WO2019190347A1 - Composition for whitening teeth - Google Patents

Abstract

The invention relates to a composition for use in the oral cavity, comprising a combination of the enzymes pectinase, xylanase and beta-glucanase, and also to a toothpaste and to a mouthwash containing said combination. The composition, the toothpaste and the mouthwash can be used for whitening teeth. The invention makes it possible to safely brighten dental enamel by means of targeted action on enamel-colouring melanoidins.

Description

 COMPOSITION FOR WHITENING TEETH

FIELD OF TECHNOLOGY

 Changing the color of teeth (discolorite) is a fairly common cause of a violation of the aesthetics of a smile. The prevalence of this condition in the structure of dental pathology is about 15%. According to Goryunova M.V. [1] acquired discolorites are found 3.2 times more often than congenital ones. In the structure of acquired discolorites, medium staining predominates (48.55%), and in the structure of congenital discoloration, strong (62.5%).

 The causes of disco- loritis can be the effects of internal factors: staining of teeth with hereditary lesions, systemic lesions, with the use of certain medications during odontogenesis, with lesions of the tooth pulp, under the influence of iatrogenic factors, etc. [2].

 A wide range of external factors affecting the color of enamel is also distinguished.

Enamel discoloration may occur due to the activity of various bacteria. So, S. Mutans form a plaque biofilm to which various chromophores are already attached. Actinomycetes, in turn, produce hydrogen sulfide, which, after reaction with iron cations in saliva, forms an insoluble precipitate of black ferrous sulfide. Serratia marcescens, Flavobacterium lutescens are less common, they are present in the oral cavity in only 3% of the population, leading to the formation of an orange plaque [19].

 Also, enamel can acquire a hue due to the penetration of various metals into the pellicle. Thus, the presence of copper leads to a greenish tint of enamel [20].

 The use of products rich in essential oils, as well as mouthwashes containing a significant amount of essential oils, leads to staining of enamel in yellow [20]. Similarly, violet staining appears due to the presence of potassium permanganate in mouthwashes [21].

Antibacterial components that are widespread in dental practice also lead to a discoloration of the enamel. Thus, the use of chlorhexidine and triclosan leads to a strong darkening of the enamel due to chemical reactions [22]. Superficial staining of the tooth also occurs when chromogens enter the tooth pellicle. The main types of food products that cause direct coloring are tobacco, tea, and coffee containing polyphenolic and other pigments [3-5]. The chemical nature of the pigments themselves is extremely diverse. For example, the most famous are tannins, which are found in large quantities in red wine.

 The most complex in nature are pigments, which are formed as a result of the Mayair reaction. Such reactions include the interaction of amino acids and sugars when heated, for example, in the process of roasting coffee beans. As a result, dark colored products are formed, indicating the occurrence of the Maillard reaction.

[27]. These products are called melanoidins and often have a complex branched polysaccharide structure, the destruction of which requires an integrated approach using a variety of approaches. In addition, food proteins and carbohydrates (polysaccharides) can also enter into the condensation and polymerization reactions in the pellicle, as a result of which a number of colored substances are formed [6]. The difficulty in the destruction of such molecules lies in the fact that they form complex structures consisting of parts of different molecules that differ in their chemical nature; therefore, to clarify melanoidins, it is necessary to develop complex approaches using several enzymes. Thus, the main groups of chromogens that cause enamel staining are bacteria, polyphenolic compounds, melanoidins, tannins, tobacco resins, and other substances (chlorhexidine, triclosan).

BACKGROUND

 Existing products on the market allow one way or another to solve the bleaching problem, but each of them is not without drawbacks.

