Oral care regimens and kits for use thereof

Abstract

Oral care regimens, oral care kits, and uses of oral care kits are disclosed herein. In accordance with at least one aspect, provided is an oral care regimen comprising applying a dentifrice composition to an oral cavity using a high-density tufted toothbrush, the dentifrice composition comprising a stannous source, a nitrate source, and a phosphate source, wherein the high-density tufted toothbrush comprises end-rounded bristles and tapered bristles; and applying a mouthwash composition to the oral cavity, the mouthwash composition comprising cetylpyridinium chloride and a zinc source.

Description

Docket No.: 1096285-OO-WO-Ol-OCORAL CARE REGIMENS AND KITS FOR USE THEREOFCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority from U.S. Patent Application No. 63 / 703,413, filed October 4, 2024, the content of which is hereby incorporated herein by reference in their entirety.BACKGROUND OF DISCLOSURE

[0002] Despite being largely preventable, oral diseases, including dental caries, gingivitis and periodontitis, are classified by the World Health Organization as the number one ranking condition in global prevalence, regardless of country income. Dental caries and gum diseases originate from the accumulation of plaque on tooth surfaces, which is the result of complex networks of oral bacteria adhering to the enamel over time.

[0003] Dental plaque is a sticky biofilm or mass of bacteria that is commonly found between the teeth, along the gum line, and below the gum line margins. Dental plaque can give rise to dental caries and periodontal problems such as gingivitis and periodontitis. Dental plaque can further cause or exacerbate dental erosion, which involves demineralization and damage to the tooth structure typically due to acid attack from nonbacterial sources. Dental caries, tooth decay, and / or tooth demineralization can be caused or exacerbated by acid produced from the bacterial degradation of fermentable sugar.BRIEF SUMMARY

[0004] This summary is intended merely to introduce a simplified summary of some aspects 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. This summary is not an extensive overview, nor is it intended to identify key or critical 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.

[0005] Aspects of the invention are directed to oral care regimens, oral care kits, and uses of oral care kits. In accordance with at least one aspect, provided is an oral care regimen including applying a dentifrice composition to an oral cavity using a high-density tufted toothbrush, the dentifrice composition comprising a stannous source, a nitrate source, and a phosphate source,Docket No.: 1096285-OO-WO-Ol-OC wherein the high-density tufted toothbrush comprises end-rounded bristles and tapered bristles; and applying a mouthwash composition to the oral cavity, the mouthwash composition comprising cetylpyridinium chloride and a zinc source.

[0006] According to further aspects, provided is a kit comprising a dentifrice composition comprising a stannous source, a nitrate source, and a polyphosphate source; and a high-density tufted toothbrush comprising comprises end-rounded bristles and tapered bristles. Preferably, the kit further comprises a mouthwash composition comprising cetylpyridinium chloride and a zinc source.

[0007] A list of non-limiting embodiments in accordance with aspects of the invention is provided below:

[0008] In accordance with an embodiment 1, provided is an oral care regimen comprising: applying a dentifrice composition to an oral cavity using a high-density tufted toothbrush, the dentifrice composition comprising a stannous source, a nitrate source, and a phosphate source, wherein the high-density tufted toothbrush comprises end-rounded bristles and tapered bristles; and applying a mouthwash composition to the oral cavity, the mouthwash composition comprising cetylpyridinium chloride and a zinc source.

[0009] In accordance with an embodiment 2, provided is an oral care regimen according to embodiment 1, wherein the dentifrice composition is applied to an oral cavity by brushing one or more teeth of the oral cavity using the toothbrush.

[0010] In accordance with an embodiment 3, provided is an oral care regimen according to embodiment 1 or embodiment 2, wherein the dentifrice composition is applied to the toothbrush in an amount from about 0.1 gram to about 3 grams.

[0011] In accordance with an embodiment 4, provided is an oral care regimen according to embodiment 2 or embodiment 3, wherein the one or more teeth of the oral cavity are brushed for about 1 minute or more, preferably about 1.5 minutes or more, or preferably 2 minutes or more.

[0012] In accordance with an embodiment 5, provided is an oral care regimen according to any foregoing embodiment, wherein the stannous source of the dentifrice composition is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof.

[0013] In accordance with an embodiment 6, provided is an oral care regimen according to anyDocket No.: 1096285-OO-WO-Ol-OC foregoing embodiment, wherein the stannous source of the dentifrice composition comprises stannous fluoride.

[0014] In accordance with an embodiment 7, provided is an oral care regimen according to any foregoing embodiment, wherein the nitrate source of the dentifrice composition is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination two or more thereof.

[0015] In accordance with an embodiment 8, provided is an oral care regimen according to embodiment 7, wherein the nitrate source of the dentifrice composition comprises potassium nitrate.

[0016] In accordance with an embodiment 9, provided is an oral care regimen according to any foregoing embodiment, wherein the dentifrice composition has a molar ratio of nitrate ions to stannous ions, both measured as free ions, of about 0.5:1 to about 2:1.

[0017] In accordance with an embodiment 10, provided is an oral care regimen according to any foregoing embodiment, wherein phosphate source of the dentifrice composition is selected from tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.

[0018] In accordance with an embodiment 11, provided is an oral care regimen according to any foregoing embodiment, wherein the toothbrush comprises a plurality of tufts of bristles.

[0019] In accordance with an embodiment 12, provided is an oral care regimen according to embodiment 11, wherein the plurality of bristle tufts comprises about 4000 to about 6000 bristles.

[0020] In accordance with an embodiment 13, provided is an oral care regimen according to embodiment 11 or embodiment 12, wherein the plurality of bristle tufts comprises one or more central bristle tuft.

[0021] In accordance with an embodiment 14, provided is an oral care regimen according to any one of embodiments 11 to embodiment 13, wherein the plurality of bristle tufts comprises a perimeter of bristle tufts surrounding the central bristle tuft, the perimeter of bristle tufts comprising a distal bristle tuft, a proximal bristle tuft, a peripheral bristle tuft, or a combination of two or more thereof.

[0022] In accordance with an embodiment 15, provided is an oral care regimen according toDocket No.: 1096285-OO-WO-Ol-OC embodiment 14, wherein the perimeter of bristle tufts comprises two or more peripheral bristle tuft.

[0023] In accordance with an embodiment 16, provided is an oral care regimen according to embodiment 14 or embodiment 15, wherein the perimeter of bristle tufts comprises one or more distal bristle tuft and one or more distal bristle tuft.

[0024] In accordance with an embodiment 17, provided is an oral care regimen according to any one of embodiments 14 to 16, wherein at least one of the bristle tufts of the perimeter of bristle tufts has about 10 to about 25 bristle tips / mm2.

[0025] In accordance with an embodiment 18, provided is an oral care regimen according to any one of embodiments 13 to 17, wherein the central bristle tuft has about 10 to about 25 bristle tips / mm2.

[0026] In accordance with an embodiment 19, provided is an oral care regimen according to any one of embodiments 13 to 18, wherein the central bristle tuft comprises a convex inner surface.

[0027] In accordance with an embodiment 20, provided is an oral care regimen according to any one of embodiments 14 to 19, wherein at least one of the bristle tufts of the perimeter of bristle tufts is tapered such that the bristles have a length that decreases toward the central bristle tuft.

[0028] In accordance with an embodiment 21, provided is an oral care regimen according to any one of embodiments 14 to 16, wherein the at least one of the bristle tufts of the perimeter of bristle tufts has a length that is greater than a length of the central bristle tuft by about 10% or more.

[0029] In accordance with an embodiment 22, provided is an oral care regimen according to any one of embodiments 14 to 21, wherein the length of each of the bristle tufts of the perimeter of bristle tufts is greater than the length of the central bristle tuft by about 10% or more.

[0030] In accordance with an embodiment 23, provided is an oral care regimen according to any foregoing embodiment, wherein at least one of the bristle tufts of the perimeter of bristle tufts comprise tapered bristles having a tapered tip of about 0.005 to about 0.05 mm.

[0031] In accordance with an embodiment 24, provided is an oral care regimen according to any foregoing embodiment, wherein the mouthwash composition further comprises from about 1 to about 10 wt.% of a nonionic surfactant.

[0032] In accordance with an embodiment 25, provided is an oral care regimen according to any foregoing embodiment, wherein the mouthwash composition further comprises a from about 60 to about 85 wt.% of a polyol.Docket No.: 1096285-OO-WO-Ol-OC

[0033] In accordance with an embodiment 26, provided is an oral care regimen according to any foregoing embodiment, wherein the mouthwash composition further comprises from about 11 to about 30 wt.% of water.

[0034] In accordance with an embodiment 27, provided is an oral care regimen according to any foregoing embodiment, wherein the mouthwash composition is essentially free or free of monoalcohols.

[0035] In accordance with an embodiment 28, provided is an oral care regimen according to any foregoing embodiment, wherein the mouthwash composition is essentially free or free of hydrocarbon oils.

[0036] In accordance with an embodiment 29, provided is a kit comprising: a dentifrice composition comprising a stannous source, a nitrate source, and a polyphosphate source; and a high-density tufted toothbrush comprising end-rounded bristles and tapered bristles.

[0037] In accordance with an embodiment 30, provided is the kit according to embodiment 29 further comprising: a mouthwash composition comprising cetylpyridinium chloride and a zinc source.

[0038] In accordance with an embodiment 31, provided is the kit according to embodiment 29 or embodiment 30 for the use of reducing one or more pathogenic bacteria associated with gingivitis by at least 10%.

[0039] In accordance with an embodiment 32, provided is the kit according to any one of embodiments 29 to 31 for the use of reducing Porphyromonas gingivalis by at least 10%.

[0040] In accordance with an embodiment 33, provided is the kit according to any one of embodiments 29 to 32, wherein the stannous source of the dentifrice composition is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof.

[0041] In accordance with an embodiment 34, provided is the kit according to any one of embodiments 29 to 33, wherein the stannous source of the dentifrice composition comprises stannous fluoride.

[0042] In accordance with an embodiment 35, provided is the kit according to any one of embodiments 29 to 34, wherein the nitrate source of the dentifrice composition is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate,Docket No.: 1096285-OO-WO-Ol-OC silver nitrate, ammonium nitrate, and a combination two or more thereof.

[0043] In accordance with an embodiment 36, provided is the kit according to embodiment 35, wherein the nitrate source of the dentifrice composition comprises potassium nitrate.

[0044] In accordance with an embodiment 37, provided is the kit according to any one of embodiments 29 to 36, wherein the dentifrice composition has a molar ratio of nitrate ions to stannous ions, both measured as free ions, of about 0.5:1 to about 2:1.

[0045] In accordance with an embodiment 38, provided is the kit according to any one of embodiments 29 to 37, wherein phosphate source of the dentifrice composition is selected from tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.

[0046] In accordance with an embodiment 39, provided is the kit according to any one of embodiments 29 to 38, wherein the toothbrush comprises a plurality of tufts of bristles.

[0047] In accordance with an embodiment 40, provided is the kit according to embodiment 39, wherein the plurality of bristle tufts comprises about 4000 to about 6000 bristles.

[0048] In accordance with an embodiment 41, provided is the kit according to embodiment 39 or embodiment 40, wherein the plurality of bristle tufts comprises one or more central bristle tuft.

[0049] In accordance with an embodiment 42, provided is the kit according to any one of embodiments 39 to 41, wherein the plurality of bristle tufts comprises a perimeter of bristle tufts surrounding the central bristle tuft, the perimeter of bristle tufts comprising a distal bristle tuft, a proximal bristle tuft, a peripheral bristle tuft, or a combination of two or more thereof.

[0050] In accordance with an embodiment 43, provided is the kit according to embodiment 42, wherein the perimeter of bristle tufts comprises two or more peripheral bristle tuft.

[0051] In accordance with an embodiment 44, provided is the kit according to embodiment 42 or embodiment 43, wherein the perimeter of bristle tufts comprises one or more distal bristle tuft and one or more distal bristle tuft.

[0052] In accordance with an embodiment 45, provided is the kit according to any one of embodiments 42 to 44, wherein at least one of the bristle tufts of the perimeter of bristle tufts has about 10 to about 25 bristle tips / mm2.

[0053] In accordance with an embodiment 46, provided is the kit according to any one ofDocket No.: 1096285-OO-WO-Ol-OC embodiments 41 to 45, wherein the central bristle tuft has about 10 to about 25 bristle tips / mm2.

[0054] In accordance with an embodiment 47, provided is the kit according to any one of embodiments 41 to embodiment 46, wherein the central bristle tuft comprises a convex inner surface.

[0055] In accordance with an embodiment 48, provided is the kit according to any one of embodiments 42 to 47, wherein at least one of the bristle tufts of the perimeter of bristle tufts is tapered such that the bristles have a length that decreases toward the central bristle tuft.

[0056] In accordance with an embodiment 49, provided is the kit according to any one of embodiments 42 to 45, wherein the at least one of the bristle tufts of the perimeter of bristle tufts has a length that is greater than a length of the central bristle tuft by about 10% or more.

[0057] In accordance with an embodiment 50, provided is the kit according to any one of embodiments 42 to 49, wherein the length of each of the bristle tufts of the perimeter of bristle tufts is greater than the length of the central bristle tuft by about 10% or more.

[0058] In accordance with an embodiment 51, provided is the kit according to any one of embodiments 29 to 49, wherein at least one of the bristle tufts of the perimeter of bristle tufts comprise tapered bristles having a tapered tip of about 0.005 to about 0.05 mm.

[0059] In accordance with an embodiment 52, provided is the kit according to any one of embodiments 30 to 51, wherein the mouthwash composition further comprises from about 1 to about 10 wt.% of a nonionic surfactant.

[0060] In accordance with an embodiment 53, provided is the kit according to any one of embodiments 30 to 52, wherein the mouthwash composition further comprises a from about 60 to about 85 wt.% of a polyol.

[0061] In accordance with an embodiment 54, provided is the kit according to any one of embodiments 30 to 53, wherein the mouthwash composition further comprises from about 11 to about 30 wt.% of water.

[0062] In accordance with an embodiment 55, provided is the kit according to any one of embodiments 30 to 54, wherein the mouthwash composition is essentially free or free of monoalcohols.

[0063] In accordance with an embodiment 56, provided is the kit according to any one of embodiments 30 to 55, wherein the mouthwash composition is essentially free or free of hydrocarbon oils.Docket No.: 1096285-OO-WO-Ol-OC

[0064] In accordance with an embodiment 57, provided is the kit according to any one of embodiments 30 to 55, wherein a pre-applied amount of dentifrice is disposed on at least a portion of the bristles of the toothbrush.BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:

[0066] FIG. 1 is a perspective view of a personal care implement in accordance with an embodiment of the present invention;

[0067] FIG. 2 is a partially exploded perspective view of the personal care implement of FIG. 1;

[0068] FIG. 3 is a rear perspective view of the personal care implement of FIG. 1;

[0069] FIG. 4 is a front view of the personal care implement of FIG. 1;

[0070] FIG. 5 is a side view of the personal care implement of FIG. 1;

[0071] FIG. 6A is a perspective view of a core component in accordance with an embodiment of the present invention;

[0072] FIG. 6B is a front view of the core component of FIG. 6A;

[0073] FIG. 6C is a side view of the core component of FIG. 6A;

[0074] FIG. 6D is a cross-sectional view taken along line VIID-VIID of FIG. 6A;

[0075] FIG. 6E is a cross-sectional view taken along line VIIE-VIIE of FIG. 6A;

[0076] FIG. 7A is a perspective view of an external body component in accordance with an embodiment of the present invention;

[0077] FIG. 7B is a front view of the core component of FIG. 7A;

[0078] FIG. 7C is a side view of the core component of FIG. 7A;

[0079] FIG. 7D is a cross-sectional view taken along line VIID-VIID of FIG. 7A;

[0080] FIG. 8 is a cross-sectional view taken along line V-V of FIG. 1;

[0081] FIG. 9 is a cross-sectional view taken along line IX-IX of FIG. 1;

[0082] FIG. 10 is a cross-sectional view taken along line X-X of FIG. 1;

[0083] FIG. 11 is a close-up front view of a head of a personal care implement in accordance with an embodiment of the present invention;

[0084] FIG. 12 is a close-up rear view of a head of a personal care implement in accordance with an alternative embodiment of the present invention;Docket No.: 1096285-OO-WO-Ol-OC

[0085] FIG. 13 is a graph showing the effect of a non-limiting exemplary oral care regimen and a comparative oral care regimen on plaque index, plaque severity, and intcrproximal plaque according to aspect of the present invention; and

[0086] FIG. 14 graph showing the effect of a non-limiting exemplary oral care regimen and a comparative oral care regimen on gingival index, gingival severity, and intcrproximal gingival according to aspect of the present invention.

[0087] It should be understood that the various aspects are not limited to the arrangements and instrumentality shown in the drawings.DETAILED DESCRIPTION

[0088] For illustrative purposes, the principles of the present invention are described by referencing various exemplary embodiments thereof. Although certain embodiments of the invention 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 the disclosed embodiments of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of any particular embodiment disclosed herein. The terminology used herein is for the purpose of description and not of limitation.

[0089] 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”.

[0090] As used throughout, ranges are used as shorthand for describing each and every value that is within the 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.Docket No.: 1096285-OO-WO-Ol-OC

[0091] 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.%.

