Composition for treatment and / or prevention of oral diseases

The combination of aqueous and lipophilic extracts of aspen bark with auxiliary agents in dental care products addresses the limitations of current products by providing enhanced, long-lasting prevention and treatment of oral diseases.

JP2025072430APending Publication Date: 2025-05-09OBSHCHESTVO S OGRANICHENNOJ OTVETSTVENNOST YU WDS
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Patent Information

Application Number
JP2025013706
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-08-24
Filing Date
2025-01-30
Publication Date
2025-05-09

AI Technical Summary

Technical Problem

Current dental care products often have limited therapeutic efficacy and short-lasting effects, failing to effectively prevent and treat a variety of oral diseases, such as tooth decay, periodontal disease, and oral inflammation.

Method used

A composition comprising an effective amount of an aqueous and lipophilic extract of aspen bark, combined with one or more auxiliary agents or carriers, providing a prophylactic and/or therapeutic effect for the treatment and prevention of oral diseases.

Benefits of technology

The composition achieves long-lasting, combined therapeutic and prophylactic effects, significantly enhancing the prevention and treatment of oral diseases compared to products using only aqueous extracts of aspen bark.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a composition that is effective in the treatment and / or prevention of various oral diseases, the composition having a complex effect and a long-lasting effect.SOLUTION: There is provided a composition for the treatment and / or prevention of oral diseases, comprising an effective amount of aqueous and lipophilic extracts of aspen bark and at least one or more auxiliary compounds for the treatment and / or prevention.SELECTED DRAWING: Figure 1
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Description

FIELD OF THEINVENTION

[0001] The present invention relates to health care, more particularly to dentistry, and is aimed at treating and / or preventing oral diseases. The present invention includes a composition for treating and / or preventing oral diseases, comprising an effective amount of an aqueous extract and a lipophilic extract of aspen bark, and at least one or more auxiliary compounds for treating and / or preventing. The present invention also includes the use of the composition for manufacturing a product for treating and / or preventing oral diseases. [Background technology]

[0002] According to the World Health Organization (https: / / www.who.int / ru / news-room / fact-sheets / detail / oral-health), oral diseases are the most common non-communicable diseases, causing pain and discomfort, leading to tooth loss and complications, and affecting people throughout their lives.

[0003] Oral diseases not only reduce the quality of life and cause cosmetic oral diseases, but in some cases, oral diseases (with their complications) can cause permanent incapacitation and lead to disability. Currently, about half of the world's population suffers from oral diseases, and the most common oral diseases are dental caries, periodontal disease, and diseases caused by oral injuries.

[0004] Treating such diseases is expensive and time-consuming: in many high-income countries, dental care accounts for, on average, 5% of all health care costs and about 20% of out-of-pocket health care costs (https: / / www.who.int / ru / news-room / fact-sheets / detail / oral-health).

[0005] Expensive and painful treatment methods result in irregular and inconvenient treatment for the dentist, which increases the likelihood of complications, tooth loss, serious diseases such as acute and chronic stomatitis, periodontal diseases such as gingivitis, periodontitis or periodontitis, dental caries, pulpitis, and conditions that contribute to oral inflammation and the formation of ulcers and erosions.

[0006] The solution to the above problems is timely and appropriate prevention as well as an effective combined therapy aimed at achieving a full oral cavity effect.

[0007] There are many different forms of dental care products and compositions available on the market today that are designed for regular use.

[0008] The most common of these are toothpastes, mouthwashes, gum balms, and non-abrasive gels for teeth and / or gums.

[0009] However, most of them only have cleansing and cosmetic effects.

[0010] Products containing active substances in their composition, especially anti-caries and / or anti-inflammatory agents, are generally characterized by a weak direct effect and a short duration of action after use, which generally indicates their low therapeutic effectiveness.Home preventive and therapeutic products do not provide sufficiently effective prevention. Summary of the Invention [Problem to be solved by the invention]

[0011] The aim of the present invention is to create a composition that is effective in the treatment and / or prevention of various oral diseases, with multiple and long-lasting effects, even at home. [Means for solving the problem]

[0012] To achieve this goal, the inventors have created a prophylactic and / or therapeutic composition comprising an effective therapeutic and / or prophylactic amount of an aqueous and lipophilic extract of aspen bark, and at least one or more acceptable carriers and / or adjuvants.

