RU2457829C2 - Mineral and vitamin complex for strengthening tooth enamel, composition for oral cavity hygiene and toothpaste - Google Patents

Abstract

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions relates to dentistry, namely to mineral and vitamin complex for strengthening tooth enamel, as well as compositions for oral cavity hygiene, including claimed complex, in particular to toothpastes. Vitamin and mineral complex for tooth enamel strengthening contains the following components: per 100 wt fractions of hydroxyapatite - 15.0-30.0 wt fractions of aminofluoride, 3.0-24.0 wt fractions of extract of plant Crithmum Maritimum and 0.1-0.2 wt fractions of pearl powder. Complex can additionally contain, at least, one extract of alga, selected from the group including Himanthalia Elongata, Laminaria Digitata, Laminaria Saccharina, Lithothamnium Calcareum, Palmaria Palmata, Porphyra Umbilicalis and Spirulina Maxima Extract in amount from 3.0 to 12.0 wt fractions. Also claimed are compositions for oral cavity hygiene with application of said complex, in particular, toothpaste.

EFFECT: application of compositions for oral cavity hygiene based on claimed vitamin and mineral complex ensures high cleaning capability, anti-caries effect, reduction of gum inflammation, reduction of teeth sensitivity to temperature and tactile stimuli and reduction of pigmented plaque.

10 cl, 10 tbl, 1 ex, 1 dwg

Description

The field of technology.

The invention relates to cosmetology, in particular to a mineral-vitamin complex for strengthening tooth enamel, as well as to compositions for oral hygiene, including this complex, in particular, toothpastes and other compositions.

The prior art.

Minerals are involved in building the human body. They provide the structure of blood, bones, muscles, teeth, hair and skin. Minerals are widely used in oral hygiene products, for example, for remineralization (restoration) of tooth enamel. In the patent literature there are a large number of publications disclosing the use in various compositions for oral hygiene of both individual minerals and mineral complexes.

So, for example, in the patent RU 2297212, edible salt is introduced into the toothpaste as a mineral complex, which, according to the authors, is a valuable natural mineral complex consisting of halite and minerals - sylvin, bischofite, polygalite containing trace elements - potassium, magnesium calcium.

The patent RU 2311168 discloses a composition for remineralizing tooth tissues, according to which it contains calcium glycerophosphate as a mineral complex, which is a source of active phosphorus and calcium in teeth and periodontal tissues and helps to improve the physiological mineralization process in the enamel / saliva system, and also magnesium chloride. Magnesium is introduced into the complex as a microelement, which is a cofactor for phosphatases. Under the influence of these enzymes, the inclusion of phosphates in the hard tissues of the teeth increases.

In the patent RU 2355380 on "Dental elixir for the prevention and treatment of initial forms of dental caries" a mineral complex is disclosed, including calcium hydroxyapatite - a mineralizer that promotes a change in the kinetics of mineralization of tooth enamel, and sodium fluoride, which prevents the adsorption of organic substances and microorganisms on the surface of enamel and is involved in building enamel prisms.

And in patent RU 2367407 C1, issued to a dental varnish, a mineral complex is disclosed which is added to the varnish to restore hard tooth tissues and reduce tooth hypersensitivity. This complex contains aminofluoride and alcohol colloid (gel) of nanosized hydroxyapatite

The use of mineral complexes in the compositions for oral hygiene can improve tooth cleaning, mineralization, increase enamel resistance, etc.

It should be noted that not only minerals affect the condition of the teeth.

It is well known that insufficient intake of vitamins disrupts the metabolism, weakens the body's defenses. A prolonged and deep deficiency of vitamins worsens the condition of the teeth. Therefore, vitamin-mineral complexes are often introduced into the compositions of toothpastes and other compositions for oral hygiene.

From the patent RU 2068688 C1, a vitamin-mineral complex based on kelp concentrate and natural hay lipid complex is known. Laminaria concentrate is obtained by repeated crystallization and contains macroelements (calcium, phosphorus, magnesium, sodium, etc.), microelements (copper, zinc, silver, vanadium, titanium, iron, nickel, etc.). Senna lipid complex contains chlorophyll derivatives (40.0-50.0 mg%), carotenoids (50-60 mg%), tocopherol (including alfatocopherol up to 300 mg%), vitamins C and P, provitamin D, sterols, alkoloids , sennidine, aloe-ecgodine, glycosides, organic acids (palmetic, linoleic, etc.). Accordingly, this patent also discloses the composition of the toothpaste in which this mineral-vitamin complex is used.

All of the above compounds to some extent have a mineralizing effect on hard tooth tissues, strengthen enamel and inhibit the development of caries, however, this effect is not sufficient. In addition, these complexes do not have bleaching properties.

Disclosure of the invention.

