (v) higher alkyl sulfoacetates, such as sodium lauryl sulfoacetate (dodecyl sodium sulfoacetate), higher fatty acid esters of 1 ,2 dihydroxy propane sulfonate, sulfocolaurate (N-2-ethyl laurate potassium sulfoacetamide) and sodium lauryl sarcosinate.

[0056] In some embodiments, the oral care compositions disclosed herein may comprise an anionic surfactant. In some embodiments, the anionic surfactant is the water soluble salt of alkyl sulfates having from 10 to 21 carbon atoms in the alkyl radical and water soluble salts of sulfonated monoglycerides of fatty acids having from 10 to 18 carbon atoms. Sodium lauryl sulfate, sodium13344-00- WO-Ol-OClauryl sarcosinate, and sodium coconut monoglyceride sulfonates are examples of anionic surfactants of that type.

[0057] In some embodiments, the oral care compositions further comprise one or more antimicrobial agents and / or one or more preservatives, such as methylisothiazolinone (MIT), sodium benzoate, potassium sorbate, benzyl alcohol, and combinations thereof. In another example, the oral care composition may comprise one or more antibacterial agents selected from halogenated diphenyl ether (e.g. triclosan), herbal extracts and essential oils (e.g., tea extract, magnolia extract, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak extract, sea-buckthorn extract), bisguanide antiseptics (e.g., chlorhexidine, alexidine or octenidine), quaternary ammonium compounds (e.g., cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecylpyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinium chloride (TDEPC)), phenolic antiseptics, hexetidine, octenidine, sanguinarine, povidone iodine, delmopinol, salifluor, other metal ions (e.g.. stannous salts, copper salts, iron salts), sanguinarine, propolis and oxygenating agents (e.g., hydrogen peroxide, buffered sodium peroxyborate or peroxycarbonate), phthalic acid and its salts, monoperthalic acid and its salts and esters, ascorbyl stearate, oleoyl sarcosine, alkyl sulfate, dioctyl sulfosuccinate, salicylanilide, domiphen bromide, delmopinol, octapinol, and other piperidino derivatives, nicin preparations, chlorite salts; and combinations of any of the foregoing.

[0058] The one or more antibacterial or preservative agents may optionally be present in the oral care composition in a combined total amount of, for example, from about 0.01 wt% to about 0.5 wt%, based on the total weight of the oral care composition.

[0059] In some embodiments, the oral care compositions further comprise at least one thickening agent. A thickening agent may provide a desirable consistency and / or stabilize and / or enhance performance (e.g.. provide desirable active release characteristics upon use) of the oral care compositions disclosed herein. Exemplary thickening agents include, for example, carboxy vinyl polymers, carrageenan (also known as carrageenan gum), xanthan, hydroxyethyl cellulose (HEC), natural and synthetic clays (e.g., VEEGUM® and laponite), water soluble salts of cellulose ethers (e.g., sodium carboxymethylcellulose (CMC) and sodium carboxymethyl hydroxyethyl cellulose), natural gums (e.g., gum karaya, xanthan gum, gum arable, and gum tragacanth), colloidal magnesium aluminum silicate, silica (e.g., finely divided silica), polyvinyl pyrrolidone,13344-00- WO-Ol-OCcarbowaxes, fatty acids and salts thereof, and mixtures thereof. In some embodiments, a mixture of thickening silica and carrageenan gum may be used as the thickener in the oral care compositions disclosed herein. The one or more thickening agents may be present in the oral care composition in a combined total amount of, for example, from about 0.5 wt% to about 20 wt%, based on the total weight of the oral care composition.

[0060] In some embodiments, the oral care compositions further comprise one or more whitening agents. The one or more whitening agents can include materials or substances that are effective to, capable of, or configured to provide whitening of a tooth surface to which it is applied and can include, for example, peroxides, metal chlorites, perborates, percarbonates, peroxyacids, hypochlorites, hydroxyapatite, and combinations thereof.

[0061] Additional whitening agents include hydrogen peroxide or a hydrogen peroxide source, e.g., urea peroxide or a peroxide salt or complex (e.g., such as peroxyphosphate, peroxycarbonate, perborate, peroxysilicate, or persulphate salts); for example, calcium peroxyphosphate, sodium perborate, sodium carbonate peroxide, sodium peroxyphosphate, and potassium persulfate or hydrogen peroxide polymer complexes such as hydrogen peroxide-polyvinyl pyrrolidone polymer complexes.