[0013] It has been found that the inclusion of aqueous extract and lipophilic extract of aspen bark in the composition characterized by one or more auxiliaries and / or carriers disclosed herein makes it possible to create an effective combined therapeutic and / or preventive long-acting product suitable for home use.In view of the experiments carried out, it can be asserted that the use of aqueous extract and lipophilic extract of aspen bark in the composition gives a significantly greater effect than the use of these extracts separately in the composition.

[0014] Further dental compositions containing aqueous extracts of aspen bark are known from the prior art.

[0015] For example, from patent RU2263499, a dental elixir is known which contains ethyl alcohol, a polyatomic alcohol, an extract of vegetable raw materials, an essential oil, a flavor additive, and drinking water, and which further contains lignans from lignan-containing plants, selenocysteine, as extracts of vegetable raw materials, black hawthorn, stevia leaves, turnip leaves, cerapadus leaves, and a water extract of aspen bark, as essential oils, tea tree oil and myrrh oil, and as a flavor additive, rebaudioside A.

[0016] The inventors of the RU2263499 patent indicate that the addition of aspen bark extract to the proposed composition is intended to enhance the remineralizing properties of this elixir, but the inventors do not investigate the remineralizing properties of this composition and do not disclose the amount required to obtain the remineralizing effect.

[0017] From author's certificate SU1814553 a composition for preventing periodontal disease is known, which comprises a plant extract, ethyl alcohol, menthol, flavourings and water, characterized in that it further comprises polyvinylpyrrolidone, sodium lauryl sulfate, a bactericide and an aqueous extract of aspen bark as plant extract in the following component contents to enhance activity by improving the permeability of the oral mucosa: aqueous extract of aspen bark 20.0-25.0 wt.%, polyvinylpyrrolidone 4.0-6.0 wt.%, sodium lauryl sulfate 1.0-3.0 wt.%, bactericidal preservative (propyl ether of paraoxybenzoic acid or sodium benzoate) 0.2-0.5 wt.%, ethyl alcohol (96°) 10.0-20.0 wt.%, menthol 1.0-1.8 wt.%, flavourings 0.7-1.5 wt.%, water up to 100 wt.%.

[0018] The document states that the aqueous extract of aspen bark contains glycosides (salicin, salicortin, etc.), up to 10% tannins, essential oils, phytoncides, amino acids, macro- and microelements, substances with P-vitamin activity (coumarins and flavonoids) and other biologically active substances. These have anti-inflammatory, anti-radiation, bactericidal and hemostatic, as well as astringent effects. The latter increase the permeability of the oral mucosa to biologically active substances, which improves the trophism of the periodontal tissues and has therapeutic, preventive and curative effects.

[0019] The therapeutic and prophylactic toothpaste "Osinka" known from patent RU2090183 contains plant extracts, chalk, glycerin, sodium carboxymethylcellulose, flavorings, AEROSIL, sodium lauryl sulfate, perfume oils, germicidal preservatives and water, gliderinine sodium salt, polyvinylpyrrolidone, xylitol-sorbitol syrup, as well as an aqueous extract of aspen bark.

[0020] The inventors point out that the hemostatic, healing, anti-radiation, antiseptic and astringent effects are brought about by the incorporation into the paste of an aqueous extract of aspen bark containing glycosides, tannins, essential oils, phytoncides and other biologically active components, as well as a licorice preparation.

[0021] The above-mentioned product contains only an aqueous extract of aspen bark as the active agent.

[0022] However, in addition to the water-soluble components, aspen bark contains substances that are soluble in organic solvents. Extraction of aspen bark with water generally releases tannins, organic acids, mineral salts, etc.

[0023] Extraction with organic solvents makes it possible to isolate fats, resins, waxes, essential oils, vitamins, as well as phenolic glycosides and flavonoids that cannot be obtained during aqueous extraction.