The most popular are products that provide enamel brightening, primarily due to mechanical plaque removal. The disadvantage of this method is the possibility of damage to the pellicle and tooth enamel itself (as in the case of using coal as an abrasive [7-11]). At the same time, it is not always possible to achieve the desired whitening effect, since low molecular weight pigments penetrate deep into the enamel, contributing to the formation of persistent staining stains that cannot be removed using only mechanical action. Mechanical methods are more aimed at removing bacterial biofilms, but only in the early stages of formation. In the case of formation of more resistant deposits, professional enamel bleaching methods must be used. Whitening systems using reactive oxygen species (hydrogen peroxide and its derivatives) work more effectively in this regard, however, their use in toothpastes and rinses is limited, since they lead to the formation of eroded zones on the enamel surface. This, in turn, leads to increased sensitivity and the formation of caries [12]. Another way to overcome discolorite is to use alpha hydroxy acids (ANA acids). At the same time, the effectiveness of acid whitening has not yet been proven [13], and the effect of acids leads to the dissolution of enamel, and, as a result, increased tooth sensitivity, demineralization, erosion and caries. [14-16].

 Not so long ago, approaches to optical whitening based on the use of the blue pigment Covarine Blue (Cl 74160, Phthalocyanine Blue BN, etc.) were demonstrated, however, it is specific only to slightly colored enamel, and for most people with a strong pigmented coating does not give the desired whitening strength [17].

Enzymatic bleaching methods have a significant advantage, as they are safe for enamel and do not lead to its destruction, but the optimal composition of enzymes in products known on the market does not yet exist. Of the enzymatic methods that relate to gentle enamel whitening, several oral care inventions are known. However, most of these developments are aimed at breaking down protein plaque or protecting against caries. As such, bleaching systems, the main active component of which would be enzymes, do not exist. For example, papain and bromelain break down protein plaque, but they do not bleach pigments that penetrate deeper into enamel, which necessitates the use of other bleaching agents, such as peroxides. Also, most of the compositions are aimed at the complex cleavage of plaque and tartar in combination with a whitening effect, which leads to the need to use incompatible components. For example, the simultaneous use of proteolytic enzymes and any components of a protein nature, for example, amylase, cellulase, xylanase enzymes, leads to the destruction of the latter, since proteolytic enzymes break down proteins to short peptides and amino acid residues. Accordingly, all developments aimed at the simultaneous cleavage of protein and polysaccharide plaque turn out to be ineffective, since enzymes that break down polysaccharide plaque are of a protein nature. Moreover, inventions that seek to achieve the whitening effect, act due to the splitting of the bacterial plaque, which can again form, which eliminates the whitening effect. In addition, some of the patented complexes contain components that are incompatible with the components of toothpastes. For example, the simultaneous introduction of a carboxymethyl cellulose thickener and a cellulase enzyme leads to the destruction of the thickener, since this enzyme has substrate specificity for celluloses. This can lead to a decrease in the activity of the enzyme in the finished product, since part of it will be spent on a chemical reaction with a thickener.

In the patent of the Russian Federation RU2300366C2 (published on June 10, 2007), a two-component composition of a dentifrice is disclosed having an increased antibacterial effectiveness. Enzymes that can be used in the implementation of the disclosed composition include enzymes extracted from natural fruit products, such as well-known protein substances within the class of proteases, which break down or hydrolyze proteins. Proteolytic enzymes are obtained from natural sources or by the action of microorganisms having a nitrogen source and a carbon source. Examples of proteolytic enzymes that can be used in the practice of the present invention include naturally occurring enzymes papain (from papaya), bromelain (from pineapple), as well as serine proteases, such as chymotrypsin. Additional enzymes include ficin and alkalase. Papain derived from the papaya tree’s milky sap is a proteolytic enzyme preferred for use in the open composition. Enzymes that can be used in combination with proteolytic enzymes include carbohydrases, such as glucoamylase, alpha-amylase, beta-amylase, dextranase and mutanase, tannase, and lipases, such as plant lipase, gastric lipase, and pancreatic lipase. However, the disadvantage of this invention is the use of proteolytic enzymes in conjunction with carbohydraz class enzymes. Proteolytic enzymes destroy almost all proteins, including enzymes that are substances of protein nature. Thus, this invention contains components that inhibit the action of each other, which leads to a decrease or complete lack of effectiveness of the use of this composition. Moreover, the patent proposes the use of the glucoamylase enzyme, which does not have the ability to cleave polysaccharide molecules, since alpha amylase must be used for these purposes. It is also proposed to use tin salts in the composition, in particular tin fluoride, and it has a coloring effect on enamel. In the European publication EP2298904A1 (publ. 23.03.2011), xylanases and the possibility of their use in dentifrices, such as toothpastes, tooth creams, gels or tooth powders, means for washing the mouth, chewing gum, lollipops or candies. However, the use of only one enzyme is insufficient to obtain a whitening effect, since plaque has a more complex polysaccharide nature. Cleavage of only one polysaccharide will not lead to the desired whitening effect, since in order to remove pigmented plaque, it is necessary to destroy the structure of all molecules.