[0062] In some embodiments, the oral care compositions further comprise one or more colorants. Colorants herein include pigments, dyes, lakes and agents imparting a particular luster or reflectivity such as pearling agents. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and / or to modify appearance, in particular color and / or opacity, of the composition to enhance attractiveness to the consumer. Any orally acceptable colorant can be used, including FD&C dyes and pigments, talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, magnesium aluminum silicate, silica, titanium dioxide, zinc oxide, red, yellow, brown and black iron oxides, feme ammonium ferrocyanide, manganese violet, ultramarine, titaniated mica, bismuth oxychloride, and mixtures thereof. The one or more colorants may be present in the oral care composition in a combined total amount of, for example, from about 0.001 wt% to about 20 wt%, based on the total weight of the oral care composition.

[0063] In some embodiments, the oral care composition comprises one or more pH adjusters to increase or decrease the overall pH of the oral care composition. For example, one or more acids13344-00- WO-Ol-OCmay be included to decrease the pH of the oral care composition. Examples of suitable acids for decreasing the pH of the oral care composition include, but are not limited to, citric acid, acetic acid, and the like. The oral care composition may include one or more bases, such as sodium hydroxide, potassium hydroxide and the like, to increase the pH of the oral care composition. Additional or alternative acids and bases that are suitable for adjusting the pH of the oral care composition are readily known to one of ordinary skill in the art.

[0064] The amount of the pH adjuster in the oral care composition may be based on the desired pH of the final oral care composition and / or product. For example, the total amount of the pH adjuster may range from about 0.05 wt% to about 20 wt%, based on the total weight of the oral care composition.

[0065] The oral care compositions may have a pH from 4.5 to about 10, 4.5 to about 9, 4.5 to about 8, 4.5 to about 7, 4.5 to about 6; from about 5 to about 10, about 5 to about 9, about 5 to about 8, about 5 to about 7, about 5 to about 6; from about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7; from about 7 to about 10, about 7 to about 9, or about 7 to about 8, including any ranges and subranges therebetween.

[0066] In some embodiments, the oral care compositions further comprise one or more bicarbonate salts useful for example to impart a “clean feel” to teeth and gums due to effervescence and release of carbon dioxide. Any orally acceptable bicarbonate can be used, including without limitation alkali metal bicarbonates such as sodium and potassium bicarbonates, ammonium bicarbonate, and the like. The one or more bicarbonate salts may be present in the oral care composition in a combined total amount of, for example, from about 0.1 wt% to about 50 wt%, based on the total weight of the oral care composition.

[0067] In some embodiments, the oral care compositions further comprise at least one foam modulator, useful for example to increase amount, thickness or stability of foam generated by the composition upon agitation. Any orally acceptable foam modulator can be used, including without limitation polyethylene glycols (PEGs), also known as polyoxyethylenes. High molecular weight PEGs are suitable, including those having an average molecular weight of 200,000 to 7,000,000, for example 500,000 to 5,000,000, or 1,000,000 to 2,500,000. One or more PEGs may be present in the oral care composition in a combined total amount of, for example, from about 0.1 wt% to about 10 wt%, based on the total weight of the oral care composition.13344-00- WO-Ol-OC

[0068] In some embodiments, the oral care compositions further comprise at least one viscosity modifier, useful for example to help inhibit settling or separation of ingredients or to promote redispersibility upon agitation of a liquid oral care composition. Any orally acceptable viscosity modifier can be used, including without limitation, mineral oil, petrolatum, clays and organo-modified clays, silicas and the like. The one or more viscosity modifiers may be present in the oral care composition in a combined total amount of. for example, from about 0.01 wt% to about 10 wt%, based on the total weight of the oral care composition.

[0069] In some embodiments, the oral care compositions further comprise one or more antisensitivity agents, e.g., potassium salts such as potassium nitrate, potassium bicarbonate, potassium chloride, potassium citrate, and potassium oxalate; capsaicin; eugenol; strontium salts; chloride salts and combinations thereof. The one or more antisensitivity agents may be present in the oral care composition in a combined total amount of, for example, from about 1 wt% to about 20 wt%, based on the total weight of the oral care composition.

[0070] In some embodiments, the oral care compositions further comprise one or more antioxidants. Any orally acceptable antioxidant can be used, including butylated hydroxy anisole (BHA), butylated hydroxytoluene (BHT), vitamin A, carotenoids, co-enzyme Q10, PQQ, Vitamin A, Vitamin C, Vitamin E, anethole-dithiothione, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin, and mixtures thereof.