[0024] Diethyl ether extracts of aspen bark rinds are active against bacterial species such as Bacillus subtilus, Escherichia coli, Clavibacter ms michiganensis, Xanthomonas compestris, etc. (Natalia Mikhailovna Faustova, dissertation submitted in partial fulfillment of the requirements for the degree of candidate of chemical sciences, Chemical composition of aspen bark and wood, St. Petersburg 2005, p. 7). The phenolic glycoside and flavonoid fractions isolated from the ethanolic extract show antiulcer activity, i.e. they reduce the prevalence of ulcerative processes by 40% and 50%, respectively. For the active ingredient of such medicines, a dried aspen bark extract obtained by extracting the raw material with 40% ethanol is used (Chalmers, RA A Method for the Determination of Phosphorus in organic compounds. / R. A Chalmers., D. A Thompson. Anal. Chim. Acta. 1958. Vol.18, N4-6, pp. 575-577).

[0025] The composition according to the invention uses an aqueous extract and a lipophilic extract prepared by extracting aspen bark with liquefied carbon dioxide, which allows the most complete use of the components of aspen bark that are useful in the prevention of oral diseases.

[0026] The resulting composition is characterized by high efficacy in the treatment and / or prevention of various oral diseases, action against various pathogens of oral diseases, and long-lasting effect compared to a composition containing only an aqueous extract of aspen bark.

[0027] Use of such compositions reduces the likelihood of oral inflammation and the occurrence and / or resolution of conditions that contribute to the formation of ulcers and sores.

[0028] Such conditions include the action of pathogens causing bacterial infections of the oral cavity, chemical or thermal burns, and injuries to the oral cavity caused by sharp instruments.

[0029] The present invention also relates to the use of the described compositions for treating and / or preventing oral diseases, furthermore, the use of said compositions ensures a high-quality hygienic cleaning of the dental surfaces and the oral cavity as a whole, at the same time as the therapeutic and / or preventive effect.

[0030] The use of the claimed compositions makes it possible to increase the buffering capacity of saliva, normalize the pH of saliva, and increase the mineralizing capacity of saliva. These properties make it possible to use the compositions in patients with fixed orthodontic appliances during long-term orthodontic treatment.

[0031] The above-mentioned effects can be considered as technical results of the invention group.

[0032] Conditions and / or diseases against which the proposed compositions have a preventive effect include, but are not limited to, acute and chronic stomatitis, periodontal diseases such as gingivitis, periodontitis or periodontitis, dental caries, and pulpitis.

[0033] The compositions of the present invention also prevent the formation of plaque and / or tartar.

[0034] The compositions of the present invention also contribute to the healing of oral and dental lesions.

[0035] Alcohol extraction does not result in the lipophilic extract used in this composition, since it has a significant drawback: the lipid complexes are not extracted prior to alcohol extraction, which creates certain difficulties in isolating the product of interest and requires the introduction of a purification step (Natalia Mikhailovna Faustova, dissertation submitted in partial fulfillment of the requirements for the degree of candidate of chemical sciences, Chemical composition of aspen bark and wood, St. Petersburg 2005).

[0036] To prepare the lipophilic extract according to the invention, liquefied carbon dioxide gas is used.

[0037] Liquefied carbon dioxide is a colourless, easily mobile liquid, whose viscosity is 14 times lower than that of water and 5 times lower than that of ethyl alcohol. These properties of carbon dioxide distinguish it as the extractant with the best diffusion properties. The boiling point of liquefied CO2 is determined by the saturated vapor pressure and ranges from -56.6 to +31 °C, which creates a wide range of regulation for the low-temperature distillation of CO2 from the extract with almost no residue. This property makes it possible to quickly remove the extractant from the extract even with slight temperature effects and to preserve the extracted substances in their native state. The low values ​​of the heat of evaporation (condensation) show that the use of liquefied carbon dioxide in this technological cycle requires a relatively small consumption of energy for the evaporation and condensation of the solvent.

[0038] Liquefied CO2 is a strong and inert substance that shows complete chemical indifference towards the raw materials processed, the recoverable materials and the construction materials of the equipment. The dielectric constant of liquefied CO2 at 10°C is 2.6. This value of the dielectric constant is characteristic of a non-polar solvent, which makes it possible to extract non-polar or weakly polar substances from the rind. These include essential and fatty oils, carbonyl compounds, fat-soluble vitamins (A, D, K, F, E), sterols, alkaloids in the form of bases, etc.

