Manufacture and efficacy of teeth whitening tablets containing SHMP

Abstract

The present invention relates to a confectionery capable of providing a teeth whitening effect to an end user, said confectionery comprising sodium hexametaphosphate (SHMP), one or more sweeteners, and optionally a food-grade acid, e.g., citric acid. The present invention also relates to a method for providing a teeth whitening benefit to a consumer, said method comprising the steps of inserting the said confectionery into the consumer's mouth and allowing it to dissolve in the consumer's mouth, and repeating said steps over a long period of time.

Description

Technology Field

[0001] The present invention generally relates to a confectionery product for teeth whitening containing sodium hexametaphosphate (SHMP).

[0002] Cross-reference

[0003] This application is a PCT international patent application and claims priority to U.S. provisional patent application No. 62 / 772,910 filed on November 29, 2018, and incorporates the entire said provisional application by reference herein. Background Technology

[0004] Currently, there are chewing gum-based products available that can remove tooth stains through the mechanical action of chewing or the use of abrasive ingredients. However, many consumers do not like chewing gum or are unable to chew gum, yet they want to obtain similar teeth whitening benefits by using tablet-type snacks (e.g., mint-based products).

[0005] SMHP is known as an effective stain-removing ingredient in toothpaste products. It has also been used for teeth whitening in some chewing gum-based products. U.S. Patent No. 4,808,401 discloses the efficacy of liquid and other formulations containing SHMP and other linear polyphosphates when the pH is generally in the range of about 4.5 to about 9, typically about 5.5 to 8. The pH is preferably in the range of about 6 to about 8.0. Notably, the '401 patent found that the composition can be applied orally at a pH of less than 5 without substantially decalcifying or otherwise damaging the tooth enamel.

[0006] U.S. Patent No. 5,037,637 also discloses the efficacy of an antimicrobial plaque inhibitor (e.g., triclosan) in the use of polyphosphate salts (e.g., sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate). However, a toothpaste composition, particularly one containing tetrasodium pyrophosphate but not triclosan, is [specifically] Bacteriodes zingivalis ( Bacteriodes gingivalis It was found that it does not inhibit the growth of ). Refer to Table 3 of the above '637 patent.

[0007] U.S. Patent No. 6,685,916 claims a novel combination of two or more active ingredients selected from peroxide compounds, polyphosphates, and anionic surfactants.

[0008] There is still a demand for effective tablet-type mint-based products.

[0009] A tablet-type mint-based product is needed to provide an effective teeth whitening effect.

[0010] This summary is provided to introduce a selection of concepts in a simplified form, which is further described in the detailed description below. This summary is not intended to identify the principal or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0011] The disclosed embodiments satisfy the needs of the art by providing an effective teeth-whitening confection in tablet form. The confection can provide teeth-whitening benefits to the end user over the course of use. The present invention also relates to a method for providing a teeth-whitening effect to a consumer, the method comprising the step of inserting the confection into the consumer's mouth and allowing the confection to dissolve in the consumer's mouth by a sucking motion. Repeating the dissolution step yields teeth-whitening benefits. Brief explanation of the drawing

[0012] The teeth whitening mint using sodium hexametaphosphate according to the present invention and the method of using the same are further described with reference to the attached drawings. Figure 1 is the chemical structure of the polyphosphate of the present invention, showing the structure of SHMP when M is sodium (Na). Figure 2 is a digital image of the pre-coloring of a bovine enamel specimen used to test the formulation of the present invention. FIG. 3 is a digital image of Example 1 of a bovine enamel slab subjected to six different treatment conditions using the formulation of the present invention, wherein the left and middle columns below 28 cycles or 56 cycles are moderately colored enamel slabs, and the right column below 28 cycles or 56 cycles is a heavily colored enamel slab. Figures 4a and 4b are charts of Example 1 showing the change in color difference (ΔE value) of heavily colored (4a) and moderately colored (4b) enamel slabs after 28 cycles (blue / left bar) and 56 cycles (orange / right bar). FIG. 5 is a digital image of Example 2 of a bovine enamel slab subjected to four different treatment conditions using the formulation of the present invention, wherein the left and middle columns under cycles 0, 28, and 56 are moderately colored enamel slabs, and the right column under cycles 0, 28, and 56 are heavily colored enamel slabs. Figures 6a and 6b are charts of Example 2 showing the change in color difference (ΔE value) of heavily colored (6a) and moderately colored (6b) enamel slabs after 28 cycles (blue / left bar) and 56 cycles (orange / right bar). Figure 7 is a digital image of Example 3 of a bovine enamel slab subjected to four different treatment conditions using the formulation of the present invention. FIG. 8 is a graph of Example 3 showing the change in color difference (ΔE value) of an intermediately colored enamel slab after 28 cycles (blue / bottom curve) and 56 cycles (orange / top curve). FIG. 9 is a digital image of Example 4 of a bovine enamel slab subjected to six different treatment conditions using the formulation of the present invention. Figure 10 is a chart of Example 4 showing the change in color difference (ΔE value) of the intermediately colored enamel slab after 28 cycles (blue / left bar) and 56 cycles (orange / right bar). Specific details for implementing the invention