The objective of the invention is to improve the consumer properties of oral hygiene products using the inventive mineral-vitamin complex: improving cleansing ability, anti-carious effect, reducing gum inflammation, reducing tooth sensitivity to temperature and tactile irritants and reducing pigmented plaque.

The problem is solved by a vitamin-mineral complex for strengthening tooth enamel containing hydroxyapatite and aminofluoride, according to which it additionally contains pearl powder and Crithmum Maritimum plant extract in the following ratio: per 100 wt. parts of hydroxyapatite - 15.0-30.0 wt. parts of aminofluoride, 3.0-24.0 wt. parts of the plant extract Crithmum Maritimum and 0.1-0.2 wt. parts of pearl powder.

In private embodiments of the invention, the problem is solved in that the complex additionally contains at least one algae extract selected from the group comprising Himanthalia Elongata, Laminaria Digitata, Laminaria Saccharina, Lithothamnium Calcareum, Palmaria Palmata, Porphyra Umbilicalis and Spirulina Maxima Extract from 3.0 to 12.0 wt. parts.

The problem is also solved by the composition for oral hygiene, which contains the above vitamin-mineral complex to strengthen tooth enamel in an effective amount and an acceptable carrier.

In particular embodiments of the invention, the composition may be a toothpaste or rinse composition, including a foam.

The composition may also be chewing gum.

The problem is also solved by toothpaste for oral hygiene, which contains the above vitamin-mineral complex to strengthen tooth enamel in an effective amount and an acceptable carrier containing substances selected from the group consisting of solvents, thickeners, surfactants, abrasive substances, emulsifiers , emulsion stabilizers, moisturizers and mixtures thereof.

In particular embodiments of the invention, in this paste, the carrier comprises water as a solvent, silicon dioxide as an abrasive substance, sodium carboxymethyl cellulose as a thickener, and at least one moisturizer selected from the group consisting of glycerin, sorbitol and polyethylene glycol as a humectant PEG-400, as a stabilizer of the emulsion polydon-A, as surface-active substances - sodium lauryl sarcosinate in the following ratio, wt.%:

Vitamin and Mineral Complex 2.0-10.0 Silica 1,0-60,0 Sodium carboxymethyl cellulose 0.1-10.0 Humidifier 0.5-70 Polydon A 0.1-10.0 Sodium Lauryl Sarcosinate 0.01-10.0 Water rest

The paste may additionally contain sodium monofluorophosphate, menthyl lactate, mica, zinc glucanate, menthol, isopropyl methylphenol, sweeteners, colorants, flavors and preservatives in the following ratio, wt.%:

Vitamin and Mineral Complex 2.0-10.0 Silica 1,0-60,0 Sodium carboxymethyl cellulose 0.5-4.0 Humidifier 0.5-70 Polydon A 0.1-10.0 Sodium Lauryl Sarcosinate 0.05-5.0 Sodium Monofluorophosphate no more than 1,5 Mentyl Lactate no more than 10.0 Mica no more than 10.0 Zinc Glucanate no more than 5,0 Menthol no more than 10.0 Isopropyl methylphenol no more than 0.1 Sweeteners no more than 15.0 Dyes no more than 10.0 Preservatives no more than 1,0 Water rest.

The invention consists in the following.

The components in the mineral-vitamin complex are natural substances found in nature or similar to natural substances.

So, hydroxyapatite is a biological calcium phosphate, devoid of impurities, it is the main mineral in the composition of tooth enamel (by 97%) and dentin (by 70%). Aminofluoride fluoride ions react with hydroxyapatite, the main building block of enamel, to form fluorapatite, which is significantly superior in strength and acid resistance to hydroxyapatite. Thus, fluoride ions accelerate enamel recovery processes (remineralization), slow down and stabilize the already begun carious process (at the initial stage). Fluoride ions also have a bactericidal effect on cariogenic and other bacteria.

Aminofluoride is a source of organic fluoride. Organic fluorides are the most effective form of fluoride.

It is advisable to use amorphous hydroxyapatite with a particle size of 20-80 nm as part of the complex. This form of hydroxyapatite does not have abrasive properties and is biocompatible with tooth tissue.

Pearl powder consists mainly of calcium carbonate, therefore it provides enamel strengthening due to the content of calcium salts. In addition to calcium carbonate, pearl powder also contains conchiolin, which includes amino acids, including glycine, valine, leucine, lysine, arginine, aspartame and glutamic acid, which also contribute to the restoration and regeneration of tooth enamel.

The complex also contains an extract of the plant Crithmum maritimum L (common name: "sea dill", "stone drill"). This plant belongs to the umbrella family, grows in rock cracks or in sands on the coast of the English Channel and the Atlantic, which determines the properties of the plant - a long creeping stem allows the plant to find the required amount of water in the rock cracks enriched with sea salts and other minerals it needs.

