MINERAL-ENZYME COMPLEX FOR STRENGTHENING AND WHITENING TOOTH ENAMEL, ORAL HYGIENE COMPOSITION, AND TOOTHPASTE

Abstract

The invention relates to the field of cosmetology, namely to mineral-enzyme complexes for tooth enamel strengthening and whitening, and also to compositions for oral hygiene comprising said complex, in particular, to toothpastes and other compositions. The described mineral-enzyme complex for tooth enamel strengthening and whitening is characterized by the fact that it contains calcium hydroxyapatite and tannase with the following component proportions: from 0.2 to 10 parts of tannase per 100 mass parts of calcium hydroxyapatite. The said complex may also additionally contain grapeseed extract. Besides, a variety of compositions for oral hygiene are disclosed that comprise the claimed mineral-enzyme complex. The invention makes it possible to improve consumer properties of the complex and compositions for oral cavity hygiene using the claimed mineral-enzyme complex: cleaning ability, whitening properties, reduction of gum inflammation and gum bleeding, improvement of desensitizing action while retaining remineralizing effect in respect of dental tissues.

Claims

1. Mineral-enzymatic complex for cleaning, whitening and firming of tooth enamel and reduction of inflammation and bleeding of gums, the said complex characterized in that it contains tannase and amorphous calcium hydroxyapatite with 20-80 nm particle size, the said complex containing the following components; 0.2-10 weight parts of tannase per 100 weight parts of amorphous calcium hydroxyapatite.

Description

EXAMPLES

[0055] The examples provided describe and demonstrate options falling within the scope of this invention. These examples are given for illustration purposes only, and should not be construed as limiting this invention.

Example I

A General Method of Preparing a Composition for Dental Care and Oral Hygiene Based on the Mineral-Enzymatic Complex

1. Preparation Actions:

[0056] 2) Prepare a dispersion of a thickening agent in a solvent [0057] 3) If necessary, prepare a premix containing a flavor and menthol, essential oils, oil-soluble active components. [0058] 4) If necessary, prepare a water-based surfactant solution. [0059] 5) If necessary, prepare a premix of active components.

1. Cooking Process:

[0060] 2.1 Load successively into the reactor: [0061] water, [0062] moisturizers, [0063] thickener dispersion in a solvent prepared according to par. 1.1.

[0064] 2.2 Mix, stir and homogenize in vacuum until homogeneous state for 15-20 minutes.

[0065] 2.3 Load successively into the reactor: [0066] active additives, including a premix of active components made according to par. 1.4, [0067] dyes.

[0068] 2.4 Mix, stir and homogenize in vacuum until homogeneous state for 15-20 minutes.

[0069] 2.5 Take a sample to determine viscosity (a sample should be homogeneous, without lumps and crumbs).

[0070] 2.6 Load an abrasive component in small portions into the reactor and, alter wetting the abrasive component, homogenize the mass until homogeneous under vacuum.

[0071] 2.7 Load successively into the reactor: [0072] Active components sensitive to temperatures above 38 C., [0073] a premix made according to par. 1.2.

[0074] 2.8 Mix, stir aid homogenize in vacuum until homogeneous state for 5-10 minutes.

[0075] 2.9 Load into the reactor a water-based surfactant solution made according to par. 1.3.

[0076] 2.10 Mix, stir and homogenize in vacuum until homogeneous state for 15-25 minutes.

[0077] 3. Take a sample to determine physico-chemical and organoleptic indicators for conducting a microbiological analysis.

Example II

A Method of Preparing Compositions for Dental Care and Oral Hygiene Based on a Mineral-Enzymatic Complex

II.1 Process #1

1. Preparation Actions:

[0078] 2) Disperse sodium carboxymethyl cellulose and Stevia in PEG-400. [0079] 3) Dissolve Trilon BD in water, [0080] 4) Dissolve citric acid in water. [0081] 5) Mix polidon A with, water. [0082] 6) Dissolve Thymol and Biosol in a flavoring agent and, if necessary, heat to 40 C. [0083] 7) Dissolve tannase in water. [0084] 8) Prepare a suspension of 15% amorphous hydroxyapatite with 20-80 nm particle size (15% HAP),

1. Cooking Process:

[0085] 2.1 Load successively into the reactor: [0086] sorbitol [0087] glycerine, [0088] suspension according to par. 1.7.

[0089] 2.2 Mix, stir and homogenize.

[0090] 2.3 Load successively into the reactor: [0091] dispersion according to par. 1.1, [0092] water.

[0093] 2.4 Mix, stir and homogenize.

[0094] 2.5 Load successively into the reactor; [0095] solution according to par. 1.2, [0096] sodium monofluorophosphate, [0097] xylitol, [0098] methylparaben sodium salt, [0099] solution according to par. 1.3.

[0100] 2.6 Mix, stir and homogenize.

[0101] 2.7 Load successively into the reactor: [0102] solution according to par. 1.4, [0103] olaflur.

[0104] 2.8 Mix, stir and homogenize,

[0105] 2.9 Take a sample to determine viscosity (a sample should be homogeneous, without lumps and crumbs.

[0106] 2.10 Load successively into the reactor: [0107] silicone dioxide (Sorbosil TC15), [0108] titanium dioxide, [0109] Sorbosil AC43.

[0110] 2.11 Mix, stir and homogenize.

[0111] 2.12 Load successively in to the reactor: [0112] Sorbosil AC39.

[0113] 2.13 Mix, stir and homogenize.