[0039] Solvent extraction and distillation at low temperatures (up to 30°C) allow the extraction of essential oils and biologically active components in their natural state. Liquefied CO2 does not support the vital activity of microorganisms and fungi, which makes it possible to obtain a sterile extract. Extraction in a liquefied CO2 environment makes it possible to completely eliminate oxidation due to the lack of aeration.

[0040] The physicochemical characteristics of the solvents used contribute to extracting substances from plant material without substantially altering their properties. Distillation is carried out by reducing pressure, which converts the liquefied CO2 into a gaseous state, while releasing the CO2 extract (lipophilic extract).

[0041] The water extract is obtained using standard methods. Extraction can be carried out at room temperature or at elevated temperature, extraction can also be carried out using boiling water or aqueous solutions and standard containers and connections. If necessary, water or aqueous alkali or acid solutions can be used as the extractant, and the pH of the solution can be adjusted if necessary, the values ​​and methods of which are standard and known to experts in the field.

[0042] The extract according to the invention can be obtained by using any suitable technique, including techniques known to those skilled in the art.

[0043] If desired, the extract can be separated from negative compounds by filtration, chromatography, extraction or other standard techniques.

[0044] The ratio of the amounts of the aqueous extract and the lipophilic extract of aspen bark in the mixture is from 1:1 to 100:1, which can be expressed by ratios of 1:1, 2:1, 5:1, 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1 and ratios close thereto (within the error of the corresponding measurements).

[0045] The extracts can be premixed or added separately to the composition.

[0046] The proposed compositions are used to prepare cosmetic, preventative and / or therapeutic products.

[0047] The product can be made in the form of a toothpaste, a non-abrasive gel or a mouthwash.

[0048] For the preparation of the compositions according to the invention, auxiliaries such as thickeners, binders, abrasives (for toothpastes), humectants, foaming agents, flavoring agents, sweeteners, stabilizers, preservatives, anti-caries additives may be used.

[0049] Auxiliary substances or adjuvants are substances which contribute to giving the composition acceptable form and properties for cosmetic, prophylactic and / or therapeutic use.

[0050] The thickening agents may be various cellulose derivatives such as, for example, carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, alginic acids such as sodium alginate, carrageenan, xanthan gum, guar gum.

[0051] A composition in the form of a toothpaste according to the invention can be prepared, for example, using the following abrasives: hydroxyapatite, calcium phosphate, calcium, magnesium, aluminum silicate, silicon oxide, calcium, magnesium carbonate, sodium bicarbonate (baking soda).

[0052] The humectant in the composition may be glycerin, sorbitol, xylitol, polyethylene glycol or mixtures thereof.

[0053] Alkylamidobetaines, laurylsarcosinate salts, methyl cocoyltaurate salts, non-ionic surfactants such as PEG-40 hydrogenated castor oil or polysorbate-20 can be used as surfactants in the composition.

[0054] The following flavoring agents may be used in the composition: essential oils or extracts of mint, lemon balm, clove, eucalyptus, orange, lemon, sage, lavender, sandalwood, cypress, and the like.

[0055] Acceptable sweeteners in the proposed composition include, but are not limited to, saccharin or its derivatives, aspartame or its derivatives, stevioside, neohesperidin dihydrohalcone, glycyrrhizic acid, acesulfame potassium, perillartin, p-methoxycoric aldehyde, and xylitol.

[0056] Vitamin E, Vitamin C or their derivatives may be used as stabilizers in the composition.

[0057] Hydroxybenzoic acid esters, alkyldiaminoethylglycine hydrochlorides, parabens such as methylparaben, ethylparaben, propylparaben, sodium benzoate, potassium sorbate, ortho-5-cumen-ol can be used as preservatives in the composition.

[0058] Calcium glycerophosphate, magnesium glycerophosphate, sodium fluoride, potassium fluoride, sodium monofluorophosphate, potassium monofluorophosphate may be used as anticaries additives in the composition.

