WO2006089139A2

WO2006089139A2 - Oral care cleaning compositions and methods

Info

Publication number: WO2006089139A2
Application number: PCT/US2006/005688
Authority: WO
Inventors: Martin S. Giniger
Original assignee: LAB39 LLC
Current assignee: LAB39 LLC
Priority date: 2005-02-15
Filing date: 2006-02-15
Publication date: 2006-08-24
Anticipated expiration: 2007-08-15
Also published as: WO2006089139A3

Abstract

An oral cleaning composition including an orally-acceptable cleaning solvent, an orally-acceptable surfactant and an orally-acceptable alkaline agent. Some implementations include one or both of charged and neutral surfactants. In many instances, the cleaning solvent is ethanol, the surfactant is sodium laurel sulfate and the alkaline agent is potassium hydroxide. An additional surfactant of polaxamer and/or an additional alkaline agent of sodium citrate may be included. Either or both of a peroxygen compound and a chelating agent may also be used.

Description

ORAL CARE CLEANING COMPOSITIONS AND METHODS

INVENTOR: Martin S. Giniger of New York, NY

BACKGROUND

[0001] The present invention relates to improvements in oral care compositions, and more particularly relates to a composition for tooth cleaning.

[0002] Many oral care tooth whitening compositions, and their associated methods of delivery, have been described and commercialized, yet numerous significant issues remain. Limitations of current art whitening compositions include: (1) reliance on a single dominant mechanism of action, involving decomposition of a strong oxidizer, that only inefficiently lightens one class of stains over relatively long treatment times; (2) a limited ability to physically remove stain molecules, especially deep seated ones; (3) a propensity to have high osmotic pressures which lead to tooth dehydration and subsequent inducement of transient dentinal hypersensitivity; and (4) almost universal reliance on carbomer-like thickener carrier vehicles that scavenge some active free radicals and limit surface penetration ability.

[0003] Prior art in other aspects of dentistry have shown that penetration ability is a major aspect of creating efficacy. Prior art has shown that active ingredients such as fluoride or triclosan (an anti-gingivitis agent), work best with enhanced ability to penetrate between teeth, or into the nooks and crannies on/of teeth, to provide their benefits to those oral features. Tooth whitening compositions also optimally require high penetration ability to reach and treat deep-seated tooth stains that have typically accumulated over many years.

[0004] The structure of enamel adds to the difficulty of treating tooth stains, because of its tightly packed crystalline structure and the high amount of electronegativity that is caused by incorporated enamel fluoride ions. Negatively charged teeth have a propensity to attract cationic stain molecules which unfortunately are also the most likely types of stain molecules to be colored and unaesthetic. Furthermore the enamel structure of a tooth is dense, but porous, in a deeply striated manner. Tightly packed enamel rods are arranged in a roughly parallel configuration, and over time, staining agents and discoloring substances permeate between the enamel rods and discolor the tooth, sometimes all the way through to the dentin. As the stains penetrate deeper into the enamel, between the densely packed rods, the activity

Hensley Kim & Edgington, LLC \ 281 -005-PCT of whitening compositions become increasingly reliant on carrier vehicle surface tensions and the ability of the active to penetrate into the enamel. Thus depth of tooth stains, in combination with electrostatic charges that further bind stains, make the challenge of efficiently and reliably whitening teeth even more difficult. The current art of whitening compositions rarely make mention of or address these issues.

[0005] A further limiting factor not well addressed in current art of oral care tooth whitening compositions is the lack of a multi-purpose active formulation strategy. This shortcoming ultimately causes current art whitening compositions to have unpredictable effectiveness, because they cannot lighten the broad spectrum of possible tooth stains that are present on teeth. The literature shows that there are many substances that have the ability to "stain" or reduce the "whiteness" of one's teeth including foods, medicines, job-related chemicals, air pollutants, food pigments, tobacco byproducts, and the like. These products can be organic or inorganic, hydrophilic, dry or oily. Oxidizer-reliant tooth whitening compositions are mostly limited to the lightening of some organic stains, and do not account very well for the other classes of stains.

[0006] The current art has also not overcome long treatment times that remain an unavoidable issue when oral compositions primarily rely on oxidizer chemistry. This is because the fundamental requirement for compositions that lighten teeth with oxidizing agents is prolonged contact time and the number of exposure cycles. To overcome this limitation formulations have opted for high concentrations of caustic oxidizers which further has the potential to cause tooth sensitivity. For maximum whitening, a long treatment time with a highly concentrated bleaching composition has generally been recommended.

[0007] Furthermore, a review of the current art shows a common reliance on moderately or highly viscous carrier, further limiting efficacy, and further enhancing susceptibility to tooth sensitivity. Carbomers such as carbopol and similar polymeric, carbon-based thickeners are almost universally chosen for tooth whitening compositions because: (1) they can enhance substantivity of the active within the wet oral environment; (2) they are generally regarded as safe; (3) they have very familiar and flexible chemical properties making compositions easier to formulate; and (4) because their adhesiveness and rheology are needed to help contain caustic peroxygen actives to the enamel surface. However use of thickening agents also causes unintended, undesirable effects on the safety and efficacy. This is because:

Hensley Kim & Edgington, LLC 2 281 -005-PCT 1) thickness, in general, causes high surface tensions and low wetting ability that prevents penetration of the active to reach deep seated stains; 2) thickness and density, in general, causes the osmotic pressure to be shifted such that the carrier gels tend to dehydrate the tooth, causing odontoblast cell processes to be drawn into dentinal tubules, further contributing to tooth sensitivity; and, 3) they have carbon bonded atomic structure that is somewhat similar in structure to stain molecules with high omnipresence and proximity to the oxidizer actives causing the scavenging of active free radicals, and further reducing efficacy.

[0008] Thus it is clear that these extant methods are not efficient, not rapid acting, not free of significant untoward side effects and are not able to truly clean teeth. This suggests that any new oral care composition that has a chemical formulation, that can enhance all other oral care whitening compositions so that they do not solely rely on or require strong oxidizers for activity, and works so rapidly and safely that thickened carrier vehicles are not required and as a result: (1) reduces the time required to achieve satisfactory efficacy levels; (2) increases patient comfort; (3) achieves more complete and longer lasting stain removal and (4) works via multiple chemical mechanisms to increase the reliability of the treatment outcome, should be highly useful, novel and desirable..

SUMMARY

[0009] An oral cleaning composition is described which involves an orally-acceptable cleaning solvent, an orally-acceptable surfactant and an orally-acceptable alkaline source or alkaline builder. The alkaline builder creates an alkaline environment for enhancing the cleaning activity of the surfactant and/or may also enhance or activate any peroxide whiteners, if used, and thereby accelerate the formation of free radicals from the peroxide to effect the oxidation of organic molecules causing staining of the dentition. The cleaning composition hereof may be used by itself for cleaning oral features such as the dentition, i.e., a tooth or teeth, and may be used to clean and/or remove stains from the dentition. Such a composition may also be used with and/or in advance application to the dentition before the application of any whitening compound. An example of preferred application would be as a daily high cleaning mouth rinse or applied topically with a swab applicator, on an as needed basis, after consuming foods, such as coffee, with propensity for causing tooth staining. Such a composition may also be used in advance, as a pre-treatment mouth rinse that could create and set oral environmental and tooth surface parameters just before the application of any whitening compound.

Hensley Kim & Edgington, LLC 3 281-005-PCT [0010] The primary components of such an oral cleaning composition are a cleaning solvent, a surfactant and an alkaline or base compound that in combination may in many implementations form a deep penetrating, rapid acting orally acceptable stain removal fluid. An exemplar cleaning solvent for this purpose is ethanol. A first exemplar anionic surfactant or detergent is sodium lauryl sulfate (SLS) and a second exemplar neutral surfactant is a high foaming polaxamer such as polaxamer 188. One exemplary alkaline building agent or base that may be used is potassium hydroxide (KOH) and a second is sodium citrate, which also has a high value as a saponification agent. Other basic compounds may alternatively be used to create the alkalinity of the overall composition. A peroxide may be added to the cleaning composition to provide a mildly higher level of tooth whitening. Other additives for taste, texture, viscosity, and other oral care or oral hygiene purposes may also be included in the cleaning composition hereof.

[0011] In some embodiments, an oral care foam-tipped device or swab-like applicator which may be pre-disposed in sealed tube with an oral care composition. The sealed tube may have a break open means to provide access to the device or applicator. The foam of the swab-like tip preferably is of a polymer or polyester type which is resistant to degradation in the presence of the oral compositions described herein as well as any others which might be used herewith. In a variety of embodiments, the foam is of an open cell type, and in some embodiments has an inner resilient layer, and an outer softer layer. In some embodiments, the foam has an abrasive quality for breaking plaque and debris from the teeth. [0012] In further embodiments, the oral care composition may be a preliminary enhancing composition which may create an alkaline environment for activating peroxide whiteners and accelerating the formation of free radicals from the peroxide to effect the oxidation of organic molecules causing staining of the dentition. Such an enhancing composition may be used for advance application to the dentition before the application of any whitening compound. The primary components of such an enhancing composition are a solvent and a base compound.