[0013] Detailed description of preferred embodiments

[0014] The following detailed description is intended only to provide preferred exemplary embodiments and is not intended to limit the scope, applicability, or configuration of the invention disclosed herein. Rather, the following detailed description of preferred exemplary embodiments will provide those skilled in the art with possible descriptions for implementing preferred exemplary embodiments according to the invention disclosed herein. It is understood that various modifications may be made to the function and arrangement of elements without departing from the true spirit and scope of the invention, as described in the appended claims.

[0015] To aid in describing the present invention, directional terms, such as upper, lower, left, right, etc., may be used in the specification and claims to describe parts of the present invention. These directional definitions are intended merely to aid in describing and claiming the present invention and are not intended to limit the present invention in any way. Additionally, reference numbers introduced in the specification in relation to the drawings may be repeated in one or more subsequent drawings without further explanation in the specification to provide context for other features.

[0016] In this document, the terms “confectionery,” “mint,” and “confectionery products in tablet form” are used interchangeably to refer to food in the form of tablets or lozenges, such as breath mint.

[0017] Each % provided in the specification and claims should be understood to represent a % based on weight, unless otherwise specifically stated.

[0018] Over the past decade, the teeth whitening product market has grown exponentially, and the market contains numerous non-food products, such as toothpastes, gels, and strips, that claim to offer whitening benefits. Additionally, chewing gum products exist in the food category that also claim to provide these benefits. Chewing gum-based products remove stains primarily through the mechanical action of chewing and / or by using abrasive ingredients, or by using peroxide-based oxidizing agents to remove stain molecules. The use of abrasives or oxidizing agents can cause enamel erosion. The literature identifies numerous stain-removing ingredients that are not abrasive or oxidizing in nature, capable of whitening teeth when added to gum or tablet products. Depending on efficacy, one of these teeth whitening ingredients is a polyphosphate compound.

[0019] The literature contains numerous clinical studies using SHMP, a polyphosphate commonly used in Crest toothpaste formulations to remove extrinsic staining. SHMP is a linear polyphosphate widely used in many toothpaste formulations to remove extrinsic staining. It is also used in some chewing gum formulations for teeth whitening. The general formula of SHMP is Na (n+2) P n O (3n+1) The structure of SHMP is shown in Fig. 1, where M is sodium (Na).

[0020] SHMP is also referred to as Graham's salt, which is obtained by quenching a liquid melt of sodium trimetaphosphate to form a glassy polymeric product. This salt is used for water softening purposes where calcium ions bind to polyphosphate anions via sodium ion exchange. Thus, it has a strong affinity for calcium ions. SHMP is hypothesized to remove discoloration and provide a whitening effect due to the following mechanism of action: it is strongly attracted to calcium ions present in the hydroxyapatite of enamel; it has the ability to destroy pellicles on the enamel and remove extrinsic discoloration; it binds to the tooth surface to prevent new extrinsic discoloration.

[0021] A SHMP-containing formulation in tablet form having whitening efficacy, as demonstrated using a pre-colored bovine enamel slab, is disclosed herein. A commercially available bovine enamel slab was purchased from Theremetrics Inc. An enamel specimen was immersed in a colored broth containing coffee, tea, and gastric mucin, and the specimen was air-dried to prepare a slab. Gastric mucin (a glycoprotein) was added to the colored broth to form a pellicle on the surface of the enamel. This mimics the tooth pellicle formed by the glycoprotein present in saliva. The broth immersion and air-drying procedure was repeated several times for up to 4 days to obtain a heavily colored film containing a pellicle as illustrated in FIG. 2.