[0059] The auxiliary ingredients and / or carriers may be present in the composition from about 0.1% to about 99% wt., in some cases from about 0.1% to about 1% wt., in some cases from about 1% to about 10% wt., and in some cases from about 10% to about 99% wt.

[0060] The recommended adult dose of the active ingredient is 0.02-3%. The recommended dose of the extract is up to 65% of the adult dose for adolescents (up to 25 years), up to 10% for infants, and 50% for children 7-14 years. [Brief description of the drawings]

[0061] [Figure 1] Culture of Streptococcus mutans with the studied samples of toothpaste is shown. EXAMPLES

[0062] Example 1. Toothpaste preparation. A composition in the form of a toothpaste is prepared as follows. The required amount of water is weighed out with a measuring dispenser, then the water is filled into a mixer and heated to a temperature of 50-60°C, if necessary. Thickeners, humectants, sweeteners, preservatives, and anticaries additives are added to the water. The mixture is mixed until a homogenous gel is obtained, homogenized and vacuumed, if necessary. Abrasive fillers are added to the resulting gel, mixed until a homogenous mass is obtained, homogenized and vacuumed, if necessary. If necessary, the resulting mass is cooled to a temperature of 30-40°C and a mixture of surfactants, aqueous extract of aspen bark, stabilizers, and flavorings including CO2 extract of aspen bark is added. If necessary, it is mixed, homogenized, and vacuumed. The manufactured toothpaste is pumped into a storage tank and packed into tubes on a filling machine.

[0063] Example 2. Preparation of a non-abrasive gel. A composition in the form of a non-abrasive gel is prepared as follows. The required amount of water is weighed out with a measuring dispenser, then the water is filled into a mixer and, if necessary, heated to a temperature of 50-60°C. Thickeners, humectants, sweeteners, preservatives, and caries prevention additives are added to the water. The mixture is mixed until a homogeneous gel is obtained, homogenized and vacuumed if necessary. If necessary, the resulting mass is cooled to a temperature of 30-40°C and a mixture of surfactants, aqueous extract of aspen bark, stabilizers, and flavorings including CO2 extract of aspen bark is added. If necessary, mixing, homogenization, and vacuuming are performed. The produced gel is pumped into a storage tank and packed into tubes on a filling machine.

[0064] The compositions according to the invention can be prepared using standard techniques.

[0065] Example 3. Examples of compositions according to the invention. The following are examples of specific formulations of the compositions according to the present invention. These examples are illustrative in nature and not limiting. It is clear to the expert that the compositions having the characteristics of the present invention can be incorporated into other formulations that meet the characteristics of the present invention.

[0066] 1.Non-abrasive gel: [Table 1]

[0067] 2. Toothpaste: [Table 2]

[0068] The aqueous extract of aspen used to prepare the composition is characterized by a mass fraction of water and volatile substances of 86.6% and a mass fraction of tannins of 2.0%.

[0069] The lipophilic (fat-soluble) CO2 extract contained 4.35% water and volatile matter and 4.0% tannins.

[0070] The mixture of extracts is characterized by the presence in the preparation of phenolic glycosides (salicin, salicortin, tremuloicin), tannins, organic acids (oleic, linoleic, palmitic, capric, lauric, arachic, begen), triterpenoids, pectin, glycine betaine, flavonoids, waxes, sterols, carotenoids, polysaccharides, anthocyanins, glycolipids, and phospholipids.

[0071] Example 4. Antibacterial activity of the compositions. A comparative analysis of the antibacterial (Streptococcus mutans) activity of toothpaste 1 and toothpaste 2 was carried out using an automated system for monitoring the growth of microorganisms.

[0072] In the experimental part, a bioreactor "RTS-1" (BioSan, Latvia) with a mixing system "reverse spinner" was used. This system is designed to cultivate microorganisms and evaluate their growth in real time. The results were interpreted by measuring the optical density (OD) at a wavelength of λ = 850 nm.

[0073] Todd Hewitt Broth (M313), a liquid nutrient medium, was used to culture S. mutans. To culture the microorganisms in the bioreactor, a 50 ml tube with a membrane filter (TubeSpin SW) was used.