[0092] All references cited herein are hereby incorporated by reference in their entireties. In the event of a conflict in a definition in the present disclosure and that of a cited reference, the present disclosure controls.

[0093] The abbreviations and symbols as used herein, unless indicated otherwise, take their ordinary meaning. The abbreviation “wt.%” means percent by weight relative to the respective oral care composition (e.g., dentifrice composition or mouthwash composition). The symbol “°” refers to a degree, such as a temperature degree or a degree of an angle. The symbols “h”, “min”, “mL”, “nm”, and " m” refer to hour, minute, milliliter, nanometer, and micrometer, respectively. The abbreviation “UV-VIS” referring to a spectrometer or spectroscopy, means Ultraviolet- Visible. The abbreviation “rpm” means revolutions per minute.

[0094] When referring to chemical structures, and names, the symbols “C”, “H”, and “O” mean carbon, hydrogen, and oxygen, respectively. The symbols “=” and “=” mean single bond, double bond, and triple bond, respectively.

[0095] “Volatile”, as used herein, means having a flash point of less than about 100° C. “Nonvolatile”, as used herein, means having a flash point of greater than about 100° C.

[0096] 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.

[0097] 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 E” 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 saltDocket No.: 1096285-OO-WO-Ol-OC thereof, and a mixture thereof,” it indicates that that one or more of A, B, C, D, 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.

[0098] All components and elements positively set forth in this disclosure can be negatively excluded from the claims. In other words, the oral care compositions (e.g., dentifrice composition or mouthwash composition) 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.

[0099] Some of the various categories of components identified may overlap. In such cases where overlap may exist and the oral care composition (e.g., dentifrice composition or mouthwash 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 fluoride ion source and a stannous ion source. If a particular oral care composition includes both a fluoride ion source and a stannous ion source, stannous fluoride will serve only as either a fluoride ion source or a stannous ion source — not both.

[0100] For readability purposes, the chemical functional groups are in their adjective form; for each of the adjectives, the word “group” is assumed. For example, the adjective “alkyl” without a noun thereafter, should be read as “an alkyl group.”

[0101] As used herein, the term “prokaryotes” refers to a group of organisms that usually lack a cell nucleus or any other membrane-bound organelles. In some embodiments, prokaryotes a e bacteria. The term “prokaryote” includes both archaea and eubacteria.

[0102] As used herein, the term “subject” refers to individuals (e.g., human) to be treated by the methods or compositions of the present invention. Subjects include, but are not limited to, mammals (e.g., murines, simians, equines, bovines, porcines, canines, felines, and the like), andDocket No.: 1096285-OO-WO-Ol-OC most preferably includes humans. In the context of the invention, the term “subject” generally refers to an individual who will receive or who has received treatment for a condition characterized by the presence of biofilm-forming bacteria, or in anticipation of possible exposure to biofilmforming bacteria.

[0103] As used herein the term, “in vitro” refers to an artificial environment and to processes or reactions that occur within an artificial environment. In vitro environments include, but are not limited to, test tubes and cell cultures. The term “in vivo” refers to the natural environment (e.g., an animal or a cell) and to processes or reaction that occur within a natural environment.

[0104] As used herein, the term “pathogen” refers to a biological agent that causes a disease state (e.g., infection, cancer, etc.) in a host. “Pathogens” include, but are not limited to, viruses, bacteria, archaea, fungi, protozoans, mycoplasma, prions, and parasitic organisms.

[0105] As used herein, the term “microbe” refers to a microorganism and is intended to encompass both an individual organism, or a preparation comprising any number of the organisms.

[0106] As used herein, the term “microorganism” refers to any species or type of microorganism, including but not limited to, bacteria, archaea, fungi, protozoans, mycoplasma, and parasitic organisms.

[0107] The terms “bacteria” and “bacterium” refer to all prokaryotic organisms, including those within all of the phyla in the Kingdom Procaryotae. It is intended that the term encompass all microorganisms considered to be bacteria including Mycoplasma, Chlamydia, Actinomyces, Streptomyces, and Rickettsia. All forms of bacteria are included within this definition including cocci, bacilli, spirochetes, spheroplasts, protoplasts, etc. Also included within this term are prokaryotic organisms that arc Gram-negative or Gram-positive. “Gram-negative” and “Grampositive” refer to staining patterns with the Gram-staining process, which is well known in the art. (See e.g., Finegold and Martin, Diagnostic Microbiology, 6th Ed., CV Mosby St. Louis, pp. 13-15 (1982)). “Gram-positive bacteria” are bacteria that retain the primary dye used in the Gram-stain, causing the stained cells to generally appear dark blue to purple under the microscope. “Gramnegative bacteria” do not retain the primary dye used in the Gram-stain, but are stained by the counterstain. Thus, Gram-negative bacteria generally appear red.

[0108] The term “non-pathogenic bacteria” or “non-pathogenic bacterium” includes all known and unknown non-pathogenic bacterium (Gram-positive or Gram-negative) and any pathogenic bacterium that has been mutated or converted to a non-pathogenic bacterium. Furthermore, aDocket No.: 1096285-OO-WO-Ol-OC skilled artisan recognizes that some bacteria may be pathogenic to specific species and non- pathogenic to other species; thus, these bacteria can be utilized in the species in which it is non- pathogenic or mutated so that it is non-pathogenic.

[0109] As used herein, the term “cell culture” refers to any in vitro culture of cells, including, e.g., prokaryotic cells and eukaryotic cells. Included within this term are continuous cell lines (e.g., with an immortal phenotype), primary cell cultures, transformed cell lines, finite cell lines (e.g., non-transformed cells), bacterial cultures in or on solid or liquid media, and any other cell population maintained in vitro.

[0110] Aspects of the invention are directed to oral care regimens, oral care kits, and uses of oral care kits. It was discovered that particular combinations of certain dentifrice compositions and certain toothbrushes (e.g., high-density tufted toothbrushes preferably configured for rapid foaming of the dentifrice composition) provide an enhanced reduction of plague. Further, certain combinations of certain dentifrice compositions and certain high-density tufted toothbrushes achieve an unexpectedly significant reduction of pathogenic bacteria (e.g., bacteria associated with gingivitis). The benefits achieved by the combinations of certain dentifrice compositions and certain high-density tufted toothbrush disclosed herein can be further enhanced by particular mouthwash compositions.

[0111] In accordance with at least one aspect, provided is an oral care regimen comprising applying a dentifrice composition to an oral cavity using a high-density tufted toothbrush, the dentifrice composition comprising a stannous source, a nitrate source, and a phosphate source, wherein the high-density tufted toothbrush comprises end-rounded bristles and tapered bristles; and applying a mouthwash composition to the oral cavity, the mouthwash composition comprising cetylpyridinium chloride and a zinc source.

[0112] According to further aspects, provided is a kit comprising a dentifrice composition comprising a stannous source, a nitrate source, and a polyphosphate source; and a high-density tufted toothbrush comprising comprises end-rounded bristles and tapered bristles. The kit may further comprise a mouthwash composition comprising cetylpyridinium chloride and a zinc source.

[0113] The regimens may further comprise applying the dentifrice composition to an oral cavity by brushing one or more teeth of the oral cavity using the toothbrush and, thus, the dentifrice composition applied to the bristles of the toothbrush. Similarly, the kits disclosed herein may haveDocket No.: 1096285-OO-WO-Ol-OC the dentifrice disposed on at least a portion of the bristles of the toothbrush. In some embodiments, the kit includes a toothbrush having a prc-applicd amount of dentifrice disposed on at least a portion of the bristles of the toothbrush. In some cases, the one or more teeth are brushed in a circular motion, a vertical motion (e.g., from the upper jaw to lower jaw and visa-versa), and / or horizontal motion.

[0114] The regimen may comprise applying about 0.1 gram to about 3 grams of the dentifrice composition to the toothbrush. For example, the remine may comprise applying about 0.1 gram to about 3 grams of dentifrice, e.g., in the form of a dentifrice, to the toothbrush and / or to the oral cavity. For example, the dentifrice may applied, e.g., in the form of a dentifrice, to the toothbrush and / or the ultimately the oral cavity in an amount of about 0.1 to about 3 grams, about 0.3 to about 3 grams, about 0.5 to about 3 grams, about 1 to about 3 grams, about 1.5 to about 3 grams, about 2 to about 3 grams, about 2.5 to about 3 grams; from about 0.1 to about 2.5 grams, about 0.3 to about 2.5 grams, about 0.5 to about 2.5 grams, about 1 to about 2.5 grams, about 1.5 to about 2.5 grams, about 2 to about 2.5 grams; from about 0.1 to about 2 grams, about 0.3 to about 2 grams, about 0.5 to about 2 grams, about 1 to about 2 grams, about 1.5 to about 2 grams; from about 0.1 to about 1.5 grams, about 0.3 to about 1.5 grams, about 0.5 to about 1.5 grams, about 1 to about 1.5 grams; from about 0.1 to about 1 gram, about 0.3 to about 1 gram, about 0.5 to about 1 gram; from about 0.1 to about 0.7 gram, about 0.3 to about 0.7 gram, about 0.5 to about 0.7 gram; from about 0.1 to about 0.4 gram, about 0.3 to about 0.4 gram, or any range or subrange thereof.

[0115] The methods disclosed herein may include applying the dentifrice composition to the oral cavity, such as in the form of brushing one or more teeth of the oral cavity, for about 30 seconds or more, preferably about 1 minute or more, preferably about 1.5 minutes or more, or preferably 2 minutes or more.

[0116] Preferably, the regimens and kits disclosed herein reduce and / or inhibit the growth of pathogenic bacteria (e.g., Porphyromonas gingivalis) in the oral cavity. In some embodiments, the regimens and / or kits disclosed herein reduce the growth rate of pathogenic bacteria (e.g., Porphyromonas gingivalis) by 5% or more, e.g., as compared to the growth rate of Porphyromonas gingivalis under similar conditions without the regimens and / or application of the kits disclosed herein. In certain embodiments, the regimens and / or kits disclosed herein reduce the growth rate of pathogenic bacteria (e.g., Porphyromonas gingivalis) by about 10% or more, about 15% or more, about 20% or more, about 22% or more, about 24% or more, about 25% or more, about 26%Docket No.: 1096285-OO-WO-Ol-OC or more, about 28% or more, or about 30% or more, e.g., as compared to the growth rate of the same pathogenic bacteria (e.g., Porphyromonas gingivalis) under similar conditions without the regimens and / or application of the kits disclosed herein.

[0117] The regimens and kits disclosed herein may preferably reduce the proteolytic activity and / or rate of pathogenic bacteria (e.g., Porphyromonas gingivalis) by 25% or more after about 12 hours from completion of the regimen and / or application of the kits, e.g., as compared to the proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis) under similar conditions without the regimens and kits disclosed herein. In some instances, the regimens and / or kits may reduce the proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis) in the periodontal pocket. For example, the methods disclosed herein may reduce the proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis) by about 15% or more, about 20% or more, about 25% or more, about 30% or more, about 35% or more, about 38% or more, about 41% or more, about 44% or more, about 47% or more, about 50% or more, about 53% or more, about 56% or more, or about 59% or more, after about 12 hours from completion of the regimen and / or application of the kit, e.g., using whole cell cultures and / or whole wash cell cultures as compared to the proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis) under similar conditions without the regimen and / or kits disclosed herein.

[0118] The regimen and / or kits disclosed herein may achieve any of the foregoing reductions in the proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis) after 2 minutes or about 12 hours, as measured in the periodontal pocket and / or in the periodontal tissue. The reduced proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis) can be determined by measuring Rgp activity. For example, the regimens and / or kits disclosed herein may reduce the proteolytic activity of pathogenic bacteria (e.g., Porphyromonas gingivalis), e.g., as measured by Rgp activity, by one of the foregoing amounts as compared to the proteolytic activity of the same pathogenic bacteria (e.g., Porphyromonas gingivalis), e.g., as measured by Rgp activity, without the regimen and / or kits disclosed herein.

[0119] The oral care regimens and kits disclosed herein may utilize the same or similar' dentifrice compositions, high-density tufted toothbrushes, and mouthwash compositions, which are further discussed below.

[0120] As mentioned above, the dentifrice compositions typically comprise a stannous source, a nitrate source, and a phosphate source. Suitable components, such as those listed below, may beDocket No.: 1096285-OO-WO-Ol-OC included or excluded from the formulations for the dentifrice compositions depending on the specific combination of other ingredients and the form of the oral care compositions. Additionally or alternatively, the dentifrice compositions may in some embodiments have a single phase, which contains that components and / or ingredients of the dentifrice composition.

[0121] The dentifrice compositions typically comprise a stannous source, which may comprise or consist of one or more stannous source. The stannous source may be present in the dentifrice composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the dentifrice composition. For example, the amount of stannous present in the dentifrice composition may be from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition. In at least one embodiment, dentifrice composition includes about 0.4 to about 0.5 wt.% of stannous source, based on the total weight of the dentifrice composition.

[0122] The stannous source may be selected from the group consisting of: stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof. The stannous source may comprise stannous fluoride, stannous chloride, stannous acetate, and a combination of two or more thereof. In at least one embodiment, the stannous ion source comprises stannous fluoride.

[0123] The dentifrice compositions typically comprise one or more nitrate source. The nitrate source may consist of one or more nitration ion source. The nitrate source(s) may be present in the dentifrice composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the dentifrice composition. In some instances, the amount of the nitrate source present in the dentifrice composition may be from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to aboutDocket No.: 1096285-OO-WO-Ol-OC3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0124] The one or more nitrate source may be in the form of a salt or an ion derived therefrom, including, e.g., nitrate salt is selected from an alkali or alkaline earth metal nitrate. Examples of nitrate sources include lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or a combination two or more thereof. In at least one embodiment, the nitrate ion source comprises potassium nitrate.

[0125] The dentifrice compositions may be formulated to have a molar ratio of nitrate ions to stannous ions, both measured as free ions, that is about 2:1 or less. For example, the dentifrice composition may have a molar ratio of nitrate ions to stannous ions, both measured as free ions, of from about 0.5:1 to about 2:1, about 0.5:1 to about 1.8:1, about 0.5:1 to about 1.6:1, about 0.5:1 to about 1.4:1, about 0.5:1 to about 1.2:1, about 0.5:1 to about 1:1; from about 0.7: 1 to about 2: 1, about 0.7:1 to about 1.8:1, about 0.7:1 to about 1.6:1, about 0.7:1 to about 1.4:1, about 0.7:1 to about 1.2: 1, about 0.7: 1 to about 1 : 1; from about 0.9: 1 to about 2: 1, about 0.9: 1 to about 1.8: 1, about 0.9:1 to about 1.6:1, about 0.9:1 to about 1.4:1, about 0.9:1 to about 1.2:1, about 0.9:1 to about 1:1, or any range or subrange thereof. In some embodiments, the dentifrice composition is formulated to have a molar ratio of nitrate ions to stannous ions, both measured as free ions, of about 1:1.

[0126] The dentifrice compositions typically comprise one or more phosphate source(s), which may comprise or consist of one or more phosphate ion sources. The phosphate source(s) is preferably present in an effective amount. In some instances, the dentifrice composition may include one or more phosphate source(s) in an amount from about 0.1 to about 7 wt.%, based on the total weight of the dentifrice composition. For example, the one or more phosphate source(s) may be present in the dentifrice composition in an amount from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2Docket No.: 1096285-OO-WO-Ol-OC wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0127] The phosphate source may preferably comprise a soluble phosphate compound, such as a phosphate salt. The phosphate source may be a phosphate ion source. Examples of phosphate sources include tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, or a combination thereof. The phosphate source may be a pyrophosphate salt, such as an alkali metal pyrophosphate salt. In certain embodiments, the alkali metal pyrophosphate is selected from a tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. For instance, the phosphate source may include tetrasodium pyrophosphate (TSPP), tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate or a combination of two or more thereof. The phosphate source may be chosen from orthophosphates, polymetaphosphates, pyrophosphates, and a combination of two or more thereof. In some instances, the phosphate source includes tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), or a combination thereof. In at least one embodiment, the phosphate source comprises tetrasodium pyrophosphate. The phosphate source, when in the form of a salt, maybe in their hydrated and / or unhydrated forms.

[0128] Additionally or alternatively, the dentifrice composition may include one or more anticalculus agent. Examples of anti-calculus 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-Docket No.: 1096285-OO-WO-Ol-OC2,2-diphosphonic acid), N-methyl azacyclopentane-2,3-diphosphonic acid, ethane- 1 -hydroxy- 1 ,1 - diphosphonic acid (EHDP) and ethane- 1 -amino- 1,1-diphosphonatc, phosphonoalkanc carboxylic acids and. Useful inorganic phosphate and polyphosphate salts include monobasic, dibasic and tribasic sodium phosphates. Soluble pyrophosphates, such as those disclosed herein may be useful anticalculus agents. The pyrophosphate salts can be any of the alkali metal pyrophosphate salts.