 In European application EP2280686A1 (publ. 23.03.2011) a-glucanases and the possibility of their use in dentifrices for preventing or reducing plaque are disclosed. The use of a-glucanases leads to a decrease in plaque, but since many chromogens penetrate deep into the enamel, it is not enough to get rid of polysaccharide plaque alone to obtain a whitening effect. The disadvantage of this invention is the targeted cleavage of only 1,6-a-glucoside bonds of dextran, and the polysaccharide coating consists of a mixture of polysaccharides (intracellular, consisting mainly of reserve polymers such as glycogen, amidopectin, and extracellular, which are dextrins and levanes), and for effective cleavage of plaque, it is necessary to use components that destroy all bonds of the polysaccharide matrix.

 The famous line of HappyDent toothpastes (At Krajina) (“Toothpastes for adults without fluoride”, on-line, <URL: http: //www.happy- dent.pro/ru/products/toothpastes_without_fluoride>), containing Amilolin® - a combination of the natural enzyme Amilosubtilin, a vitamin complex (B, C, E, PP, K, A vitamins) and minerals. The natural enzyme Amilosubtilin is a complex of enzymes (alpha-amylase, neutral and slightly alkaline proteinases, beta-glucanase, cellulase, xylanase), which prevent the formation of plaque and stone. Enzymes have a cleansing effect on the oral cavity, promote the breakdown of protein plaque.

The simultaneous combination of proteases and hydrolases leads to the destruction of the latter due to their protein nature; as a result, the complex loses its effectiveness in the formulation of toothpaste. The enzyme papain promotes the breakdown of protein plaque, but does not destroy enamel-staining melanoidins. In this connection, even with careful disposal of protein and polysaccharide plaque, the color of the enamel changes slightly. The newly developed whitening complex can significantly overcome the above-described disadvantages and is aimed at clarifying the products of the Maillard reaction, one of the products of which are melanoidins, which give a stable color to tooth enamel [18].

SUMMARY OF THE INVENTION

 The present invention relates to a composition for use in an oral composition comprising a combination of pectinase, xylanase and b-glucanase enzymes.

 In one aspect, the composition of the invention may further comprise a filler.

 In another aspect, the composition of the invention may contain 0.05-0.15% by weight of pectinase, 0.05-0.15% of May. xylanases, 0.01-0.05% of May. beta-glucanases and up to 100% of May. filler.

 In another aspect, the composition of the invention may contain about 0.2% by weight of pectinase, about 0.2% of May. xylanase, about 0.1% in May. beta-glucanases and up to 100% of May. filler.

 In another aspect, the composition of the invention may contain 0.1-1.0% by weight pectinase, 0, 1-1, 0% May. xylanase, 0.05-0.6% in May. beta-glucanases and up to 100% of May. filler.

 In yet another aspect, the composition of the invention further comprises phosphates: calcium glycerophosphate, calcium pyrophosphate, tetra potassium pyrophosphate, tetrasodium pyrophosphate, disodium pyrophosphate, tricalcium phosphate, trimagnesium phosphate, sodium tripolyphosphate, sodium hexametaphosphate.

 In another aspect, phosphates are contained in the composition in an amount of 0.5-4.5% in May.

In another aspect, phosphates are contained in the composition in an amount of 0.5-3.0% in May.

In another aspect, phosphates are contained in the composition in an amount of 0.5-1.0% May.

The present invention also relates to a toothpaste containing the composition of the invention.

 The present invention also relates to an oral rinse containing the composition of the invention.

The present invention also relates to the use of a composition of the invention for whitening teeth. The present invention also relates to the use of the toothpaste of the invention for whitening teeth.