[0114] 2.14 Load successively into the reactor: [0115] anethole, [0116] eucalyptol, [0117] solution according to par. 1.5, [0118] Vitamin E, [0119] CO2 extract of grape-seed, [0120] solution according to par. 1.6.

[0121] 2.15 Mix, stir and homogenize.

[0122] 2.16 Take a sample to determine viscosity (a sample should be homogeneous, without lumps and crumbs).

[0123] 2.17 Load successively into the reactor: [0124] 33% solution of cocamidopropyl betaine [0125] 30% solution of sodium lauroyl sarcosinate.

[0126] 2.18 Mix, stir and homogenize.

[0127] 3. Take a sample to determine pH and viscosity values.

[0128] Color: white.

[0129] pH 25%: 6.0-7.0.

II.2 Process #2

1. Preparation Actions:

[0130] 2) Disperse sodium carboxymethyl cellulose and Stevia in PEG-400. [0131] 3) Dissolve Triton BD in water. [0132] 4) Dissolve citric acid in water. [0133] 5) Dissolve dry extracts of bergenia and scullcap (Scutellaria) in water at to 40-45 C. [0134] 6) Dissolve Thymol and Biosol in a flavoring agent and, if necessary, heat to 40 C. [0135] 7) Dissolve tannase and extract of Azadirachta indica in water. [0136] 8) Prepare a suspension of 15% amorphous hydroxyapatite with 20-80 nm particle size (15% HAP).

1. Cooking Process:

[0137] 2.1 Load successively into the reactor: [0138] sorbitol, [0139] glycerine, [0140] suspension according to par. 1.7.

[0141] 2.2 Mix, stir and homogenize.

[0142] 2.3 Load successively into the reactor: [0143] dispersion according to par. 1.1, [0144] water.

[0145] 2.4 Mix, stir and homogenize.

[0146] 2.5 Load successively into the reactor: [0147] solution according to par. 1.2, [0148] xylitol, [0149] methylparaben sodium salt, [0150] solution according to par. 1.3.

[0151] 2.6 Mix, stir and homogenize.

[0152] 2.7 Load successively into the reactor: [0153] solution according to par. 1.4,

[0154] 2.8 Mix, stir and homogenize.

[0155] 2.9 Take a sample to determine viscosity (a sample should be homogeneous, without lumps and crumbs).

[0156] 2.10 Load successively into the reactor: [0157] silicone dioxide (Sorbosil TC15), [0158] titanium dioxide, [0159] Sorbosil AC43,

[0160] 2.11 Mix, stir and homogenize.

[0161] 2.12 Load successively into the reactor: [0162] Sorbosil AC39.

[0163] 2.13 Mix, stir and homogenize.

[0164] 2.14 Load successively into the reactor: [0165] anethole, [0166] eucalyptol, [0167] solution according to par. 1.5, [0168] Vitamin E, [0169] CO2 extract of grape-seed, [0170] solution according to par. 1.6.

[0171] 2.15 Mix, stir and homogenize.

[0172] 2.16 Take a sample to determine viscosity (the sample should be homogeneous, without lumps and crumbs).

[0173] 2.17 Load successively into the reactor: [0174] 33% solution, of cocamidopropyl betaine, [0175] 30% solution of sodium lauroyl sarcosinate.

[0176] 2.18 Mix, stir and homogenize.

[0177] 3. Take a sample to determine pH and viscosity values.

[0178] Color: light-beige.

[0179] pH 25%: 6.0-7.0.

II.3 Process #3

1. Preparation Actions:

[0180] 2) Disperse sodium carboxymethyl cellulose and Stevia in PEG-400. [0181] 3) Dissolve Triton BD in water. [0182] 4) Dissolve citric acid in water. [0183] 5) Dissolve Thymol and Biosol in a flavoring agent and, if necessary, heat to 40 C. [0184] 6) Dissolve tannase in water. [0185] 7) Prepare a suspension of 15% amorphous hydroxyapatite with 20-80 nm particle size (15% HAP).

1. Cooking Process:

[0186] 2.1 Load successively into the reactor: [0187] sorbitol, [0188] glycerine, [0189] suspension according to par. 1.6.

[0190] 2.2 Mix, stir and homogenize.

[0191] 2.3 Load successively into the reactor: [0192] dispersion according to par. 1.1, [0193] water.

[0194] 2.4 Mix, stir and homogenize.

[0195] 2.5 Load successively into the reactor: [0196] solution according to par; 1.2, [0197] sodium monofluorophosphate, [0198] xylitol, [0199] methylparaben sodium salt, [0200] solution according to par. 1.3.

[0201] 2.6 Mix, stir and homogenize.

[0202] 2.7 Load successively in to the reactor: [0203] calcium lactate, [0204] olaflur.

[0205] 2.8 Mix. stir and homogenize.

[0206] 2.9 Take a sample to determine viscosity (the sample should be homogeneous, without lumps and crumbs).

[0207] 2.10 Load successively into the reactor: [0208] silicone dioxide (Sorbosil TC15), [0209] titanium dioxide, [0210] Sorbosil AC43,

[0211] 2.11 Mix, stir and homogenize.

[0212] 2.12 Load successively into the reactor: [0213] Sorbosil AC39.

[0214] 2.13 Mix, stir and homogenize.

[0215] 2.14 Load successively into the reactor: [0216] anethole, [0217] eucalyptol, [0218] solution according to par. 1.4, [0219] Vitamin E, [0220] CO2 extract of grape-seed, [0221] solution according to par. 1.5.

[0222] 2.15 Mix, stir aid homogenize.

[0223] 2.16 Take a sample to determine viscosity (the sample should be homogeneous, without lumps and crumbs).