[0129] The dentifrice composition may include the anti-calculus agents in an amount from about 0.1 to about 7 wt.%, based on the total weight of the dentifrice composition. For example, the anticalculus agent(s) may be present in the dentifrice composition in an amount from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0130] The dentifrice compositions may include a fluoride ion source. The fluoride ion source may be present in an effective amount. In some cases, the fluoride ion source is present in the dentifrice composition in an amount of about 0.01 to about 5 wt.%, based on the total weight of the dentifrice composition. For example, the fluoride ion source is present in an amount of about 0.01 to about 5 wt.%, about 0.01 to about 4 wt.%, about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%; from about 0.05 to about 5 wt.%, about 0.05 to about 4 wt.%, about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%; from about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%,Docket No.: 1096285-OO-WO-Ol-OC about 1 .2 to about 3 wt.%, about 1 .2 to about 2 wt.%; from about 1 .5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0131] The fluoride ion source may be selected from soluble fluoride ion salts. For example, the fluoride ion source may comprise sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, stannous fluorozirconate, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, amine fluorides or a combination of two or more thereof. In some embodiments, the fluoride ion source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof. Additional examples of fluoride ion source are disclosed in U.S. Patent No. 3,535,421, U.S. Patent No. 4,885,155, and U.S. Patent No. 3,678,154, the disclosure of each of which is hereby incorporated by reference in their entirety.

[0132] In certain embodiments, the dentifrice composition of the disclosure may contain stannous fluoride and a source of fluoride ions or fluorine-providing agents in amounts sufficient to deliver, in total, from 25 ppm to 25,000 ppm (mass fraction) of fluoride ions, generally at least 500 ppm, e.g., from about 500 to about 2000 ppm, from about 800 to about 1800 ppm, from about 1000 to about 1600 ppm, from about 1200 to about 1550 ppm, or about 1450 ppm.

[0133] The dentifrice compositions may comprise one or more surfactant(s) in an amount that may vary, but typically may be from about 0.1 to about 8 wt.%, based on the total weight of the dentifrice composition. For example, the amount of one or more surfactant(s) present in the dentifrice composition may be from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 8 wt.%, about 0.3 to about 6 wt.%, about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 8 wt.%, about 0.6 to about 6 wt.%, about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 8 wt.%, about 0.9 to about 6 wt.%, about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9Docket No.: 1096285-OO-WO-Ol-OC to about 2 wt.%; from about 1 .2 to about 8 wt.%, about 1 .2 to about 6 wt.%, about 1 .2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 8 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0134] The dentifrice composition may comprise a surfactant system comprising of a plurality of surfactants. The surfactant system may comprise one or more anionic surfactant, one or more cationic surfactant, one or more nonionic surfactants, one or more amphoteric surfactants, one or more zwitterionic surfactants, one or more bacterial surfactant, or combinations of two or more thereof.

[0135] The one or more anionic surfactant(s) may be selected be selected from sulfate based anionic surfactants and / or from non- sulfate based anionic surfactants, such as sulfonated monoglycerides of fatty acids, isethionates, sarcosinates, taurate, and a combination of two or more thereof. Examples of anionic surfactants, which may be included or excluded in some instances from the dentifrice composition, include sodium lauryl sulfate, sodium lauryl sarcosinate, sodium cocoy 1 methyl taurate, sodium monoglyceride sulfate, sodium cetaryl sulfate, potassium cocoy 1 glycinate, sodium lauryl phosphate, sodium lauryl lactylate, sodium lauryl sulfoacetate, sodium lauryl glutamate, sodium lauryl isethionate, sodium laureth carboxylate, sodium dodecyl benzenesulfonate, and combinations thereof. In one embodiment, sodium lauryl sulfate is a preferred surfactant. Additional anionic surfactants are disclosed in U.S. Pat. No. 3,959,458, which is incorporated herein in its entirety for all purposes.

[0136] The surfactant system may comprise one or more amphoteric surfactant(s). The amphoteric surfactant(s) may include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched. In some cases, one of the aliphatic substituents of the amphoteric surfactant contains about 8 to about 18 carbon atoms and one of the aliphatic substituents contains an anionic water solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate. The amphoteric surfactants disclosed herein may be present in the dentifrice composition in a salt form.Docket No.: 1096285-OO-WO-Ol-OC

[0137] The amphoteric surfactants may include alkyl amphopropionates, betaines, alkyl sultaines, alkyl amphoacctatcs, or a combination of two or more thereof. Examples of amphoteric surfactants include betaine surfactants, such as cocamidopropyl betaine, lauryl dimethyl betaine (sold under the trade name Macat LB), cetyl dimethyl betaine, and cocoamphodiacetate.

[0138] The surfactant system may comprise one or more nonionic surfactant(s). The one or more nonionic surfactant(s) may be selected from glucosides, compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature. Examples of glucoside surfactants include decyl glucoside, stearyl glucoside, lauryl glucoside, coco-glucoside, cetearyl glucoside, decyl lauryl glucoside, lauroyl ethyl glucoside, myristoyl ethyl glucoside, oleoyl ethyl glucoside, or a combination of two or more thereof. Further examples of nonionic surfactants include poloxamers, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, acids, and esters, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides and mixtures of such materials. Additional examples of nonionic surfactants include polyoxyethylene, polyoxyethylene sorbitan esters, polyoxyl 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides, or a combination of two or more thereof.

[0139] The dentifrice compositions may include one or more abrasive(s), e.g., in an amount from about 5 to about 35 wt.%, based on the total weight of the dentifrice composition. In some embodiments, the one or more abrasive(s) is present in an amount from about 5 to about 30 wt.%, about 5 to about 25 wt.%, about 5 to about 21 wt.%, about 5 to about 17 wt.%, about 5 to about 14 wt.%, about 5 to about 11 wt.%; from about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%, about 10 to about 21 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 15 to about 35 wt.%, about 15 to about 30 wt.%, about 15 to about 25 wt.%, about 15 to about 21 wt.%, about 15 to about 19 wt.%; from about 18 to about 35 wt.%, about 18 to about 30 wt.%, about 18 to about 25 wt.%, about 18 to about 21 wt.%; from about 21 to about 35 wt.%, about 21 to about 30 wt.%, about 21 to about 25 wt.%; from about 24 to about 35 wt.%,Docket No.: 1096285-OO-WO-Ol-OC about 24 to about 30 wt.%; from about 27 to about 35 wt.%, about 27 to about 30 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0140] The one or more abrasive(s) may include: 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.

[0141] As used herein, “mica” refers to any of a group of hydrous aluminum silicate minerals with plate morphology and / or perfect basal (micaceous) cleavage. Mica can be, for example, sheet mica, scrap mica or flake mica, as exemplified by muscovite, biotite or phlogopite type micas. The abrasive may be selected from insoluble phosphates, such as orthophosphates, polymetaphosphates, pyrophosphates, and a combination thereof. Synthetic silicas include both silica gels and precipitated silicas that are prepared by the neutralization of aqueous silicate solutions with a strong mineral acid. Abrasives comprising silica may be useful in certain embodiments of the dentifrice composition. In certain embodiments, the oral compositions may comprise a particularly efficacious combination of silica abrasive particle species. For example, the abrasive(s) be selected from high cleaning silica, tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), and a combination of two or more thereof.

[0142] The dentifrice compositions may include an abrasive system comprising two or more abrasives. For example, an abrasive system comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3 to 7, 3 to 6, 2 to 5, or 3 to 5 abrasives. The abrasives may comprise one or more cleaning abrasive and / or one or more polishing abrasives. As appreciated by one of skill in the art, a single abrasive species typically performs at least some cleaning and polishing simultaneously. However, particles are generally categorized in the art by the predominant effect they have on a target oral surface. Typically, “polishing abrasives” are considered to be relatively small particles having high hardness, where abrasives with relatively large particle sizes and low hardness are considered to be “cleaning abrasives.” In certain embodiments, the dentifrice composition comprises two or more abrasives comprising silica. In some embodiments, the first abrasive is selected to be a harder and smaller abrasive, e.g., a higher cleaning and / or polishing abrasive, and the second abrasive isDocket No.: 1096285-OO-WO-Ol-OC a typical cleaning abrasive. In some embodiments, the dentifrice composition includes at least one polishing abrasive and / or at least one cleaning abrasive. Further examples of abrasives arc disclosed in U.S. Patent Publication No. 2007 / 140986, which is incorporated herein in its entirety by reference for all purposes.

[0143] The dentifrice composition may include one or more thickening agent(s), e.g., in an amount from about 0.5 to about 20 wt.%, based on the total weight of the dentifrice composition. For example, the amount of thickening agent(s) in the dentifrice composition may be from about 0.5 to about 17 wt.%, about 0.5 to about 14 wt.%, about 0.5 to about 11 wt.%, about 0.5 to about 9 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%; from about 1 to about 20 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%, about 1 to about 9 wt.%, about 1 to about 7 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%; from about 2 to about 20 wt.%, about 2 to about 17 wt.%, about 2 to about 14 wt.%, about 2 to about 11 wt.%, about 2 to about 9 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 4 to about 20 wt.%, about 4 to about 17 wt.%, about 4 to about 14 wt.%, about 4 to about 11 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%; from about 7 to about 20 wt.%, about 7 to about 17 wt.%, about 7 to about 14 wt.%, about 7 to about 11 wt.%; from about 10 to about 20 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 14 to about 20 wt.%, about 14 to about 17 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0144] Thickening agents may be referred to as “thickeners” or “viscosity modifying agents.” Thickening agents are typically included to increase the viscosity of the dentifrice compositions. The one or more thickening agent(s) may be selected from a polysaccharide, a silica thickener, an acrylate, a polymer, and a combination of two or more thereof. Examples of polysaccharides include cellulose, carboxymethyl hydroxyethylcellulose, cellulose acetate propionate carboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or a combination of two more thereof. Natural gums such as xanthan gum, karaya, gum arabic, and gum tragacanth can also be incorporated. Colloidal magnesium aluminum silicate can also be used as a component of the thickening composition to further improve the composition's texture. Silica thickeners, which form polymeric structures or gels in aqueous media,Docket No.: 1096285-OO-WO-Ol-OC may be present. Silica thickeners are typically physically and functionally distinct from the particulate silica abrasives as the silica thickeners arc very finely divided and provide little or no abrasive action.

[0145] In some embodiments, the one or more thickening agent(s) comprises a polymer selected from polysaccharides, acrylates, polyvinyl pyrrolidone, polyitaconates, an acrylamides, and combinations thereof. Polyvinyl pyrrolidone generally refers to a polymer containing vinylpyrrolidone (e.g., N-vinylpyrrolidone, N-vinyl-2-pyrrolidione, and N-vinyl-2-pyrrolidinone) as a monomeric unit. The monomeric unit may include a polar imide group, four non-polar methylene groups, and a non-polar methane group. The polyvinyl pyrrolidone may have an average molecular weight in the range 5,000 to 100,000, preferably in the range 5,000 to 50,000.

[0146] Examples of acrylates that may be included in the dentifrice composition include, e.g., isobutyl acrylate, tert-butyl acrylate, 2-ethylhexyl acrylate, lauryl acrylate, lauryl / tridecyl acrylate, cetyl acrylate, stearyl acrylate, cyclohexyl acrylate, benzyl acrylate, isobornyl acrylate, 2- methoxyethyl acrylate, 2-ethoxyethyl acrylate, 2-ethoxyethoxyethyl acrylate, 2-phenoxyethyl acrylate, tetrahydrofurfuryl acrylate, 2-hydroxyethyl acrylate, 2-hydroxypropyl acrylate, 4- hydroxybutyl acrylate, dimethylaminoethyl acrylate, 1 ,4-butanediol acrylate, or a combination of two or more thereof.

[0147] The acrylate may be chosen from diacrylates. In some embodiments, the dentifrice composition includes a diacrylate chosen from 1 ,4-butanediol, 1,6-hexanediol, tetraethylene glycol, tripropylene glycol, ethoxylated bisphenol-A, and a combination of two or more thereof. Triacrylate monomers include trimethylol propane, ethoxylated, glyceryl propoxy, and pentaerythritol.

[0148] Acrylates further include methacrylates, such as methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, isobutyl methacrylate, tert-butyl methacrylate, 2-ethylhexyl methacrylate, lauryl methacrylate, alkyl methacrylate, tridecyl methacrylate, stearyl methacrylate, cyclohexyl methacrylate, benzyl methacrylate, isobornyl methacrylate, 2-hydroxyethyl methacrylate, 2- hydroxypropyl methacrylate, dimethylaminoethyl methacrylate, diethylaminoethyl methacrylate, glycidyl methacrylate, tetrahydrofurfuryl methacrylate, allyl methacrylate, ethylene glycol methacrylate, triethylene glycol methacrylate, tetraethylene glycol methacrylate, 1,3- butyleneglycol methacrylate, 1,6-hexanediol methacrylate, trimethylopropane methacrylate, ethoxyethyl methacrylate, trifluoroethyl methacrylate, or a combination of two or more thereof.Docket No.: 1096285-OO-WO-Ol-OC

[0149] Examples of acrylamides include, but are not limited to, acrylamide, methacrylamide and di(Ci-C3o) alkyl-acrylamidcs and -methacrylamides such as those of methyl, ethyl, propyl, butyl, pentyl, hexyl and the like. N-substituted acrylamides that may be suitable include N- ethylacrylamide, N-tert-butylacrylamide, N-tert-octylacrylamide, N-octylacrylamide, N- decylacrylamide, N-dodecylacrylamide and the corresponding N-substituted methacrylamides. Other N-substituted acrylamides include N-hydroxy methyl acrylamide, N-isopropylacrylamide, N-methylacrylamide, N,N'-methylenebisacrylamide, N-isobutoxymethylacrylamide, N,N- dimethylacrylamide, and 2-acrylamido-2-methylpropanesulfonic acid.

[0150] The dentifrice compositions may include one or more polyol(s). The one or more polyol(s) may be present in the dentifrice composition in an amount from about 1 to about 60 wt.%, based on the total weight of the dentifrice composition. For example, the dentifrice composition may include polyol(s) in an amount from about 20 to about 60 wt.%, about 20 to about 55 wt.%, about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 60 wt.%, about 25 to about 55 wt.%, about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 60 wt.%, about 28 to about 55 wt.%, about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 60 wt.%, about 31 to about 55 wt.%, about 31 to about 50 wt.%, about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 37 wt.%; from about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; from about 37 to about 60 wt.%, about 37 to about 55 wt.%, about 37 to about 50 wt.%, about 37 to about 45 wt.%; from about 40 to about 60 wt.%, about 40 to about 55 wt.%, about 40 to about 50 wt.%, about 40 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0151] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25 °C). The polyol may be a humectant. In some preferred embodiments, the polyol(s) comprises glycerin, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG, a saccharide (e.g., fructose, glucose, sucrose and mixtures of saccharides, such as honey), or a combination of two or more thereof. For instance,Docket No.: 1096285-OO-WO-Ol-OC the dentifrice composition comprises maltitol, mannitol, sorbitol, xylitol, a polypropylene glycol (PPG), a polyethylene glycol (PEG), a block copolymer of PPG and PEG, or a combination or two or more thereof.

[0152] In some cases, the dentifrice composition includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the dentifrice composition may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional, non-limiting examples of polyols that may, optionally, be included in the oral care include and / or may be chosen from alkanediols such as glycerin, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-l,4-diol, 2-ethyl-l,3-hexanediol, 2-methyl-2,4-pentanediol, caprylyl glycol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-l,2-pentanediol; glycol ethers such as ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethylene glycol monomethyl ether acetate, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, diethylene glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1 -methyl- 1-methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-t- butyl ether, propylene glycol mono-n-propyl ether, propylene glycol mono-iso-propyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol mono-iso-propyl ether, sorbitol, sorbitan, triacetin, and a mixture thereof.

[0153] Additionally or alternatively, the dentifrice composition may include polyol(s) having a molecular weight of from about 100 to 5000 g / mol. For instance, the polyol may comprise a polyethylene glycol, a polypropylene glycol, a block polymer of polyethylene glycol and polypropylene glycol, or a combination of two or more thereof. In some embodiments, the polyol comprises a polypropylene glycol, a polypropylene glycol, and / or a block polymer of polyethylene glycol and polypropylene glycol having a molecular weight of about 100 to about 900, about 200 to about 800, about 400, about 1500 to about 2500, about 2000 to about 4500 or any range orDocket No.: 1096285-00-WO-01-OC subrange thereof. In some embodiments, the polyol is a polyethylene glycol, such as polyethylene glycol 600 (CAS-25322-68-3). In some embodiments, the dentifrice compositions comprise one or more polyethylene glycols, for example, polyethylene glycols in a molecular weight range from 200 to 800.

[0154] In some embodiments, the dentifrice compositions may include one or more sweeteners. The dentifrice composition may include caloric sweeteners and / or non-caloric sweeteners. Examples of non-caloric sweeteners include saccharin, for example, sodium saccharin, acesulfame, neotame, cyclamate or sucralose; natural high-intensity sweeteners, such as thaumatin, stevioside or glycyrrhizin; or sugar alcohols, such as sorbitol, xylitol, maltitol and mannitol. Examples of caloric sweeteners include sugars, such as fructose, glucose, sucrose, and high fructose syrups.