Critmum in large quantities contains mineral salts, oligoelements (zinc, iron, magnesium, copper, manganese) and vitamins E and C and has a strong antioxidant effect, which favorably affects the condition of periodontal tissues - periodontal diseases are associated with a decrease in the antioxidant potential of saliva and an increase in oxidative damage to the oral cavity.

Cryptum extract may be oil, glycerin, water, water-alcohol, propylene glycol, butylene glycol, etc.

Studies have also shown that all of the above components of the vitamin-mineral complex must be together and certain proportions must be observed between their contents in the complex, in this case all components of the complex have a synergistic effect on each other: we believe that hydroxyapatite in this composition due affinities with the substance of tooth enamel in combination with aminofluoride, among other things, performs the function of delivering micro and macro elements and vitamins from other components of the complex to the tooth nd enamel and around the mineral and vitamin complexes also exhibited significant antioxidant activity, all of which allows nonlinear improve the condition of tooth enamel and periodontal tissues.

When going beyond the claimed ratio between the components of the complex, the declared technical result is not achieved.

The added benefits of the claimed vitamin-mineral complex are given by the injected extracts of various seaweeds, since they contain a large amount of macro- and microelements, as well as vitamins. Algae contains a fairly large amount of calcium, iron and magnesium, which favorably affect the condition of tooth enamel and gums, as well as water-soluble salts of potassium and sodium (chlorides, sulfates). Also, all of these algae contain a large amount of provitamin A and vitamins B1, E and C, which are known to have a very positive effect on tooth enamel and periodontal tissue:

Himanthalia elongata contains vitamins A and C.

Laminaria digitata - especially rich in iodine in organic form and vitamins A, B1, B2, B12, C and D

Laminaria saccharina contains iodide and bromide salts, as well as a large amount of vitamin C.

Lithothamnium calcareum is a family of red algae: the skeleton of algae consists mainly of calcium carbonate and magnesium carbonate.

Palmaria palmata - red algae, rich in vitamins A, C, B6 and B12, iron, fluoride and sodium.

Porphyra Umbilicalis is a red alga rich in vitamins A and C.

Spirulina Maxima - a high concentration of vitamins A, B1, B2, B6, B12, E, D and K, as well as trace elements - magnesium, zinc, copper, iron, selenium.

Mineral-vitamin complex for strengthening tooth enamel is one of the components of the oral hygiene compositions.

Compositions for oral hygiene in the broadest sense are understood to mean a composition containing the above mineral-vitamin complex for strengthening tooth enamel as an active active principle in an effective amount and an acceptable carrier.

The term “mineral-vitamin complex for strengthening tooth enamel” in the present invention means a mixture of natural substances with a high content of minerals and vitamins that is non-toxic and provides the desired effect.

The effective amount of the mineral-vitamin complex may be different depending on the type of composition, the specific composition or combination of substances in the complex, etc.

This effective amount in any individual case can be determined by a person skilled in the art through routine experimentation.

For some embodiments of the invention (toothpaste), this amount is determined by us and is given in the claims.

An acceptable carrier is understood to be a carrier that allows the desired composition for oral hygiene to be obtained in the form of, for example, toothpaste, rinse liquid, tooth powder, gel, foam, chewing gum, etc. In this sense, the composition of the present invention can be a liquid - a solution of ingredients, such as a mouthwash, can be semi-solid - in the form of toothpaste or gel for cleaning teeth, or solid, for example, in the form of chewing gum.

If the composition is a liquid, for example, for rinsing the mouth, then an acceptable carrier, as a rule, is a water-alcohol mixture. To reduce the alcohol content in the mouthwash compositions or even completely eliminate it, solubilizers and other additives can be added to the rinse composition.

If the composition is a chewing gum, then an acceptable carrier includes synthetic or natural polymers with plasticizers, flavors, flavors, preservatives, sweeteners and other additives.

If the composition is a toothpaste, then an acceptable carrier includes solvents, thickeners, surfactants, abrasives, emulsifiers, solubilizers, moisturizers, sweeteners, flavorings, preservatives and mixtures thereof.

An analysis of the prior art shows that for toothpaste, the abrasive content in the paste, as a rule, ranges from 5 to 60 wt.%, Which corresponds to the content of abrasives in the inventive paste. Preferred abrasives for use in the present invention include silica-based materials, for which, in the following examples of the invention, silica grade Sorbosil (manufactured by PQ Corporation) and grade Tixosil (manufactured by Rhodia) were used. However, the invention is not limited to these substances as abrasive substances - alumina, calcium carbonate, sodium metaphosphate, potassium metaphosphate, tricalcium phosphate, dihydrated dicalcium phosphate, aluminum silicate, calcined alumina, bentonite or other silicon materials can also be used as abrasive substances. or combinations thereof.