[0224] 2.17 Load successively into the reactor: [0225] 33% solution of cocamidopropyl betaine, [0226] 30% solution of sodium lauroyl sarcosinate.

[0227] 2.18 Mix, stir and homogenize.

[0228] 3. Take a sample to determine pH and viscosity values.

[0229] Color: white

[0230] pH 25% 6.0-7.0.

Example III

Toothpaste Compositions

[0231] The toothpaste compositions, the formulations of which are disclosed in Table 1, contain a mineral-enzymatic complex based on tannase and amorphous calcium hydroxyapatite with 20-80 nm particle size, the said complex strengthening and whitening tooth enamel reducing tooth sensitivity; having anti-inflammatory and hemostatic properties.

TABLE-US-00004 TABLE 1 Toothpaste compositions. Toothpaste compositions, mass % Composition Composition Composition Composition Content Ser. # Component A.sup.1 B.sup.2 C.sup.3 D.sup.4 range Function 1. Mineral- 6.06 1.52 10.05 11.10 1.50-30.00 Source of mineral substances enzyme and tannase enzyme; complex contributes to strengthening and whitening of enamel, reduction of tooth sensitivity, possesses anti-inflammatory and blood-stopping properties 2. Sorbitol 30.00 20.00 20.00 20.0 1.00-60.00 Moisturizer. 70% Influences the product texture imparting special softness and plasticity thereto. 3. Glycerin 10.00 5.00 5.00 5.00 0.50-70.00 Moisturizer. (99.7%) Contributes to obtaining a plastic, thixotropic mass, stabilizes foam, improves toothpaste flavor. 4 Polyethylene 5.00 5.00 0.10-20.00 Moisturizer. glycol Influences the product PEG 400 texture imparting special softness and plasticity thereto. 5. Silicium 10.0 16.0 10.0 15 1.00-60.00 Thickener and/or abrasive dioxide 6. Sodium 1.00 1.5 1.50 1.50 0.5-10.00 Thickener, structure-forming carboxy- agent methylcellulose 7. Xanthan 0.10 0.02-3 Thickener, structure-forming gum agent 8. Sodium 4.00 2.00-5.00 Surfactant myristoyl sarcosinate 9 Cocamido 1.00 0.01-10.00 Surfactant propyl betaine 10. Sodium 1.00 3.0 0.01-10.00 Surfactant lauryl sarcosinate 11. Sodium 2.0 0.01-10.00 Surfactant lauryl sulphate (sodium coco- sulphate) 12. Stevia 0.20 0.20 0.20 0.05-3 Sweetener extract 13. Xylitol 0.50 1.0 0.01-1 Sweetener 14. Sucralose 0.05 0.01-1 Sweetener 15. Flavoring 0.50 1.0 1.0 1.0 0.05-3 Flavoring additive agent 16. Sodium 0.30 0.25 0.300 0.05-0.3 Preservative methylparaben 17. Titanium 0.10 0.10 0.10 0.01-5.00 Whitening agent, colorant dioxide 18. Anise 0.150 0.01-1 Polyphenol, aseptic camphor 19. Eucalyptol 0.10 0.01-1 Polyphenol, aseptic 20. Thymol 0.08 0.01-1 Polyphenol, aseptic 21. Isopropyl 0.100 0.10 0.01-0.2 Aseptic, caries prevention methylphenol 22. Sodium 0.50 0.01-10.00 Anti-caries agent monofluorophosphate 23. Aminefluoride 1.00 0.01-10.00 Anti-caries agent 24. Vitamin E 0.10 0.10 0.01-5.00 Anti-oxidizing agent, anti- inflammatory action 25. Tetrasodium 0.50 0.01-5.00 Foam stabilizer, chelating glutamate and whitening agent diacetate 26. Polydon A 0.90 0.01-5.00 Foam stabilizer, whitening agent 27. Trilon BD 0.05 0.05 0.01-5.00 Foam stabilizer, chelating (disodium and whitening agent EDTA) 28. Calcium 1.00 0.01-10.00 Mineralizing agent lactate 29. Citric acid 0.10 0.20 0.0001-0.50 Acidity regulating agent 30. Dry 0.10 0.01-10.00 Anti-inflammatory, binding, skullcap blood-stopping agent extract 31. Dry 0.10 0.01-10.00 Anti-inflammatory, binding, bergenia blood-stopping agent extract 32. Neem 0.05 0.005-5.00 Antibacterial agent extract 33. Water Up to 100% Solvent .sup.1In the mineral-enzymatic complex containing 0.2 weight parts of tannase per 100 weight parts of hydroxyapatite. .sup.2In the mineral-enzymatic complex containing 2 weight parts of tannase per 100 weight parts of hydroxyapatite. .sup.3In the mineral-enzymatic complex containing 0.5 weight parts of tannase per 100 weight parts of hydroxyapatite. .sup.4In the mineral-enzymatic complex containing 2 weight parts of tannase per 100 weight parts of hydroxyapatite.