[0022] Snack ingredients

[0023] Sodium hexametaphosphate (SHMP)

[0024] Polyphosphate is of the general formula M (n+2) P n O (3n+1)It has. Its anion consists of a chain in which each phosphorus atom is connected to its neighbors through two oxygen atoms, forming a linear, unbranched structure that can be schematically represented as shown in Fig. 1. Furthermore, it is well understood that polyphosphate and metaphosphate are equivalent terms. Tripolyphosphate and tetrapolyphosphate are linear polyphosphates, in contrast to cyclopolyphosphates, which have mono-compounds and dimeric compounds still called orthophosphate and pyrophosphate, respectively. See the literature [The Second Edition of the Biochemistry of Inorganic Polyphosphates].

[0025] The general formula for SHMP is Na (n+2) P n O (3n+1) is. Preferably, SHMP has an n value in the range of 13 to 21. More preferably, SHMP has an n value of 21.

[0026] SHMP preferably accounts for 10 weight percent or less of the confectionery product. More preferably, SHMP accounts for 6 to 10 weight percent of the confectionery product. Most preferably, SHMP accounts for 7 to 9 weight percent of the confectionery product.

[0027] sweetener

[0028] The sweetener is preferably a sugar alcohol, such as xylitol, maltitol, mannitol, sorbitol, erythritol, arabitol, glycerol, lactitol, etc. Preferably, the sweetener is sorbitol. Combinations of sugar alcohols may also be used. A secondary sweetener may also be used. A preferred secondary sweetener is aspartame.

[0029] The primary sweetener preferably accounts for 60 to 100 weight percent of the confectionery, more preferably 85 to 95 weight percent of the confectionery, and most preferably 80 to 90 weight percent of the confectionery.

[0030] Arbitrary component

[0031] The above confectionery may optionally contain a food-grade organic acid. A preferred food-grade organic acid is citric acid. If present, the food-grade organic acid accounts for 0.1 to 2.0 weight percent of the confectionery. More preferably, the food-grade organic acid accounts for 0.2 to 1.5 weight percent of the confectionery. Most preferably, the food-grade organic acid accounts for 0.7 to 1.01 weight percent of the confectionery.

[0032] The above confectionery may also contain one or more flavoring agents. Suitable flavoring agents include, but are not limited to, essential oils, spices, and salts commonly used in confectionery products. Particularly preferred flavoring agents are derived from mint oils (e.g., peppermint, spearmint, etc.) because the resulting flavor complex provides a particularly refreshing taste when combined with sugar alcohols.

[0033] The flavoring agent may be in a solid form, e.g., powder, crystalline, amorphous crystal, semicrystalline, etc. It may be in a liquid form, encapsulated, or spray-dried. Additional flavorings include those derived from essential oils, as well as those having flavors characterized by natural or artificial flavors. Examples thereof include essential oils, e.g., cinnamon, spearmint, peppermint, birch; natural or artificial fruit flavors, e.g., apple, pear, peach, strawberry, cherry, apricot, orange, lemon, watermelon, banana; and bean-derived flavors, e.g., coffee, cocoa powder. The flavoring agent may be a spice commonly used in food. Examples thereof include chili powder, curry powder, etc. The flavoring agent may be a salt commonly used in the food industry, e.g., sodium chloride, potassium iodide, potassium chloride, sodium iodide. In some embodiments, the product of the present invention contains one or more flavoring agents.

[0034] If present, the flavoring agent is present in an effective amount of flavor known in the art. The flavoring agent preferably accounts for 0.005% to 10% by weight of the confectionery, more preferably 0.01% to 5% by weight of the confectionery, and most preferably 0.01% to 2% by weight of the confectionery.

[0035] The above confectionery may optionally include one or more food additives commonly found in confectionery, such as preservatives, food-grade processing agents, and other food additives typically used in confectionery products. Examples thereof include, but are not limited to, food-grade processing agents, such as magnesium stearate, and solubilizers, such as medium-chain triglycerides.

[0036] If present, the food additive accounts for 4% or less by weight of the pastry, more preferably 2% or less by weight of the pastry, and most preferably 1% or less by weight of the pastry.

[0037] Examples

[0038] The following examples were performed on cattle slabs using SHMP tablets of various formulations. In the following examples, the SHMP level was fixed at a maximum acceptable level of 10.0 wt% based on the favorability score in a small-scale sensory study.