[0155] The one or more sweetener(s) may be present in the dentifrice composition in an amount from about 0.1 to about 50 wt.%, based on the total weight of the dentifrice composition. For example, the dentifrice composition may have a total amount of sweetener(s) from about 0.1 to about 40 wt.%, about 0.1 to about 30 wt.%, about 0.1 to about 20 wt.%, about 0.1 to about 10 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%; from about 1 to about 50 wt.%, about 1 to about 40 wt.%, about 1 to about 30 wt.%, about 1 to about 20 wt.%, about 1 to about 10 wt.%, about 1 to about 5 wt.%, about 1 to about 3 wt.%; from about 5 to about 50 wt.%, about 5 to about 40 wt.%, about 5 to about 30 wt.%, about 5 to about 20 wt.%, about 5 to about 10 wt.%; from about 10 to about 50 wt.%, about 10 to about 45 wt.%, about 10 to about 40 wt.%, about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%; from about 15 to about 50 wt.%, about 15 to about 45 wt.%, about 15 to about 40 wt.%, about 15 to about 37 wt.%, about 15 to about 34 wt.%, about 15 to about 31 wt.%, about 15 to about 28 wt.%, about 15 to about 25 wt.%; from about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 50 wt.%, about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 37 wt.%; from about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; from about 37Docket No.: 1096285-OO-WO-Ol-OC to about 50 wt.%, about 37 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0156] In some embodiments, the dentifrice composition preferably is substantially free or free of caloric sweeteners. For example, the dentifrice compositions may have about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the weight of the dentifrice composition. In at least one embodiment, the dentifrice composition contains about 0 wt.% or 0 wt.% of caloric sweeteners, based on the weight of the dentifrice composition.

[0157] The dentifrice compositions of the present disclosure may include a flavoring agent. The flavoring agent is typically incorporated in the dentifrice composition at a concentration of about 0.01 to about 3 wt.% by weight of the dentifrice composition. For example, the amount of flavoring agent(s) present in the dentifrice composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 3 wt.%, including any range or subrange thereof, based on the total weight of the dentifrice composition.

[0158] Suitable flavoring agents include, but are not limited to, 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.

[0159] The dentifrice compositions may include one or more colorants. Exemplary colorants can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the colorant can include dyes, certified aluminum lakes or colors derived from a natural source. The colorant may be water-based, oil-based or dry. The colorants can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. The concentrationsDocket No.: 1096285-OO-WO-Ol-OC of the colorant in the dentifrice composition may be from trace amount to about 0.6 wt.%, from about 0.1 to about 0.5 wt.%, about 0.2 to about 0.4 wt.%, or about 0.15 to about 0.35 wt.%, based on the total weight of the dentifrice composition.

[0160] The dentifrice composition may include one or more pH adjusters to increase or decrease the overall pH of the dentifrice composition. For example, one or more acids may be included to decrease the pH of the dentifrice composition. Examples of suitable acids for decreasing the pH of the dentifrice composition include, but are not limited to, citric acid, acetic acid, and the like. The dentifrice composition may include one or more bases, such as sodium hydroxide, potassium hydroxide and the like, to increase the pH of the dentifrice composition. Additional or alternative acids and bases that are suitable for adjusting the pH of the dentifrice composition are readily known to one of ordinary skill in the ail.

[0161] The amount of the pH adjuster in the dentifrice composition may be based on the desired pH of the final dentifrice composition and / or product. For example, the total amount of the pH adjuster may range from about 0.05 to about 20 wt.%, based on the total weight of the dentifrice composition. In some instances, the total amount of pH adjuster is from about 0.05 to about 15 wt.%, about 0.1 to about 10 wt.%, or about 0.12 to about 5 wt.%, including ranges and sub-ranges therebetween, based on the total weight of the dentifrice composition.

[0162] The dentifrice 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.

[0163] The dentifrice composition may include water in some embodiments. The water may be present in the dentifrice composition in an amount from about 5 to about 37 wt.%, based on the total weight of the dentifrice composition. For example, the dentifrice composition may include water in an amount from about 5 to about 34 wt.%, about 5 to about 31 wt.%, about 5 to about 28 wt.%, about 5 to about 25 wt.%, about 5 to about 20 wt.%; from about 10 to about 37 wt.%, about 10 to about 34 wt.%, about 10 to about 31 wt.%, about 10 to about 28 wt.%, about 10 to about 25 wt.%; from about 15 to about 37 wt.%, about 15 to about 34 wt.%, about 15 to about 31 wt.%, about 15 to about 28 wt.%, about 15 to about 25 wt.%; from about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to aboutDocket No.: 1096285-OO-WO-Ol-OC37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%, or any range or subrange thereof, based on the total weight of the dentifrice composition.

[0164] In addition to the dentifrice composition, the regimens and kits disclosed herein typically employ a toothbrush. Referring first to FIGS. 1 and 2, a toothbrush 100 will be described in accordance with an embodiment of the present invention. In the exemplified embodiment, the toothbrush 100 is a manual toothbrush. However, the toothbrush is not to be so limited in all embodiments and can take on other structural forms, including being a powered toothbrush.

[0165] Referring first to FIGS. 1-5, the toothbrush 100 will be described in accordance with an embodiment of the present invention. The toothbrush 100 may comprise a head portion 110 extending along a head axis A- A from a proximal end 111 to a distal end 112, and a handle portion 120 extending along a handle axis B-B from a proximal end 121 to a distal end 122. The head portion 110 of the toothbrush 100 may be configured to perform a personal care treatment function during a personal care treatment session. In an embodiment, the head portion 110 may be configured to perform an oral treatment function, such as teeth cleaning, gum scraping, flossing, or the like. The handle portion 120 of the oral care implement 100 may be held by a user to manipulate the head portion 110 during performance of a personal care treatment session. The head portion 110 and the handle portion 120 may be coupled together to form a singular unitary structure. In some embodiments, the head portion 110 may be permanently attached to the handle portion 120. In other embodiments, the head portion 110 may be detachable from the handle portion 120.

[0166] The head portion 110 may comprise a front surface 113 and a rear surface 116. A plurality of tooth cleaning elements 130 may extend from the front surface 113 of the head portion 110. The tooth cleaning elements 130 may be coupled to the head 110 in any manner known in the art, including staples, in-mold tufting (IMT), anchor-free tufting (AFT), or a modified AFT known as AMR. While a specific pattern of the tooth cleaning elements 130 is shown in the exemplified embodiment, the invention is not to be so limited in all embodiments and various different tooth cleaning element patterns may be used in other embodiments. The details of the tooth cleaning element pattern for the exemplified embodiment will be described below with reference to FIG. 11. A soft tissue cleanser 140 may be coupled to or positioned on the rear surface 116 of the head portion 110. The soft tissue cleanser 140 may be formed from an elastomeric material, such as aDocket No.: 1096285-OO-WO-Ol-OC thermoplastic elastomer, a thermoplastic polyurethane, or the like. In certain other embodiments, the soft tissue cleanser 140 may include protuberances, which can take the form of elongated ridges, nubs, or combinations thereof. Of course, the invention is not to be so limited and in certain embodiments and the toothbrush 100 may not include any soft tissue cleaner.

[0167] Where it does not conflict with the other disclosure provided herein or the claims, it should be appreciated that the term "tooth cleaning elements” may be used in a generic sense to refer to any structure that can be used to clean, polish, or wipe the teeth and / or soft oral tissue (e.g., tongue, cheek, gums, etc.) through relative surface contact. Common examples of "tooth cleaning elements" include, without limitation, bristle tufts, filament bristles, fiber bristles, nylon bristles, polybutylene terephthalate (PBT) bristles, spiral bristles, rubber bristles, elastomeric protrusions, flexible polymer protrusions, combinations thereof, and / or structures containing such materials or combinations. Thus, any combination of these tooth-cleaning elements may be used within the tooth cleaning element field in some embodiments. Furthermore, where bristles are used for one or more of the tooth cleaning elements 105, such bristles can be tapered, end-rounded, spiral, or the like. In certain preferred embodiments, the toothbrush includes tapered bristles having a tip of about 0.005 to about 0.05 mm, e.g., about 0.01 to about 0.05 mm, about 0.003 to about 0.05 mm, about 0.005 to about 0.03 mm, about 0.005 to about 0.01 mm, or any range or subrange thereof.

[0168] In embodiments that use elastomeric materials to form the tooth cleaning elements 130 or soft tissue cleaner 140, suitable elastomeric materials may include any biocompatible resilient material suitable for uses in an oral hygiene apparatus. To provide optimum comfort as well as cleaning benefits, the elastomeric material of any such tooth-cleaning element may have a hardness property in the range of A10 to A70 Shore hardness in one embodiment, or A8 to A25 Shore hardness in another embodiment. One suitable elastomeric material is styrene-ethylene / butylene- styrene block copolymer (SEBS) manufactured by GLS Corporation. Nevertheless, SEBS material from other manufacturers or other materials within and outside the noted hardness range could be used.

[0169] The handle portion 120 may have voids or recesses or slots, described in detail below, to, among other purposes, facilitate this reduction in plastic material while having a design that ensures that the structural integrity of the toothbrush 100 is maintained. These features may also provide additional functional benefits to the user, such as pressure control, grip enhancements, andDocket No.: 1096285-OO-WO-Ol-OC various pivoting actions of the head portion 110 relative to the handle portion 120 to gain better access to areas deeper within the oral cavity.

[0170] As best shown in FIG. 2, the toothbrush 100 may comprise a core component 200 and a main structural body 300. The main structural body 300 may comprise the head portion 110 of the toothbrush 100 and an exterior body portion 301 of the handle portion 120. Thus, the handle portion 120 may be formed by the exterior body portion 301 of the main structural body 300 and the core component 200. The main structural body 300 may be a monolithic structure that comprises the exterior body portion 301 of the handle portion 120 and the head portion 110. The core component 200 may be a separate component that is affixed to the main structural body 300, or more specifically to the exterior body portion 301 of the main structural body 300, in the finished and assembled toothbrush 100. In alternative embodiments, the entire toothbrush 100 (with the exception of the tooth cleaning elements 130 and the soft tissue cleanser 140) may be formed as an integral, monolithic structure.

[0171] The handle portion 120 may be an elongated structure that extends along the handle axis B-B from a proximal end 122 to a distal end 121. As noted above, the handle portion 120 is the portion of the toothbrush that is gripped by a user during use of the toothbrush 100. Specifically, a user may wrap his / her hand around the handle 120 to manipulate the toothbrush 100 during use in order to brush teeth or perform other operations with the toothbrush 100. The handle portion 120 may be formed from a hard plastic. In the exemplified embodiment, the core component 200 and the main structural body 300 are both formed from a hard plastic. The handle portion 120 may be formed from a transparent material, an opaque material, or a mix of both transparent and opaque materials. In some embodiments, the core component 200 may be transparent or translucent and the main structural body 300 may be opaque. In some embodiment, the care component 200 and the main structural body 300 may have a different light transmissivity. Thus, in some embodiments the core component 200 and the main structural body 300 may have differing degrees of transparency, translucency, and / or opacity.

[0172] Examples of hard plastic materials that could be used to form the core component 200 and the main structural body 300 may include, for example without limitation, polypropylene, polyethylene terephthalate, polyethylene, polystyrene, polyvinyl chloride, or the like in various different embodiments. In some embodiments, a grip formed from an elastomeric material may be located along portions of an exterior surface of the exterior body portion 301 of the main structuralDocket No.: 1096285-OO-WO-Ol-OC body 300. In such embodiments, the elastomeric material may be formed from a thermoplastic elastomer, a thermoplastic polyurethane, rubber, silicone, or the like. Such an elastomeric grip component is not included in the exemplified embodiment.

[0173] In the exemplified embodiment, and as described in more detail below, the exterior body portion 301 of the main structural body 300 may comprise a cavity 319, and the core component 200 may be positioned within the cavity 319 of the exterior body portion 301. The main structural body 300 may be injection molded over top of the core component 200 to manufacture the structure as described. The exterior body portion 301 may form an exterior or outer surface of the handle portion 120 and the core component 200 may form an interior structure within the exterior body portion 301 of the handle portion 120. The exterior body portion 301 may comprise an outer exterior surface 304 that forms an exterior surface or outer surface of the handle portion 120 of the toothbrush 100. The outer exterior surface 304 of the exterior body portion 301 may comprise gripping features 330 thereon to aid a user in gripping the handle portion 120 of the toothbrush 100. The gripping features 330 will be described in greater detail below, with specific reference to FIGS. 7A-7C.

[0174] Referring to FIGS. 6 A through 6E, the core component 200 of the handle portion 120 of the toothbrush 100 will be described in detail. The core component 200 may extend along a longitudinal axis C-C from a proximal end 201 to a distal end 202. As mentioned above, the core component 200 may be configured to fit inside the cavity 319 formed by the exterior body portion 301. The core component 200 may be fixed within the cavity 319 of the exterior body portion 301 such that the core component 200 may be unable to be removed from the cavity 319. That is, while the exterior body portion 301 and the core component 200 may be separate components, they may be fixed together in a non-separable manner (other than by breaking) to form the end product which is intended to be used by consumers.

[0175] The core component 200 may comprise a top surface 203, a bottom surface 204, a first lateral side 205, and a second lateral side 206. The first and second lateral sides 205, 206 may extend between the top surface 203 and the bottom surface 204. An aperture 219 may extend through the core component 200 from the first lateral side 205 to the second lateral side 206. The aperture be elongated along the longitudinal axis C-C. The aperture 219 may extend through the core component 200 in a direction transverse to the longitudinal axis C-C. The aperture 219 may be open along at least a portion of the first lateral side 205 and at least a portion of the secondDocket No.: 1096285-OO-WO-Ol-OC lateral side 206. While in the exemplified embodiment the core component 200 has a singular aperture 219, alternative embodiments of the core component 200 may comprise a plurality of apertures 219 of similar or varying sizes.

[0176] The core component 200 may generally comprise an upper portion 210 having an inner surface 211 and an outer surface 212, a lower portion 213 having an inner surface 214 and an outer surface 215, and at least one beam portion 216 that extends from the inner surface 211 of the upper portion 210 to the inner surface 214 of the lower portion 213. The upper and lower portions 210, 213 may have a greater width, measured in a direction transverse to the handle axis B-B, than the beam portion 216. In some embodiments, the beam portion 215 may extend along a portion of the length of the core component 200, but not the entirety of the core component 200 due to the core component 200 comprising the aperture 219. The aperture 219 may be formed through the beam portion 216 only and not also through the upper and lower portions 210, 213.

[0177] The beam portion 216 may have a first side surface 217 and a second side surface 218 that is opposite the first side surface. Specifically, the first lateral side 205 of the core component 200 may comprise the first side surface 217 of the beam portion 215 and the second lateral side 206 of the core component 200 may comprise the second side surface 218 of the beam portion 215. The top surface 203 of the core component 200 may be formed from the outer surface 212 of the upper portion 210 and the bottom surface 204 of the core component 200 may be formed from the outer surface 215 of the lower portion 213. In the exemplified embodiment, the aperture 219 may extend through the core component 200 so that the roof of the aperture 219 is formed from the inner surface 211 of the upper portion 210 and the floor of the aperture 219 is formed from the inner surface 214 of the lower portion 213. That is, the aperture 219 may be bounded by the inner surfaces 211, 214 of the upper and lower portions 210, 213 while being open along the lateral sides of the core component 200.

[0178] In the exemplified embodiment, the beam portion 216 may be conceptually divided into a first beam portion 216A that is located on a first side of the aperture 219 and a second beam portion 216B that is located on a second side of the aperture 219. Thus, in the exemplified embodiment the aperture 219 may be located between the first and second beam portions 216A, 216B. Thus, the first and second beam portions 216A, 216B may be separated from one another by the aperture 219. The first beam portion 216A may extend from a first end 238 of the aperture 219 towards the proximal end 201 of the core component 200 and the second beam portion 216B may extend fromDocket No.: 1096285-OO-WO-Ol-OC a second end 239 of the aperture 219 towards the distal end 202 of the core component 200. While the beam portion 216 is divided into two beam portions 216A, 216B in the exemplified embodiment, the beam portion 216 may be divided into any number of portions in various other embodiments, including having a singular beam portion or more than two beam portions. For example, the core component 200 may comprise one beam portion 216 and one aperture 219, or the core component 200 may comprise three beam portions 216 and two apertures 219 such that each aperture 219 separates two of the beam portions 216 from one another.

[0179] As mentioned above, the beam portion 216 may extend from the inner surface 214 of the lower portion 213 to the inner surface 211 of the upper portion 210. That is, the beam portion 216 may be coupled to the inner surface 214 of the lower portion 213 and to the inner surface 211 of the upper portion 210. The first and second side surfaces 217, 218 of the beam portion 216 may be recessed relative to the side edges of the upper and lower portions 210, 213 of the core component 200. The beam portion 216 may be elongated along the longitudinal axis C-C from the proximal end 201 of the core component 200 to the distal end 202 of the core component 200.

[0180] As best seen in FIG. 6E, in some embodiments, the core component 200 may comprise a first recess 207 and a second recess 208, both of which may be elongated along the longitudinal axis C-C. Thus, the first side surface 217 of the beam portion 216 may be recessed relative to first side surfaces 206, 207 of the upper and lower portions 210, 213 of the core component 200 and the second side surface 218 of the beam portion 216 may recessed relative to second side surfaces 228, 229 of the upper and lower portions 210, 213 of the core component 200. The first recess 207 may be defined by the first side surface 217 of the beam portion 216, a portion of the inner surface 211 of the upper portion 210, and a portion of the inner surface 214 of the lower portion 213. The second recess 208 may be defined by the second side surface 218 of the beam portion 216, a portion of the inner surface 211 of the upper portion 210, and a portion of the inner surface 214 of the lower portion 213. In the exemplified embodiment the first and second recesses 207, 208 may form a U-shape. However, it should be understood that the first and second recesses 207, 208 could have other shapes.