An acceptable carrier useful for preparing a paste or rinse composition may contain a humectant. The humectant is preferably sorbitol, glycerin and / or polyethylene glycol PEG-400; however, you can also use other humectants and mixtures thereof with a molecular weight in the range of 200-1000. In known technical solutions, the concentration of the humidifier is usually from about 0.5 to about 70 wt.% The composition.

As a rule, thickeners are present in compositions for oral hygiene in amounts of up to 10 wt.%. Thickeners include natural and synthetic resins and colloids. In the present invention, the thickener is sodium carboxymethyl cellulose, in addition, the above-described silicon dioxide also functions as a thickener.

In any of the above compositions, any suitable flavoring or sweetening agents may additionally be present.

Various other substances can be incorporated into toothpastes, including preservatives, such as methyl paraben, methyl paraben sodium and chlorophilic compounds. Such excipients are introduced into the compositions in amounts that do not adversely affect the desired properties and characteristics.

The introduction of emulsion stabilizers into the paste ensures the dispersed state of fats and oils in aqueous emulsions.

Requirements for stabilizers: ensuring the stability of the composition, inertness to other components of the composition, non-irritating effect, non-toxicity, lack of unpleasant odor. All of these requirements are met by polydon-A, given in particular embodiments of the invention.

Toothpaste may contain surfactants and, in particular, anionic surfactants, such as sodium lauryl sulfate or sodium lauryl sarcosinate, which have a multifunctional effect: solubilizing, dispersing and wetting. In addition, their function is to formulate emulsions with other components of the oral hygiene compositions, including those with flavoring additives. In addition to the above surfactants, other anionic surfactants can also be used, as well as cationic, nonionic, amphoteric, zwitterionic or a mixture of these surfactants.

The effect of the presence of a surfactant is that it promotes foaming of toothpaste. The introduction of a surfactant with a high degree of foaming helps to create a sensation of effective cleaning of the oral cavity.

The oral hygiene compositions of the present invention can be prepared by mixing the ingredients.

Example 1

As the vitamin-mineral complex used the compositions shown in table 1.

All plant components were glycerin extracts.

For the manufacture of toothpaste as a vitamin-mineral complex used a complex with composition E, containing all extracts in equal amounts.

Toothpaste, the composition of which is shown in table 2, was prepared as follows: moisturizers, for example glycerin, sorbitol, polyethylene glycol, were dispersed in water with stirring in an ordinary mixer. Thickeners, a sweetener, a preservative, any salts that are active components, and foam stabilizers were added to the dispersion. Dyes and a pigment such as TiO ₂ were added to the gel phase. If the paste is not in the form of a gel, then any acid or base required to adjust the pH is added. These ingredients were mixed until a homogeneous phase was obtained. The mixture was then transferred to a high-speed vacuum mixer, in which an inorganic thickener based on silicon dioxide was added to the mixture, then successively abrasive based on silicon dioxide with other abrasives for use in the composition, a mineral-vitamin complex. Vitamin-mineral complex before its introduction was a clear, colorless liquid with a white suspension or sediment, with a weak specific taste and odor with a hydrogen index (pH), 5% rp = 7.0-8.0.

Flavors and surfactants were also added; any water-insoluble component was added along with a moisturizer. The resulting product in each case was a homogeneous semi-solid paste or gel product.

Cooked pastes were tested according to the following.

During control dental examinations, the state of oral hygiene, hard tissues of teeth, periodontal tissues and oral mucosa was determined by the following criteria.

Material and research methods.

The study involved 80 patients aged 18 to 55 years. After the initial dental examination, the patients were divided into two groups, equivalent in number, age and gender composition, and average indicators of dental status.

Group No. 1 (prophylactic) - 50 patients using toothpaste "according to the invention;

Group No. 2 (comparison group) - 30 patients using placebo toothpaste.

Patients were recommended to brush their teeth 2 times a day (morning and evening) for at least 3 minutes.

During control dental examinations, the state of oral hygiene, hard tissues of teeth, periodontal tissues and oral mucosa was determined by the following criteria.

Determination of the hygiene of the oral cavity

Using a solution to indicate plaque revealed its presence in the interdental spaces:

- I-th (upper right) III-th (lower left) quadrants of the dentition from the oral surface;

- II-th (upper left) and IV-th (lower right) quadrants of the dentition from the vestibular surface.

Codes and evaluation criteria for plaque: 0 - no staining, 1 - staining was detected.

The calculation of the API index was carried out according to the formula: API = (total points: number of teeth) × 100%

The calculation of the pH index was carried out according to the formula: PHP = (the sum of the PHP points): n, where n is the number of teeth (usually 6).