Example IV

Mouthwash Composition

[0232]

TABLE-US-00005 TABLE 2 Mouthwash composition. Ser. Composition, # Composition component mass % Function 1 Mineral-enzyme complex.sup.5 1.60 Contributes to strengthening and whitening of enamel, reduction of tooth sensitivity, possesses anti- inflammatory and blood-stopping properties 2 Glycerin (99.7%) 5.00 Moisturizer, solvent 3 Triton BD (disodium 0.05 Stabilizer, chelating and EDTA) whitening agent 4 Sucralose 0.05 Sweetener 5 Sodium methylparaben 0.30 Preservative 7 Xanthan gum 0.50 Thickener, structure-forming agent 8 Calcium lactate 1.00 Mineralizing agent 9 Polyethylene glycol PEG 400 5.00 Moisturizer. 10 Thymol 001-017 0.08 Polyphenol, aseptic 11 PEG-40 hydrogenized 1.00 Moisturizer, solubilizer castor oil 13 Vitamin E 0.05 Anti-oxidizing agent, anti- inflammatory action 14 Flavoring agent 0.30 Flavoring additive 15 Anise camphor 0.10 Polyphenol, aseptic 16 Eucalyptol 0.05 Polyphenol, aseptic 18 Citric acid (dry) 0.20 Acidity regulating agent 19 Purified water Up to 100% Solvent .sup.5In the mineral-enzymatic complex containing 10.0 weight parts of tannase per 100 weight parts of hydroxyapatite.

Example V

Composition for Rinsing and Application for Sensitive Teeth

[0233]

TABLE-US-00006 TABLE 3 Composition for rinsing and application for sensitive teeth. Ser. Composition Composition, # component mass % Function 1 Mineral- 20.15 Source of mineral substances and enzyme tannase enzyme; contributes complex.sup.6 to strengthening and whitening of enamel, reduction of tooth sensitivity, possesses anti-inflammatory and blood-stopping properties 2 Glycerin Up to 100% Moisturizer, (99.7%) Contributes to obtaining a plastic, thixotropic mass, stabilizes foam, improves toothpaste flavor. 3 Japanese 1.00 Antibacterial agent honeysuckle extract 4 p-methoxy- 0.10 Antibacterial agent benzoic acid 5 Glyceryl 0.10 Antibacterial agent monocaprilate (Cosphaderm GMCY) .sup.6In the mineral-enzymatic complex containing 0.25 weight parts of tannase per 100 weight parts of hydroxyapatite.

Example VI

Foam Mouthwash Composition

[0234]

TABLE-US-00007 TABLE 4 Foam mouthwash composition. Compo- Composition sition, Ser. component mass % Function Mineral-enzyme 0.71 Source of mineral substances complex.sup.7 and tannase enzyme; contributes to strengthening and whitening of enamel, reduction of tooth sensitivity, possesses anti-inflammatory, and blood-stopping properties Sorbitol 70% 10.00 Moisturizer. Influences the product texture imparting special softness and plasticity thereto. Triton BD 0.10 Stabilizer, chelation (disodium EDTA) and whitening agent Sodium 0.25 Preservative methylparaben L-arginine 0.100 Acidity regulating agent Sucralose 0.05 Sweetener Liquorice extract 0.05 Anti-inflammatory and anti-caries agent Sodium lauryl 4.00 Surfactant sarcosinate Polyvinyl 0.10 Whitening agent, foam stabilizer pyrrolidone/ vinylacetate Flavoring agent 1.00 Flavoring additive PEG-40 1.00 Moisturizer, solubilizer polysorbate-20 1.00 Moisturizer, solubilizer carragheenan 0.05 Foam stabilizer Citric acid 0.20 Acidity regulating agent Enzyme complex: 0.50 Antibacterial agent lactoferrin, lactoperoxidase, glucose oxidase, potassium thiocyanate, glucose pentaacetate Purified Up to Solvent water 100% .sup.7In the mineral-enzymatic complex containing 0.25 weight parts of tannase per 100 weight parts of hydroxyapatite.

Example VII

Study of Effectiveness of the Toothpastes According to the Invention

[0235] The toothpastes prepared (compositions A, B, C, and D from Table 1) and the reference standard D without tannase were tested as follows.

[0236] Check-up dental examinations were to identify the condition of oral cavity hygiene, hard tooth tissue, periodontal tissue and mouth mucosa by the following criteria.

Material and Methods of the Study.

[0237] In approval of the claimed toothpaste subjects with sensitive teeth participated. The total of 480 sensitive teeth were found in the study subjects, in average 6 sensitive teeth per subject. Depending on the toothpaste variant applied, the study subjects were divided into groups:

[0238] Group 1the group participants used a paste with composition A;

[0239] Group 2the group participants used a paste with composition B:

[0240] Group 3the group participants used a paste with composition C;

[0241] Group 4the group participants used a paste with composition D;

[0242] Group 5the group participants used a paste with composition D.

[0243] It was a double-blind randomized study.

[0244] The toothpastes were used by the study subjects themselves twice daily (in the morning and at night) for one month. Following the initial examination, repeated examinations were performed on a weekly basis for 4 weeks.

1) The Study of Cleaning Action and Effect.

[0245] To determine the cleaning action, the study authors used Green-Vermillion hygienic factor and reagent tablets by PARO.

[0246] According to Green-Vermillion hygienic factor, the cleaning effect was determined by the following formula:

Effect (%)=[100(OHI.sub.0OHI.sub.n)]/OHI.sub.0

[0247] where OHI.sub.0 is index value at research start, prior to hygienic procedure;

[0248] OHI.sub.n is index value after n weeks of research, at the last check-up prior to hygienic procedure.

[0249] Table 5.1 summarizes data for 4-weeks' dynamics of Green-Vermillion hygienic factor, while Table 5.2 provides data as changes in cleaning effectiveness according to Green-Vermillion hygienic factor.