[0181] The core component 200, or portions thereof, may comprise an I-beam shaped transverse cross-sectional area. Specifically, for any transverse cross-section taken through the core component 200 that intersects one of the beam portions 216, the core component 200 may have an I-beam shaped transverse cross-sectional area. This is due to the fact that the lateral sides of theDocket No.: 1096285-OO-WO-Ol-OC beam portions 216 are recessed relative to the lateral sides of the upper and lower portions 210, 213, thereby forming the I-beam like shape.

[0182] The aperture 219 may divide the core component 200 into different segments. In some embodiments, the core component 200 may have at least a first axial portion 232 comprising the aperture 219, and a second axial portion comprising the beam portion 216. The division of the core component 200 is generally created by the location of the aperture 219. In the exemplified embodiment, the aperture 219 divides the core component 200 into a first axial portion 232 containing the aperture 219, a second axial portion 231 that extends from the first axial portion 232 to the distal end 202, and a third axial portion 230 that extends from the first axial portion 232 to the proximal end 201. The core component 200 may be configured so that the first axial portion 232 is located axially between the second and third axial portions 230, 231. In the exemplified embodiment, the first axial portion 232 comprises the aperture 219, the second axial portion 231 comprises the second beam portion 216B, and the third axial portion comprises the first beam portion 216A.

[0183] In embodiments, the second and third axial portions 230, 231 may comprise an I-beam structure. In some embodiments, the first axial portion 232 may also have an I-beam structure, albeit with the aperture 219 extending through at least a portion of a vertical wall portion of the I- beam structure. In other embodiments the first axial portion 232 may have planar top and bottom surfaces, but no vertical wall portion and therefore no I-beam structure.

[0184] While the segmented portions of the toothbrush 100 are referred to as the first, second, and third axial portions, it should be understood that the portions could be referenced by their position such that the first axial portion 232 may be referred to as the central axial portion, the second axial portion 231 may be referred to as the distal axial portion, and the third axial portion 230 may be referred to as the proximal axial portion.

[0185] The second and third axial portions 230, 231 may comprise additional features such as additional cleaning elements, or elements to aid in assembling the toothbrush 100. In the exemplified embodiment, the second and third axial portions 230, 231 comprise a through-hole 221 and a connection feature 222. The through-hole 221 may extend from the top surface 203 of the core component 200 to the bottom surface 204 of the core component 200. The through-hole 221 may be configured to allow material from the exterior body portion 301 to pass through the core component 200 during manufacture to facilitate the fixed attachment between the exteriorDocket No.: 1096285-OO-WO-Ol-OC body portion 301 and the core component 200. In some embodiments, the second axial portion 231 may comprise a first through-hole 221 A located adjacent to the second end 239 of the aperture 219 and a first connection feature 222 A located at the proximal end 201 of the core component 200. The third axial portion 230 may comprise a second through-hole 22 IB located adjacent to the first end 238 of the aperture 219 and a second connection feature 222B located at the distal end 202 of the core component 200. The first and second connection features 222A, 222B may be protrusions or the like that extend from a main body of the core component 200 in an axial direction. The first and second connection features 222A, 222B may function to enhance the attachment between the core component 200 and the main structural body 300. The connection feature 222 may be any feature known in the art. In some embodiments, the connection feature 222 is a structural feature having a shape that is configured to mate with or nest within a corresponding feature located on the interior of the main structural body 300.

[0186] The core component 200 may comprise a rib 220 that is elongated along the longitudinal axis C-C. The rib 220 may protrude from the top surface 203 of the core component 200, the bottom surface 204 of the core component 200, or both of the top and bottom surfaces 203, 204 of the core component 200. The rib 220 may be configured to nest within a channel in the exterior body portion 301, as described further below. In the exemplified embodiment, the core component 200 comprises two ribs 220A, 220B with one rib 220A being located on and protruding from the top surface 203 and one rib 220B being located on and protruding from the bottom surface 204. While in some embodiments the rib 220 may protrude from any portion of the top or bottom surface 203, 204 of the core component 200, in the exemplified embodiment, the ribs 220 are located along the first (or central) axial portion 232. The ribs 220 may be located between the through-holes 221A, 221B in an embodiment, although this is not required and other locations for the ribs 220 could be used in other embodiments.

[0187] The first axial portion 232 of the core component 200 may comprise a first length LI. The second axial portion 231 of the core component 200 may comprise a second length L2. The third axial portion 230 of the core component 200 may comprise a third length L3. The third length L3 may be greater than the second length L2. The first length LI may be greater than the second length L2. As noted above, in some embodiments the core component 200 may be formed from a hard plastic material, such as polypropylene, polyethylene, or other materials with similar characteristics and hardness.Docket No.: 1096285-OO-WO-Ol-OC

[0188] Referring to FIGS. 7A through 7D, the main structural body 300 will be described in detail. As noted above, the main structural body 300 comprises the exterior body portion 301 of the handle 120 and also the head portion 110 of the toothbrush 100 in a single, integral, monolithic structure. The exterior body portion 301 is coupled to the head portion 110 via a neck portion 316 of the main structural body 300. Thus, the main structural body 300 is a singular monolithic elongated structure that comprises the exterior body portion 301 of the handle portion 120, the neck portion 316, and the head portion 110. The main structural body 300 may be formed from a hard plastic material, such as polyethylene, polypropylene, or other hard plastic materials with similar hardness values. The main structural body 300 may be opaque and may have one or more colors to create a desired aesthetic.

[0189] The main structural body 300 may extend along a longitudinal axis D-D from a proximal end 302 that forms a bottommost end of the exterior body portion 301 to a distal end 303 that forms a top-most end of the head portion 110. The exterior body portion 301 may comprise the outer exterior surface 304, an inner surface 305 (that defines / bounds the cavity 319), a first lateral side 323 and a second lateral side 324. As noted, the exterior body portion 301 comprises the cavity 319 that extends transversely through the exterior body portion 301 from the first lateral side 323 to the second lateral side 324. Specifically, the cavity 319 extends from a first opening 321 (not shown in FIGS. 7A-7D, but called out in FIGS. 9 and 10) in the first lateral side 323 to a second opening 322 in the second lateral side 324. The core component 200 may be visible through the first and / or second openings 321, 322.

[0190] The exterior body portion 301 may comprise an upper strip portion 310 and a lower strip portion 313. The upper strip portion 310 may comprise an outer surface 311 and an inner surface 312, and the lower strip portion 313 may comprise an outer surface 314 and a lower surface 315. The inner surfaces 312, 315 of the upper and lower strip portions 310, 313 may collectively form the inner surface 305 of the exterior body portion 301. The inner surfaces 312, 315 of the upper and lower strip portions 310, 313 may comprise one or more channels 307 that are configured to receive the ribs 220A, 220B of the core component 200 to further facilitate the attachment between the core component 200 and the main structural body 300. The nesting of the ribs 220A, 220B within the channels 307 may further lock the core component 200 to the exterior body portion 301 of the main structural body 300. The outer exterior surface 304 of the exterior body portion 301 is generally formed from the outer surfaces 311, 314 of the upper and lower strip portion 310, 313.Docket No.: 1096285-OO-WO-Ol-OCThe inner surface 305 of the exterior body portion is generally formed from the inner surfaces 312, 315 of the upper and lower strip portions 310, 313. In some embodiments, the outer surface 311 of the upper portion 210 forms a top exterior surface 308 of the toothbrush 100 and the outer surface 314 of the lower strip portion 313 forms a bottom exterior surface 309 of the toothbrush 100.

[0191] The inner surfaces 312, 315 of the upper and lower strip portion 310, 313 may be spaced apart from one another by the cavity 319. In some embodiments, the cavity 319 may be exposed through the first and second openings 321, 322 of the exterior body portion 301. When the toothbrush 100 is in its finished state, the first and second lateral sides 205, 206 of the core component 200 may be exposed through the first and second openings 321, 322. In alternative embodiments, the cavity 319 may be only partially exposed, or only exposed on one lateral side 323, 324.

[0192] As mentioned above, the exterior body portion 301 may comprise gripping features 330 located on the outer exterior surface 304. The gripping features 330 may comprise raised features 331, recessed features 332, or any mixture thereof. The gripping features 330 may be located on any portion of the exterior body portion 310. In the exemplified embodiment, the gripping features 330 comprise a central region with raised features 331 and peripheral regions with recessed features 332. Specifically, in the exemplified embodiment the gripping features 330 comprise a first grouping of recessed features 332a, a second grouping of recessed features 332b, and a grouping of raised features 331 located axially in between the first and second groupings of recessed features 332a, 332b. The gripping features 330 thereby provide by an aesthetic enhancement as well as a gripping enhancement. In the exemplified embodiment, the gripping features 330 are all diamond- shaped, although the invention is not to be so limited and the gripping features 330 may take on other shapes including, for example without limitation, star-shaped, circular, squared, diamond-shaped, etc.

[0193] The exterior body portion 301 may comprise one or more filler portions 306 that extend through the cavity 319 from the inner surface 312 of the upper strip portion 310 to the inner surface 315 of the lower strip portion 313. The filler portions 306 may be cylindrical or otherwise shaped. As shown below with reference to FIG. 8, the filler portions 306 may fill the through-holes 221 of the core component 200 to further enhance the connection between the core component 200 and the main structural body 300.Docket No.: 1096285-OO-WO-Ol-OC

[0194] The head portion 1 10 is part of the main structural body 300, as described. The head portion 110 may comprise a recess for receiving a head plate that has the cleaning clcmcnts / bristlcs attached thereto, as best shown in FIGS. 7D and 8.

[0195] Referring to FIGS. 8-10, various cross- sections of the toothbrush 100 are provided to facilitate a description of the relationship between the exterior body portion 301 of the main structural body 300 and the core component 200. As described above, as best seen in FIG. 9, at least a portion of the core component 200 may comprise an I-beam shaped transverse cross- sectional area formed from the upper portion 210, the lower portion 213, and the beam portion 216 of the core component 200. In the exemplified embodiment, the second and third axial portions 230, 231 of the core component 200 comprise an I-beam shaped transverse cross-sectional area. It should be understood that when the exterior body portion 301 is overlaid on top of the core component 200, the toothbrush 100 may continue to comprise an I-beam shaped transverse cross- sectional area. Thus, in an embodiment, portions of the handle portion 120 of the toothbrush 100 may comprise an I-beam shaped transverse cross-sectional area. In an embodiment the main structural body 300 and the core component 200 may be formed as a singular, integral, monolithic structure having the shape as shown in FIGS. 8-10.

[0196] The exterior body portion 301 may cover a portion of the top and bottom surfaces 203, 204 of the core component 200. In an embodiment, the exterior body portion 301 may cover the entirety of the top and bottom surfaces 203, 204 of the core component 200 so that the top and bottom surfaces 203, 204 of the core component 200 are concealed in the final assembled product. In the exemplified embodiment, the exterior body portion 301 covers the top and bottom surfaces 203, 204 of the core component 200, and the proximal and distal ends 201, 202 of the core component 200. However, in the exemplified embodiment, the first and second lateral sides 205, 206 of the core component are left exposed, through the first and second openings 321, 322 so that the first and second recesses 207, 208 are visible to the user. The first and second connection features 222A, 222B of the core component 200 may be covered by the exterior body portion 301.

[0197] The inner surface 305 of the exterior body portion 301 may be configured to be in contact with at least a portion of the top and bottom surfaces 203, 204 of the core component 200. In the exemplified embodiment, the inner surface 312 of the upper strip portion 310 is configured to be in contact with the top surface 203 of the core component 200, and the inner surface 315 of the lower strip portion 313 is configured to be in contact with the bottom surface 204 of the coreDocket No.: 1096285-OO-WO-Ol-OC component. As noted above, the ribs 220A, 220B of the core component 200 may nest within the channels 307 in the upper and lower strip portions 310, 313.

[0198] As noted above, the core component 200 may comprise first and second through-holes 221A, 221B each of which extends from the top surface 203 of the core component to the bottom surface 204 of the core component 200. The through-holes 221A, 221B may be in spatial or fluid communication with the aperture 219 of the core component 200. The filler portions 306 of the exterior body portion 301 of the main structural body 300 may extend into and through the first and second through-holes 221A, 221B so that the first and second through-holes 221A, 221B are filled by the filler portions 306 of the exterior body portion 301. As such, portions of the filler portion 306 of the exterior body portion 301 may be exposed to the aperture 219 which may make the portions of the filler portion 306 visible to a user who is peering into the aperture 219.

[0199] When the toothbrush 100 is in an assembled state, the core component 200 and the exterior body portion 301 may be configured to deflect into the aperture 219 of the core component 200 in response to forces being applied to the handle and head portions 110, 120 of the toothbrush 100. In some embodiments, the force being applied is an excessive downward force applied to the head portion 110 while the handle portion 120 is held in a fixed position. That is, if an excessive downward force is applied onto the head portion 110, the toothbrush 100 may bend at a position along the aperture 219, which can be used to indicate to a user of the excessive pressuring being applied.

[0200] Referring to FIG. 11, the tooth cleaning elements 130 on the head portion 110 of the toothbrush 100 will be described. In the exemplified embodiment, the plurality of tooth cleaning elements 130 are bristles. The invention is not to be so limited in all embodiments and in some alternative embodiments one or more of the tooth cleaning elements or “tufts” of cleaning elements may be formed as a lamella from an elastomeric material. The front surface 113 of the head portion 110 may comprise a peripheral portion 150 that is adjacent to a peripheral edge of the head portion 110 and a central portion 151 that is surrounded by the peripheral portion 150. The plurality of tooth cleaning elements 130 may comprise a plurality of peripheral bristle tufts 150 positioned on the peripheral portion 114 of the front surface 113 of the head portion 110 and a plurality of central bristle tufts 151 positioned on the central portion 115 of the front surface 113 of the head portion 110. The plurality of peripheral bristle tufts 150 may be arranged in a loop-like manner so that the peripheral bristle tufts 150 collectively surround the central bristle tufts 151.Docket No.: 1096285-OO-WO-Ol-OC

[0201] The plurality of peripheral bristle tufts 150 may comprise one or more distal bristle tufts 152 that arc positioned adjacent to the distal end 112 of the head portion 110 and one or more proximal bristle tufts 153 that are adjacent to the proximal end 111 of the head portion 110. The one or more proximal bristle tufts 153 may collectively form a U-shape. The one or more distal bristle tufts 152 may collectively form a U-shape. The one or more distal bristle tufts 152 and the one or more proximal bristle tufts 153 may be arranged to collectively surround the central bristle tufts 151. The one or more distal bristle tufts 152 and the one or more proximal bristle tufts 153 collectively surrounding the central bristle tufts 151 may form a perimeter of bristle tufts surrounding the central bristle tufts 151.

[0202] In the exemplified embodiment, the one or more distal bristle tufts 152 may comprise a central distal bristle tuft 160 located adjacent to the distal end 112 of the head portion 110, a first distal lateral tuft 161 positioned on one side of the central distal bristle tuft 160, and a second distal lateral tuft 162 positioned on the opposite side of the central distal bristle tuft 160. Each of the central distal bristle tuft 160 and the first and second distal lateral tufts 161, 162 may be arcuate having concave interior surfaces that face the central portion 115 of the front surface 113 of the head portion 110 and convex exterior surfaces that face the peripheral edge of the head portion 110.

[0203] In the exemplified embodiment, the one or more proximal bristle tufts 153 may comprise a central proximal bristle tuft 163 located adjacent to the proximal end 111 of the head portion 110, a first proximal lateral tuft 164 positioned on one side of the central proximal bristle tuft 163, and a second proximal lateral tuft 165 positioned on the opposite side of the central proximal bristle tuft 163. Each of the central proximal bristle tuft 163 and the first and second proximal lateral tufts 164, 165 may be arcuate having concave interior surfaces that face the central portion 115 of the front surface 113 of the head portion 110 and convex exterior surfaces that face the peripheral edge of the head portion 110.

[0204] The plurality of peripheral bristle tufts 150 may further comprise a first central peripheral bristle tuft 166 and a second central peripheral bristle tuft 167. The first central peripheral bristle tuft 166 may be located on a first side of the head axis A- A and the second central peripheral bristle tuft 167 may be located on a second side of the head axis A-A. The first central peripheral bristle tuft 166 may be located between the first distal lateral tuft 161 and the first proximal lateral tuft 164. The second central peripheral bristle tuft 167 may be located between the second distal lateralDocket No.: 1096285-OO-WO-Ol-OC tuft 162 and the second proximal lateral tuft 165. The first and second central peripheral bristle tufts 166, 167 may comprise convex inner surfaces that face the head axis A-A and concave outer surfaces that face the peripheral edge of the head portion 110.