[0013] In addition, a finishing composition hereof may be used after the application of the whitening composition to neutralize the alkaline environment in the oral cavity caused by alkaline whitener compositions or cleaners, or by an alkaline whitening or cleaning process and thereby return the user's mouth to a neutral pH. A tooth glossing composition may be used as part of a tooth whitening process to enhance the effect of a whitening composition. [0014] Whitening and/or cleaning procedure(s) and/or composition(s), particularly involving multiple components or parts are described here. In many embodiments, an

Hensley Kim & Edgington, LLC 4 281-005-PCT activation or enhancing composition may be used initially to create an alkaline environment for activating/enhancing peroxide or other oxidation whiteners or alkaline cleaners. The alkaline- environment for oxidizing whiteners may accelerate the formation of free radicals from the peroxide or like oxidizer to effect the oxidation of organic molecules causing staining of the dentition. Application of a whitening or cleaning composition to the dentition would follow as a further component or step. Then, a finishing or post-enhancing composition could be applied. A two or three (or four or more) step process and/or set of components may thus be used. Any combination or sub-combination hereof would also be included, e.g., use of a whitener/cleaner with or without the preliminary enhancer and/or with or without the finishing or post enhancing composition may be included. Moreover, preliminary enhancing composition may in some instances be used alone, or solely with a finishing composition. In some instances, the finishing composition may be used alone as well. In these latter examples, the preliminary and/or finishing compositions may have effectiveness otherwise than necessarily in conjunction with a discrete whitener or cleaner. [0015] Other embodiments are described in further detail herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Fig. 1 is a schematic diagram of whitening and/or cleaning of a tooth stain according hereto;

[0017] Fig. 2 is a schematic diagram of an exemplary series of steps for whitening and/or cleaning of a tooth stain;

[0018] Fig. 3 is a schematic diagram alkaline builder activity;

[0019] Fig. 4 is a schematic diagram of chelator activity;

[0020] Fig. 5 is a schematic diagram of a method of application;

[0021] Fig. 6 is a flow diagram of an exemplary series of steps for creating a cleaning composition.

[0022] Fig. 7 is a flow diagram of an exemplary series of steps for applying the cleaning composition as part of a tooth cleaning process;

[0023] Fig. 8 is a table of data regarding whitening; and,

[0024] Fig. 9 is a table of data regarding sensitivity; and,

[0025] FIG. 10 is an isometric view of a self-contained swab unit employed herein, the enclosed swab being shown in dotted line;

Hensley Kim & Edgington, LLC 5 281 -005-PCT [0026] FIG. 11 is an exploded isometric view showing the swab and sleeve of the assembly of which the unit of FIG. 10 is made;

[0027] FIG. 12 is an elevational, cross-sectional view of the unit of FIG. 10, with the sleeve shown in cross-section;

[0028] Fig. 13 is a flow diagram of an exemplary series of steps for using an oral care composition and swab unit hereof.

DETAILED DESCRIPTION

[0029] The detailed description set forth herein is intended as a description of several exemplary compositions for tooth cleaning, tooth stain removal and/or tooth whitening and/or other oral care compounds according to the present invention and is not intended to represent the only forms in which such compositions may be disposed, prepared or utilized. The description sets forth features of the compositions themselves as well as steps for preparing and using the compositions of the present invention. It is to be understood, however, that the same or equivalent ingredients incorporated in different embodiments of compositions such as those described here may accomplish the same or similar functions or achieve the same or similar results and such compositions are also intended to be encompassed within the spirit and scope of this description.

[0030] An oral cleaning composition or agent hereof may in many implementations minimally include a cleaning solvent; a surfactant; and, an alkaline source, here often also referred to as an alkaline builder. The result may provide a pH-controlled alkaline solution of solvent(s) and/or surfactant(s) for use in the cleaning of tooth surfaces. Indeed, this type of composition can provide rapid, deep-cleaning of tooth surfaces. Examples of how these may generally operate are shown in FIGs. 1 and 2.

[0031] In many implementations, the cleaning solvent will be either one of or a mixture of both ethanol and/or water, though numerous alternatives, such as a variety of other alcohols, inter alia, may be used as described further below. In some preferred cases, the cleaning solvent is up to 92% ethanol with Q. S. (quantitation standard) of water. De-ionized water may be preferred in many implementations. In various implementations, the cleaning solvent is one or both of hydrophilic and water soluble.

[0032] Typically, two kinds of surfactants, anionic and non-ionic, may be used. In many implementations, sodium laurel sulfate and/or a polaxamer such as polaxamer 188 may be used. The charged surfactant may provide for desirable attachment to a stain molecule where

Hensley Kim & Edgington, LLC 6 281 -005-PCT the non-charged surfactant may provide for an optional effervescence, or foaming to lift the stain molecule or particle, as attached to the charged surfactant molecule(s) from the dentition surface.

[0033] Many of the oral or tooth cleaning compositions hereof, will typically include at least one alkaline agent or alkaline builder to create an alkaline environment for the cleaning process (see FIG. 3). An alkaline environment will typically assist the surfactant cleaning. Typical alkaline agents include potassium or sodium hydroxide and/or sodium citrate. An alkaline agent such as used here may also or alternatively act as a saponifier to saponify any oily stain material to assist in the removal thereof from the oral feature being cleaned. [0034] The herein described tooth cleaning agent will typically contain some combination of ingredients that work together to remove and optionally lighten unwanted tooth stains. The following is a classification of ingredients and a description of how each will typically work to cause stain removal or lightening.

Cleaning Solvent — dissolves stains, may be a thickener and aids in penetration;

Charged Surfactant - acts as a detergent; binds stains and solvent or neutral surfactant;

Neutral Surfactant — provides surface wetting, penetration, foaming, and/or stain lifting;

Alkaline Builder -assists activity of surfactants and converts oily stains into soap, and, if a whitening agent is used, causes decomposition of whitening agent,;

Whitening Agent — optionally used to lighten any tooth stains that are not removed;

Chelator - prevents minerals from inhibiting surfactants.

[0035] The many possible tooth cleaning embodiments of cleaners of the present invention can be formulated to do or focus on one or more specific jobs. In some implementations, the tooth cleaner will not contain many of these ingredients; in other implementations, it will contain all of these types of ingredients.

[0036] Following hereafter is a description of each category of ingredient that could be used in a tooth cleaning system.

[0037] First, for the category of Cleaning Solvents; the principal stain removing solvents are first orally-acceptable, and preferably also water miscible and hydrophilic. These may then preferably have the ability to bind to and/or with the surfactant system (see below) and present a further ability to break down tooth stains and any present peroxide gel thickeners, if used or otherwise present. Thus, a cleaning solvent will preferably suspend in solution or dissolve the stain molecularly or at a larger, more macroscopic, particle level. Such a solvent would at least provide a medium in which a stain can be suspended and carried away from the surface of the dentition or other oral feature being cleaned. Solvents also improve the

Hensley Kim & Edgington, LLC 7 281 -005-PCT wetting properties of the composition of matter such that better penetration into the tooth surface can be achieved.

[0038] Note, tooth cleaning compositions or like oral care products will typically include some sort of liquid solvent. Such a solvent would in most cases minimally provide for dissolving and carrying the other active molecules contained in the tooth cleaning composition, thus acting at least as a carrier. Preferably, the solvent will also act in some cleaning capacity and provide for suspending and carrying stain molecules or particles from the surface being cleaned. Water is the oldest, least expensive and most widely used solvent which can act in both capacities, carrying and cleaning. Given sufficient time, water will have the ability to clean or remove just about every type of stain or soil, be it organic, inorganic, petroleum or a combination. The compositions hereof will typically contain some water, acting in either or both capacities, i.e., as a stain cleaning solvent and/or for the purpose of dissolving and carrying (i.e., acting as a carrier) the other cleaning molecules contained in and/or cleaned stain molecules carried by the tooth cleaning composition. [0039] The second category of cleaning materials introduced above includes the Charged or Anionic Surfactants (detergents). The word surfactant is short for "surface active agent". Anionic surfactants work at the interface between the stain and the solvent. Each anionic surfactant molecule typically has two chemical groups; one that is attracted to water (the hydrophile) and one that is attracted to soil (the hydrophobe). In a cleaning solution, the hydrophobic end of the surfactant molecule orients toward the positively charged stain molecules. Most tooth stain molecules are cationic because teeth contain fluoride which are highly negatively charged. Anionic surfactant molecules will be highly attracted to and attack the cationic stains, breaking them up into small pieces and completely surrounding each of them. The hydrophilic ends of the anionic surfactant molecules will concurrently be projecting into the solvent, helping to cause the stain to be broken up, removed from the surfaces, and lifted and suspended into the cleaning solution. Note, the Alkaline Builders (addressed in more detail below) may assist the anionic stain molecules at the interface between the solvent and stain.

[0040] The third of the above categories includes the Neutral Surfactants which are typically penetrating and wetting agents. Modern technology provides many different types of surfactants by changing the chemical composition of the hydrophobic and hydrophilic ends of the molecule. By changing the chemical composition, neutral surfactants can be created that have greater or lesser abilities in different areas; namely, Penetrating and Wetting (providing for deeper penetration of the stain remover); Foaming (creating bubbles that lift

Hensley Kim & Edgington, LLC 8 281 -005-PCT the stain material from the surface); Emulsifying (providing for the breaking up of greasy petroleum stain materials into small droplets that can be dispersed thoroughly); and Dispersing (spreading the minute stain particles throughout the solution to prevent them from sticking to any surface such as back onto the cleaned surface).

[0041] To make better, if not the best possible tooth cleaning composition, the formula may include a mixture of anionic and non-ionic surfactants, allowing for high amounts of foaming, wetting/penetrating agents to be combined with high stain binding ability. Typically, though not necessarily, at least two surfactants may be used in combination to create a cleaning composition with a good balance of detergency, foaming, wetting, emulsifying, solubilizing and dispersing properties. Each mixture of surfactants may have its own special abilities as a cleaning formula.