[0071] In some embodiments, the oral care compositions further comprise a source of calcium and phosphate selected from (i) calcium-glass complexes, e.g., calcium sodium phosphosilicates, and (ii) calcium-protein complexes, e.g., casein phosphopeptide-amorphous calcium phosphate, a soluble calcium salt, e.g., selected from calcium sulfate, calcium chloride, calcium nitrate, calcium acetate, calcium lactate, and combinations thereof.

[0072] In some embodiments, the oral care compositions further comprise water. The amount of water may depend on the form of the oral care composition, e.g., as a mouthwash, a dentifrice, a film, a gel, a paste, etc. Water employed in the preparation of commercial oral compositions should be deionized and free of organic impurities. Water commonly makes up the balance of many compositions and includes about 5 wt% to about 99 wt%, such as from about 10 wt% to about 90 wt%, from about 65 wt% to about 85 wt%, or about 70 wt% to about 80 wt%, or any range or subrange thereof, by weight based on the total weight of the oral care composition. This amount of water includes the free water that is added plus any amount of water that may be introduced13344-00- WO-Ol-OCwith other materials, such as with sorbitol or silica or any components of the oral care composition disclosed herein. The Karl Fischer method is a one measure of calculating free water.

[0073] The amount of water can vary depending on the type of oral care composition. In an embodiment where the composition is a dentifrice, such as toothpaste, the amount of water can range, for example, from about 5 wt% to about 50 wt%, based the total weight of the dentifrice composition.

[0074] In some embodiments, the oral care composition is a solid film, such as a ribbon strip or tape. The solid film may be dissolvable and / or disintegrable. As used herein, the term or expression “dissolvable” may refer to the ability to disperse into a liquid. For example, a dissolvable solid film may disperse into a liquid, such as saliva or water. As used herein, the term or expression “disintegrable” may refer to the ability to decompose into constituent elements, parts, and / or small particles. It should be appreciated that the ability of the solid film to be dissolvable and / or disintegrable may be provided by one or more components of the oral care composition. For example, an orally acceptable vehicle and / or water-soluble polymer incorporated into the oral care composition may at least partially contribute to the dissolvable and / or disintegrable properties of the oral care composition. In at least one implementation, the solid film may be dissolvable and / or disintegrable in water, saliva, or a combination thereof. For example, the oral care composition may be applied to soft tissue surface of the oral cavity, such as the gum, lip or cheek, and added water and / or saliva acts to dissolve or disintegrate the film to release the components of the composition. In certain embodiments, the oral care composition may be applied to the teeth.

[0075] The solid film may be dissolvable and / or disintegrable in a predetermined amount of time and / or rate. For example, the solid film may be completely dissolvable and / or disintegrable in about 30 seconds or less, about 1 minute or less, about 2 minutes or less, about 3 minutes or less, about 5 minutes or less, or about 10 minutes or less. It should be appreciated that conventional oral care compositions in the form of a solid film are often not dissolvable or disintegrable and thus, need to be physically removed (e.g., peeling, abrading, etc.) after a predetermined period of time.

[0076] Methods of the disclosure include treating periodontitis in a subject in need thereof, which comprise applying an oral care composition to the oral cavity of the subject suffering from periodontitis to promote osteoblast cell mineralization, wherein the oral care composition comprises:an orally acceptable carrier; and13344-00- WO-Ol-OCa mixture of plant materials,wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil. lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract.

[0077] In certain embodiments, further disclosed herein are methods of preventing periodontitis and / or ameliorating symptoms associated with periodontitis in a subject in need thereof, including a subject at risk of developing periodontitis, which comprise applying an oral care composition as disclosed herein to the oral cavity of the subject to promote osteoblast cell mineralization.

[0078] In certain embodiments, disclosed herein are methods of promoting osteoblast cell mineralization in the oral cavity of a subject in need thereof, including a subject suffering from periodontitis or at risk of developing periodontitis, which methods comprise applying an oral care composition as disclosed herein to the oral cavity of the subject.

[0079] As used herein, the term “subject” includes, but is not limited to, humans and other mammals (e.g., murines, simians, equines, bovines. porcines, canines, felines, and the like). In the context of the disclosure, the term “subject” generally refers to an individual who will receive treatment for periodontitis or who is at risk of developing periodontitis.

[0080] Compositions of the disclosure can in some embodiments inhibit the growth of one or more periodontal pathogens in the oral cavity of the subject selected from Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Fusobacterium nucleatum.