[0205] Thus, the bristle tufts 160-167 of the peripheral bristle tufts 150 may collectively form a loop structure that surrounds the central bristle tufts 151 and the central portion 115 of the front surface 113 of the head portion 110. In some cases, the one or more distal bristle tufts 152, the one or more proximal bristle tufts 153, and the peripheral bristle tufts 150 are arranged to collectively surround the central bristle tufts 151. The one or more distal bristle tufts 152, the one or more proximal bristle tufts 153, and the peripheral bristle tufts 150 may collectively form a perimeter of bristle tufts surrounding the central bristle tufts 151. Although the perimeter of bristle tufts may be continuous in certain embodiments, as seen in FIG. 1 the perimeter of bristle tufts may be non- continuous, such that there are gaps between the bristle tufts forming the perimeter of bristle tufts.

[0206] In some embodiments, the bristles of the perimeter of bristle tufts surrounding the central bristle tufts 151 may be 6 mil while the central bristle tufts 151 may be 5 mil. In other embodiments, all of the bristles of central bristle tufts 151 and of the perimeter of bristle tufts surrounding the central bristle tufts 151 are 5 mil or all of the bristles of central bristle tufts 151 and of the perimeter of bristle tufts surrounding the central bristle tufts 151 are 6 mil, with each bristle being the same thickness or diameter.

[0207] One or more of the bristle tufts of the perimeter of bristle tufts may be tapered such that the bristles have a length that decreases toward the central bristle tufts. In other words, one or more of the bristle tufts of the perimeter of bristle tufts may be tapered such that the bristles have a length that increases toward the perimeter or edge of the toothbrush. In certain preferred embodiments, each of the bristle tufts of the perimeter of bristle tufts is tapered such that the bristles have a length that decreases toward the central bristle tufts.

[0208] The toothbrush may be configured such that at least one of the bristle tufts of the perimeter of bristle tufts has a length that is greater than a length of the central bristle tuft by about 10% or more. For example, one or more bristle tufts of the perimeter of bristle tufts may have a length that is greater than a length of the central bristle tuft by about 15% or more, about 20% or more, about 25% or more, about 30% or more, or about 35% or more.

[0209] Preferably, the central bristle tufts 151 have about 10 to about 25 bristle tips / mm2. For example, the central bristle tufts 151 may have about 13 to about 25 bristle tips / mm2, about 16 toDocket No.: 1096285-OO-WO-Ol-OC about 25 bristle tips / mm2, about 18 to about 25 bristle tips / mm2, about 20 to about 25 bristle tips / mm2; from about 10 to about 22 bristle tips / mm2, about 13 to about 22 bristle tips / mm2, about 16 to about 22 bristle tips / mm2, about 18 to about 22 bristle tips / mm2, about 20 to about 22 bristle tips / mm2; from about 10 to about 20 bristle tips / mm2, about 13 to about 20 bristle tips / mm2, about 16 to about 20 bristle tips / mm2, about 18 to about 20 bristle tips / mm2; from about 10 to about 18 bristle tips / mm2, about 13 to about 18 bristle tips / mm2, about 16 to about 18 bristle tips / mm2, or any range or subrange thereof. In at least one embodiment, the toothbrush is considered to be a high-density tufted toothbrush when the central bristle tufts 151 have an amount of bristle tips per mm2disclosed herein, such as from about 10 to about 25 bristle tips / mm2.

[0210] The perimeter of bristle tufts (e.g., the one or more distal bristle tufts 152, the one or more proximal bristle tufts 153, and the one or more peripheral bristle tufts 150 are arranged to collectively surround the central bristle tufts 151) may comprise one or more tuft having about 10 to about 25 bristle tips / mm2. For example, one or more of the bristle tufts of the perimeter of bristle tufts surrounding the central bristle tufts 151 may have about 13 to about 25 bristle tips / mm2, about 16 to about 25 bristle tips / mm2, about 18 to about 25 bristle tips / mm2, about 20 to about 25 bristle tips / mm2; from about 10 to about 22 bristle tips / mm2, about 13 to about 22 bristle tips / mm2, about 16 to about 22 bristle tips / mm2, about 18 to about 22 bristle tips / mm2, about 20 to about 22 bristle tips / mm2; from about 10 to about 20 bristle tips / mm2, about 13 to about 20 bristle tips / mm2, about 16 to about 20 bristle tips / mm2, about 18 to about 20 bristle tips / mm2; from about 10 to about 18 bristle tips / mm2, about 13 to about 18 bristle tips / mm2, about 16 to about 18 bristle tips / mm2, or any range or subrange thereof. In at least one embodiment, the all of the bristle tufts of the perimeter of bristle tufts surrounding the central bristle tufts 151 have one of the foregoing listed amounts of bristle tips per mm2. In at least one embodiment, the toothbrush is considered to be a high-density tufted toothbrush when the majority of perimeter of bristle tufts (e.g., in some cases, at least 65% or more, at least 85% or more, at least 95% or more, or 100% of the perimeter of bristle tufts) have an amount of bristle tips per mm2disclosed herein, such as from about 10 to about 25 bristle tips / mm2.

[0211] The toothbrush may comprise a total number of bristles of about 4000 to about 6000. For instance, the toothbrush may have a plurality of tufts that comprise a total a number of bristles ranging from about 4000 to about 6000, about 4250 to about 6000, about 4500 to about 6000, about 4750 to about 6000, about 5000 to about 6000, about 5250 to about 6000; from about 4000Docket No.: 1096285-OO-WO-Ol-OC to about 5750, about 4250 to about 5750, about 4500 to about 5750, about 4750 to about 5750, about 5000 to about 5750, about 5250 to about 5750; from about 4000 to about 5500, about 4250 to about 5500, about 4500 to about 5500, about 4750 to about 5500, about 5000 to about 5500; from about 4000 to about 5250, about 4250 to about 5250, about 4500 to about 5250, about 4750 to about 5250; from about 4000 to about 5000, about 4250 to about 5000, about 4500 to about 5000, about 4750 to about 5000, or any range or subrange thereof.

[0212] The plurality of central bristle tufts 151 may comprise a first bristle tuft 170, a second bristle tuft 171, and a third bristle tuft 172. The first bristle tuft 170 may have a first transverse cross-sectional shape, the second bristle tuft 171 may have a second transverse cross-sectional shape, and the third bristle tuft 172 may have a third transverse cross-sectional shape. The first, second, and third transverse cross-sectional shapes may be the shapes that are visible in FIG. 11, such as the shape when viewed in a top plan view. The third bristle tuft 172 may be located axially in between the first and second bristle tufts 171, 172 such that the third bristle tuft 172 is located centrally on the front surface 113 of the head portion 110. The first bristle tuft 170 may be partially surrounded by the distal bristle tufts 152 and the second bristle tuft 171 may be partially surrounded by the proximal bristle tufts 153. In some embodiments, the first bristle tuft 170 may extend along a first bristle axis, the second bristle tuft 171 may extend along a second bristle axis, and the third bristle tuft 172 may extend along a third bristle axis.

[0213] The first and second transverse cross-sectional shapes may be the same as one another, although rotated relative to one another. The first, second, and third cross-sectional shapes may be any known shape in the art including a circle, rectangle, star, ring, hourglass, pear, etc. In the exemplified embodiment, the first and second transverse cross-sectional shapes are circles or circular segments, and the third transverse cross-sectional shape is rectangular and elongated in the direction of the head axis A-A. Specifically, the first and second transverse cross-sectional shapes may be circles or circular segments. The first and second transverse cross-sectional shapes may be circular segments such that each comprises a linear portion 180 and an arcuate portion 181. The lineal' portions of the first and second transverse cross-sectional shapes may face one another, and may face the third bristle tuft 172. The third transverse cross-sectional shape of the third bristle tuft 172 may be different than the first and second transverse cross-sectional shapes of the first and second bristle tufts 170, 171. The third transverse cross-sectional shape may be an hourglass shapeDocket No.: 1096285-OO-WO-Ol-OC in an embodiment. The third bristle tuft 172 may comprise first and second side surfaces 182, 183 that arc concave.

[0214] The first central bristle tuft 166 of the plurality of peripheral bristle tufts 150 may be positioned adjacent to the first side surface 182 of the third bristle tuft 172 of the plurality of central bristle tufts 151. The convex inner surface of the first central bristle tuft 166 may face the concave first side surface 182 of the third bristle tuft 172. The second central bristle tuft 167 of the plurality of peripheral bristle tufts 150 may be positioned adjacent to the second side surface 183 of the third bristle tuft 172 of the plurality of central bristle tufts 151. The convex inner surface of the second central bristle tuft 167 may face the concave second side surface 183 of the third bristle tuft 172.

[0215] The plurality of central bristle tufts 151 may collectively define a central cleaning element arrangement. The central cleaning element arrangement may collectively have an hourglass shape. The invention is not to be so limited in all embodiments and in other embodiments the central cleaning element arrangement may have different shapes, such as pear, ring, star, or oval shaped arrangements, to name a few. The central cleaning element arrangement may comprise a bulbous distal portion (formed by the arcuate portion 181 of the first bristle tuft 170 of the plurality of central bristle tufts 151), a bulbous proximal portion (formed by the arcuate portion 181 of the second bristle tuft 171 of the plurality of central bristle tufts 151), and a non-bulbous central portion (formed by the third bristle tuft 172 of the plurality of central bristle tufts 151) located between the bulbous proximal and distal portions. In the exemplified embodiment, the outermost lateral surface portions of the bulbous proximal and distal portions of the central cleaning element arrangement are located further from the head axis A-A than the outermost lateral surface portions of the non-bulbous central portion of the central cleaning element arrangement.

[0216] As used herein, it should be understood that a bristle tuft is a collection of bristles or cleaning elements that are disposed within a single tuft hole in the head portion 110 of the toothbrush 100.

[0217] The front surface 113 of the head 110 has a total surface area TSA. Furthermore, the plurality of bristle tufts (e.g., the one or more distal bristle tufts 152, the one or more proximal bristle tufts 153, the one or more peripheral bristle tufts 150, and the one or more central bristle tufts 151) collectively occupy a total cleaning element area (TCEA), which is a portion of the total surface area TSA of the front surface 113 of the head 110 that is occupied by the cleaning elementsDocket No.: 1096285-OO-WO-Ol-OC115. In some embodiments the total cleaning element area TCEA may be in a range of 105- 120mm2, although TCEA outside of the noted range is possible in other embodiments. In some TCEA embodiments, may be in a range of 0.4 to 0.6, or more specifically 0.45 to 0.55, and still more specifically 0.5-0.55. Thus, the cleaning elements 115 may collectively occupy approximately 40%-60%, more specifically 45% to 55%, and still more specifically 50% to 55% of the total surface area TSA of the front surface 113 of the head 110.

[0218] There may be any desired number of cleaning elements 115 on the head 110. Thus, it may be recited that there are X number of tooth cleaning elements 115 on the head 110, with each of the tooth cleaning elements 115 being a distinct bristle tuft. Thus, in the exemplified embodiment there are 11 bristle tufts (i.e., X=ll), but there could be more than nine or less than nine tooth cleaning elements in other embodiments. In some embodiments there may be between seven and fifteen tooth cleaning elements, and thus X may be in a range of 7 to 15, or more specifically 9 to 13. In the exemplified embodiment, each of the tooth cleaning elements may occupy less than 9% of the total surface area of the front surface 113 of the head 110 as noted above. In some embodiments, each of the tooth cleaning elements 115 may occupy between 5% and 25% of the total surface area of the front surface 113 of the head 110. More specifically, in some embodiments each of the perimetric bristle tufts 160 may occupy between 5% and 8% of the total surface area TSA of the front surface 113 of the head 110 and the central bristle tuft 130 may occupy between 8% and 12% of the total surface area TSA of the front surface 113 of the head 110.

[0219] Moreover, in the exemplified embodiment each of the bristle tufts of the perimeter of bristle tufts may occupy between 8% and 13% of the tooth cleaning element area TCEA whereas the central bristle tuft 150 may occupy between 15% and 21% of the tooth cleaning element area TCEA. In some embodiments, the bristle tufts of the perimeter of bristle tufts may each occupy between 9% and 13% of the TCEA while the central bristle tuft 150 occupies between 14% and 17% of the TCEA. In another embodiment, each of the bristle tufts of the perimeter of bristle tufts may occupy between 8% and 12% of the TCEA while the central bristle tuft 150 occupies between 20% and 22% of the TCEA. Thus, the central bristle tuft 150 may have a transverse cross-sectional area that is greater than the transverse cross-sectional area of each of the bristle tufts of the perimeter of bristle tufts. Stated another way, the central bristle tuft 150 occupies a greater surface area of the front surface 113 of the head 110 than each of the bristle tufts of the perimeter of bristle tufts individually. In some embodiments, the central bristle tuft 150 may occupy a greater surfaceDocket No.: 1096285-OO-WO-Ol-OC area of the front surface 113 of the head 110 than two of the bristle tufts of the perimeter of bristle tufts collectively.1 TCEA

[0220] In some embodiments, - X = Z , such that Z is in a range of 0.04 to 0.065, or morespecifically 0.05 to 0.062. Specifically, in the exemplified embodiment X is nine because there are nine bristle tufts (one central bristle tuft 150 and eight bristle tufts of the perimeter of bristle tufts). Furthermore, TCEA / TS A equals somewhere in a range of 0.5 and 0.55. Thus, (l / 9)*0.5=0.056 and (l / 9)*0.55=0.061, both falling with the range of 0.05 to 0.062. Modifications to X, TCEA, and / or TSA may be made in some embodiments while Z remains within the range provided in this disclosure.

[0221] Referring to FIG. 12, the head portion 110 may comprise a soft tissue cleaner 140 located on the rear surface 116 of the head portion 110. In certain embodiments, the soft tissue cleaner 140 may comprise a plurality of protrusions. In the exemplified embodiment, the soft tissue cleaner 140 is a tongue-cleaning element comprising a plurality of nubs 141 and at least one ridge 142. The plurality of nubs 141 may be arranged in circular’ groups and the at least one ridge 142 may be arranged in a central region on the rear surface 116 of the head portion 110. However, the particular arrangement and style of the protrusions is not to be limiting of the invention in all embodiments. Thus, in other embodiments, the soft tissue cleaner 140 could comprise nubs 141 but no ridges 142, orridges 142 butno nubs 141, or some other combination of elements protruding from the rear surface 116 of the head portion 110 designed to clean the papillae of the tongue. In some embodiments, the soft tissue cleaner 140 may be formed from the same material as the exterior body portion. In the exemplified embodiment, the soft tissue cleaner 140 may be formed from an elastomeric material.

[0222] In certain embodiments, the toothbrush 100 of the present invention may be manufactured by injection molding. The method of injection molding may comprise the steps of (1): injection molding the core component 200 from a first hard plastic material, which may be transparent, and (2) injection molding the main structural body 300 so that the exterior body portion 301 of the main structural body 300 is formed onto the top and bottom surfaces 203, 204 of the core component 200 without covering the first and second lateral sides 205, 206 of the core component 200; and (3) allowing the exterior body portion 301 to extend through and fill at least one through- hole 221 in the core component 200. The main structural body 300 may be formed from a second hard plastic material or from a generally opaque material.Docket No.: 1096285-OO-WO-Ol-OC

[0223] In addition to the dentifrice composition and toothbrush, certain embodiments of the regimens and / or kits may include a mouthwash composition. The mouthwash compositions typically include cetylpyridinium chloride and a zinc source. Suitable components, such as those listed below, may be included or excluded from the formulations for the mouthwash composition depending on the specific combination of other ingredients and the form of the mouthwash compositions. Additionally or alternatively, the mouthwash compositions may in some embodiments have a single phase, which contains that components and / or ingredients of the mouthwash composition.

[0224] The mouthwash compositions typically comprise cetylpyridinium chloride in an amount that may vary, but generally in an amount from about 0.01 to about 0.3 wt.%, based on the total weight of the mouthwash composition. For example, the total amount of the cetylpyridinium chloride in the mouthwash composition may be about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%, about 0.01 to about 0.08 wt.%, about 0.01 to about 0.05 wt.%; from about 0.05 to about 0.3 wt.%, about 0.05 to about 0.2 wt.%, about 0.05 to about 0.1 wt.%, about 0.05 to about 0.08 wt.%; from about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%, or any range or subrange thereof, based on the total weight of the mouthwash composition.

[0225] The mouthwash composition may include a zinc source. The zinc source may comprise or consist of one or more zinc ion source(s). The zinc source (e.g., zinc ion source) may be present in the mouthwash composition in an amount from about 0.1 to about 8 wt.%, based on the total weight of the mouthwash composition. For example, the amount of zinc source (e.g., zinc ion source) present in the mouthwash composition may be from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 8 wt.%, about 0.3 to about 6 wt.%, about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 8 wt.%, about 0.6 to about 6 wt.%, about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 8 wt.%, about 0.9 to about 6 wt.%, about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 8 wt.%, about 1.2 to about 6 wt.%, about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 8 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 8 wt.%, aboutDocket No.: 1096285-OO-WO-Ol-OC2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the mouthwash composition.