[0042] The next category includes the Alkaline Builders and/or Saponifiers. A first functionality of the alkaline builder group (as shown in FIG. 3) is to bring the cleaning composition to a desirable pH level, particularly for assisting in the cleaning process. At higher pH levels, the surfactants will operate better for their intended purposes, as for example being able to penetrate more deeply to and/or between surfaces. This may include between the surface of a tooth, for example, and a stain molecule or particle thereon. Alkaline builders may also provide the anionic surfactants of the tooth cleaning composition a sort of additional or reserve strength, enabling the cleaning molecules of the anionic surfactants to more strongly bind to the stain molecules. This can be especially important when the teeth are heavily stained or soiled. The alkaline builders may also be used to provide a desirable pH above a lower level of about 6.0 (where there will be free radical formation, see peroxide description below) up to below about 10.0 (which is caustic, or nearly so, and thus, not generally orally-acceptable). A further potentially useful functionality of some alkaline builders may be in saponification. Alkaline agents such as at least some of those described herein may be and typically are strong alkaline chemicals that can convert animal fats and oils into natural soaps. This is the same chemical reaction that has been used to make natural soaps for many centuries, and the conversion of fats to soap is called saponification. Once the fats and oils are converted to soap, they are soluble in water and can be easily washed away. Various phosphate and citrate salts are used as alkaline builders and saponifiers in modern cleaning solutions.

[0043] The next category are the Whiteners or lightening agents which are optional here and may be used to lighten any remaining tooth stains which may not be removed during the tooth cleaning operation. These are optionally included in compositions hereof and are

Hensley Kim & Edgington, LLC ^' 9 281-005-PCT particularly useful in compositions for use with teeth which are heavily stained. Peroxygen compounds are the most common of these whitening materials, which with other alternatives are described in more detail further below.

[0044] Particularly if, though not necessarily only when Whiteners are used, the sixth category of agents introduced above, called Chelating agents or chelators may be useful. As shown in FIG. 4, these chelating agents may bind to or "tie up" calcium or any other positively charged minerals or like materials in the tooth cleaning environment. Hard water minerals may be found in such an environment and will thereby be bound with such chelating agents. Calcium ions are also typically released when the tooth enamel surface is exposed to peroxides. Dissolved calcium in the tooth cleaning environment is a typical cause of hardness which in turn hinders cleaning ability of a cleaning solution. This is because the anionic detergents and other active ingredients in the cleaning composition see the calcium minerals as an equivalent of a stain molecule (both the calcium molecules and the stain particles are positively-charged or cationic and are thereby attractive to the anionic detergent). These active agents, or a significant amount thereof, might then bind the calcium, or like minerals, instead of the tooth stains, and would then not be available to clean the stain as desired. This problem can be solved by adding chelating agents to the cleaning formula. These chelating agents can efficiently and effectively "tie up" the hardness promoting calcium, leaving the detergents and other active agents to work on the target tooth stains. Because chelators are so efficient, only a very small amount of chelating agent is typically used to eliminate a great deal of any such hardness from the water.

[0045] In preparing the present compositions, it may be desirable to include one or more aqueous carriers as parts of the overall compositions. Such materials are well known in the art and are readily chosen by one skilled in the art based on the physical and aesthetic properties desired for the compositions being prepared. These aqueous carriers may be included at levels which do not prevent the interaction between the certain surface active agents and the necessary solvents and/or surfactants that will enable tooth cleaning. The amounts of alkaline builders, surfactants and solvents may be adjusted if necessary to compensate for any additional actives such as any peroxide-based whitening agents and/or chelators, if used (see below). Chelators, as introduced above, may also be adjusted in amounts relative to peroxide-based whitening agents, again, if such are used. Aqueous carriers may typically comprise from about 8% to about 90%, or more preferably from about 70% to about 88% by weight of the oral composition.

Hensley Kim & Edgington, LLC I Q 281 -005-PCT [0046] De-ionized water may be one preferred carrier/solvent medium for the overall cleaning composition. Water in de-ionized form may minimize contamination of the cleaning solution from trace minerals which might otherwise be disposed in a water solvent/carrier. Thus, an advantage of using de-ionized water as a solvent would be that it evaporates with little or no residue after delivering the cleaning agents to the target surface(s).

[0047] As described above, the oral care compositions described herein will preferably have a cleaning solvent which, as introduced above, firstly will be orally-acceptable. Next, the cleaning solvent will also preferably be able to assist in providing the penetration of the active cleaning agent(s), and improve the solubility of poorly soluble organic and inorganic substances. Such a cleaning solvent may also preferably assist in the decomposition of stain molecules, and break bonds between the stain molecules and the enamel and dentinal surfaces. An ideal solvent would typically be water miscible, forming a hydrophilic co- solvent system with water. The water miscible solvents for such a co-solvent system include one or more orally acceptable hydrophilic solvents, such as ethanol (ethyl alcohol), glycerol, propylene glycol, or one of the orally acceptable polyethylene glycols, e.g., polyethylene glycol 400 and/or 600 (PEG 400 and/or PEG 600), and/or may be an organic thickener. These components can be present in the cleaning composition in effective amounts. For example, ethanol or ethyl alcohol can be present in the overall composition in the range of about 0.5% to about 15%, or even up to about 20% (or more), or more preferably about 10% (w/w) by weight in the overall composition. The cleaning solvent itself may be of pure ethanol (dehydrated or anhydrous); or in some more particular implementations, may be a solution of up to about 92% ethanol; or, e.g., may be of a mixture of ethanol and water, or more particularly the cleaning solvent may be of up to about 92% ethanol with Q.S. (quantitation standard) water.

[0048] Cleaning solvents hereof may include orally acceptable hydrophilic or hydrophobic solvents (examples including the herein listed orange oil, ethyl alcohol, propylene glycol, PEG 400 or PEG 600). A preferred embodiment utilizes a combination hydrophobic / hydrophilic approach and specifically uses dehydrated ethyl alcohol or ethanol and orange oil. For example, the ethyl alcohol can be present in the range of about 0.5% to about 15%, and preferably between about 5% and about 10% and most preferably about 8.5%. Since orange oil is only slightly miscible, it can be present in the range of about 0.01% to about 0.5%, and preferably between about 0.08% and about 1% and most preferably between about 0.1% and about 0.2% by weight of the oral care composition.

Hensley Kim & Edgington, LLC H 281-005-PCT [0049] As introduced, other cleaning solvents may include one or more of various PEG components, one or more various propylene glycol components, and/or a glycerol, apart from or together with ethanol and/or water. Still further alternatives may include: benzyl alcohol, ether, methyl salicylate (wintergreen flavor); phenol; acrylic acid (typically to be professionally-applied, if used herein); synthetic or natural orange oil, or citragold™ (available from Gallade Chemical, Santa Ana, California); acetic acid, vinegar, acetone, formic acid, methanol, propanol, ethanolamine, lactic acid ethyl ester (mild pleasant odor, clear colorless, soluble in water), propionic acid, diethanolamine, triethanolamine, diethylene glycol, diethylamine (DEA), triethylamine (TEA), tetraethylene glycol, formaldehyde, 1- octanol (orange-rose). Note, avoidance of cancer-causing agents as solvents is preferred, though not necessary.

[0050] As also introduced above, orally-acceptable surfactants useful in the present invention include nonionic and anionic surfactants. Oral surfactants employed may also include block co-polymers of polyoxyethylene and polyoxypropylene such as the Pluronics (see the polaxamers described further below). Other oral surfactants include soluble alkyl sulfonates having 10 to 18 carbon atoms, such as sodium lauryl sulfate (SLS), and sulfates of monoglycerides of fatty acids having 10 to 18 carbon atoms or sarcosinates (including salts and derivatives) such as sodium-N-lauroyl sarcosinate. Mixtures of anionic and nonionic surfactants may preferably be used. Anionic surfactants may typically be present from about 0.1% by weight to about 2.0% by weight, or more preferably from about 0.5% by weight to about 1.2% by weight, and most preferably about 0.7% by weight; and, the non-ionic surfactants may typically be from about 0.1% by weight to about 2.0% by weight, or more preferably from about 0.5% by weight to about 1.2, and most preferably about 0.7% by weight. Preferably, the anionic and non-ionic surfactants would be disposed in roughly equivalent amounts.

[0051] The list of alternative surfactants may include block polymers or at least some difunctional block copolymer surfactants, e.g., those having terminal groups of primary hydroxyl groups, and groups comprising a hydrophobic and a hydrophilic segment. Included here may be Pluronic F68 or F88, or polaxamer 188, polaxamer 124, 338, 407 (the distinctions in these polaxamers being the provision of smaller or larger bubbles/foams, the amount of debridement, molecular weights 1000-16,000, and water solubility), sodium laurel sulfate (SLS), dioctyl sodium sulfosuccinate, ethylene oxide polymer; other non-block polymer surfactants; polyethyloxylated castor oil; cremophor 40 (foamer and saponifier), or Nikkol™ hco-60 (hydrogenated castor oil) (available from Nikko Chemical, Japan).

Hensley Kim & Edgington, LLC 12 281 -005-PCT Considering the anionic or charged surfactants which may be used here, these include sodium laurel sulfate (SLS), also known as sodium laureth sulfate and known as dioctyl succinate and/or dioctyl sodium sulfosuccinate. Another anionic surfactant alternative is cocamidopropyl betaine is preferably used as stain binding detergent. The list of non-ionic surfactants include phosphates, sulfates such as sodium dodecyl-sulfate, and polysorbates, sorbitan esters, sorbitan fatty acids, and polysorbitan fatty acid esters, e.g., polysorbate 80 (a surfactant and wetting agent also known as TWEEN-80) and certain mono-glycerides such as glycerol mono-oliate, glycerol mono-palmitate, glycerol mono-stearate; caprilic and octaoic acids, and soybean lecithin and other phospholipids, as well as biosalts such as sodium taurocholate.