[0081] In some embodiments, the subject has one or more risk factors that can contribute to periodontitis. For instance, the subject suffering from periodontitis or at risk of developing periodontitis may also suffer from one or more of diabetes, obesity, leukemia, HIV / AIDS, cardiovascular disease, osteoporosis, rheumatoid arthritis and Crohn's disease. The subject suffering from periodontitis or at risk of developing periodontitis may also be a tobacco user, may be undergoing cancer treatment, and / or could be 65 years or older.

[0082] According to certain embodiments of the methods disclosed herein, the oral care composition may be applied to the oral cavity of the subject in need thereof for about 5 seconds to about 30 minutes, such as for about 10 seconds to about 20 minutes, or such as for about 30 seconds to about 2 minutes. The methods may include, for example, applying the oral care composition to the subject at least once a day, such as at least twice a day, or such as at least three times a day.13344-00- WO-Ol-OC

[0083] According to additional embodiments, the mixture of plant materials increases the mineralization of osteoblast cells by 50% or more, such as by 60% or more, 70% or more, 80% or more, or 90% or more, such as from 50% to 90% more or from 50% to 80% more, compared to a composition that does not comprise the mixture of plant materials. For instance, FIG. 1 in the Example below illustrates an increase of osteoblast cell mineralization by over 80% upon addition of SUPRAPEIN® (A6) at a concentration of 1 p.g / ml (0.483 with SUPRAPEIN® vs. 0.265 with only the positive control).

[0084] The oral care compositions disclosed herein may be made according to methods and procedures known to those skilled in the art. In certain embodiments, the compositions can be made by incorporating the mixture of plant materials into a pre-formulated mouthwash, mouth rinse, toothpaste, dentifrice, or gel or the like, or including the mixture of plant materials in a formulation that is then processed into a solid film or disposed on a patch.

[0085] The Example and other embodiments described herein are exemplary and not intended to be limiting in describing the full scope of compositions and methods of this disclosure. Equivalent changes, modifications and variations of specific embodiments, materials, compositions and methods may be made within the scope of the present disclosure, with substantially similar results.EXAMPLE

[0086] An experiment was conducted to evaluate the influence of SUPRAPEIN® on osteoblast cell mineralization.

[0087] Human fetal osteoblast (hFOB) cells were seeded at 3 x 104cells / cm2in a 12-well microplate and incubated for 4 days to reach confluence. Culture medium was removed and replaced with fresh medium supplemented with the test ingredient, which was a composition comprising SUPRAPEIN® (A6) at non-cytotoxic concentrations of 100 pg / ml, 1 pg / ml, 0.5 pg / ml, 0.25 pg / ml, 0.125 pg / ml, and 0.0625 p.g / ml. SUPRAPEIN® was used in conditioned media with 25 pg / ml ascorbic acid / 5 mM beta glycerophosphate. Cultures were further incubated for 2 days at 39.5°C to allow differentiation of osteoblasts. The degree of mineralization was determined by Alizarin Red staining. A positive control (Clt+) was a mineralization medium containing 25 pg / ml ascorbic acid / 5 mM beta glycerophosphate, which are both believed to be required to induce mineralization.

[0088] FIG. 1 is a bar graph illustrating the effect of SUPRAPEIN® (A6) on the osteoblast cell13344-00- WO-Ol-OCmineralization compared to controls Clt- and Clt+. The results illustrate that SUPRAPEIN® promotes the mineralization activity of the osteoblast cells in a dose-dependent fashion.

[0089] In view of this experiment, SUPRAPEIN® may be included in an oral care composition to promote osteoblast cell mineralization and thereby treat periodontitis by improving the bone remodeling balance and promoting periodontal tissue growth.

[0090] The present disclosure has been described with reference to exemplary implementations. Although a limited number of implementations have been shown and described, it will be appreciated by those skilled in the art that changes may be made in these implementations without departing from the principles and spirit of the preceding detailed description. It is intended that the present disclosure be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

13344-00- WO-Ol-OCWhat Is Claimed Is:

1. An oral care composition, which comprises:an orally acceptable carrier; anda mixture of plant materials,wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil, lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract; andwherein the mixture of plant materials is present in the oral care composition in an amount ranging from about 0.001 wt% to about 0.09 wt%, such as from about 0.01 wt% to about 0.08 wt%, or such as from about 0.03 wt% to about 0.07 wt%, based on the total weight of the oral care composition.