[0226] The zinc source may be in the form of a salt. For example, the zinc source may comprise one or more zinc salt(s) chosen from zinc sulfate, zinc chloride, zinc acetate, zinc phenol sulfonate, zinc borate, zinc bromide, zinc nitrate, zinc glycerophosphate, zinc benzoate, zinc carbonate, zinc camosine, zinc citrate, zinc hexafluorosilicate, zinc diacetate trihydrate, zinc oxide, zinc peroxide, zinc salicylate, zinc silicate, zinc stannate, zinc tannate, zinc titanate, zinc tetrafluoroborate, zinc gluconate, zinc lactate, zinc glycinate, zinc phosphate, and a combination of two or more thereof. In some embodiments, the zinc source is selected from zinc citrate, zinc oxide, zinc phosphate, zinc lactate, zinc sulfate, zinc silicate, zinc gluconate, and a combination of two or more thereof. Preferably, the zinc source comprises zinc lactate. In at least one preferred embodiment, the zinc source consists of zinc lactate.

[0227] The mouthwash composition may include two or more, three or more, four or more, five or more, or six or more zinc sources. For instance, mouthwash composition may comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3 to 7, 3 to 6, 2 to 5, or 3 to 5 zinc sources. In some embodiments, the mouthwash composition comprises zinc oxide, zinc citrate, zinc phosphate, or a combination of two or more thereof. In at least one prcl'crrcd embodiment, the mouthwash composition comprises zinc phosphate.

[0228] The mouthwash compositions may be formulated to have a weight ratio of the amount of zinc oxide to zinc citrate of from about 1.5:1 to about 4.5:1. For instance, the weight ratio of the amount of zinc oxide to zinc citrate may be from about 1.5:1 to about 4.5:1, about 1.5:1 to about 4: 1, about 1.5: 1 to about 3.5: 1, about 1.5:1 to about 3: 1, about 1.5: 1 to about 2.5: 1; from about 2: 1 to about 4.5: 1, about 2: 1 to about 4: 1, about 2: 1 to about 3.5: 1, about 2: 1 to about 3: 1; from about 2.5:1 to about 4.5:1, about 2.5: 1 to about 4: 1, about 2.5: 1 to about 3.5: 1; from about 3: 1 to about 4.5:1, about 3:1 to about 4:1, or any range or subrange formed thereof. In some embodiments, the weight ratio of the amount of zinc oxide to zinc citrate is about 2:1, about 2.5:1, about 3:1, about 3.5:1, about 4: 1, or a range formed thereof.

[0229] The mouthwash compositions also comprise one or more polyol(s). The amount of polyol(s) in the mouthwash composition may be from about 10 to about 25 wt.%, based on theDocket No.: 1096285-OO-WO-Ol-OC total weight of the mouthwash composition. In some cases, the mouthwash composition comprises a total amount of polyol(s) of about 10 to about 25 wt.%, about 10 to about 22 wt.%, about 10 to about 19 wt.%, about 10 to about 16 wt.%; from about 10 to about 25 wt.%, about 10 to about 22 wt.%, about 10 to about 19 wt.%, about 10 to about 16 wt.%; from about 13 to about 25 wt.%, about 13 to about 22 wt.%, about 13 to about 19 wt.%; from about 16 to about 25 wt.%, about 16 to about 22 wt.%, about 16 to about 19 wt.%, about 10 to about 16 wt.%; from about 18 to about 25 wt.%, about 18 to about 22 wt.%, or any range or subrange thereof, based on the total weight of the mouthwash.

[0230] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25 °C). In some preferred embodiments, the polyol(s) comprises glycerin, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG, a saccharide (e.g., fructose, glucose, sucrose and mixtures of saccharides, such as honey), or a combination of two or more thereof. For instance, the mouthwash composition may comprise maltitol, mannitol, sorbitol, xylitol, a polypropylene glycol (PPG), a polyethylene glycol (PEG), a block copolymer of PPG and PEG, or a combination or two or more thereof. The polyol may be a humectant including, e.g., glycol, sorbitol, glycerin, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a saccharide, polyoxypropylene-polyoxyethylene block copolymer, and a combination of two or more thereof.

[0231] In some cases, the mouthwash composition includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the mouthwash composition may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional, non-limiting examples of polyols that may, optionally, be included in the mouthwash composition include and / or may be chosen from alkanediols such as glycerin, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-l,4-diol, 2-ethyl-l,3-hexanediol, 2-methyl-2,4-pentanediol, caprylyl glycol, 1 ,2-hexanediol, 1 ,2-pentanediol, and 4-methyl-l,2-pentanediol; glycol ethers such asDocket No.: 1096285-OO-WO-Ol-OC ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethylene glycol monomethyl ether acetate, dicthylcnc glycol monomethyl ether, dicthylcnc glycol monoethyl ether, diethylene glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1 -methyl- 1-methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-t- butyl ether, propylene glycol mono-n-propyl ether, propylene glycol mono-iso-propyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol mono-iso-propyl ether, sorbitol, sorbitan, triacetin, and a mixture of two or more thereof.

[0232] Additionally or alternatively, the mouthwash composition may include polyol(s) having a molecular weight of from about 100 to 5000 g / mol. For instance, the polyol may comprise a polyethylene glycol, a polypropylene glycol, a block polymer of polyethylene glycol and polypropylene glycol, or a combination of two or more thereof. In some embodiments, the polyol comprises a polypropylene glycol, a polypropylene glycol, and / or a block polymer of polyethylene glycol and polypropylene glycol having a molecular weight of about 100 to about 900, about 200 to about 800, about 400, about 1500 to about 2500, about 2000 to about 4500 or any range or subrange thereof. In some embodiments, the polyol is a polyethylene glycol, such as polyethylene glycol 600. In some embodiments, the mouthwash composition comprises one or more polyethylene glycols, e.g., polyethylene glycols in a molecular weight range from 200 to 800. For example, the compositions may comprise one or more of polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol, 600 or polyethylene glycol 800.

[0233] The mouthwash compositions may comprise one or more surfactant(s), e.g., in an amount from about 1 to about 10 wt.%, based on the total weight of the mouthwash composition. For instance, the mouthwash composition may comprise a total amount of surfactant(s) of about 1 to about 8 wt.%, about 1 to about 7 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%; from about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%; from about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from about 6 to about 10 wt.%, about 6 to aboutDocket No.: 1096285-00-WO-01-OC8 wt.%; from about 7 to about 10 wt.%, about 7 to about 9 wt.%, or any range or subrange thereof, based on the total weight of the mouthwash composition.

[0234] The one or more surfactant(s) may be selected from anionic surfactants, amphoteric surfactants, nonionic surfactants, or combinations of two or more thereof. The one or more surfactant(s), in some preferrable embodiments, comprises at least one nonionic surfactant. In certain embodiments, the mouthwash composition is free of surfactants other than nonionic surfactants. The one or more nonionic surfactant(s) may be selected from sorbitan surfactants, poloxamers, fatty alcohol ethoxylates, alkylphenol ethoxylates, tertiary amine oxides, tertiary phosphine oxides, dialkyl sulfoxides, glucosides, and / or compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature. For example, the nonionic surfactants may be selected from sorbitan surfactants, poloxamers, or a combination of two or more thereof.

[0235] The mouthwash composition may comprise one or more anionic surfactant, which may be selected from sulfate based anionic surfactants and / or from non-sulfate based anionic surfactants, such as sulfonated monoglycerides of fatty acids, isethionates, sarcosinates, taurate, and a combination of two or more thereof. Examples of anionic surfactants, which may be included or excluded in some instances from the mouthwash composition, include sodium lauryl sulfate, sodium lauryl sarcosinate, sodium cocoyl methyl taurate, sodium monoglyceride sulfate, sodium cetaryl sulfate, potassium cocoyl glycinate, sodium lauryl phosphate, sodium lauryl lactylate, sodium lauryl sulfoacetate, sodium lauryl glutamate, sodium lauryl isethionate, sodium laureth carboxylate, sodium dodecyl benzenesulfonate, and combinations thereof. In one embodiment, sodium lauryl sulfate is a preferred surfactant. Additional anionic surfactants are disclosed in U.S. Pat. No. 3,959,458, which is incorporated herein in its entirety for all purposes.

[0236] The mouthwash composition may include one or more carbonate and / or bicarbonate. The carbonate and / or bicarbonate may be selected from sodium bicarbonate, sodium carbonate calcium bicarbonate, calcium carbonate, calcium bicarbonate, potassium carbonate, potassium bicarbonate, or a combination of thereof. The total amount of carbonate and / or bicarbonate in the mouthwash composition may be from about 0.01 to about 2 wt.%, based on the total weight of the mouthwash composition. For example, the total amount of carbonate and / or bicarbonate present in the mouthwash composition may be from about 0.01 to about 1.5 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 2 wt.%, aboutDocket No.: 1096285-OO-WO-Ol-OC0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, about 1 to about 2 wt.%, or any range or subrange thereof, based on the total weight of the mouthwash composition.

[0237] The mouthwash compositions may include a fluoride ion source. The fluoride ion source may be present in an effective amount. In some cases, the fluoride ion source is present in the mouthwash composition in an amount of about 0.01 to about 2 wt.%, based on the total weight of the mouthwash composition. For example, the fluoride ion source may be present in an amount of from about 0.01 to about 1.5 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, about 1 to about 2 wt.%, or any range or subrange thereof, based on the total weight of the oral are composition.

[0238] The fluoride ion source may be selected from soluble fluoride ion salts. For example, the fluoride ion source may comprise sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine glycine potassium fluoride, glycine hydrofluoride, amine fluorides or a combination of two or more thereof. In some embodiments, the fluoride ion source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof. Additional examples of fluoride ion source are disclosed in U.S. Patent No. 3,535,421, U.S. Patent No. 4,885,155, and U.S. Patent No. 3,678,154, the disclosure of each of which is hereby incorporated by reference in their entirety.

[0239] In some embodiments, the mouthwash compositions may include one or more sweeteners. The mouthwash composition may include caloric sweeteners and / or non-caloric sweeteners. Examples of non-caloric sweeteners include saccharin, for example, sodium saccharin, acesulfame, neotame, cyclamate or sucralose; natural high-intensity sweeteners, such as thaumatin, stevioside or glycyrrhizin; or sugar alcohols, such as sorbitol, xylitol, maltitol and mannitol. Examples of caloric sweeteners include sugars, such as fructose, glucose, sucrose, and high fructose syrups.

[0240] The one or more sweetener(s) may be present in the mouthwash composition in an amount of about 0.1 to about 7 wt.%, based on the total weight of the mouthwash composition. ForDocket No.: 1096285-OO-WO-Ol-OC example, the sweetener(s) may be present in an amount of about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%, about 0.8 to about 1.5 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 7 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the mouthwash composition.

[0241] In some embodiments, the mouthwash composition preferably is substantially free or free of caloric sweeteners. For example, the mouthwash compositions may have about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the weight of the mouthwash composition. In at least one embodiment, the mouthwash composition contains about 0 wt.% or 0 wt.% of caloric sweeteners, based on the weight of the mouthwash composition.

[0242] The mouthwash compositions of the present disclosure may include a flavoring agent. The flavoring agent is typically incorporated in the mouthwash composition at a concentration of about 0.01 to about 3 wt.% by weight of the mouthwash composition. For example, the amount of flavoring agent(s) present in the mouthwash composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 3 wt.%, including any range or subrange thereof, based on the total weight of the mouthwash composition.

[0243] Suitable flavoring agents include, but are not limited to, 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 ofDocket No.: 1096285-OO-WO-Ol-OC 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.

[0244] The mouthwash compositions may include one or more colorants. Exemplary colorants can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the colorant can include dyes, certified aluminum lakes or colors derived from a natural source. The colorant may be water-based, oil-based or dry. The colorants can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. The concentrations of the colorant in the mouthwash composition may be from trace amount to about 0.6 wt.%, from about 0.1 to about 0.5 wt.%, about 0.2 to about 0.4 wt.%, or about 0.15 to about 0.35 wt.%, based on the total weight of the mouthwash composition.

[0245] The mouthwash composition may include one or more pH adjusters to increase or decrease the overall pH of the mouthwash composition. For example, one or more acids may be included to decrease the pH of the mouthwash composition. Examples of suitable acids for decreasing the pH of the mouthwash composition include, but are not limited to, citric acid, acetic acid, and the like. The mouthwash composition may include one or more bases, such as sodium hydroxide, potassium hydroxide and the like, to increase the pH of the mouthwash composition. Additional or alternative acids and bases that are suitable for adjusting the pH of the mouthwash composition are readily known to one of ordinary skill in the ail.

[0246] The amount of the pH adjuster in the mouthwash composition may be based on the desired pH of the final mouthwash composition and / or product. For example, the total amount of the pH adjuster may range from about 0.05 to about 20 wt.%, based on the total weight of the mouthwash composition. In some instances, the total amount of pH adjuster is from about 0.05 to about 15 wt.%, about 0.1 to about 10 wt.%, or about 0.12 to about 5 wt.%, including ranges and sub-ranges therebetween, based on the total weight of the mouthwash composition.

[0247] The mouthwash compositions may have a pH from about 5.5 to about 9, about 6 to about 8, about 6.5 to about 7.5, about 6 to about 9, about 6 to about 8, or about 6 to about 7, about 7 to about 9, or about 7 to about 8, including any ranges and subranges therebetween.

[0248] The mouthwash may have water present in an amount of about 50 to about 95 wt.%, based on the total weight of the mouthwash. For instance, the total amount of water in the mouthwash composition may be from about 50 to about 95 wt.%, about 70 to about 95 wt.%, about 80 to aboutDocket No.: 1096285-OO-WO-Ol-OC95 wt.%; from about 50 to about 85 wt.%, about 70 to about 85 wt.%; from about 50 to about 75 wt.%, about 60 to about 75 wt.%, about 50 to about 65, or any range or subrange thereof, based on the total weight of the mouthwash composition.EXAMPLES

[0249] A 12- week, phase III, double-blind, two-arm, parallel-group, randomized controlled trial conducted to evaluate a non-limiting example oral care regimen (Example Oral Care Regimen). Specifically, a total of 82 healthy male and female participants with 18-70 years of age were enrolled from the Costa Mesa, California area. Qualifying participants were randomized into regimen groups based on initial gingivitis and plaque scores. The Example Oral Care Regimen participants were instructed to brush once in the morning and once at night for two minutes with a full ribbon of their assigned toothpaste on the study provided toothbrush and rinse for 30 seconds with 20 mL of mouthwash following each instance of brushing. The participants undergoing a comparative oral care regimen (Comparative Oral Care Regimen) were instructed to brush once in the morning and once at night for two minutes with a full ribbon of their assigned toothpaste on the study provided toothbrush. Assessments of oral soft- and hard-tissue, in addition to gingivitis and plaque evaluations were conducted at baseline, week 1, week 3, week 6, and week 12. Examiners, participants, and statistician were blind to regimen allocation.

[0250] The Example Oral Care Regimen included a dentifrice composition (Example Dentifrice) having about 0.5 wt.% of stannous fluoride stabilized with nitrate and phosphates in accordance with aspects of the invention, a mouthwash (Example Mouthwash) containing 0.08 wt.% of cetylpyridinium chloride and 0.3 wt.% zinc lactate in accordance with aspects of the invention, and a high-density tufted toothbrush in accordance with aspects of the invention. The Comparative Oral Care Regimen included dentifrice composition (Comparative Dentifrice) comprising 0.76 wt.% of sodium monofluorophosphate, no mouthwash, and a commercially available manual toothbrush.

[0251] The formulations for the Example Dentifrice and Comparative Dentifrice are provided in Table 1.Docket No.: 1096285-OO-WO-Ol-OCTable 1

[0252] The formulation for the Example Mouthwash is provided in Table 2.Table 2

[0253] The Example Oral Care Regimen group and the Comparative Oral Care Regimen group were compared in respect to gender using a Chi-Square analysis and in respect to age using anDocket No.: 1096285-OO-WO-Ol-OC independent t-test. Participants were scored on the Loe-Silness Gingival Index and the Quigley- Hein Plaque Index at baseline, week 1, week 3, week 6, and week 12. Bctwccn-group baseline gingival index scores and plaque index scores were also compared using an independent t-test. Between-group comparisons were compared with baseline-adjusted gingival and plaque scores using analyses of covariance (ANCOVA). Within-group baseline versus follow-up gingival index scores and plaque index scores were compared using paired t- tests. All statistical tests of hypotheses were two sided and employed a level of significance of a = 0.05.

[0254] No significant differences were observed between the two regimen groups at the baseline with respect to gingival index scores (p = 0.461), gingival severity scores (p = 0.883), and gingival interproximal scores (p = 0.407) (see Table 3). Baseline plaque index scores (p = 0.014) and interproximal plaque scores (p = 0.010) were significantly higher in the Control Oral Care Regimen group compared to the Example Oral Care Regimen group. At the baseline, no significant difference was observed between the two regimen groups for mean plaque severity (p = 0.119).Table 3SD: Standard deviation. Statistical analyses were conducted using independent t-test. p < 0.05 indicated in bold.