[0052] Nonionic surfactants may include, but are not limited to, compounds comprising hydrophilic (having an affinity for water) and hydrophobic components (lacking an affinity for water). These surfactants may be produced by the condensation of alkylene oxide groups, which are hydrophilic in nature, with an organic hydrophobic compound, which may be aliphatic or alkyl-aromatic in nature. Examples of suitable nonionic surfactants include low viscosity poloxamers, e.g., poloxamer 188 (under trade name Pluronic), low viscosity hydroxyethyl cellulose, polysorbates, polyoxyethylene sorbitan esters (under trade name Tweens), 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, and mixtures thereof. Anionic and othert amphoteric surfactants may include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic component may be a straight chain or branched. One of the aliphatic substituents may contain from about 8 to about 18 carbon atoms and one may contain an anionic water- solubilizing group, e.g., carboxylate, sulfonate, sulfate, phosphate, phosphonate, betaines (e.g., cocamidopropyl betaine), and mixtures thereof. Many of these nonionic and amphoteric surfactants are disclosed in U.S. Patent No. 4,051,234, which is hereby incorporated herein by reference in its entirety. Furthermore surfactants may also be included in the oral care activation compositions in solid form. Solid form surfactants may include, for example, sodium carbonate anhydrous, sodium bicarbonate, potassium iodide, and mixtures thereof. Exemplary surfactants may also include at least some difunctional block copolymer surfactants, e.g., those having terminal groups of primary hydroxyl groups, and

Hensley Kim & Edgington, LLC 13 281-005-PCT groups comprising a hydrophobic and a hydrophilic segment. Examples include Pluronic F68, Pluronic F88, and mixtures thereof.

[0053] Again as introduced earlier, the present compositions may contain a buffering or alkaline builder agent. Buffering or alkaline builder agents, as used herein, refer to agents that can be used to adjust the pH of the compositions to a range of higher than about pH 6.0 to more preferably from about pH 7.0 to about pH 10. The phase of the oral composition containing the surfactant cleaners will typically have a pH of from about 8.0 to about 10.0, and more preferably from about 8.2 to about 9.2. In many implementations, a target pH will be about 8.8; where in others this may be about 9.0 or about 9.1. As introduced, oral cleaning agents according hereto may typically include an alkaline source or builder which is one or more of potassium hydroxide (KOH) and sodium citrate; and/or may include baking soda (sodium bicarbonate), sodium hydroxide, calcium hydroxide, calcium phosphate tribasic, dipotassium phosphate, sodium monobasic phosphate and sodium dibasic phosphate (optionally anhydrous), sodium aluminum phosphate, sodium tripolyphosphate, and/or sodium hexametaphosphate. Preferred buffers would be those that control the pH in the target alkaline range without negatively affecting taste, odor or the cleaning ability of the composition of matter. Buffering/alkaline agents may be used at a level of from about 0.1% to about 30%, preferably from about 0.5% to about 10%, and more preferably from about 0.8% to about 3%, by weight of the overall present composition.

[0054] As introduced, in many implementations, an exemplar alkaline agent or base that may be used is potassium hydroxide (KOH), which easily dissolves in water to form a strongly alkaline liquid. The dissolution of KOH in water also generates substantial heat, which may be conducive to the dissolution of additional ingredients in the overall composition.

[0055] Further, an oral cleaning agent according hereto may include sodium citrate which may be used as one or both of the alkaline builder and/or a saponifier to create a detergent/surfactant. When acting as a saponifier, the sodium citrate may be used for removal of oily stains, to saponify the oily stain material by combining therewith to create a detergent-like surfactant. This may operate best with oily hydrophobic and difficult to dissolve stains which can then be converted into a kind of soap which is then easily dissolved and carried away from the tooth.

[0056] The possible range of buffering or alkaline building agents may also or alternatively include alkali metal hydroxides, carbonates, sesquicarbonates, borates, silicates,

Hensley Kim & Edgington, LLC 14 2S1-005-PCT phosphates, imidazole, and mixtures thereof. Specific buffering or alkaline building agents include monosodium phosphate, trisodium phosphate, sodium benzoate, benzoic acid, sodium hydroxide, potassium hydroxide, alkali metal carbonate salts, sodium carbonate, imidazole, pyrophosphate salts, citric acid, and sodium citrate. Other potential buffering or alkaline building agents include acetic acid, sodium acetate, citric acid, sodium citrate, benzoic acid and sodium benzoate.

[0057] Other additives could include sweeteners such as saccharin and sucralose, inter alia. The use of multiple sweeteners may be desirable because, for example, saccharin may provide a sweeter flavor while sucralose (i.e., Splenda® sweetener) may, as is often reported, taste better. I.e., the sucralose may be used to cover the less desirable taste or aftertaste of sodium saccharin.

EXAMPLES

[0058] In a first couple of implementations of an oral or tooth cleaning solution hereof, the following ingredients, see TABLES A and B, may be combined to form exemplar oral or tooth cleaning solutions according hereto.

TABLE A INGREDIENTS PCT %w/w

TABLE B INGREDIENTS PCT %w/w

Hensley Kim & Edgington, LLC 15 281-005-PCT

[0059] Some details of these ingredients of the exemplar tooth cleaning solutions of TABLES A and B are addressed here. First, de-ionized water may be preferred as an overall solvent for the dissolving of all the other ingredients thereinto; de-ionized to provide for little or no residue upon evaporation. Second, ethanol (a typically dehydrated alcohol) may be used as a preferable, orally-acceptable cleaning solvent that breaks up stain molecules and aids penetration of the cleaning solution. A further, orally-acceptable cleaning solvent such as polyethylene glycol 600 (PEG 600) may also be included for breaking up stain molecules and aiding penetration of the cleaning solution.

[0060] One or more surfactants, such as sodium lauryl sulfate (SLS) - a negatively- charged surfactant, may act as a detergent at the boundary of the stain and the solvent to remove the stain from the surface of the tooth or other oral feature. A further surfactant such as poloxamer 188, a neutral surfactant, may be used to aid penetration and cause foaming when agitated to lift stain complexes above the surface of the tooth or other oral feature. [0061] In the examples of TABLES A and B, two alkaline sources or alkaline builders are shown, potassium hydroxide, which may provide assistance to surfactant cleaning ability (and as described below, may cause immediate or rapid degradation of a peroxide, if used, into oxidizing free radicals); and sodium citrate, a buffer which may be used to achieve and maintain alkaline pH. Note, as introduced above, the sodium citrate may also assist surfactant cleaning as well as possibly acting as a saponifier to saponify oily stains. Tartaric acid may be used for pH adjustment, particularly if the other ingredients have created a more caustic (higher pH) environment than targeted/desired. Thus, tartaric acid is typically, though not necessarily, added last to bring the pH to a desirable level.

[0062] Other additives may include flavorings and/or sweeteners such as the peppermint oil flavoring as shown in TABLE B and the sodium saccharin (flavoring/sweetener) and sucralose (sweetener also known under the tradename, Splenda®). [0063] In another example, see TABLE C, a whitening agent may also be included.

TABLE C INGREDIENTS PCT %w/w

Hensley Kim & Edgington, LLC 16 281 -005-PCT

[0064] As shown, a Whitening agent may be included as an oral care active agent in the present invention. Hydrogen peroxide (e.g., a 30% soln) may be used as an oxidizing agent at about 2% by weight of the overall composition. Also added in the example of TABLE C is ethylene diamine tetra acetate, known also as EDTA, a chelating agent that can bind up any free positively charged ions, as for example, may be evident in any calcium present in the environment. The EDTA may also assist in binding surfactant to charged stain molecules and thereby provide for easier removal. Alternative chelators include sodium EDTA; disodium EDTA, calcium disodium EDTA, and/or tetrasodium EDTA. A chelator may be especially useful in a cleaning composition where positively charged minerals such as calcium may be formed, as in the presence of peroxide (a decalcification agent relative to teeth). Thus, the chelator can bind with or chelate with the positively charged minerals (e.g., calcium) and thereby prevent the interference of those minerals with the negatively-charged surfactant cleaning (e.g., the SLS cleaning) described herein.

[0065] Note, a whitener, if used, would preferably have the property of decomposition under alkaline conditions. Such substances are typically selected from the group of peroxygens or peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and/or combinations thereof. Suitable peroxide compounds include hydrogen peroxide, or one or more of other peroxides, for example, metal-ion-free peroxide compounds including urea peroxide (carbamide peroxide), salts of peroxides formed from the alkali and alkaline earth metals (e.g., calcium peroxide), glyceryl peroxide, benzoyl peroxide, and other organic peroxides, and/or mixtures thereof. In one embodiment the peroxide compound is carbamide peroxide. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Additional bleaching substances may be sodium hypochlorite and chlorine dioxide. In one embodiment the

Hensley Kim & Edgington, LLC 17 281-005-PCT chlorite is sodium chlorite. The preferred embodiment uses hydrogen peroxide as the whitening agent. The level of any of these substances is dependent on desirability of adding a stain lightening function to the tooth cleaning function of the composition of matter described hereabove. These substances provide either or both the oxygen or chlorine respectively that the molecule is capable of providing to bleach the stain. This level generally used in compositions of the present invention is from about 0% to about 10%, preferably 0 to 5%.

Note also that the oral care compositions described hereabove would, particularly when used with an added whitening agent, or in conjunction with a third-party whitening product, include an alkaline building agent that has sufficient capacity to decompose the optional whitening agent that could be included in this composition of matter or used in conjunction this composition of matter. Such alkaline building agents, as used herein, refer to agents that as described above, can be used to adjust the pH of the compositions to a range of about pH 7.0 to about pH 10, and would assist in decomposing the optional whitening agent. For such a functionality, the pH of the overall composition ideally should have a pH of from about 8.8 to about 9.2, although free radical formation may begin in the range of about 6.OpH. In any case, preferably when a whitening agent is included in the composition of matter the pH should ideally range from about 8.8 to about 9.2 and may be further stabilized with sodium EDTA.