 The present invention also relates to the use of the rinse aid of the invention for whitening teeth.

DETAILED DESCRIPTION OF THE INVENTION

 The claimed complex tooth whitening agent contains a combination of enzymes of the pectinase, xylanase and b-glucanase groups.

 Pectinase is a general term for pectin-cleaving enzymes. Includes pectoliasis, pectosis and polygalacturonase. It belongs to a heterogeneous group of enzymes that catalyze the degradation of pectin. In the composition of pectinases, the following groups of enzymes can be distinguished:

 Pectin esterases (enzyme class 3.1.1.11, pectin methyl hydrolases) catalyze the elimination of pectin methyl groups to form pectic acid.

 Polygalacturonases (enzyme class 3.2.1.15) hydrolyze a-1,4-glycosidic bonds in a chain of pectin substances. They are divided into polymethylgalacturonases (act on pectin) and polygalactronases (act on pectic acid).

 -Pectanliases (enzyme class 4.2.2.10) catalyze the non-hydrolytic cleavage of pectin. Pectolytic preparations are divided into two groups depending on the pH optimum of enzyme activity: acidic and alkaline. These properties determine the possibility of using pectinases for various industries. Acid pectinases are used in the production of juices and wines, and alkaline pectinases are used in the textile industry.

Many microorganisms are considered as possible producers of pectinases: microscopic fungi, yeast, and bacteria. Pectinases obtained with the help of fungal strains of producers are active at acidic pH values, while alkaline enzymes are produced by bacterial strains. The most common technology is the production of pectinase from Aspergillus niger using methods of deep and surface cultivation. It is noted that the use of solid-phase fermentation methods for the cultivation of fungal producer strains allows one to obtain a high yield of concentrated pectinases at a lower cost than with deep fermentation. Cultivation conditions using the surface cultivation method are most optimal for the growth of Aspergillus sp. To obtain bacterial pectinases, both cultivation methods are used. Despite the fact that for the growth of bacteria the use of deep cultivation is optimal; an increase in the yield of pectinases with the use of solid-phase fermentation has been reported. In superficial cultivation of Bacillus sp. DT7 on wheat bran shows a higher yield of alkaline thermostable pectinase. [23].

 Xylanase is a general term for enzymes involved in the degradation of a heterogeneous polysaccharide, xylan. The main enzyme is endo-1,4-xylanase (enzyme class 3.2.1.8), which catalyzes the decomposition of xylan to xylo-oligosaccharides. Other enzymes such as xylosidase, b-arabinofurazidase, glucuronidase and esterase (xylanacetyl esterase and feryloyl esterase) perform the complete hydrolysis of xyloligosaccharides to monomers. Xylanases are glycoproteins with a molecular weight of 6-80 kDa. Enzymes are active in the temperature range 40-60 ° C and pH 4, 5-6, 5. [24].

 b-Glucanase (beta-glucanase) is a generic term for enzymes that break down non-starch polysaccharides (LCPs) of hemicelluloses (glucans). It belongs to the group of enzymes catalyzing the cleavage of b-glucans with b-1,2-, b-1,3-, b-1,4- and b-1,6-bonds. All b-glucanases are acidic proteins containing a large number of carboxyl and hydroxyl groups. These enzymes are glycoproteins; they have carbohydrate fragments containing residues of mannose, glucose, galactose [25]. Trichoderma, Aspergillus, Penicillium, Bacillus, etc. are used as producer strains in the production of beta-glucanase.

Surprisingly, it was found that the combination of pectinase, xylanase and beta-typucanase in the composition for the oral cavity has certain advantages: effective splitting of melanoidin molecules, safe whitening. The invention makes it possible to safely clarify tooth enamel by targetedly affecting enamel-staining melanoidins. In addition, the proposed complex is capable of cleaving unpolished polysaccharide plaque, thereby preventing the formation of a cariogenic biofilm, which is a prevention of caries prevention. The inventors also unexpectedly found that the additional use of a component from phosphate groups enhances the whitening effect of the enzymatic complex (synergism). So, it is allowed to use components from the group of phosphates, such as calcium glycerophosphate [28–29], calcium pyrophosphate [26], tetracal and tetrasodium pyrophosphate, as well as disodium pyrophosphate [30–32], tricalcium and trimagnesium phosphates [33–37], sodium tripolyphosphate [38-39], sodium hexametaphosphate [40]. In the framework of the present disclosure, the invention relates to a composition for use in an oral composition comprising a combination of pectinase, xylanase and b-glucanase enzymes.