[0255] With regard to the analysis of plaque indices, there was significant improvement across all plaque indices for the Example Oral Care Regimen after just 1 week of adherence to the regimen compared to the base line measurements. Baseline-adjusted mean plaque index decreased significantly from 3.19 (±0.25) at baseline to 3.08 (±0.02) (p < 0.001) at week 1. Plaque severity decreased from 0.86 (±0.13) at baseline to 0.83 (±0.01) (p = 0.002). Interproximal plaque decreased from 3.37 (±0.24) at baseline to 3.23 (±0.03) (p < 0.001). The Example Oral Care Regimen had a 5.3% reduction in plaque (p < 0.001), a 7.0% reduction in plaque severity (p = 0.002), and a 6.2% reduction in interproximal plaque (p < 0.001) after 1 week from baseline.Docket No.: 1096285-OO-WO-Ol-OC

[0256] Average plaque scores continued to decrease across all indices for the Example Oral Care Regimen after 3 weeks of continuous use compared to baseline. Baseline-adjusted mean plaque index decreased to 2.92 (±0.02) (p < 0.001). Plaque severity decreased to 0.78 (±0.01) (p < 0.001). Interproximal plaque decreased to 3.03 (±0.03) (p < 0.001). The Example Oral Care Regimen had a 10.0% reduction in plaque (p < 0.001), a 11.6% reduction in plaque severity (p < 0.001), and a 11.6% reduction in interproximal plaque (p < 0.001).

[0257] At the 6-week analysis, plaque scores showed continued improvement for the Example Oral Care Regimen. Baseline-adjusted mean plaque index decreased to 2.69 (±0.03) (p < 0.001). Plaque severity decreased to 0.60 (±0.02) (p < 0.001). Interproximal plaque decreased to 2.78 (±0.03) (p < 0.001). Clinicians noted a 17.2% reduction in mean plaque index score (p < 0.001), a 32.6% reduction in average plaque severity (p < 0.001), and a 19.0% reduction in average interproximal plaque (p < 0.001) for the Example Oral Care Regimen at 6 weeks compared to baseline.

[0258] The final analysis at week 12 confirmed significant reduction in plaque and improvement in gum health. The average plaque index score was reduced by 23.5% to 2.49 (±0.03) (p < 0.001) in the Example Oral Care Regimen group compared to baseline. The average plaque severity score was reduced by 51.2% to 0.44 (±0.02) (p < 0.001) compared to baseline. Average interproximal plaque scores were 25.5% lower than baseline at 2.56 (±0.03) for the Example Oral Care Regimen group (p < 0.001). There was a steady decrease in score across all plaque indices over the 12-week study for the Example Oral Care Regimen group.

[0259] Regarding the Comparative Oral Care Regimen, the Comparative Oral Care Regimen had no significant reduction in plaque at week 1 compared to baseline. After 3 weeks of regimen use, a mild reduction in average plaque index from 3.32 (±0.22) to 3.24 (±0.02) (p = 0.045) and interproximal plaque index from 3.51 (±0.23) to 3.43 (±0.03) (p = 0.044) was observed in the Comparative Oral Care Regimen group. This resulted in a 0.9% and 1.1% reduction in scores compared to baseline, respectively. Average plaque severity scores did not significantly change from baseline.

[0260] At the 6-week examination, the Comparative Oral Care Regimen group showed no change in reduction in average plaque index and interproximal plaque index from the 3-week analysis, remaining at a 0.9% (p = 0.024) and 1.1% (p = 0.017) reduction in scores compared to the baseline, respectively. There continued to be no improvement from baseline in average plaque severityDocket No.: 1096285-OO-WO-Ol-OC scores for the Comparative Oral Care Regimen. Average plaque index, plaque severity, and intcrproximal plaque did not significantly change from week 6 to week 12. There was little to no change in average plaque index scores, plaque severity scores, and interproximal plaque scores from week 1 to week 12 for the Comparative Oral Care Regimen group. The overall percent reduction in average plaque index and interproximal plaque index remained at 0.9% (p = 0.011) and 1.1% (0.008), respectively.

[0261] Plaque scores were significantly different between the Example Oral Care Regimen group and the Comparative Oral Care Regimen group at week 1. Compared to the Comparative Oral Care Regimen group, the Example Oral Care Regimen group had 4.9% lower average plaque index with a mean difference of 0.16 (C.I. 95% [0.09, 0.22]; p < 0.001), 5.7% lower plaque severity with a mean difference of 0.05 (C.I. 95% [0.02, 0.08]; p = 0.005), and 5.8% lower interproximal plaque with a mean difference of 0.20 (C.I. 95% [0.11, 0.27]; p < 0.001). This week 1 difference resulted in 15x more plaque reduction for the Example Oral Care Regimen group compared to the Comparative Oral Care Regimen group.

[0262] Significant differences between the plaque scores for the Example Oral Care Regimen group and the Comparative Oral Care Regimen group continued into 3 weeks of treatment. Specifically, the Example Oral Care Regimen group had 9.6% lower average plaque index with a mean difference of 0.31 (C.I. 95% [0.24, 0.38]; p < 0.001), 10.3% lower average plaque severity with a mean difference of 0.09 (C.I. 95% [0.05, 0.13]; p < 0.001), and 11.4% lower average interproximal plaque scores with a mean difference of 0.39 (C.I. 95% [0.30, 0.46]; p < 0.001) compared to the Comparative Oral Care Regimen group.

[0263] The differences between average plaque scores of each regimen group continued to increase after 6 weeks of treatment. The Example Oral Care Regimen group had 17.0% lower average plaque index with a mean difference of 0.55 (C.I. 95% [0.47, 0.62]; p < 0.001), 31.8% lower average plaque severity with a mean difference of 0.28 (C.I. 95% [0.22, 0.34]; p < 0.001), and 18.7% lower average interproximal plaque with a mean difference of 0.64 (C.I. 95% [0.56, 0.72]; p < 0.001) compared to the Comparative Oral Care Regimen group.

[0264] Average plaque scores after 12 weeks also reflected the increased disparity between the plaque scores for the Example Oral Care Regimen group and the Comparative Oral Care Regimen group. By week 12, there was a 22.9% difference in mean plaque index score with a mean difference of 0.74 (C.I. 95% [0.66, 0.82]; p < 0.001), a 50.0% difference in average plaque severityDocket No.: 1096285-00-WO-01-OC with a mean difference of 0.44 (C.I. 95% [0.38, 0.49]; p < 0.001) , and a 24.9% difference in average interproximal plaque with a mean difference of 0.85 (C.I. 95% [0.76, 0.93]; p < 0.001) between regimen groups, with the Example Oral Care Regimen providing the better results for each of the plaque scores. A summary of the effect associated with the Example Oral Care Regimen and the Comparative Oral Care Regimen on the plaque index, plaque severity, and interproximal plaque is shown in FIG. 13.

[0265] With regard to the gingival indices, there was significant improvement in gingival scores for the Example Oral Care Regimen group across all gingival indices after 1 week of adherence to the regimen compared to baseline measurements. The Example Oral Care Regimen group exhibited a 3.2% reduction in mean gingival index score from 1.86 (±0.12) at baseline to 1.81 (±0.01) on the Loe-Silness Gingival Index (p = 0.001), a 6.3% reduction in average gingival severity from 0.79 (±0.07) at baseline to 0.74 (±0.01) (p = 0.003), and a 3.3% reduction in average gingival interproximal score from 2.10 (±0.12) at baseline to 2.04 (±0.02) (p < 0.001).

[0266] At the week 3 analysis, significant improvement in gingival index scores for the Example Oral Care Regimen group continued across all indices. The Example Oral Care Regimen group had an average baseline-adjusted gingival index score of 1.71 (±0.01) after 3 weeks of regimen adherence, which was an 8.6% reduction (p < 0.001). The average baseline-adjusted gingival severity score for the Example Oral Care Regimen group was 0.67 (± 0.01), which was a 15.2% reduction (p < 0.001). The average baseline-adjusted interproximal gingival score was 1.96 (± 0.01), a 7.1% reduction (p < 0.001). 100% of the Example Oral Care Regimen group exhibited improved gingival index scores after 3 weeks of adherence to the regimen.

[0267] Continued improvement in gingival index scores for the Example Oral Care Regimen group was observed across all indices after 6 weeks of adherence. The Example Oral Care Regimen group had an average baseline-adjusted gingival index score of 1.60 (±0.01) after 6 weeks of regimen adherence, which was a 14.5% reduction from baseline (p < 0.001). The average baseline- adjusted gingival severity score for the Example Oral Care Regimen group was 0.57 (± 0.01), which was a 27.8% reduction in severity compared to baseline (p < 0.001). The average baseline- adjusted interproximal gingival score for the Example Oral Care Regimen group at 6 weeks of adherence was 1.81 (± 0.01), a 14.3% reduction from baseline (p < 0.001).

[0268] The disparity in oral health between the Example Oral Care Regimen group and the Comparative Oral Care Regimen group was evident at the week- 12 analysis for all gingivalDocket No.: 1096285-00-WO-01-OC indices. The average gingival index score had reduced by 20.4% in the Example Oral Care Regimen group to a score of 1.49 (±0.01) (p < 0.001), while the average gingival severity score was reduced by 40.5% compared to 0.47 (±0.01) (p < 0.001). Average interproximal gingival scores for the Example Oral Care Regimen group were 21.4% lower than baseline at 1.65 (±0.02) (p < 0.001). There was a steady decrease in score across all gingival indices over the 12-week study for the Example Oral Care Regimen group.

[0269] The Comparative Oral Care Regimen group had no significant reduction in gingival scores at week 1 compared to baseline. The Comparative Oral Care Regimen group showed mild reduction in average gingival index and intcrproximal gingival index after 3 weeks with a 0.5% (p = 0.036) and 1.1% (p = 0.044) reduction in scores to 1.86 (±0.01) and 2.1 l(±0.01), respectively. Average gingival severity scores for the Comparative Oral Care Regimen group did not significantly change from baseline. At week 3 compared to week 1, baseline-adjusted average gingival index and interproximal gingival scores did not change at all.

[0270] The Comparative Oral Care Regimen group showed a small but significant reduction in average gingival index and interproximal gingival index after 6 weeks with a 0.5% (p = 0.003) and 0.9% (p = 0.003) reduction in scores compared to baseline, respectively. Average gingival severity scores did not significantly change from baseline for the Comparative Oral Care Regimen group. Compared to week 3, baseline-adjusted average gingival severity and interproximal gingival scores did not change at all for the Comparative Oral Care Regimen group.

[0271] At the week 12 examination, the Comparative Oral Care Regimen group had reduced baseline-adjusted mean gingival index scores by 1.1% to a score of 1.85 (±0.01) (p = 0.002). Gingival severity scores did not significantly for the Comparative Oral Care Regimen group at week 12. Interproximal gingival scores for the Comparative Oral Care Regimen group was reduced by 1.1% from baseline to a score of 0.78 (±0.01) (p = 0.008). There was little to no change in average gingival index scores, gingival severity scores, and interproximal gingival scores from week 1 to week 12 for the Comparative Oral Care Regimen group.

[0272] In comparison to the Comparative Oral Care Regimen group, the Example Oral Care Regimen group achieved significant improvements in gingival scores. Surprisingly, by week 1, there was a significant difference between the gingival scores of the Example Oral Care Regimen group and the Comparative Oral Care Regimen group. The Example Oral Care Regimen group had 2.7% lower average gingival index with a mean difference of 0.05 (C.I. 95% [0.02, 0.09]; p =Docket No.: 1096285-OO-WO-Ol-OC0.001), 6.3% lower average gingival severity with a mean difference of 0.05 (C.I. 95% [0.02, 0.07]; p = 0.003), and 3.3% lower average gingival interproximal scores with a mean difference of 0.07 (C.I. 95% [0.03, 0.11]; p < 0.001) compared to the Comparative Oral Care Regimen group.

[0273] Significant differences between regimen group gingival scores continued into 3 weeks of treatment. The Example Oral Care Regimen group had 8.1% lower average gingival index with a mean difference of 0.15 (C.I. 95% [0.12, 0.17]; p < 0.001), 14.1% lower average gingival severity mean difference of 0.11 (C.I. 95% [0.09, 0.14]; p = 0.003), and 7.1% lower average gingival interproximal scores mean difference of 0.15 (C.I. 95% [0.11, 0.18]; p < 0.001) compared to the Comparative Oral Care Regimen group.

[0274] Additionally, significant differences between the gingival scores of the Example Oral Care Regimen group and the Comparative Oral Care Regimen group increased after 6 weeks of treatment. The Example Oral Care Regimen group had 14.0% lower average gingival index mean difference of 0.26 (p < 0.001), 26.9% lower average gingival severity mean difference of 0.21 (p < 0.001), and 14.2% lower average gingival interproximal scores mean difference of 0.30 (p < 0.001) compared to the Comparative Oral Care Regimen group.

[0275] The disparity in oral health between regimen groups resulted in a 19.5% difference in mean gingival index score of 0.36 (C.I. 95% [0.33 0.40]; p < 0.001), a 33.9% difference in average gingival severity of 0.31 (C.I. 95% [0.29, 0.34]; p < 0.001), and a 21.4% difference in average interproximal gingival score 0.45 (C.I. 95% [0.40, 0.49]; p < 0.001) between regimen groups after 12 weeks of regimen adherence, with the Example Oral Care Regimen group achieving the better results. A summary of the effect associated with the Example Oral Care Regimen and the Comparative Oral Care Regimen on the gingival index, gingival severity, and interproximal gingival is shown in FIG. 14.

[0276] Overall, Participants in the Example Oral Care Regimen group showed 15 times more plaque reduction than the Comparative Oral Care Regimen participants after just 1 week of use. After 3 weeks of regimen adherence, 100% of Example Oral Care Regimen participants had improved gingival index scores. By 12 weeks of regimen adherence, clinicians observed a 40.5% reduction in average gingival severity scores compared to baseline for the Example Oral Care Regimen group and only 1.3% reduction for the Comparative Oral Care Regimen.

Claims

Docket No.: 1096285-OO-WO-Ol-OCCLAIMSWhat is claimed is:

1. An oral care regimen comprising: applying a dentifrice composition to an oral cavity using a high-density tufted toothbrush, the dentifrice composition comprising a stannous source, a nitrate source, and a phosphate source, wherein the high-density tufted toothbrush comprises end-rounded bristles and tapered bristles; and applying a mouthwash composition to the oral cavity, the mouthwash composition comprising cetylpyridinium chloride and a zinc source.

2. The oral care regimen according to claim 1, wherein the dentifrice composition is applied to the toothbrush in an amount from about 0.1 gram to about 3 grams.

3. The oral care regimen according to any foregoing claim, wherein the stannous source of the dentifrice composition is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof.

4. The oral care regimen according to any foregoing claim, wherein the nitrate source of the dentifrice composition is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination two or more thereof.

5. The oral care regimen according to any foregoing claim, wherein the dentifrice composition has a molar ratio of nitrate ions to stannous ions, both measured as free ions, of about 0.5:1 to about 2: 1.

6. The oral care regimen according to any foregoing claim, wherein phosphate source of the dentifrice composition is selected from tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate,Docket No.: 1096285-OO-WO-Ol-OC p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.

7. The oral care regimen according to any foregoing claim, wherein the toothbrush comprises a plurality of tufts of bristles, wherein the plurality of bristle tufts comprises one or more central bristle tuft and a perimeter of bristle tufts surrounding the central bristle tuft.

8. The oral care regimen according to claim 7, wherein the perimeter of bristle tufts comprising a distal bristle tuft, a proximal bristle tuft, a peripheral bristle tuft, or a combination of two or more thereof.

9. The oral care regimen according to claim 7 or claim 8, wherein at least one of the bristle tufts of the perimeter of bristle tufts has about 10 to about 25 bristle tips / mm2.

10. The oral care regimen according to any one of claims 7 to 9, wherein the central bristle tuft comprises a convex inner surface.

11. The oral care regimen according to any one of claim 7 to 10, wherein at least one of the bristle tufts of the perimeter of bristle tufts is tapered such that the bristles have a length that decreases toward the central bristle tuft.

12. The oral care regimen according to any one of claims 7 to 11, wherein the at least one of the bristle tufts of the perimeter of bristle tufts has a length that is greater than a length of the central bristle tuft by about 10% or more.

13. The oral care regimen according to any one of claims 7 to 12, wherein the length of each of the bristle tufts of the perimeter of bristle tufts is greater than the length of the central bristle tuft by about 10% or more.Docket No.: 1096285-OO-WO-Ol-OC14. The oral care regimen according to any one of claims 7 to 13, wherein at least one of the bristle tufts of the perimeter of bristle tufts comprises tapered bristles having a tapered tip of about 0.005 to about 0.05 mm.

15. The oral care regimen according to any foregoing claim, wherein the mouthwash composition further comprises: from about 1 to about 10 wt.% of a nonionic surfactant, from about 60 to about 85 wt.% of a polyol, and from about 11 to about 30 wt.% of water.

16. The oral care regimen according to any foregoing claim, wherein the mouthwash composition is essentially free or free of monoalcohols and hydrocarbon oils.

17. A kit comprising: a dentifrice composition comprising a stannous source, a nitrate source, and a polyphosphate source; and a high-density tufted toothbrush comprising end-rounded bristles and tapered bristles.

18. The kit according to claim 17 further comprising: a mouthwash composition comprising cetylpyridinium chloride and a zinc source.

19. The kit according to claim 17 or claim 18 for the use of reducing one or more pathogenic bacteria associated with gingivitis by at least 10%.

20. The kit according to any one of claims 17 to 19 for the use of reducing Porphyromonas gingivalis by at least 10%.

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