[0066] The composition of the present invention can also include other active ingredients, such as peroxide photo-activators. The addition of peroxide photo-activators can also increase the photobleaching efficiency of the compositions hereof. Suitable peroxide photo- activators include those with lower oxidative state transition metal salt. The metal salt may catalyze the bleaching action of the peroxide to produce faster effective bleaching at lower peroxide concentrations. The preferred transition metals are those of lower atomic numbers including lower atomic number transition metals such as those ranging from atomic number 21 to 30. Also, those with lower oxidative states may be more preferred, including, e.g., Iron(II), manganese(II), cobalt(II), copper(II) and mixtures thereof, and most preferably Iron(II), as in a ferrous gluconate. When used, only a very small amount of the transition metal salt is needed, for example, from about 0.01% by weight to about 4% by weight, further for example, from about 0.03% by weight to about 2% by weight, and even further for example, from about 0.04% to about 1% by weight. The peroxide photo-activator can also include alkali salts such as potassium iodide, potassium chloride, sodium iodine, sodium chloride and combinations thereof.

Hensley Kim & Edgington, LLC 18 281 -005-PCT [0067] Amorphous calcium compounds such as amorphous calcium phosphate (ACP), amorphous calcium phosphate fluoride (ACPF) and amorphous calcium carbonate phosphate (ACCP) amorphous calcium carbonate phosphate (ACCP), and amorphous calcium carbonate phosphate fluoride (ACCPF) can be used for re-mineralizing teeth. In addition to or as an alternative to amorphous calcium compounds, amorphous strontium compounds such as amorphous strontium phosphate (ASP), amorphous strontium phosphate fluoride (ASPF)₅ amorphous strontium calcium phosphate (ASCP), amorphous strontium calcium carbonate phosphate (ASCCP), amorphous strontium carbonate phosphate fluoride (ASCPF) and amorphous strontium calcium carbonate phosphate fluoride (ASCCPF) may be included for use for re-mineralization, as noted above. In practice, it may in some embodiments be preferred to include as much phosphate as possible, as the phosphate salt may further act to adjust the pH of the overall composition.

[0068] Note also, the fluoride-containing amorphous compounds may also be used for fluoridating teeth. Otherwise, fluorides may be added separately and then, many, if not all of the above amorphous compounds or solutions which form the amorphous compounds, when applied either onto or into dental tissue, particularly in the presence of fluoride, may operate to promote fluoridation. Such fluoridation or other mineralization may serve to assist in prevention and/or repair of dental weaknesses such as dental caries, exposed roots and dentin sensitivity.

[0069] Although tooth sensitivity should be substantially eliminated hereby, an overall composition hereof can nevertheless also include other active ingredients, such as de-sensitizing agents. Even with improved efficiency and shorter treatment time, some patients may still experience sensitivity from tooth whitening compositions. Inclusion of desensitizing agents in the composition allows time for desensitization of the oral tissue before the application of the whitening compound. Suitable desensitizing agents can include Eugenol and/or alkali nitrates such as potassium nitrate, sodium nitrate, and lithium nitrate and other potassium salts such as potassium chloride and potassium bicarbonate. The desensitizing agent may make up to about 3% to 5% percent by weight of the composition. Eugenol may also act as an antimicrobial or antibacterial agent.

[0070] Further additives may include calcium nitrate and/or sodium mono and/or dibasic hydrate. These compounds may be added to lower the viscosity of the composition and provide a composition that has greater ability to penetrate recesses and interstices of the dentition. Such additives may also improve the stability of the overall composition.

Hensley Kim & Edgington, LLC 19 281-005-PCT Potassium nitrate may alternatively and/or additionally be added to achieve desired viscosity effects.

[0071] In addition, optional additives including emulsifiers, flavorings, coloring agents, anti-plaque agents, anti-staining compounds, excipients such as emollients, preservatives, other types of stabilizers such as antioxidants, and tonicity modifiers (e.g., sodium chloride, manitol, sorbitol, or glucose) may be included in the overall composition. The concentration of each may easily be determined by a person skilled in the art. Lecithin, a natural emulsifier found in soy and other plants, and gum arabic, which comes from the sap of certain species of acacia trees, can be added for use as an emulsifier, dispersant, and/or wetting agent. Suitable preservatives may include benzalkonium chloride, parabens, chlorhexidine acetate, chlorhexidine gluconate, sorbic acid, potassium sorbitol, chlorbutanol, and phenoxyethanol. Suitable emollients such as those used for topical applications are, for example, di-n-octyl ether, fatty alcohol polyalkylene glycol ether, 2-ethylhexyl palmitate, and isopropyl fatty acid esters.

[0072] The ingredients of a composition hereof, as for example any of the compositions of TABLES A, B and or C, may be mixed according to the exemplary method depicted in Fig. 6. Initially, approximately O.lg of potassium hydroxide is completely dissolved in 55ml of water, as for example, de-ionized water (step 105). The dissolution of potassium hydroxide is an exothermic process that heats the solution. Next, approximately 0.5g of poloxamer 188 is dissolved in the H₂O-KOH mixture (step 110). The generation of heat may be advantageous because heat may be beneficial for the dissolution of the poloxamer 188. Application of additional heat to the mixture may assist in completely dissolving the poloxamer 188. The mixture of H₂O, KOH, and poloxamer 188, which may be referred to as Mixture 1, can be set aside.

[0073] A second mixture, Mixture 2, is prepared by dissolving approximately 0.3g of sodium saccharin and 0.2g of sucralose in 18ml of water (step 115). Mixture 2 is completed by dissolving approximately 0.7g of sodium citrate into the water-sodium saccharin solution (step 120). Note, Mixture 2 includes optional ingredients for the overall mixture, although sodium citrate may be a desirable alkaline builder added to Mixture 1 at this point. Nevertheless, in the primarily described embodiment, Mixture 1 would then be combined with Mixture 2 (step 125). Next, if a whitener is to be included as shown in TABLE C, approximately 6.7g of 30% hydrogen peroxide solution may then be slowly introduced to the combination of Mixture 1 and Mixture 2 to form Mixture 3 (step 130). Mixture 3 may then be set aside.

Hensley Kim & Edgington, LLC 20 ²⁸¹ -005-PCT [0074] Either for the provision of ethanol alone, or another mixture, Mixture 4 with optional additional ingredients, can be created by dissolving approximately 0.3 g of methyl salicylate and O.lg of orange oil in approximately 16g of ethanol (step 135). A coloring additive, for example, food coloring, may be optionally added to Mixture 4 to provide visual interest to the overall composition (step 140). In the ingredients depicted in any the compositions of any of TABLES A, B and/or C, several, or approximately two drops of food coloring may be added to Mixture 4.

[0075] Next, either the ethanol, or Mixture 4, if the optional ingredients thereof are to be used, can then be slowly added to Mixture 3 to form Mixture 5 (step 145). Finally, approximately O.lg of tartaric acid may be added to Mixture 5 (step 150) to adjust the basic pH of Mixture 5 downward to a biologically compatible/desirable level, for example, between about 8.5 and 9.5, with a target pH of about 8.8 or about 9.0. The mixture of the ingredients as in any of the components of TABLES A, B and/or C according to the steps set forth in Fig. 6 may thus result in an approximate 100ml volume of an exemplary cleaning composition for treatment of dentition. The increase in pH created by the composition enhances the effectiveness of the tooth whitening compound.

[0076] Although certain steps for combining the ingredients identified in TABLES A, B and/or C are indicated in Fig. 6 and the accompanying discussion above, it should be recognized that additional or alternative ingredients described above may also be included or substituted in the composition. Further, the steps depicted in Fig. 6 are merely exemplary and other variations for mixing ingredients of the overall composition are possible and contemplated.

[0077] The compositions hereof may be applied to a user' s dentition in any of a variety of ways. For example, if the composition has a low viscosity, the overall composition may be provided in the form of a mouth rinse or through the use of a swab such as a foam-tipped swab. At a higher viscosity, for example, in the form of a gel or paste. The composition may be in the form of a toothpaste and applied with a tooth brush or swab, foam-tipped or otherwise. The composition may also be applied with a prophy cup if supplied as a prophylaxis paste, e.g., a prophy paste. If the composition is applied with a swab (e.g., the composition is a gel), the swab may be formed of a foam material rather than other materials. A polymer foam may be more structurally sound and uniformly absorptive as compared to cotton swabs or other materials. Polymer foam will typically also be resistant to breaking down and will not typically permanently deform.

Hensley Kim & Edgington, LLC 21 281 -005-PCT [0078] Thus, a stain removing composition has been described. Moreover, also included here are methods for removing stains, as well as including the option of providing a booster for whitening teeth. Note, the use of stain removing and/or stain whitening or lightening may occur substantially simultaneously or sequentially, i.e., if sequential, the stain removing composition can be applied to the teeth and a tooth whitening composition applied thereafter. Note, the alkaline environment of the stain-removing compositions hereof may provide an enhancing effect for a peroxide whitener by enhancing the peroxide break down into free radical oxygens. Note further, that the present compositions may be useful for tooth bonding systems and/or for hole cleaning by providing good cleaning and/or a beneficial alkaline environment.