[0039] Example 1

[0040] In this embodiment, the efficacy of removing color from a sodium hexametaphosphate (SHMP) component in tablet form is demonstrated using a pre-colored bovine enamel slab. The effects of pH and an artificial saliva buffer medium on color removal are also demonstrated.

[0041] Example 1 discloses a formulation and a method for enamel whitening. The stain-removing efficacy of SHMPs having two different molecular weights was tested. The general formula of SHMP is Na (n+2) P n O (3n+1) In this embodiment, two grades of SMHP were used: a Hexaphos SHMP granule grade with n of 13 (SHMP-Hexa); and a Glass H (registered trademark) SHMP long-chain granule grade with n of 21 (SHMP-LC). The whitening efficacy of the SHMP component alone was determined using the Hexaphos grade. The effect of the salivary medium (artificial saliva versus deionized water) on the removal of discoloration was determined.

[0042] Preparation of SHMP and control tablets

[0043] Both of the above SHMP crystalline grade granular products were ground to a small particle size using a Retsch ZM200 ball mill with a 20 micro mesh. Using a Manesty tablet press, the following batches were prepared with tablet weights of 1.8 g (see Table 1 below).

[0044]

[0045] methodology

[0046] Six treatments were performed using three small enamel slabs (two moderately colored and one heavily colored) per treatment. The treatment conditions are listed in Table 2 below. The following treatment regimens were followed. Pre-colored enamel slabs were suspended in an aqueous medium using a thin rod in a plastic container. HEPES (47.66 g, buffer), potassium chloride (8.95 g), potassium dihydrogen phosphate (0.39 g), and calcium chloride dihydrate (0.71 g) were added, and the salts were dissolved in 4000 g of deionized water (DI) to prepare an artificial saliva preparation, i.e., 4 L of artificial saliva (AS) mother liquor. The pH of the solution was adjusted from 5.2 to 7.0 by carefully adding a 1N NaOH solution.

[0047] Three mints and a magnetic stirring rod were placed in a plastic container containing the above slab, and filled with 45 mL of solution (artificial saliva or deionized water). A mother liquor of 4.8 g SHMP was prepared in 500 mL of aqueous solution (artificial saliva or deionized water). For component-only treatment, 45 mL of the above solution was added per treatment cycle. The contents were stirred for 15 minutes in an oven maintained at 37°C. It took about 10 minutes to dissolve the tablet.

[0048] After treatment, the solution was emptied, the slab was rinsed with deionized water, and wiped with a paper towel. The treatment was repeated at a rate of 4 treatment cycles per day. Whitening index (L * a * b * ) was measured using an Xrite spectrophotometer at the end of 28 and 56 cycles or at the end of the treatment. At the same time, digital images of the enamel samples were also taken.

[0049]

[0050] The term ΔE, known as a whitening index value, represents the change in color difference from the baseline measurement. L * a * b * The value was measured using an X-Rite spectrophotometer calibrated prior to each use. The measurements were performed from the baseline, at the end of 28 cycles, and at the end of 56 cycles. L * a * b * Using the values, ΔE was calculated according to the formula presented below:

[0051]

[0052] In the above formula,

[0053] L * 0, a * 0, and b * 0 is the baseline value, and

[0054] L * n , a * n , and b * n is the nth cycle value.

[0055] result

[0056] Digital photographs of enamel slabs at the end of 28 and 56 cycles for six treatment conditions are shown in FIG. 3. For each treatment condition, two moderately colored enamel blocks and one heavily colored enamel block were used. FIG. 4a and FIG. 4b show the ΔE values ​​(change in color difference) of the heavily colored enamel slab (4a) and the moderately colored enamel slab (4b) after 28 cycles (blue) and 56 cycles (orange). A larger ΔE value indicates a greater color change from the colored state to the white state.

[0057] Referring to Figures 3 and 4a and 4b, the results show that treatments with SHMP-containing tablets and components only (unpurified) clearly demonstrate stain removal efficacy compared to the baseline on moderately stained tooth slabs after 28 cycles of treatment. Treatment with components only (codes B and A) performed better than the tablet forms (codes H, L, and D) particularly in removing severe stains. This suggests that the excipients in the tablets appear to interfere with the action of SHMP in stain removal. The ΔE value for treatment using tablets containing the stain-removing component SHMP-LC (code L) was higher than that for SHMP-Hexa (code H). Therefore, SHMP-LC appears to be more effective for stain removal compared to SHMP-Hexa. Artificial salivary media had a negative effect compared to deionized water during stain removal, particularly in the tablet forms (code H vs. code D).