 In one aspect of the present disclosure, a composition of the invention may further comprise an excipient.

 In another aspect of the present disclosure, a composition of the invention may comprise 0.05-0.15% May. pectinases, 0.05-0.15% of May. xylanases, 0.01-0.05% of May. beta-glucanases and up to 100% of May. filler. Preferably, the composition according to the invention may contain about 0.1% by weight of pectinase, about 0.1% of May. xylanase, about 0.025% wt. beta-glucanases and up to 100% of May. filler.

 In another aspect of the present disclosure, a composition of the invention may comprise about 0.2% by weight pectinase, about 0.2% May. xylanase, about 0.1% wt. beta-glucanases and up to 100% of May. filler.

 In another aspect of the present disclosure, a composition of the invention may comprise 0.1-1.0% by weight pectinase, 0.1-1.0% by weight. xylanase, 0.05-0.6% wt. beta-glucanases and up to 100% of May. filler. Preferably, the composition according to the invention may contain 0, 3-0, 8% wt. Pectinase, 0.3-0, 8% wt. xylanase, 0.2-0, 4% of May. beta-glucanases and up to 100% of May. filler. More preferably, the composition of the invention may contain 0.5% by weight pectinase, 0.5% May. xylanase, 0.3% in May. beta-glucanases and up to 100% of May. filler.

 In yet another aspect of the present disclosure, the composition of the invention further comprises phosphates that may be selected from the group: phosphates: calcium glycerophosphate, calcium pyrophosphate, tetracal potassium and tetrasodium pyrophosphate, as well as disodium pyrophosphate, tricalcium and trimagnesium phosphates, tripolyphosphate sodium, hexametha-sodium phosphate.

 In another aspect of the present disclosure, phosphates are contained in the composition in an amount of 0.5-4.5% May. Preferably, the phosphates may be contained in the composition in the amount of 2.5-3.0% in May. Preferably, the phosphates may be contained in the composition in an amount of about 2.75% May.

In another aspect of the invention, phosphates are contained in the composition in an amount of 0.5-3.0% May. Preferably, the phosphates may be contained in the composition in an amount of 1.5-2.5% of May. More preferably, phosphates may be contained in the composition in an amount of about 2.0% in May. In another aspect of the present disclosure, phosphates are contained in the composition in an amount of 0.5-1.0% May. Preferably, the phosphates may be contained in the composition in an amount of 0.6-0, 9% May. More preferably, phosphates may be contained in the composition in an amount of about 0.75% May.

 In the framework of the present disclosure, the invention also relates to a toothpaste containing the composition of the invention.

 In the framework of the present disclosure, the invention also relates to a mouthwash containing the composition of the invention.

 In the framework of the present disclosure, the invention also relates to the use of a composition according to the invention for tooth whitening.

 In the framework of the present disclosure, the invention also relates to the use of the toothpaste according to the invention for whitening teeth.

 In the framework of the present disclosure, the invention also relates to the use of a rinsing agent according to the invention for tooth whitening.

EXAMPLES

 The examples included in the present description are not limiting of the claimed invention and are given only for the purpose of illustrating and confirming the achievement of the expected technical results. These examples are one of many experimental data obtained by the inventors that confirm the effectiveness of the agent according to the invention for whitening enamel.