Interpretation of the result:

API Index Value Oral hygiene 25% optimal 25-39% satisfactory 40-69% unsatisfactory 70-100% unacceptable

In addition, the state of periodontal tissues was also assessed by determining the gingivitis index (GI), which is defined as follows - visually and using a periodontal probe, the gum condition was examined in the area of 6 teeth in 4 areas - distal, medial, in the center of the vestibular and lingual sections .

Criteria for evaluation:

0 - no inflammation

1 - slight inflammation in the gums (slight change in color, no bleeding when probing)

2 - moderate gingival inflammation (moderate hyperemia, edema, bleeding when probing)

3 - severe inflammation of the gums (severe hyperemia, edema, tendency to spontaneous bleeding)

Index calculation:

GI of the tooth = total points / 4

GI of an individual = sum of GI of teeth / n, where n is the number of teeth (usually 6)

Interpretation of the index:

GI Index Value Criteria 0.1-1.0 mild gingivitis 1.1-2.0 moderate gingivitis 2.1-3.0 severe gingivitis

The bleeding index SBI was determined as follows: probing of the periodontal sulcus of each tooth was performed using a periodontal probe:

- I-th (upper right) and III-th (lower left) quadrants of the dentition - from the oral surface;

- II-th (upper left) and IV-th (lower right) quadrants - from the vestibular surface.

Criteria for evaluation:

0 points - no bleeding;

1 point - the presence of bleeding of the gingival sulcus.

Index calculation:

Interpretation of results:

SBI Index Value Oral hygiene 10% permissible more than 10% unacceptable

Evaluation of the anticariogenic effect was carried out by visual identification of the centers of enamel demineralization (initial carious lesions) and determining the intensity of their staining.

For this purpose, the tooth was cleaned of plaque, dried, then a 2% methylene blue solution was applied to the surface of the demineralization site with a cotton swab for 2-3 minutes. Staining intensity was determined using a 10-point control scale. This procedure was performed during an outgoing examination and after 2 months of using toothpaste.

Evaluation of the whitening effect was carried out according to the following. During control dental examinations, the area of pigmented plaque was visually determined on the surfaces of the anterior teeth - incisors, canines according to the following criteria:

0 - No pigmented plaque;

1 - Pigmented plaque covers up to 1/3 of the surface of the teeth

2 - Pigmented plaque covers from 1/3 to 2/3 of the surface of the teeth

3 - Pigmented plaque covers more than 2/3 of the surface of the teeth

The calculation was made by summing the codes for each tooth under study.

We also performed tooth color comparisons using the Vita scale at the beginning and end of the study.

To assess the sensitivity of hard tissues of the teeth, the tactile sensitivity of the teeth was determined using a dental probe and temperature sensitivity using an air jet.

Indicators of tactile and temperature sensitivity were recorded as follows:

0 - Tooth does not respond to the action of the stimulus;

1 - The tooth responds to the action of the stimulus, but the patient does not require to stop the exposure;

2 - The tooth responds to the action, the patient demands to stop the impact;

3 - The tooth responds to the action, the patient demands to stop the impact, evaluating it as sharply painful.

The following parameters of tooth sensitivity were recorded:

- the average number of sensitive teeth;

- average tooth sensitivity.

The following results were obtained.

Hygienic condition of the oral cavity.

At the beginning of the study, the oral hygiene of all study participants was assessed as unsatisfactory. The differences in the mean pH and API indices between the groups at the initial examination were unreliable (P> 0.5).

After 1 month of regular use of the declared toothpaste, there was a significant decrease in the pH and API indices in the prophylactic group (p <0.001). In the comparison group, the change in the indices of hygiene indices for this period was unreliable (p> 0.5).

An examination carried out after 2 months revealed a further improvement in the hygienic condition of the oral cavity in the participants of the prophylactic group. By the end of the study period, the amount of plaque (PHR index, see table 3) decreased by 55.5%, on approximate surfaces (API index, see table 4) - 48.1% compared with the initial values (p <0.001) .

In the comparison group, the cleaning efficiency was significantly lower and amounted to 17.3% for smooth surfaces and 14.4% for approximate tooth surfaces.

Evaluation of anticariogenic efficacy.

At the beginning of the study, 125 foci of demineralization of enamel with varying degrees of staining were detected in 30 patients of the prophylactic group. The average number of foci of demineralization of enamel with varying degrees of staining was 4.16 ± 0.46, of which 1.03 ± 0.18 (24.8%) had a low degree of staining (1-3 points), 0.50 ± 0. 18 (12.0%) - a high degree of staining (6-10 points). The average staining intensity was 4.44 ± 0.27 points.

After 2 months of using the declared paste, the average number of foci of demineralization of enamel decreased and amounted to 4.00 ± 0.43.

At the same time, a redistribution of the intensity of their staining was observed: the number of initial carious lesions with a low degree of staining significantly increased (p <0.001), and with an average degree of staining, it significantly decreased (p <0.005) compared to the initial values. The number of foci of demineralization of enamel with a high degree of staining also decreased (p> 0.05).