[0058] Example 2

[0059] Example 2 demonstrates the decolorizing efficacy of SHMP mint at different pH levels (pH 5.8, 7.0, 8.0) using a phosphate buffer medium. This example also investigates the effect of buffer salts by comparing the decolorizing efficacy of phosphate buffer and 4-(2-hydroxyethyl)-1-piperazine ethanesulfonic acid (HEPES) buffer in artificial saliva at the presented pH.

[0060] methodology

[0061] Three phosphate buffer solutions (pH 5.8, 7.0, 8.0) were prepared using 0.2 M NaH2PO4 and 0.2 M Na2HPO4. The pH of the buffer solutions was adjusted using 0.1 M NaOH solution. Four treatments were performed using three bovine enamel slabs (two with moderate discoloration and one with severe discoloration) per treatment. The treatment conditions are listed in Table 3 below. The treatment protocol according to Example 2 was similar to that of Example 1. L* a * b * Measurements were taken using an X-ray spectrophotometer, and digital images were taken at the baseline and at the end of 28 and 56 cycles.

[0062]

[0063] result

[0064] Fig. 5 shows digital images of small enamel slabs for four treatment conditions of Example 2. Fig. 6 shows the ΔE values ​​(color change) of a heavily stained enamel slab (6a) and a moderately stained enamel slab (6b) after 28 cycles (blue) and 56 cycles (orange) in Example 2. Referring to Fig. 5 and Figs. 6a and 6b, based on the ΔE values, the pH of the medium showed a significant stain removal effect. Low pH treatment performed better than high pH in stain removal on heavily and moderately stained enamel slabs. In particular, for pH 5.8 treatment, the staining of the heavily stained enamel slab was almost completely removed after 56 cycles (see Fig. 5). The type of buffer solution affected stain removal. Phosphate buffer performed better than (HEPES) buffer in artificial saliva, as shown in the ΔE value of the medium-colored enamel.

[0065] In Examples 1 and 2, the sodium hexametaphosphate (SHMP) component in tablet form showed significant ability to remove exogenous coloration compared to a baseline treatment without the component. In addition, the pH of the medium had a significant effect on color removal, as in Example 2.

[0066] Example 3

[0067] In Example 3, the stain removal efficacy according to the concentration (0%, 2%, 5%, and 8%) of the SHMP component in tablet form was evaluated using pre-stained bovine enamel slabs.

[0068] methodology

[0069] In this embodiment, artificial saliva was used as the medium. The preparation of the medium is described in Example 1. Four treatments (0%, 3%, 5%, and 8% SHMP) were performed on three medium-colored bovine enamel slabs. The protocol according to this embodiment was similar to that of Example 1. L * a * b * Measurements were taken with an X-ray spectrophotometer, and digital images were taken at baseline and after 28 and 56 cycles.

[0070] Tablet manufacturing

[0071] Similar to Example 1, four treatment variations of 500 g each were prepared according to the formulations in Table 4 below using a Manesti press with a tablet weight of 1.8 g.

[0072]

[0073] result

[0074] Figure 7 shows digital images of bovine enamel slabs for four treatment conditions of Example 3 at 0, 28, and 56 treatment cycles. Figure 8 shows the ΔE values ​​of medium-colored enamel slabs after 28 cycles (blue) and 56 cycles (orange). Referring to Figure 7, there is a linear relationship between the SHMP concentration and the ΔE value of the discoloration removal efficacy. Based on ΔE, the SHMP concentration of the tablets showed a significant discoloration removal effect after 28 and 58 treatment cycles. For example, when the SHMP level drops from 8% to 5%, the whitening efficacy decreases by 32%.

[0075] Example 4

[0076] Example 4 demonstrates the color-removing efficacy of SHMP mint in a smaller format (0.8 g tablet vs. 1.8 g tablet). This demonstrates the effect of citric acid concentration in 0.8 g tablets and the whitening efficacy of SHMP at low concentrations when acid is added.