[0079] Though the simplest form of use is application of a composition hereof to a tooth surface, tooth cleaning or tooth stain removal may typically involve a series of events whereby the tooth surface is first wetted, allowing penetration of stain removers and lighteners, if used, in a series of steps that include: loosening, decomposition, suspension of surface, dissolution, dispersement, lifting via a foaming action and prevention from re- deposition. Ingredients can be added or deleted to make a special purpose tooth cleaner for inclusion in any number of oral care products including tooth paste, tooth whitening systems, mouth rinses, prophylaxis pastes, tooth bonding agents, caries prevention systems. [0080] Fig. 7 depicts an exemplary professional tooth whitening process including steps of application using a supplied swab tube dispenser. First, the teeth may be cleaned and a shade guide used to determine initial tooth shade. In the next steps, the soft tissues are protected with cotton and a paint on rubber dam. The following next three demonstrate the correct method of opening the swab tube dispenser. After the dispenser is opened, a swab containing the composition is swiped across the facial surface of each tooth that is intended to be whitened. A professional tooth whitening composition containing approximately 20% hydrogen peroxide can then be applied to the teeth. A bleaching light is then activated and the composition gel mixture is left on the patient's teeth for no more than 5 minutes. After the first cycle is completed the whitening mixture is evacuated and wiped off, new composition is applied followed by new bleaching gel. After 5 minutes, the mixture is removed and a third cycle is commenced similar to cycles 1 and 2. After only a total of only 15-21 minutes, the teeth are rinsed, the treatment is completed by matching a shade guide. Data shown in Fig. 8 show that eight 8 shades of whitening can be achieved in a procedure that is completed in 21 minutes instead of the traditional 90 to 120 minutes. Furthermore data shown in Fig. 9 that the composition has a highly significant ability to eliminate the transient dentinal

Hensley Kim & Edgington, LLC 22 281-005-PCT hypersensitivity typically associated with tooth whitening treatments. Fig. 9 shows that while most commercial whiteners cause some level of tooth sensitivity, when used in combination with the composition, the sensitivity levels drop to near zero.

[0081] When used in the above format as a pre-whitening enhancing composition to enhance the activity of any whitening gel, it is likely that the whitening gel will likely be distributed apart from the composition(s) described herein.

TABLE D. The stain removal efficacy of various embodiments of the described Invention after rinsing or swabbing for 1 minute, 3x daily with optional twice daily Half-hour application of a 7% whitening strip where indicated.

[0082] The detailed description set forth herein is intended as a description of a swab and tube or sleeve system particularly as may be used with several exemplary compositions for enhancing the effectiveness of tooth whitening and/or other oral care compounds according to the present invention. These are not intended to represent the only forms in which such an oral care swab and tube hereof may be used, nor of how such compositions may be prepared or utilized. The description sets forth features of and steps for using the activator, enhancer, whitening, post-rinse or other oral care compositions of the present invention. [0083] The swab and tube configuration hereof may be like that in US Patent No. 4,952,204, to Korteweg, with a principal difference in many embodiments being a foam tip. In more specifics, and turning in detail to FIGS. 10-12 of the appended drawings, therein illustrated is a self-contained swab unit embodying the invention. Here shown is a swab, generally designated by the numeral 10, and a sleeve or tube generally designated by the numeral 12. The swab 10 consists of a straight stick 14, usually of plastic, with a foam tip 16 attached on one end.

[0084] The sleeve 12 is of circular cross section and hollow along its length, and may be fabricated from a plastic material. It may include a relatively small diameter cylindrical handle portion 18 at one end, a substantially larger diameter receptacle portion 20 at the

Hensley Kim & Edgington, LLC 23 ²⁸ ! -005-PCT opposite end, and a transition portion 26 of compound configuration therebetween. The tip element 22 on the handle portion 18 has a diameter slightly reduced from that of the remainder of the handle portion, and may serve to frictionally engage the tip of the swab stick 14 inserted therein.

[0085] As will be appreciated from FIG. 11, the assembly may be produced simply by inserting the swab 10 into the sleeve 12 sufficiently to enable the tip element 22 to frictionally engage the stick 14, whereupon the foam tip 16 will reside within the enlarged receptacle portion 20. It will also be noted that the handle portion 18 conforms closely to the stick 14, in some instances of a frictional or force fit along the length or in some embodiments with a small gap between their confronting surfaces throughout most of their coextensive lengths. More of a gap may facilitate insertion of the swab. After the partial assembly of disposition of the swab stick into the sleeve, the sleeve will be at least partially filled in the receptacle portion with an oral care or tooth whitening composition as described below, following which the sleeve will be closed, such as by a heat seal 28, to produce a sanitary, in some cases sterile, integral unit.

[0086] Access to the swab is gained simply by squeezing or twisting or bending or otherwise manipulating the sleeve at the intersection between its receptacle and transition portions. The transition portion is uniquely configured to coact with the receptacle portion, so as to enable ready fracture under the influence of such force. In addition to affording access, this characteristic will provide a tamper-resisting feature to the package, since any loss of integrity will tend to be evident as cracking, crazing, or opacity at stress points. [0087] As shown in FIG. 12, the transition portion consists, more particularly, of a narrow annular component 24, a short cylindrical component 25, and a frustoconical component 27, the latter merging into the handle portion 18. The annular component 24 in turn connects to the receptacle portion 20, with the adjacent components forming a sharp interior right angle intersection at 30. In some embodiments, the interior and exterior configurations together result in a minimum thickness of material at (or near) the intersection 30. Depending upon the nature of the material used to fabricate the sleeve, the stress created by compression (which arises because the adjacent components are incapable of assuming a compatible configuration upon flattening of the sleeve) will either cause it to snap at the intersection 30, or will at least crack or otherwise facilitate severance by a tearing action. The swab 10 may then be exposed for use upon removal from the receptacle portion. [0088] The close conformity of the handle portion 18 of the sleeve to the stick 14 of the swab affords a secure and natural-feeling grip. The frustoconical component 26 of the

Hensley Kim & Edgington, LLC 24 281 -005-PCT transition portion, which remains after removal of the receptacle portion, may provide means for limiting the location at which the assembly can be grasped, and may thus help to prevent inadvertent touching of the area being treated, and yet may also serve to contain any of the substance that might drip, or run down the swab stick. In some instances for best results, it has been found that a sleeve having dimensions such as those typified hereinabove will be fabricated from polypropylene, in a thickness of about 0.3 millimeter. This may afford a level of rigidity that may provide good handling and structural features while, at the same time, tending to produce fracture upon manual compression at the frangible joint. [0089] Manufacture of a tube hereof may follow one of those described in either of US Patents Nos. 4,952,204 or 6,406,451 or others which may provide for a sealed enclosure with a transition allowing for breaking and opening for use as described herein. [0090] The swab tube assembly hereof may typically be employed for the application of liquids to the oral cavity whether for the teeth or oral mucosa or other surfaces, and/or for cleaning, medicinal, disinfectant, whitening or whitening related purposes, inter alia. As used herein, therefore, the term "applicator" is to be broadly construed to include, for example, use in any application of a composition to or for the benefit of the oral cavity or the elements thereof.

[0091] The range of sizes for the assembly and its components can also vary widely (e.g., the swab can be from about 3 to 15 centimeters in length (other lengths also being available), and the receptacle portion of the sleeve can be much longer or much shorter than the handle portion), as long as the wall thicknesses are controlled appropriately to afford the desired functional characteristics, as discussed herein. It may be preferred to provide sizing appropriate for a unit dose (i.e., a single use dose) of a particular oral care composition, and/or size appropriate for an applicator tip (e.g., a foam tip) which can adequately deliver an oral care composition (fluid, powder or like flowable or other material) to the desired oral feature, such as the teeth, thus typically sized appropriate for delivery to a tooth or teeth. For best results in functioning (at least when the sleeve is of about 0.3 millimeter thick polypropylene) that the component intersecting with the receptacle portion (e.g., the annular component 24 in the embodiment of FIGS. 1-5) be about 0.1-0.5 centimeter wide, to create adequate stress at the fracture point(s). The foam tip may be as much as 18 mm long (or longer or shorter), and may be about 5 mm wide (or wider or thinner) and may taper over the length or for example only over the last 5mm (or other distance) of the length. [0092] Alternative swab tubes and transition alternatives where the breaking of the tube is made may be like those alternatives described in either of US Patents Nos. 4,952,204 or

Hensley Kim & Edgington, LLC 25 281-005-PCT 6,406,451 or in other patents or other publications or otherwise available means which may provide for a sealed enclosure with a transition allowing for breaking and opening for use as described herein.

[0093] Though cotton swabs may yet be used herewith and herein, often preferred may be foam tips used for the applicator. Cotton may not be very absorbent with oral care compositions (as for example in unit dose situations where a cotton tip may hold an approximate 0.25 ml of fluid vs. a foam tip which may hold a unit dose of 0.5 or 0.6 ml) and/or may degrade or break down in the presence of such materials (often of either a relatively alkaline or relatively acidic nature). A foam of the swab-like tip on the other hand hereof may preferably be of a polymer or polyester type which is resistant to degradation in the presence of the oral compositions described herein (whether alkaline or acidic) as well as any others which might be used herewith. In a variety of embodiments, the foam is of an open cell type, and in some embodiments has an inner resilient layer, and an outer softer layer. The cells in some instances may be of about 0.3 mm or of a size selected from about 0.3mm up to about 1 mm. In some embodiments, the foam has an abrasive quality for breaking plaque and debris from the teeth. Thus in some embodiments the cells of the foam may provide a scrubbing or scratchy surface which may be useful in applying a tooth composition wherein the user may not have first brushed their teeth. A foam tip may be straight, flat, rectangular, tapered, conical, cylindrical, round or rectangular or other straight cylinder shape or other shape as may be desired or may be useful herein or herewith. One or more undulations, ridges or other tooth appropriate projections may also/alternatively be provided.