Example 1. Proof of the effectiveness of the components of the complex in vitro. Evidence of the effectiveness of the complex was carried out on stained samples imitating tooth enamel. Initially, samples imitating tooth enamel were prepared, then they were artificially stained with a saturated solution of tea and coffee. For this, 40 g of roasted coffee beans were ground to a powder state, 50 ml of water heated to 96 ° C were added, and stirred for 10 minutes. Then the resulting mixture was filtered, and 50 ml of water heated to 99 ° C was added to the precipitate, and stirred for another 10 minutes. After filtering off the precipitate, both filtrates were combined. A high-grade coffee solution was obtained in which the samples were placed (one sample was left unpainted for control) for 24 hours at a temperature of 25 ° C. To obtain samples with tea plaque, 20 g of ground black tea (not aromatized) were placed in a clean glass and 100 ml of water heated to 99 ° C was added. It was left for 20 minutes with constant stirring, then it was filtered off and samples were added to the filtrate (one sample was left unpainted for control) for staining for 24 hours at a temperature of 25 ° C. After staining, the samples were washed under running water, dried and photographed to obtain initial staining brightness values.

 Next, a buffer solution with pH = 6.8 was prepared. To obtain 100 ml of the buffer solution, 51.0 ml of 27.2 g / l potassium dihydrogen phosphate solution was mixed with 49.0 ml of 71.6 g / l disodium hydrogen phosphate solution. The resulting solution was stored at a temperature of 2 to 8 ° C.

 To determine the bleaching ability of the studied enzymes, buffer solutions of enzymes were prepared (Table 1).

Table 1. The percentage of enzymes in the samples

 5 samples of tea and coffee plaque were placed in solutions a 1-5, and left for 6 hours at 37 ° C. Then, the samples were washed under running water, photographed, and the difference in brightness of the samples before and after was determined using the ImageJ software. The higher the indicator of the difference in brightness, the stronger the whitening effect (Table 2).

Table 2. The results of the bleaching ability of the samples

Thus, the authors proved the over-summarized (synergetic) effectiveness of the proposed composition and showed that the proposed components of the complex, taken separately, do not have a bleaching effect. Visible and significant whitening effect is achieved only with the joint use of enzymes.

 Example 2. The study of the comparative effectiveness of an in vitro enzymatic complex with known bleaching systems. The selected components of the complex have a joint whitening effect, therefore, the authors compared the developed bleaching complex with peroxide systems with high whitening efficiency. Table 3 shows the groups for comparing the whitening activity.

Table 3. Composition and description of study groups

 Staining of samples, preparation of a buffer solution, an enzyme solution was carried out in a similar manner described in Example 1.

One coffee-coated sample C) was placed in 30 ml of buffer IV, and another tea-coated (T) sample was placed in another glass with 30 ml of buffer IV. Three samples (C and T) were placed in different glasses in 100 ml of 3% solution III and in different glasses in 100 ml of solution III so that the samples did not come into contact with each other. Similarly, 3 samples of different types of staining were placed in 100 ml of a solution of the enzymatic complex I. The glasses were covered with filter paper or glass to prevent dust and other contaminants. Three samples were placed in a suspension of toothpaste II (three samples C and 7), tightly closed with a lid to prevent drying of the toothpaste. All samples were incubated at 37 ° C for 6 hours. Samples were taken from solutions, washed with running water and dried. Toothpaste was washed off the samples прот with running water, without wiping the surface, and also dried. The clarified samples were photographed, and the change in the total color intensity of the samples before and after was analyzed using the ImageJ software in monochrome mode. The results are presented in Table 4. Table 4. The results of the comparative whitening ability of the enzymatic complex

 Thus, the comparative effectiveness of the enzymatic bleaching system, as well as the most powerful peroxide to date, has been shown. The experimental results show that when using the enzymatic complex, a visible whitening effect is achieved. The strong whitening effect of the peroxide system is offset by its negative effect on the enamel, which leads to demineralization and caries [12]. This enzymatic complex of prolonged action and with prolonged use gives a safe and visible result of whitening, without harming the state of the oral cavity.

 Example 3. Evidence of the in vitro whitening efficacy of an enzymatic complex in oral care compositions. To prove the effectiveness of whitening, a toothpaste formulation with an enzymatic complex (1), a formulation with an enzymatic complex and calcium pyrophosphate (2), a basic formulation that does not contain bleaching components (3) were developed. Samples were stained similarly to Example 1 (Tables 5-7).