TABLE-US-00008 TABLE 5.1 Dynamics of Green-Vermillion hygienic factor. Distribution by Examination period Ser. # group Start Week 1 Week 2 Week 3 Week 4 1 Composition A 3.70 3.21 2.81 2.43 2.22 2 Composition B 3.72 3.23 2.84 2.43 2.27 3 Composition C 3.80 3.32 2.93 2.57 2.21 4 Composition D 3.69 3.28 2.89 2.49 2.26 5 Composition D 3.78 3.67 3.52 3.45 3.33

TABLE-US-00009 TABLE 5.2 Change in the cleaning effect according to the Green-Vermillion factor Distribution Examination period Ser. # by group Week 1 Week 2 Week 3 Week 4 1 Composition A 13.24% 24.05% 34.32% 40.00% 2 Composition B 13.17% 23.66% 34.68% 38.98% 3 Composition C 12.63% 22.89% 32.37% 41.84% 4 Composition D 11.11% 21.68% 32.52% 38.75% 5 Composition D 2.91% 6.88% 8.73% 11.90%

1) Study of Sensitivity (Tactile and Heat Samples).

[0250] Intensity of hyperesthesia in gingival recession sites before and in various periods of paste use were determined using diagnostic samples:

1) Probing:

[0251] a) assessment of tactile sensitivity with cotton wool pads (CWP); [0252] b) linear probe movement over tooth surfaces (LPM).

2) Thermometry:

[0253] a) irrigation with water jet (WJ): [0254] b) processing with direct air jet (DAJ); [0255] c) processing with side air jet (SAJ).

[0256] Tables 6.1 and 6.2 6 provide data on 4-weeks' dynamic pattern of sensitivity built on the basis of diagnostic samples.

TABLE-US-00010 TABLE 6.1 Dynamic pattern of sensitivity. Diagnostic tests In 1 week In 2 weeks In 3 weeks In 4 weeks Compositions A B D A B D A B D A B D LPM 8.8 8.7 8.1 16.9 16.7 12.1 22.5 25.7 16.2 31.0 32.0 20.2 CS 10.1 9.8 9.7 13.8 16.2 12.2 23.9 27.8 16.8 34.2 36.9 20.3 WS 8.4 8.2 8.1 11.4 13.4 11.9 20.2 20.1 15.0 30.3 32.8 21.2 LAS 9.3 9.1 9.1 14.0 15.2 11.8 18.2 23.6 14.1 32.4 33.2 22.3 DAS 10.1 9.7 9.6 18.6 18.7 12.1 22.2 23.9 14.2 32.9 33.2 23.3

TABLE-US-00011 TABLE 6.2 Dynamic pattern of sensitivity. Diagnostic tests In 1 week In 2 weeks In 3 weeks In 4 weeks Compositions C D C D C D C D LPM 8.9 10.0 17.1 16.1 22.9 25.8 31.4 32.3 CS 10.3 12.0 13.8 16.0 24.1 28.0 34.5 36.0 WS 8.8 9.5 11.6 13.6 20.4 21.1 30.4 32.8 LAS 9.3 9.6 14.1 15.0 18.4 23.6 32.3 33.4 DAS 10.6 10.8 18.8 19.0 22.4 24.5 32.8 33.8

1) Study of Desensitizing Action and Desensitizing Effectiveness.

[0257] Teeth sensitivity factor according to L. Yu. Orekhova and S. B. Ulitovskiy (Orekhova-Ulitovskiy TS factor/ C3 -) allows to trace changes in condition of teeth under the influence of desensitizing agents.

[0258] Orekhova-Ulitovskiy TS factor is the total of assessments of all described criteria divided by the number of criteria and multiplied by 100:

[00001]$\mathrm{Orekhova}.Math.\text{-}.Math.\mathrm{Ulitovskiy}.Math..Math.\mathrm{TS}.Math..Math.\mathrm{factor}=\frac{.Math.\left(a_1+\mathrm{.Math.}+a_n\right)}{5.Math.n}100.Math.\%$

[0259] where X is the total of quantitative assessments of criteria;

[0260] a.sub.1 is the score by the first criterion;

[0261] a.sub.n is the score by the n-th criterion;

[0262] n is the number of the criteria used;

[0263] 5 is the quantity of assessed parameters within each criteria.

[0264] In the object of the invention the total number of criteria and parameters is stable and equals to 11 and 55, respectively. Thus, the formula will look like:

[00002]$\mathrm{Orekhova}.Math.\text{-}.Math.\mathrm{Ulitovskiy}.Math..Math.\mathrm{TS}.Math..Math.\mathrm{factor}=\frac{.Math.\left(a_1+\mathrm{.Math.}+a_n\right)}{5.Math.n}100.Math.\%$

[0265] In the denominator the value of total criteria score ranges within 11(a.sub.1+ . . . a.sub.11)55, while bounds the rating are 20Orekhova-Ulitovskiy TS factor100.

[0266] Assessment criteria:

[0267] 81-100%highly critical condition;

[0268] 61-80%critical condition;

[0269] within 41-60%relatively compensated sensitivity of teeth;

[0270] the factor being within 21-40%relatively compensated sensitivity of teeth, however with underlying compensated mild sensitivity of teeth;

[0271] at 20% assessmenta sound tooth (group of teeth) with normal natural sensitivity towards exogenous irritants.

[0272] For long-term study of tooth sensitivity in dynamics, especially under influence of drugs or topical use of oral hygiene aids the authors use the formula of calculation of tooth sensitivity efficacy (TS efficacy/ C3):

TS efficacy (%)=[(F.sub.1F.sub.n)100%]/F.sub.1

[0273] where F.sub.1 is a numerical value of Orekhova-Ulitovskiy TS factor determined during the first visit:

[0274] F.sub.n is the numerical value of Orekhova-Ulitovskiy TS factor determined during the n-th visit.