[0094] Thus, it can be seen that the present invention provides a novel unit, including a swab and a substance contained within a plastic sleeve, and a sleeve and swab assembly for producing the same, which is neat and convenient to handle and use, and is relatively facile, simple and inexpensive to produce. The sleeve provides an enclosure that is secure, but nevertheless readily opened by manual force, and it also provides an integral element for shielding the user's hand from the contained substance and for curbing contact with the area being treated; in addition, its construction affords a secure and natural-feeling grip for manipulation of the assembled swab. Moreover, a foam tip may be enclosed for beneficial use with and/or for the application of oral care products as described below. [0095] For example, some such oral care products which may be used herewith include tooth whitening compositions, and/or compositions which may be used in or with a tooth whitening process. Herefor it may be noted that many oral care compositions, for example,

Hensley Kim & Edgington, LLC 26 281 -005-PCT tooth whitening compositions include at least one peroxide compound to create a tooth whitening composition. [0096]

[0097] The above specification, examples and data provide a complete description of the structure, process, and use of exemplary embodiments of the invention. Although various embodiments of this invention have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. Other embodiments are therefore contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the invention as defined in the following claims.

Hensley Kim & Edgington, LLC 27 ^{28 !} -005-PCT

Claims

Claims Accordingly, what is claimed is:

1. An oral cleaning agent comprising: an orally-acceptable cleaning solvent; an orally-acceptable surfactant; and, an orally-acceptable alkaline builder; wherein the orally-acceptable cleaning solvent; the orally-acceptable surfactant; and the orally-acceptable alkaline builder are disposed in relative amounts to yield an orally- acceptable oral cleaning agent.

2. An oral cleaning agent according to claim 1 wherein the relative pH of the oral cleaning agent is between about 7.5 and about 11.5.

3. An oral cleaning agent according to claim 1 wherein the relative pH of the oral cleaning agent is between about 8 and about 10.

4. An oral cleaning agent according to claim 1 wherein the relative pH of the oral cleaning agent is about 8.8.

5. An oral cleaning agent according to claim 1 wherein the cleaning solvent is one or both of hydrophilic and water soluble.

6. An oral cleaning agent according to claim 1 wherein the cleaning solvent is one or both of water and ethanol.

7. An oral cleaning agent according to claim 1 wherein the cleaning solvent is up to 92% ethanol.

8. An oral cleaning agent according to claim 1 wherein the cleaning solvent is up to 92% ethanol with Q. S. water.

9. An oral cleaning agent according to claim 1 wherein the cleaning solvent is one or more of orange oil, polyethylene glycol (PEG), PEG 600, PEG 400, propylene glycol, glycerol, ethanol; water; benzyl alcohol; ether; methyl salicylate; phenol; acrylic acid; orange oil; citragold™; acetic acid; vinegar; acetone; formic acid; methanol; propanol; ethanolamine; lactic acid ethyl ester; propionic acid; diethanolamine; triethanolamine; diethylene glycol; diethylamine (DEA); triethylamine (TEA); tetraethylene glycol; formaldehyde; 1-octanol.

10. An oral cleaning agent according to claim 1 wherein the surfactant includes one or both of charged and neutral surfactants.

11. An oral cleaning agent according to claim 1 wherein the surfactant is sodium lauryl sulfate (SLS).

Hensley Kim & Edgington, LLC 28 281-005-PCT

12. An oral cleaning agent according to claim 1 wherein the surfactant is a polaxamer of one or more of the following polaxamer 188, polaxamer 124, polaxamer 338, and polaxamer 407.

13. An oral cleaning agent according to claim 1 wherein the surfactant is one or both of a block polymer or hydrophilic surfactant.

14. An oral cleaning agent according to claim 1 wherein the surfactant is one or more of pluronic F68 or polaxamer 188, 124, 338, 407; ethylene oxide polymer; a non-block polymer surfactant; polyethyloxylated castor oil; cremophor 40; Nikkol™ hco-60 (hydrogenated castor oil); a phosphate; sulfate; sodium dodecyl-sulfate; polysorbate; sorbitan ester; sorbitan fatty acid; polysorbitan fatty acid ester; polysorbate 80; a mono-glyceride; glycerol mono- oliate; glycerol mono-palmitate; glycerol mono-stearate; caprilic acid; octaoic acid; a phospholipid; soybean lecithin; a biosalt or sodium taurocholate.

15. An oral cleaning agent according to claim 1 wherein the surfactant is one or more of sodium lauryl sulfate; sodium laureth sulfate; dioctyl succinate; and dioctyl sodium sulfosuccinate.

16. An oral cleaning agent according to claim 1 wherein the alkaline builder is one or more of potassium hydroxide; sodium hydroxide and sodium citrate.

17. An oral cleaning agent according to claim 1 wherein the alkaline builder is one or more of baking soda (sodium bicarbonate), calcium hydroxide, calcium phosphate tribasic, sodium hydroxide and potassium hydroxide, sodium monobasic phosphate and sodium dibasic phosphate (anhydrous option), dipotassium phosphate, sodium aluminum phosphate, sodium tripoly phosphate, and sodium hexametaphosphate.

18. An oral cleaning agent according to claim 1 wherein sodium citrate is used as one or more of a alkaline builder or a surfactant or a saponifier.

19. An oral cleaning agent according to claim 1 further including a peroxygen compound.

20. An oral cleaning agent according to claim 1 further comprising a chelating agent.

21. An oral cleaning agent according to claim 20 wherein the chelating agent includes one or more of EDTA, sodium EDTA; disodium EDTA, calcium disodium EDTA, and tetrasodium EDTA.

22. A method of oral cleaning comprising: applying an oral cleaning agent according to claim 1 to an oral feature.

23. A method according to claim 22 wherein the oral feature is a tooth.

24. A method according to claim 23 further including: removing a stain from the tooth.

25. A method according to claim 24 wherein the stain is chromagenic.

26. A method according to claim 22 further including:

Hensley Kim & Edgington, LLC 29 ²⁸¹ -005-PCT applying a peroxygen tooth lightening composition in conjunction with the oral cleaning agent.

27. A method for removing a stain from a tooth comprising: applying to a tooth a composition having a cleaning solvent, a surfactant and an alkaline source.

28. A method for manufacturing a tooth cleaning composition comprising: combining a surfactant and an alkaline agent with a cleaning solvent; mixing to provide a solution.

29. A swab tube for use with an oral care composition for oral use; the swab tube unit including: a swab having an elongated stick with an applicator/brush element at one end thereof; and an elongated hollow sleeve assembled with said swab disposed therein, the hollow sleeve having a handle portion at one end, a receptacle portion at the other end, and a transition portion therebetween, said handle portion of the sleeve holding said stick, said receptacle portion being of substantially larger cross section than said handle portion and adapted to receive an oral care composition therein, and the adjacent components of said receptacle and transition portions at the intersection therebetween cooperatively constituting means for creating a break open means in said sleeve to provide access to said swab for use in one of application of an oral care composition.

30. A swab tube according to claim 29 wherein one of an oral care composition and no oral care composition is pre-sealed therewithin.

30. A swab tube according to claim 29 wherein the applicator is one of a cotton swab and a foam tip, and wherein the foam tip of a polymeric type, an open cell type, a type with a strong inner layer, a type with a softer outer layer, a type with an abrasive layer, a type with a tapering tip, a type with one of undulations, ribs or one or more other projections on the surface.

31. A swab tube according to claim 29 wherein an oral care composition is pre-sealed therewithin and the oral care composition is one of fluid, powder or dried-on.

32. A swab tube according to claim 29 wherein said sleeve is integrally formed as a single piece from a relatively rigid plastic material that is manually compressible and severable in thin sections.

33. A swab tube according to claim 29 which further includes an oral care composition disposed therein, the oral care composition being one of a dentifrice, a medicine, a cleansing agent and a whitening agent.

Hensley Kim & Edgington, LLC 30 281 -005-PCT

34. A swab tube according to claim 29 which further includes an oral care composition disposed therein, the oral care composition being a whitening agent which is one of a whitening activator, an agent which whitens teeth or a post- whitening rinse.

35. A swab tube unit for use with one of an oral enhancing and an oral rinse composition for oral use in one of in advance of application of a tooth whitening composition and for use post application of a tooth whitening composition, the oral enhancing composition comprising: a solvent; and a base compound dissolved in the solvent to form an alkaline solution; the enhancing composition comprising a solvent, and an acid compound dissolved in the solvent to form an acidic solution; and the swab tube unit including: a swab having an elongated stick with an applicator element at one end thereof; and an elongated hollow sleeve assembled with said swab disposed therein, the hollow sleeve having a handle portion at one end, a receptacle portion at the other end, and a transition portion therebetween, said handle portion of the sleeve holding said stick, said receptacle portion being of substantially larger cross section than said handle portion and disposed to receive an oral care composition, and the adjacent components of said receptacle and transition portions at the intersection therebetween cooperatively constituting means for creating a break open means in said sleeve to provide access to said, swab for use in application of the oral care composition.

36. A method of using the swab tube unit of claim 35 for oral use as a pre-treatment of a tooth whitening composition, the method comprising applying the enhancing compound to a user's dentition; and applying the tooth whitening composition.

37. The method of claim 35, wherein the step of applying further comprises rinsing the enhancing compound within an oral cavity containing the user's dentition.

38. The method of claim 35, wherein the step of applying further comprises using the applicator to one of swab, agitate and brush the enhancing compound on the user's dentition.

Hensley Kim & Edgington, LLC 31 281 -005-PCT

39. A method of using a foam-tipped oral care device on a user's oral feature, the method comprising: grasping a pre-sealed swab tube having a foam-tipped oral care device pre-disposed therein; breaking open the pre-sealed swab tube; removing the foam-tipped device from the swab tube; applying the foam-tipped device to the oral feature.

40. A multi-component oral care composition comprising two or more of: a preliminary component, an oral care component; and a finishing component.

41. A multi-component oral care composition according to claim 40 wherein the oral care component is one or both of a whitener and a cleaner.

42. A multi-component oral care composition according to claim 40 wherein the oral care component includes a two-component composition.