4% of the initial carious lesions identified during the initial examination after 2 months were not stained with a 2% solution of methylene blue. This trend indicates a decrease in the permeability of enamel and the restoration of its surface layer after using the paste in accordance with the invention (see figure 1).

Evaluation of anti-inflammatory efficacy.

At the beginning of the study, most patients showed signs of inflammation of periodontal tissues in the form of bleeding gums, discoloration and swelling of the gums of varying severity.

The average GI index between the groups at the beginning of the study did not significantly differ (p> 0.5) and corresponded to moderate gingivitis.

After 1 month of regular use of the declared paste, the participants in the prophylactic group showed a significant (p <0.001) decrease in the average gingivitis index compared to the initial one. This trend continued after 2 months - the average GI index in the prophylactic group by the end of the study was 65.0% lower than the baseline.

In the comparison group for the same period, the change in the average GI value was unreliable (p> 0.5, see table 5).

Change in the degree of inflammation of the gums.

The initial mean values of the SBI gingival sulcus hemorrhage index in the participants of the prophylactic group and the comparison group did not significantly differ (p> 0.5).

After 1 month, in both groups there was a tendency towards a decrease in the average SBI, which was more pronounced in patients using the declared toothpastes, but the differences with the initial values were not significant (p> 0.5).

After 2 months, the participants in the prophylactic group showed a significant (p <0.001) decrease in bleeding of the gingival sulcus (by 52.7% compared with the initial data), while in the comparison group this indicator did not change significantly (p> 0.05 table 6).

Evaluation of whitening action.

At the initial examination in 30 (60%) patients of the prophylactic comparison group on the front teeth (incisors and fangs), a pigmented plaque of a dark brown color was revealed. The average scores did not significantly differ between the groups and amounted to 6.23 ± 0.70 and 5.99 ± 0.65, respectively (p> 0.5).

After 1 month of using the declared toothpaste in patients of the prophylactic group, a reliable (p <0.001) decrease in the amount of pigmented plaque was determined, and after 2 months it was 38.4% lower than the initial value (p <0.001). Moreover, in 7 patients, complete removal of pigmented plaque detected at the beginning of the study was observed. 3 participants of the prophylactic group observed tooth whitening by 1 tone on the VITA scale.

In patients of the comparison group, the amount of pigmented plaque during the study period remained virtually unchanged (p> 0.5).

Data on the effect of whitening are shown in table 7.

Evaluation of the effectiveness of the use of paste to reduce tooth sensitivity.

At the beginning of the study, 28 participants in the prophylactic group determined increased tooth sensitivity to tactile and thermal stimuli. 191 teeth (average number 6.82 ± 0.78) were detected, which responded to a tactile stimulus (probing) and 185 teeth (average number 6.38 ± 0.77), which reacted to a temperature stimulus (exposure to an air stream at 20 degrees Celsius) ) The initial mean tactile sensitivity was 1.72 ± 0.14.

After 1 month of using the proposed toothpaste, there was a significant decrease in tactile (p <0.001) and temperature (p <0.001)

sensitivity in points. The average number of teeth responding to tactile and thermal stimuli also decreased, but the differences with the initial indices at this stage were unreliable (p> 0.5).

By the end of the study, both tactile and temperature sensitivity in points (by 67.1 and 72.7%) and the number of teeth responding to tactile and temperature stimuli (by 56.0 and 57.8) significantly decreased (p <0.001) %) compared with the source data (tables 8 and 9). At the final examination, the reaction of the teeth to the tactile stimulus was completely absent in 3 patients, and to the temperature - in 6 patients with previously identified increased sensitivity of the teeth.

Table 1 Source components Component Structure The compositions of the vitamin-mineral complex, wt. parts: BUT AT FROM D E Hydroxyapatite Amorphous powder with a particle size of 20-80 nm one hundred one hundred one hundred one hundred one hundred Aminofto
read Liquid 15.0 30,0 20,0 20,0 20,0 Pearl powder Powder 0.1 0.2 0.1 0.15 0.15 Crithmum maritimum Glycerin extract 24.0 12.0 12.0 12.0 3.0 Himanthalia elongata Glycerin extract - 3.0 3.0 Laminaria digitata Glycerin extract ^- 3.0 Laminaria saccharina Glycerin extract - 12.0 3.0 Lithothamnium Calcareum Glycerin extract - 3.0 3.0 Palmaria palmata Glycerin extract - 12.0 3.0 Porphyra umbilicalis Glycerin extract - 3.0 Spirulina maxima extract Glycerin extract - 6.0 3.0 Minerals: Ca, Mg, F Ca - 40.0 Ca - 40.0 Ca - 40.0 Ca - 40.0 Ca - 40.0 P - 18.5 P - 18.5 P - 18.5 P - 18.5 P - 18.5 F - 0.6 F - 1.2 F - 0.8 F - 0.8 F - 0.8