[0275] Table 7 summarizes the 4-weeks' history of changes in desensitizing effectiveness according to Orekhova-Ulitovskiy TS factor.

TABLE-US-00012 TABLE 7 Changes in desensitizing effectiveness according to Orekhova-Ulitovskiy TS factor Distribution Examination period by group Week 1 Week 2 Week 3 Week 4 Composition A 6.8% 11.2% 16.4% 22.2% Composition B 6.7% 11.6% 17.6% 21.9% Composition C 6.8% 11.4% 16.5% 22.1% Composition D 7.0% 11.7% 17.9% 22.0%

[0276] 1) The Study of Whitening Effect and Whitening Effectiveness.

[0277] Whitening effect was determined prior and in various times of tooth paste use according to VITAPAN scale. After baseline values were determined according to VITAPAN scale, the authors checked correctness of hygienic care (compliance with toothbrushing technique and conditions), and provided respective training.

[0278] Table 8 summarizes the 4-weeks' whitening effect dynamics according to VITAPAN scale.

TABLE-US-00013 TABLE 8 Dynamics of whitening effect according to VITAPAN scale. Examination period Distribution In 1 In 2 In 3 In 4 by group Initial week weeks weeks weeks Composition A3.5 A3.5 A3 A3 A2 A Composition A3.5 A3.5 A3 A3 A2 B Composition A3.5 A3.5 A3 A2 A2 C Composition A.3.5 A3.5 A3.5 A3 A2.5 D Composition A3.5 A3.5 A3.5 A3 A2.5 D

1) The Study of Remineralizing Effect and Remineralizing Effectiveness.

[0279] Remineralizing effect was studied in TER test according to Okushko. Remineralizing effectiveness was calculated based on TER test.

[0280] Table 9 provides data for 4 weeks' changes in remineralizing effectiveness in TER test.

TABLE-US-00014 TABLE 9 Changes in remineralizing effectiveness in TER test. Distribution Examination period by group Week 1 Week 2 Week 3 Week 4 Composition A 9.3% 18.0% 27.1% 27.2% Composition B 9.8% 19.0% 28.2% 28.2% Composition C 9.1% 18.2% 27.3% 27.3% Composition D 10.0% 20.0% 30.0% 30.0% Composition D 9.8% 18.8% 26.7% 26.9%
1) The Study of Anti-Inflammatory Effect and Anti-Inflammatory Effectiveness. To Determine the Condition of Periodontal Tissue, PMA Indices Were Used.

[0281] Based on findings of PMA indices, the authors determined anti-inflammatory effectiveness which described the nature of changes in inflammatory process in the periodontium.

[0282] Anti-inflammatory effectiveness was determined according to the formula:

Anti-inflammatory effectiveness (%)=[100(PMA.sub.0PMA.sub.n)]/PMA.sub.0

[0283] where PMA.sub.0 is the numerical value of the index before the start of the study;

[0284] PMA.sub.n is the numerical value of the index in n weeks of the study, at the last visit.

[0285] Table 10 provides data for 4 weeks' changes in anti-inflammatory effectiveness of tooth pastes according to PMA index.

TABLE-US-00015 TABLE 10 Changes in anti-inflammatory effectiveness according to PMA index. Distribution Examination period by group Week 1 Week 2 Week Week 4 Composition A 6.9% 13.7% 22.9% 40.5% Composition B 6.4% 11.6% 21.1% 37.9% Composition C 7.1% 14.9% 23.6% 42.1% Composition D 5.8% 10.5% 21.1% 38.9% Composition D 5.7% 10.1% 18.7% 36.2%

1) The Study of Hemostatic Effect and Hemostatic Effectiveness.

[0286] To determine the condition of periodontal tissue, Muhlemann-Mazor bleeding index was used.

[0287] Based on findings of the bleeding index, the authors determined hemostatic effectiveness which showed the nature of changes in the inflammatory process in the periodontium.

[0288] Hemostatic effectiveness was determined according to the formula:

Blood-stopping effectiveness (%)=[100(BI.sub.0BI.sub.n)]/BI.sub.0

[0289] where BI.sub.0 is the numerical value of the index before the start of the study;

[0290] BI.sub.n is the numerical value of the index in n weeks of the study, at the last visit.

[0291] Table 11 provides data of 4-weeks' changes in hemostatic effectiveness using Muhlemaan-Mazor bleeding index.

TABLE-US-00016 TABLE 11 Changes in hemostatic effectiveness using Muhlemann-Mazor bleeding index. Distribution Examination period by group Week 1 Week 2 Week 3 Week 4 Composition A 8.1% 13.1% 19.8% 25.1% Composition B 5.4% 7.5% 9.0% 11.1% Composition C 8.3% 13.0% 20.9% 26.1% Composition D 5.5% 8.5% 11.0% 14.5% Composition D 3.2% 5.4% 6.8% 8.1%

[0292] The obtained results allow to conclude that the groups that brushed their teeth-using the claimed composition manifested pronounced cleansing effect, improved sensitivity, desensitizing effectiveness, whitening effectiveness, remineralizing effectiveness, anti-inflammatory effectiveness, and hemostatic effectiveness.

[0293] When the reference composition D was used, the most parameters were lower, except those that were practically equal.

Example VIII

The Comparative Study of Effectiveness of Toothpastes that Contain Glucose Amilase, Alpha-Amilase, Dextranase and Tannase.