43. A multi-component oral care composition according to claim 42 wherein the two- component composition includes a first component including at least one acid compound; and a second component including an alkaline source.

44. A multi-component oral care composition according to claim 42 wherein the multi- component oral care composition is a four-component composition.

45. A multi-component oral care composition according to claim 42 wherein the two- component composition includes one or both of a whitener and a cleaner.

46. A multi-component oral care composition according to claim 45 wherein the whitener includes one or more of a peroxide, a peracetic acid and a salt of chlorous acid.

47. A multi-component oral care composition according to claim 45 wherein the cleaner includes one or more of a cleaning solvent, a non-ionic surfactant and an anionic surfactant.

Hensley Kim & Edgington, LLC 32 281-005-PCT

48. A multi-component oral care composition according to claim 47 wherein the cleaning solvent includes one or more of a de-ionized water and an ethanol; and the non-ionic surfactant includes a poloxamer and the anionic surfactant includes sodium laurel sulfate.

49. A multi-component oral care composition according to claim 40 wherein the preliminary component is an alkaline component.

50. A multi-component oral care composition according to claim 49 wherein the preliminary component includes potassium hydroxide.

51. A multi-component oral care composition according to claim 40 wherein the finishing component is an acidic component.

52. A multi-component oral care composition according to claim 51 wherein the finishing component includes one or both of citric acid and tartaric acid.

53. A multi-component oral care composition according to claim 51 wherein the finishing component is one or both of disposed in a carrier solvent or disposed in a wax.

54. A multi-component oral care composition according to claim 40 wherein the oral care component is adapted to be used with one or both of the preliminary component and the finishing component.

55. A multi-component oral care composition according to claim 40 wherein the preliminary component is adapted to be used with one or both of the oral care component and the finishing component.

56. A multi-component oral care composition according to claim 40 wherein the finishing component is adapted to be used with one or both of the preliminary component and the oral care component.

57. The multi-component composition of claim 40 further comprising within at least one of the preliminary component, the oral care component; and the finishing component, at least

Hensley Kim & Edgington, LLC 33 281 -005-PCT one of the following ingredients: an antibacterial agent, ethanol, menthol, eucalyptol, thiamine, methyl salicylate, cetylpyridium chloride, calcium nitrate, fluoride, zinc chloride, potassium nitrate, aloe, carnauba wax, sanguinaria extract, papain, sodium laurel sulfate, a coloring agent, sodium saccharin, sodium citrate, carbamide peroxide, calcium peroxide, glyceryl peroxide, benzoyl peroxide, peppermint oil, cinnamon oil, an acid compound, a stain removing agent, a gelling agent, and a flavoring agent.

58. A method for using a multi-component composition according to claim 40 comprising: applying a first one of the preliminary component, the oral care component; and the finishing component to a user's dentition; and applying a second one of the preliminary component, the oral care component; and the finishing component to the user's dentition either simultaneously with the first one of the preliminary component, the oral care component; and the finishing component or within a period thereafter.

1. An enhancing composition for oral use as a pre-treatment enhancer of a tooth whitening composition, the enhancing composition comprising a solvent; and a base compound dissolved in the solvent to form an alkaline solution.

2. The enhancing composition of claim 0, wherein the solvent is water.

3. The enhancing composition of claim 0, wherein the base compound is potassium hydroxide.

4. The enhancing composition of claim 0, wherein a pH measure of the enhancing composition is between about 8.5 and 9.5.

5. The enhancing composition of claim 0, wherein a pH measure of the enhancing composition is approximately 8.8.

6. The enhancing composition of claim 0 further comprising an acid compound to reduce a pH measure of the enhancing composition to a biologically compatible level.

Hensley Kim & Edgington, LLC 34 281-005-PCT 7. The enhancing compound of claim 6, wherein the acid compound comprises tartaric acid.

8. The enhancing composition of claim 0 further comprising a peroxide or salt of chlorous acid.

9. The enhancing composition of claim 8, wherein the peroxide comprises hydrogen peroxide.

10. The enhancing composition of claim 0 further comprising a surfactant.

11. The enhancing composition of claim 0 further comprising a gelling agent.

12. The enhancing composition of claim 11, wherein the gelling agent comprises poloxamer 188.

13. The enhancing composition of claim 11 , wherein the enhancing composition is viscous gel.

14. The enhancing composition of claim 0, wherein the enhancing composition is a liquid.

15. The enhancing compound of claim 0 further comprising at least one of the following ingredients: an antibacterial agent, ethanol, menthol, eucalyptol, thiamine, methyl salicylate, cetylpyridium chloride, calcium nitrate, fluoride, zinc chloride, potassium nitrate, aloe, carnauba wax, sanguinaria extract, papain, sodium laurel sulfate, a coloring agent, sodium saccharin, sodium citrate, carbamide peroxide, calcium peroxide, glyceryl peroxide, benzoyl peroxide, peppermint oil, cinnamon oil, an acid compound, a stain removing agent, a gelling agent, and a flavoring agent.

16. An oral rinse composition for use post application of a tooth whitening composition, the enhancing composition comprising a solvent, and an acid compound dissolved in the solvent to form an acidic solution.

17. The oral rinse composition of claim 16 wherein the solvent is water and the acid compound is tartaric acid.

Hensley Kim & Edgington, LLC 35 281 -005-PCT 18. A method of using the enhancing compound of claim 0 for oral use as a pre- treatment composition of a tooth whitening composition, the method comprising applying the enhancing compound to a user's dentition; and applying the tooth whitening composition either simultaneously with the enhancing compound or within a period thereafter.

19. The method of claim 0, wherein the step of applying further comprises rinsing the enhancing compound within an oral cavity containing the user's dentition.

20. The method of claim 0, wherein the step of applying further comprises swabbing the enhancing compound on the user's dentition.

21. The method of claim 0, wherein the step of applying further comprises brushing the enhancing compound on the user's dentition.

22. A method preparing an enhancing composition for oral use as a pre-treatment compound of a tooth whitening composition, the method comprising dissolving a base compound in a solvent to form an alkaline solution; and adjusting a pH level of the alkaline solution to a biologically compatible level.

23. The method of claim 22 further comprising dissolving a gelling agent in the alkaline solution to form a first mixture.

24. The method of claim 22, wherein the step of adjusting further comprises dissolving an acid compound in the alkaline solution.

25. The method of claim 22 further comprising dissolving a peroxide in the alkaline solution.

26The method of claim 22 further comprising dissolving at least one of the following ingredients in the alkaline solution: sodium saccharin, sodium citrate, a flavoring oil, ethanol, and a coloring agent.

26. An enhancer composition for oral use in connection with a discrete tooth whitening composition, the enhancer composition comprising a solvent; an alkaline builder; and

Hensley Kim & Edgington, LLC 36 281 -005-PCT a dual surfactant system comprising a detergent and foaming/wetting agent.

27. The enhancer composition of claim 1, wherein the solvent is a primary cleaning solvent selected from one of more of ethanol and water.

28. The activation composition of claim 1, wherein the alkaline builder is potassium hydroxide.

29. The activation composition of claim 1, wherein the detergent is sodium lauryl sulfate.

33. The activation composition of claim 1, wherein the foaming / wetting surfactant is Pluronic F68.

30. A composition for oral use as one of a tooth gloss and a finishing composition to enhance the appearance of the dentition, the composition comprising a wax.

31. A composition according to claim 1 wherein the wax is in a carrier of water or oil.

32. A composition according to claim 1 further including an emulsifier.

33. A composition according to claim 1 further including a vegetable gelling agent.

34. A composition according to claim 1 further including a vegetable gelling agent; wherein the vegetable gelling agent is Vegelatum.

35. A composition according to claim 1 disposed in one of a paste, gel or liquid format.

36. A composition according to claim 1 further including a surfactant.

37. A composition according to claim 1 further including clear xanthan gum.

38. A composition according to claim 1 further including an antioxidant.

Hensley Kim & Edgington, LLC 37 281-005-PCT 39. A composition according to claim 1 further including an antioxidant of a pomegranate, apple, pineapple or other fruit extract.

40. A composition according to claim 1 in liquid format and further including witch hazel.

41. A composition according to claim 1 further including one or both of a neutralizer and pH adjuster.

42. A composition according to claim 1 further including one or both of a neutralizer and pH adjuster to create an acidic composition.

43. A composition according to claim 1 further including one or both of a neutralizer and pH adjuster which is one or more of citric acid or tartaric acid.

44. A composition according to claim 1 further including a tartar control agent.

45. A composition according to claim 1 further including a tartar control agent of one or more of triclosan and sodium pyrophosphate.

46. A composition according to claim 1 further including an anti-gingivitis agent.

47. A composition according to claim 1 further including an anti-gingivitis agent of one or more of cetyl pyridinium chloride and triclosan.

48. A composition according to claim 1 further including fluoride.

49. A composition according to claim 1 further including a preservative.

50. A composition according to claim 1 further including one or more of a flavorant or colarant.

51. A composition according to claim 1 further including a flavorant of one or more of methyl salicylate, thymol, menthol, eucalyptol.

52. A composition according to claim 1 further including one or both of an alcohol cleaning solvent and a baking soda cleaning abrasive.

Hensley Kim & Edgington, LLC 38 281 -005-PCT 53. A finishing composition for use after an alkaline cleaning or whitening process, the composition comprising an acidic component.

54. A composition according to claim 24 wherein the acidic component is included within a wax or water carrier.

55. A composition according to claim 24 disposed in one of a paste, gel or liquid.

59. A method of use of a oral care composition comprising one or both of a wax and an acidic component, the method comprising: applying the oral care composition to dentition to enhance one of the appearance of and the effective whitening of the dentition.

HensleyKim & Edgington, LLC 39 281-005-PCT