Table 5. The composition of the studied composition for the care of the oral cavity containing the enzymatic complex

Table 6. The composition of the studied composition for caring for the oral cavity containing the enzymatic complex and calcium pyrophosphate

Table 7. The composition of the base composition of the studied composition for caring for the oral cavity that does not contain active whitening components

One stained sample from each staining group (tea and coffee) was left as a control, 5 samples were cleaned with a brush and composition (1), 5 samples were cleaned with a brush and composition (2), 5 samples were counted with a brush and composition (3), 5 samples were brushed and brushed. To obtain reliable results, a device was made that simulated brushing your teeth. After cleaning, the samples were washed under running water and dried. The clarified samples were photographed, and the change in the total color intensity of the samples before and after was analyzed using ImageJ software in monochrome mode. The results are shown in Table 8. Table 8. The results of the comparative whitening ability of the compositions for the care of the oral cavity

 As a result of the experiment, it was proved that the developed complex effectively brightens tea and coffee plaque. When calcium pyrophosphate is added, an intensification of the whitening effect appears (synergistic effect).

 Example 4. Evidence of the in vivo whitening efficacy of an enzyme complex in oral care compositions. For clinical trials, the formulation of products containing the enzymatic complex was developed (Table 9).

Table 9. The composition of the studied composition for caring for the oral cavity containing the enzymatic complex

 A one-cent comparative randomized prospective study was conducted. The bleaching effect of the complex was determined on a Vitapan scale after 4 weeks of product use.

 The study involved male and female volunteers who gave informed consent, aged 18 to 65 years. The number of teeth is at least 20.

 Estimated duration of study participation in the study 28 ± 3 days. The maximum duration of participation in the study for each volunteer was 31 days. The minimum duration of participation in the study for each subject was 25 days. Volunteers used 1 product for a visit for 2 minutes. Further, patients used the test products 2 times a day for 2 minutes, morning and evening, for 4 weeks with an intermediate visit to the dentist on the 14th day of the study. Before and after application of the product, 6 upper front teeth were evaluated on a Vita scale (Table 10).

Table 10. The results of the whitening efficiency of the enzymatic complex according to the results of in vivo studies

 The study revealed a clarifying effect, depending on the original color of the enamel. Volunteers who had an enamel color darker than Bl, A1 and C1 were included in the study (a total of 30 people). It was found that enamel clarification by 1.5-2 tones occurred in 70% of volunteers (21 people), by 1 tone in 23% (7 people), 0-0.5 tones in 7% (2 people).

 It is important to note that the study did not reveal an increase in the sensitivity of enamel in any of the volunteers. In addition, in patients with sensitive enamel there were no complaints of increased tooth sensitivity.

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 27. https: // pubs. acs. org / doi / pdf / 10.1021 / bk-l 983-0215. chOOl

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Claims

CLAIM

1. Composition for use in an oral composition containing a combination of pectinase, xylanase and b-glucanase enzymes.

 2. The composition of claim 1, further comprising a filler.

 3. The composition according to p. 2, containing,% May .:

 pectinase 0.05-0.15;

 xylanase 0.05-0.15;

 beta glucanase 0.01-0.05;

 filler up to 100.

 4. The composition according to any one of paragraphs. 1-3, additionally containing phosphates.

 5. The composition according to claim 4, in which the phosphates are selected from the group: calcium glycerophosphate, calcium pyrophosphate, tetra potassium pyrophosphate, tetrasodium pyrophosphate, disodium pyrophosphate, tricalcium phosphate, trimagnesium phosphate, sodium tripolyphosphate, sodium hexametate phosphate.

 6. The composition according to p. 5, in which phosphates are contained in an amount of 0.5-4.5% in May.

 7. The composition according to p. 5, in which phosphates are contained in an amount of 0.5-3.0% in May.

 8. The composition according to p. 5, in which phosphates are contained in an amount of 0.5-1.0% of May.

 9. Toothpaste containing the composition according to any one of paragraphs. 1-8.

 10. Mouthwash containing the composition according to any one of paragraphs. 1-8.

 11. The use of the composition according to any one of paragraphs. 1-8 for teeth whitening.

 12. The use of toothpaste according to claim 9 for whitening teeth.

 13. The use of rinse according to claim 10 for whitening teeth.