[0294] Using the technique described in Example I, the toothpaste compositions were made in which tannase was replaced for glucose amilase, alpha-amilase, dextranase, respectively, Composition .formulations coincide with those specified in Table 1 for compositions B and C. Thus the following toothpastes were made:

[0295] B and Cwith tannase,

[0296] B.sup.1 and C.sup.1with gloucose amylase,

[0297] B.sup.2 and C.sup.2with alpha-amylase,

[0298] B.sup.3 and C.sup.3with dextranase.

[0299] The effectiveness of toothpastes was studied according to the procedure set forth in Example VII.

1) The Study of Cleaning Action and Effect.

[0300] To determine the cleaning action, the study authors used Green-Vermillion hygienic factor and reagent tablets by PARO.

[0301] According to Green-Vermillion hygienic factor, the cleaning effect was determined by the following formula:

Effect (%)=[100(OHI.sub.0OHI.sub.n)]/ OHI.sub.0

[0302] where OHI.sub.0 is index value at research start, prior to hygienic procedure;

[0303] OHI.sub.n is index value after n weeks of research, at the last check-up prior to hygienic procedure.

[0304] Table 12.1 summarizes 4-week's dynamics data for Green-Vermillion hygienic factor, while Table 12.1, provides data as changes in cleaning efficacy according to Green-Vermillion hygienic factor.

TABLE-US-00017 TABLE 12.1 Dynamics of Green-Vermillion hygienic factor. Examination period Pos. Division into 1st 2nd 3rd 4th No. groups Start week week week week 1 Composition B 3.72 3.23 2.84 2.43 1.27 2 Composition C 3.80 3.32 2.93 2.57 2.21 3 Composition 3.77 3.33 3.01 2.55 2.45 B.sup.1 4 Composition 3.74 3.42 3.11 2.69 2.45 C.sup.1 5 Composition 3.72 3.35 3.03 2.58 2.43 B.sup.2 6 Composition 3.75 3.42 3.09 2.70 2.45 C.sup.2 7 Composition 3.78 3.31 3.03 2.58 2.43 B.sup.3 8 Composition 3.78 3.41 3.12 2.71 2.46 C.sup.3

TABLE-US-00018 TABLE 12.2 Change in the cleaning effect according to the Green-Vermillion factor Examination period Pos. Division into 1st 2nd 3rd 4th No. groups week week week week 1 Composition 13.17% 23.66% 34.68% 38.98% B Composition 12.63% 21.89% 32.37% 41.84% C 3 Composition 11.67% 20.16% 32.36% 35.01% B.sup.1 4 Composition 8.56% 16.84% 28.07% 34.49% C.sup.1 5 Composition 9.95% 18.55% 30.65% 34.68% B.sup.2 6 Composition 8.80% 17.60% 28.00% 34.67% C.sup.2 7 Composition B.sup.3 12.43% 19.84% 31.75% 35.71% 8 Composition C.sup.3 9.79% 17.46% 28.31% 34.92%

1) Study of Sensitivity (Tactile and Heat Samples).

[0305] Intensity of hyperesthesia in gingival recession sites before and in various periods of paste use were determined using diagnostic samples:

1) Probing:

[0306] a) assessment of tactile sensitivity with cotton wool pads (CWP); [0307] b) linear probe movement over tooth surfaces (LPM).

2) Thermometry:

[0308] a) irrigation with water jet (WJ); [0309] b) processing with direct air jet (DAJ); [0310] c) processing with side air jet (SAJ).

[0311] Tables 13 and 14 provide data on 4-weeks' dynamic pattern of sensitivity built on the basis of diagnostic samples.

TABLE-US-00019 TABLE 13 Dynamic pattern of sensitivity. In 1 week In 2 weeks In 3 weeks In 4 weeks Compositions B C B.sup.1 C.sup.1 B C B.sup.1 C.sup.1 B C B.sup.1 C.sup.1 B C B.sup.1 C.sup.1 LPM 8.7 8.9 8.7 8.8 16.7 17.1 16.5 16.8 25.7 22.9 25.0 22.2 32.0 31.4 30.8 30.2 CWP 9.8 10.3 9.7 10.2 16.2 13.8 15.9 13.4 27.8 24.1 27.1 23.4 36.9 34.5 35.7 33.2 WJ 8.2 8.8 8.2 8.7 13.4 11.6 13.1 11.3 20.1 20.4 19.4 19.7 32.8 30.4 31.5 29.1 SAJ 9.1 9.3 9.1 9.2 15.2 14.1 14.8 13.9 23.6 18.4 22.8 17.8 33.2 32.3 32.1 30.9 DAJ 9.7 10.6 9.6 10.5 18.7 18.8 18.5 18.5 23.9 22.4 23.0 21.8 33.2 32.8 32.0 30.9

TABLE-US-00020 TABLE 14 Dynamic pattern of sensitivity. In 1 week In 2 weeks In 3 weeks In 4 weeks Compositions B.sup.2 C.sup.2 B.sup.3 C.sup.3 B.sup.2 C.sup.2 B.sup.3 C.sup.3 B.sup.2 C.sup.2 B.sup.3 C.sup.3 B.sup.2 C.sup.2 B.sup.3 C.sup.3 LPM 8.7 8.9 8.6 8.7 16.6 16.7 16.4 16.7 25.1 22.8 25.2 22.3 30.5 30.5 30.6 30.6 CWP 9.7 10.1 9.5 10.0 15.8 13.2 15.7 13.2 27.3 23.0 27.4 23.2 35.5 33.5 35.3 33.6 WJ 8.1 8.9 8.1 8.6 13.2 11.5 13.2 11.1 19.4 19.7 19.5 19.9 31.6 29.3 31.2 29.3 SAJ 9.2 9.1 9.1 9.1 14.8 14.0 14.8 13.8 22.9 17.7 22.7 17.9 32.1 30.6 32.2 30.8 DAJ 9.4 10.4 9.5 10.3 18.4 18.6 18.6 18.7 23.1 21.8 23.2 21.9 32.0 30.4 32.1 30.5

1) The Study of Whitening Effect and Whitening Effectiveness.