table 2 Toothpaste Components The spread of the components of the toothpaste content, wt.% Toothpaste in accordance with the example, wt.% Function The degree of importance of the components Vitamin and Mineral Comp
Lex 2.0-10.0 4.06 A source of minerals and vitamins that helps strengthen tooth enamel Active component Silica 1,0-60,0 24 Abrasive and thickener Base component. Sodium Carboxymethyl
cellulase 0.1-10.0 (preferred 0.5-4.0) 0.8 Thickener, builder Base component. Sorby
thol 70% 0.5-70.0 28 Humidifier. It affects the texture of the product, giving it a special softness, plasticity. Base component. Glice
rin 0.5-70.0 5 Humidifier. Promotes the production of a plastic, thixotropic mass, stabilizes the foam, improves the taste of the paste. Base component. Polyethylene glycol PEG-400 0.001-10.0 four Humidifier. Regulates viscosity, is a stabilizer of emulsions. Base component. Polydon A 0.1-10.0 0.9 The stabilizer of emulsions and systems in general, for example, with a large number of active components. Thickener and gelling agent. Base component. Lauril
sodium sarcosinate 0.01-10 (preferred 0.05-5.0) 1,5 Surfactant Base component. Flavoring 0.01-5 (preferred 0.1-1.5.0) 1.4 Gives the toothpaste taste and smell, overlaps the taste and smell of the basic components. Base component. Monofluorophos
fat sodium 0.07-1.4% 1.01 Fluoride ion source Active ingredient, optional Xylitol 0.001-10.0 one Sweetener Base component. Mentyl Lactate 0.001-10.0 0.7 It has a strong cooling effect, provides a long-lasting feeling of freshness, while not smelling. It has a mild anti-inflammatory effect. Basic, optional function. Mica 0.01-10 0.4 Mica gives the paste a light shine. Basic, optional Methylparaben Sodium Salt 0.01-0.8 (preferred 0.1-0.4) 0.3 Preservative Base component. Zinc gluco
nat 0.001-5.0 0.3 Dental growth retardant antimicrobial Active component plaques and the formation of acidic products by microorganisms. It has astringent and anti-inflammatory effects. It also exhibits antifungal properties. availability optional Menthol 0.001-10.0 0.2 It has a strong cooling effect, provides a long lasting feeling of freshness, gives a characteristic fresh aroma Basic, optional function. Isopropyl methylphenol 0.001-0.1 0.1 Antibacterial effect Active ingredient, optional Sucralose 0.001-3.0 0.08 Sweetener Base component. Two-
titanium oxide 0.001-10.0 0.05 Dye, gives the paste opacity Base component, optional Krasi-
tel blue glitter-
the one 0.001-10.0 0.01 Dye Base component, optional Water is purified
naya rest rest Solvent Base component.

Table 3 Change in indicators of the pH index Group Initial inspection After 1 month P (in comparison
source) 2 months later P (compared to the original) Purification Efficiency% No. 1 (paste in accordance with the invention) 2.16 ± 0.14 1.49 ± 0.12 <0.001 0.96 ± 0.11 <0.001 55.5 No. 2 (placebo) 2.08 ± 0.12 1.72 ± 0.15 ≥0.5 1.66 ± 0.12 <0.05 17.3

Table 4 Changes in the API Index Group Initial inspection After 1 month P (in comparison
outcome
nym) 2 months later P (compared to the original) Purification Efficiency% No. 1 (paste in accordance with the invention
eat) 69.2 ± 3.9 51.4 ± 3.7 <0.01 35.9 ± 3.3 <0.001 48.1% No. 2 (placebo) 64.7 ± 3.70 57.9 ± 3.8 ≥0.5 55.3 ± 3.60 ≥0.5 14.5%

Table 5 GI Index Change Group Initial inspection After 1 month P (compared with the outcome
nym) 2 months later P (compared with the original) Anti-inflammatory efficacy No. 1 (paste in accordance with the invention) 1.2 ± 0.08 0.78 ± 0.06 <0.01 0.42 ± 0.06 <0.01 65.00% No. 2 (placebo) 1.17 ± 0.07 0.98 ± 0.08 > 0.5 1.03 ± 0.07 ≥0.5 11.90%

Table 6 Change in SBI Index Group Initial inspection After 1 month P (compared with the outcome
nym) 2 months later P (compared with the original) Bleeding reduction
ty gum No. 1 (paste according
Wii with the invention
eat) 49.7 ± 4.7 38.8 ± 4.7 > 0.05 23.5 ± 3.3 <0.001 52.70% No. 2 (placebo) 47.3 ± 4.5 42.1 ± 4.0 > 0.05 40.7 ± 3.9 0.005 13.900%