[0077] methodology

[0078] Artificial saliva was used as the medium for Example 4. The preparation of the medium is described in Example 1. Six treatments were performed, and for each treatment, three medium-colored bovine enamel slabs were used. The protocol according to Example 4 was similar to that of Example 1. L * a * b * Measurements were taken with an X-ray spectrophotometer, and digital images were taken at baseline, after 28 treatment cycles, and after 56 treatment cycles.

[0079] Tablet manufacturing

[0080] Similar to Example 1, six treatment variations labeled A to F were prepared using a Manesti press with tablet weights of 1.8 g and 0.8 g according to the formulations in Table 5 below.

[0081]

[0082] result

[0083] Fig. 9 shows digital images of bovine enamel slabs for the four treatment conditions of Example 4 after 13, 28, and 56 treatment cycles. Fig. 10 shows the ΔE values ​​of medium-colored enamel slabs after 28 cycles (blue) and 56 cycles (orange) as shown in Fig. 9. Treatments A and B show the same level of decolorization efficacy of SHMP per treatment (0.144 g / dose), but Treatment B used a smaller format (0.8 g tablet). Treatments C, D, and E show the whitening efficacy of SHMP at low concentrations under acid addition. Treatment F shows the effect of the acid control sample without SHMP.

[0084] Based on the ΔE value, Treatment B (0.8 g, 2 mints per dose) showed superior performance compared to Treatment A (1.8 g, 1 mint per dose), although the amount of SHMP per cycle was the same for both treatments. The difference in whitening efficiency between these treatments can be attributed to the small amount of citric acid added to the Treatment B formulation. Although Treatments C, D, and E had low levels of SHMP per cycle, they removed discoloration better than Treatment B due to the high amount of citric acid present in these formulations. Additionally, Treatment E had the lowest amount of SHMP / cycle, and its whitening efficacy was equivalent to or superior to that of Treatments C and D (which had more SHMP per cycle). Treatment F (control) (acid treatment without SHMP) had the smallest change in ΔE value or the least discoloration removal ability in this study. Treatment F performed better than the case without the SHMP and acid control used in Example 3.

[0085] Example 4 demonstrates that the addition of citric acid or any food-grade organic acid can significantly improve the whitening efficacy of mint-containing SHMP. It is known that linear sodium polyphosphate (SHMP) is unstable in acidic environments and undergoes hydrolysis to form orthophosphate. The addition of acid can promote the formation of orthophosphate, and the whitening effect of orthophosphate combined with sodium polyphosphate may be superior to that of sodium polyphosphate alone.

[0086] Example 5

[0087] Example 5 is an in vivo whitening study using SHMP combined with citric acid in a purified mint product. Four test variations were evaluated according to Table 6 below.

[0088]

[0089]

[0090] A controlled, double-blind, parallel study compared subjects who received either whitening mint or a placebo mint. To induce staining, a baseline test was performed after a pre-test period of approximately 3 weeks. Subjects with sufficient extrinsic staining were eligible for this study. Extrinsic staining at baseline and Easyshade Advance 4.0 assessments were used for longitudinal comparisons during the study period and for assigning subjects to the treatment group. During the 8-week treatment period, subjects used the designated mint product, brushed their teeth at home with the designated toothbrush and toothpaste, and recorded the treatment in a diary.

[0091] The entire investigation was divided into three parts: extrinsic staining and shade screening supplemented by a medical questionnaire to identify eligible subjects; a three-week period to promote staining formation; an eight-week study period conducted according to the instructions for use of the test product, and clinical evaluations at the start (baseline test), four weeks (intermediate test), and eight weeks (final test) (e.g., soft / hard tissue health, extrinsic staining, VITA Easyshade Advance 4.0, and digital images). During this time, subjects used the mint test product four times a day and brushed their teeth with commercial toothpaste once daily. The mint was supplied in white plastic bottles containing 58 or 115 mints.

[0092] The following mint test products were used during the 8-week trial period:

[0093] A) Experiment Mint (# 5529)

[0094] A sugar-free strawberry-flavored formulation containing standard food-approved ingredients. Subjects were instructed to use one mint (0.8 g) per opportunity of use.

[0095] B) Experiment Mint (# 7989)

[0096] A sugar-free peppermint flavored formulation containing standard food-approved ingredients. Subjects were instructed to use 2 mints (0.8 g) per use opportunity.