[0312] Whitening effect was determined prior and in various times of tooth paste use according to VITAPAN scale. After baseline values were determined according to VITAPAN scale, the authors checked correctness of hygienic care (compliance with toothbrushing technique and conditions), and provided respective training.

[0313] Table 15 summarizes the 4-weeks' whitening effect dynamics according to VITAPAN scale.

TABLE-US-00021 TABLE 15 Dynamics of whitening effect according to VITAPAN scale. Division into Start In 1 In 2 In 3 In 4 groups week weeks weeks weeks Composition B A3.5 A3.5 A3 A3 A2 Composition C A3.5 A3.5 A3 A2 A2 Composition B.sup.1 A3.5 A3.5 A3 A3 A2.5 Composition C.sup.1 A3.5 A3.5 A3 A2.5 A2.5 Composition B.sup.2 A3.5 A3.5 A3 A2.5 A2.5 Composition C.sup.2 A3.5 A3.5 A3.5 A2 A2.5 Composition B.sup.3 A3.5 A3.5 A3 A2.5 A2.5 Composition C.sup.3 A3.5 A3.5 A3.5 A2 A2.5

[0314] The obtained results allow to conclude that the groups that used the claimed composition (groups B and C) for tooth brushing showed a pronounced cleaning effect, improved sensitivity and whitening effectiveness.

[0315] When the reference compositions containing other enzymes were used, the parameter values were lower; it allows for the conclusion about non-obviousness of use of a hydroxyapatite exactly in combination with tannase enzyme.

Example IX

The Comparative Study of Effectiveness of the Toothpastes that Contain Calcium hydroxyapatite.

[0316] It is advisable to use a complex containing a hydroxyapatite with 20-80 am particle size. This hydroxyapatite form lacks abrasive properties and has improved biocompatibility with denial tissues.

[0317] Toothpaste compositions were made using the: technique described in Example I. The authors studied the compositions containing a hydroxyapatite fraction with 20-80 nm particle size (HAP1) and a hydroxyapatite fraction with 100-150 nm particle size (HAP2). The composition formulations are equal to those specified in Table 1 for C.

Study of Sensitivity (Tactile and Heat Samples).

[0318] Intensity of hyperesthesia in gingival recession sites before and in various periods of paste use were determined using diagnostic samples:

1) Probing:

[0319] a) assessment of tactile sensitivity with cotton wool pads (CWP); [0320] b) linear probe movement over tooth surfaces (LPM).

2) Thermometry:

[0321] a) irrigation with water jet (WJ); [0322] b) processing with direct air jet (DAJ); [0323] c) processing with side air jet (SAJ).

[0324] Table 16 provides data on 4-weeks' dynamic pattern of sensitivity built on the basis of diagnostic samples.

TABLE-US-00022 TABLE 16 Dynamic pattern of sensitivity. In 1 week In 2 weeks In 3 weeks In 4 weeks Compositions HAP1 HAP2 HAP1 HAP2 HAP1 HAP2 HAP1 HAP2 LPM 8.9 8.7 17.1 14.0 22.9 19.8 31.4 26.2 CWP 10.3 10.1 13.8 10.7 24.1 21.1 34.5 29.9 WJ 8.8 8.5 11.6 10.0 20.4 17.6 30.4 25.4 SAJ 9.3 8.9 14.1 11.1 18.4 15.2 32.3 27.4 DAJ 10.6 10.2 18.8 15.6 22.4 19.1 32.8 27.5

[0325] The obtained results allow to conclude that the groups that used the claimed composition (group HAP1) to brush, teeth showed improved sensitivity.

[0326] When the reference composition with larger size of amorphous hydroxyapatite the values were lower; it allows for the conclusion about nonobviousness of the use of a hydroxyapatite with max. 80 nm particle size.

[0327] Restorative agents for sensitive teeth based on the claimed complex are effective no matter what caused hypersensitivity; expanded dentine tubules, weak dwarfed enamel or exposure of neck areas. Amorphous calcium hydroxyapatite, already after the first application, penetrates deep into lesions on the tooth surface and demineralization loci, thus making enamel more dense and firm, in contrast to agents that block sensitivity of nerve terminals located in dentine tubules or acting superficially. The combined firming effect of toothpastes on the basis of the declared complex is achieved by means of hemostatic, anti-inflammatory, desensiting, remineralizing and anticariogenic effects. One month of using such a toothpaste improves the condition of periodontium; elimination of inflammation and swelling of gums, concretion of soft tissues of gingival margin, no more bleeding gums, and firming of hard tissues of teeth and plugging of open dentine tubules thus ensuring lowered tooth sensitivity. Formation of calcular deposit noticeably reduces (i.e. inhibiting accumulation and growth of soft calcular deposits).

[0328] The use of the toothpastes based on the claimed complex allows to achieve such indices as: cleaning effectup to 77.7%, desensitizing effectup to 70.4%, remineralizing effectivenessup to 64.9%, anti-inflammatory effectivenessup to 67.8%, hemostatic effectivenessup to 74.1%, and anticariogenic effectup to 80.8%.

[0329] The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons of the art. When used in the following claims, the terms comprises, includes, have and their conjugates mean including but not limited to. The scope of the invention is limited only by the following claims.