Table 7 Change the amount of pigmented plaque Group Initial inspection After 1 month P (compared with the outcome
nym) 2 months later P (compared with the outcome
nym) I clean
total efficiency No. 1 (paste in accordance with the invention) 6.23 ± 0.7 4.23 ± 0.55 <0.005 3.84 ± 0.42 <0.001 38.40% No. 2 (placebo) 5.99 ± 0.65 5.93 ± 0.62 > 0.5 5.86 ± 0.59 <0.005 2.20%

Table 8 Changing the tactile sensitivity of the teeth Group Initial inspection After 1 month P (compared with the outcome
nym) 2 months later P (compared with the outcome
nym) Efficiency The average number of sensitive
teeth 6.82 ± 0.78 5.11 ± 0.54 > 0.05 3.00 ± 0.38 <0.001 56.00% SCHIFF Scores 1.7 ± 0.16 1.07 ± 0.12 <0.01 0.56 ± 0.09 <0.001 67.10%

Table 9 Change in temperature sensitivity of teeth Group Initial inspection After 1 month P (compared with the outcome
nym) 2 months later P (compared with the outcome
nym) Efficiency The average number of sensitive
teeth 6.38 ± 0.77 4.79 ± 0.55 > 0.5 2.69 ± 0.4 <0.001 57.80% SCHIFF Scores 1.72 ± 0.14 1.06 ± 0.12 <0.01 0.47 ± 0.08 <0.001 72.70%

Claims (10)

1. Vitamin-mineral complex for strengthening tooth enamel containing hydroxyapatite and aminofluoride, characterized in that it additionally contains pearl powder and plant extract Crithmum Maritimum in the following ratio: per 100 parts by weight hydroxyapatite - 15.0-30.0 parts by weight aminofluoride, 3.0-24.0 parts by weight plant extract Crithmum Maritimum and 0.1-0.2 wt.h. pearl powder. 2. The complex according to claim 1, characterized in that it further comprises at least one algae extract selected from the group consisting of Himanthalia Elongata, Laminaria Digitata, Laminaria Saccharina, Lithothamnium Calcareum, Palmaria Palmata, Porphyra Umbilicalis and Spirulina Maxima Extract in an amount of from 3.0 to 12.0 parts by weight 3. Composition for oral hygiene, characterized in that it contains a vitamin-mineral complex for strengthening tooth enamel in accordance with any one of claims 1 and 2 of the formula in an effective amount and an acceptable carrier. 4. The composition according to claim 3, characterized in that it is a toothpaste. 5. The composition according to claim 3, characterized in that it is a rinsing composition. 6. The composition according to claim 3, characterized in that it is a foam rinsing composition. 7. The composition according to claim 3, characterized in that it is a chewing gum. 8. Toothpaste for oral hygiene, characterized in that it contains a vitamin-mineral complex for strengthening tooth enamel in accordance with any one of claims 1 and 2 in an effective amount and an acceptable carrier containing substances selected from the group consisting of solvents, thickeners, surfactants, abrasives, emulsion stabilizers, moisturizers and mixtures thereof. 9. The paste according to claim 8, characterized in that the carrier contains water as a solvent, silicon dioxide as an abrasive substance, sodium carboxymethyl cellulose as a thickener, and at least one humidifier selected from the group including glycerol, sorbitol and polyethylene glycol PEG-400, as a stabilizer of the emulsion polydon A, as surface-active substances - sodium lauryl sarcosinate in the following ratio, wt.%:
Vitamin and Mineral Complex 2.0-10.0 Silica 1,0-60,0 Sodium carboxymethyl cellulose 0.1-10.0 Humidifier 0.5-70 Polydon A 0.1-10.0 Sodium Lauryl Sarcosinate 0.01-10.0 Water Rest 10. The paste according to claim 9, characterized in that it further comprises sodium monofluorophosphate, menthyl lactate, mica, zinc gluconate, menthol, isopropyl methylphenol, sweeteners, colorants, flavorings and preservatives in the following ratio, wt.%:
Vitamin and Mineral Complex 2.0-10.0 Silica 1,0-60,0 Sodium carboxymethyl cellulose 0.5-4.0 Humidifier 0.5-70 Polydon A 0.1-10.0 Sodium Lauryl Sarcosinate 0.05-5.0 Sodium Monofluorophosphate no more than 1,5 Mentyl Lactate no more than 10.0 Mica no more than 10.0 Zinc Gluconate no more than 5,0 Menthol no more than 10.0 Isopropyl methylphenol no more than 0.1 Sweeteners no more than 15.0 Dyes no more than 10.0 Preservatives no more than 1,0 Water Rest

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