[0097] C) Automotive control group Breath Mint (#1934)

[0098] A sugar-free peppermint flavored formulation containing standard food-approved ingredients. Subjects were instructed to use one mint (1.8 g) per opportunity of use.

[0099] D) Experiment Mint (# 8627)

[0100] A sugar-free peppermint flavored formulation containing standard food-approved ingredients. Subjects were instructed to use one mint (1.8 g) per opportunity of use.

[0101] At the start of the study period, all subjects who successfully completed the pre-test were evaluated by trained and skilled examiners for oral soft / hard tissue health and extrinsic staining (modified Lobene staining index), and their tooth color was evaluated for two lower anterior teeth using EasyShade Advance 4.0. In addition, standardized anterior photographs were taken for 10% of subjects from each treatment group. Approximately 200 subjects were identified and selected based on baseline inclusion criteria.

[0102] result

[0103] Table 8 below shows the improvement in the composite-modified Loven staining index (MLSI) at the 4-week and 8-week evaluations. Baseline MLSI results were equivalent between groups (F = 0.90; p = 0.441).

[0104] Referring to Table 8, the results for Mints A, B, and D showed statistically significant improvement in the combined MLSI at the 4-week (p < 0.001) and 8-week (p < 0.001) evaluations. In both the 4-week and 8-week evaluations, when comparing Mints A, B, and D respectively to Mint C, Mints A, B, and D each demonstrated statistical superiority in color removal improvement compared to the improvement observed in the control Mint C (p < 0.001; all cases of A vs. C, B vs. C, and D vs. C).

[0105]

[0106] Although exemplary embodiments of the device described herein have been described in detail above, those skilled in the art will readily understand that numerous additional variations are possible to the exemplary embodiments without substantially departing from the novel teachings and advantages of the device described herein. Accordingly, the embodiments and all variations thereof are intended to be included within the scope of the device described herein.

Claims

Claim 1 Stain removal component of the following chemical formula I: [Chemical Formula I]Na (n+2) P n O (3n+1) A confectionery product comprising a compressed tablet composed of (wherein n is 13 or 21), one or more sweeteners, and food-grade citric acid, wherein the color removal component is present in a range of 4% to 10% by weight of the confectionery product and the food-grade citric acid is present in a range of 0.1% to 4.0% by weight of the confectionery product. Claim 2 delete Claim 3 delete Claim 4 delete Claim 5 A confectionery product according to claim 1, wherein the color removal component is sodium polyphosphate. Claim 6 delete Claim 7 A confectionery product according to claim 1, wherein the food-grade citric acid is present within the range of 0.1% to 2.0% by weight of the confectionery product. Claim 8 delete Claim 9 delete Claim 10 A confectionery product according to claim 1, wherein the confectionery product further comprises sorbitol, and the sorbitol is the remainder based on the weight of the confectionery product. Claim 11 A confectionery product according to claim 1, wherein the confectionery product further comprises magnesium stearate, and the magnesium stearate is present within the range of 0.1% by weight to 2.0% by weight of the confectionery product. Claim 12 A confectionery product according to claim 1, wherein the confectionery product further comprises flavor and color components, and said flavor and color components are present within a range of 0.1% to 10.0% by weight of the confectionery product. Claim 13 A confectionery product according to claim 1, wherein the confectionery product further comprises a breath freshening ingredient, and the breath freshening ingredient is present within the range of 0.1% to 10.0% by weight of the confectionery product. Claim 14 A confectionery product according to claim 1, wherein the confectionery product further comprises sorbitol, magnesium stearate, flavor and color components, and oral refreshing components, wherein the magnesium stearate is present within a range of 0.1% to 2.0% by weight of the confectionery product, the flavor and color components are present within a range of 0.1% to 10.0% by weight of the confectionery product, the oral refreshing components are present within a range of 0.1% to 10.0% by weight of the confectionery product, and the sorbitol is the remainder based on the weight of the confectionery product. Claim 15 (a) A method for whitening the tooth enamel of a mammal having colored tooth enamel, comprising the step of dissolving the confectionery product of claim 1 in the form of a compressed tablet in the mouth of a mammal. Claim 16 A whitening method according to claim 15, further comprising the step of repeating step (a) at least twice within a period of 24 hours. Claim 17 A whitening method according to claim 16, further comprising the step of repeating step (b) at least twice within a period of 24 hours. Claim 18 delete

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