2. The oral care composition of claim 1, wherein thymol is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials.

3. The oral care composition of any one of the preceding claims, wherein peppermint oil is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials.

4. The oral care composition of any one of the preceding claims, wherein oregano oil is present in the mixture of plant materials in an amount ranging from about 1 wt% to about 20 wt%, such as from about 5 wt% to about 15 wt%, based on the total weight of the mixture of plant materials.

5. The oral care composition of any one of the preceding claims, wherein rosemary oil is present in the mixture of plant materials in an amount ranging from about 0.01 wt% to about 5 wt%, such as from about 0.1 wt% to about 4 wt%, based on the total weight of the mixture of plant materials.

6. The oral care composition of any one of the preceding claims, wherein lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract and olive leaf13344-00- WO-Ol-OCextract are each independently present in the mixture of plant materials in an amount ranging from about 0.0001 wt% to about 5 wt%, such as from about 0.01 wt% to about 2 wt%, based on the total weight of the mixture of plant materials.

7. The oral care composition of any one of the preceding claims, which further comprises a fluoride ion source.

8. The oral care composition of any one of the preceding claims, which further comprises a metal ion source.

9. The oral care composition of any one of the preceding claims, wherein the oral care composition is in the form of a mouthwash, a mouth rinse, a toothpaste, a gel, a patch, or a solid film.

10. A method of treating or preventing periodontitis in a subject in need thereof, which comprises applying an oral care composition to the oral cavity of the subject suffering from periodontitis or at risk of developing periodontitis to promote osteoblast cell mineralization, wherein the oral care composition comprises:an orally acceptable carrier; anda mixture of plant materials,wherein the mixture of plant materials comprises thymol, peppermint oil, oregano oil, rosemary oil. lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract.

11. The method of claim 10, which comprises inhibiting the growth of one or more periodontal pathogens in the oral cavity of the subject selected from Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Fusobacterium nucleatum.

12. The method of any one of claims 10-11, wherein the subject suffering from periodontitis also suffers from one or more of diabetes, obesity, leukemia, HIV / AIDS, cardiovascular disease, osteoporosis, rheumatoid arthritis, and Crohn's disease.13344-00- WO-Ol-OC13. The method of any one of claims 10-12, wherein the subject suffering from periodontitis is a tobacco user, is undergoing cancer treatment, and / or is 65 years or older.

14. The method of any one of claims 10-13, which comprises applying the oral care composition to the oral cavity of the subject for about 5 seconds to about 30 minutes, such as for about 10 seconds to about 20 minutes, or such as for about 30 seconds to about 2 minutes.

15. The method of any one of claims 10-14, which comprises applying the oral care composition to the oral cavity of the subject at least once a day, such as at least twice a day, or such as at least three times a day.

16. The method of any one of claims 10-15, wherein the mixture of plant materials is present in the oral care composition in an amount ranging from about 0.001 wt% to about 0.09 wt%, such as from about 0.01 wt% to about 0.08 wt%, or such as from about 0.03 wt% to about 0.07 wt%, based on the total weight of the oral care composition.

17. The method of any one of claims 10-16, wherein thymol is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%, such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials.

18. The method of any one of claims 10-17, wherein peppermint oil is present in the mixture of plant materials in an amount ranging from about 30 wt% to about 60 wt%. such as from about 40 wt% to about 50 wt%, based on the total weight of the mixture of plant materials.

19. The method of any one of claims 10-18, wherein oregano oil is present in the mixture of plant materials in an amount ranging from about 1 wt% to about 20 wt%, such as from about 5 wt% to about 15 wt%, based on the total weight of the mixture of plant materials.

20. The method of any one of claims 10-19, wherein rosemary oil is present in the mixture of plant materials in an amount ranging from about 0.01 wt% to about 5 wt%, such as from about 0.1 wt% to about 4 wt%, based on the total weight of the mixture of plant materials.

21. The method of any one of claims 10-20, wherein lavender oil, natural cinnamic aldehyde, lemon oil, cinnamon bark oil, golden seal root extract, and olive leaf extract are each independently present in the mixture of plant materials in an amount ranging from about 0.000113344-00- WO-Ol-OCwt% to about 5 wt%, such as from about 0.01 wt% to about 2 wt%, based on the total weight of the mixture of plant materials.

22. The method of any one of claims 10-21, wherein the mixture of plant materials increases the mineralization of osteoblast cells by 50% or more, such as by 60% or more, 70% or more, 80% or more, or 90% or more, such as from 50% to 90% or from 50% to 80% more.

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