[0074] The test sample is As a control sample, a suspension of S. mutans and A sample of toothpaste 1; Toothpaste 2 sample and It is.

[0075] [Table 3]

[0076] For each experiment, a 5 ml amount of bacterial suspension was prepared separately in a sterile test tube with a capacity of 15 ml. The optical density of the resulting suspension was measured using a DEB-1B densitometer (BioSan, Latvia). The concentration of the test sample was 0.1 g / 1 ml.

[0077] When culturing clinical isolates of S. mutans in control samples, the adaptation phase lasted up to 8 hours. The adaptation phase corresponds to the period of physiological adaptation, including induction of enzymes, synthesis and assembly of ribosomes. The initial stationary phase lasted up to 4 hours, the initial cell growth phase 4-6 hours, and the accelerated growth phase 6-8 hours. After the logarithmic phase is indicated by a standardized sharp increase in optical density in the interval of 8-16 hours, a growth lag phase with a steep transition to stationary equilibrium is identified. The peak optical density index (index α) at ​​the end of the true logarithmic growth is 4.51 ± 0.3 mcf (16 hours), and the total index (index β) for the entire period of culture growth is 5.25 ± 0.3 mcf (16 hours). The stationary phase, characterized by an equilibrium between the processes of cell growth and cell division and cell death, was short (18-24 hours) and was followed by a gradual transition to the death phase of the culture. The average optical density at steady state equilibrium is 5.28±0.3 mcf.

[0078] Cultures of the bacterial population of S. mutans spiked with the studied samples of toothpaste 1 and toothpaste 2 (see Figure 1) are shown below.

[0079] Sample 2 The adaptation phase is significantly longer compared to the control sample: the first stationary phase lasts up to 6 hours, the first cell growth phase up to 8 hours, and the accelerated cell growth phase up to 14 hours. The accelerated cell growth phase is characterized by the onset of cell division, an increase in the total mass of the population and a constant increase in the growth rate of the culture, although the first signs of logarithmic growth were observed after 15 hours of the experiment. The period of logarithmic cell growth was shortened compared to the control sample and the rate of development of the new population, and therefore the changes in the optical density indicators were one order of magnitude lower. The indicator α is 4.15 ± 0.3 mcf (22 hours) and the indicator β is 4.25 ± 0.3 mcf (24 hours). The stationary equilibrium phase was longer than in the control sample, with an average optical density of 4.25 ± 0.3 mcf (24 hours).

[0080] Sample 1 According to the results of the cultivation of the bacterial population from sample 1, the adaptation phase lasted up to 10 hours. The transition of the culture to logarithmic growth was almost immediate without obvious growth acceleration. The indicator α was 4.54 ± 0.3 mcf (20 hours) and the indicator β was 4.25 ± 0.3 mcf (22 hours). There was a stationary equilibrium phase with a mean optical density of 4.55 ± 0.3 mcf (22-32 hours).

[0081] [Table 4]

[0082] Thus, the study of samples of toothpaste 1 and toothpaste 2 containing aspen bark extract with an automated evaluation of the growth curve of the bacterial population of S. mutans showed that antibacterial activity (bacteriostatic) was present, with sample 2 (containing an additional 0.3% of CO2 of aspen bark extract) showing the best kinetics of this activity against S. mutans, the main cariogenic species for the children's body.

[0083] Example 5. Efficacy of toothpaste in patients undergoing orthodontic treatment. In the particular case of the claimed composition, patients undergoing long-term orthodontic treatment were selected as a model for studying the effectiveness of the toothpaste.

[0084] This patient group is characterized by an increased intensity of caries progression and a pronounced severity of periodontal symptoms (severe gingivitis), due to the accelerated formation of dental plaque and its altered distribution architectonics of the oral cavity.

[0085] Sixty-five patients aged 13-15 years were studied. All subjects were trained in oral hygiene regimes and all performed professional hygiene. Subsequent hygiene was performed independently by the subjects using an orthodontic toothbrush and brush. Teeth brushing was performed three times a day. The subjects were divided into three groups.

[0086] The first group performed oral hygiene using a toothpaste containing an aqueous extract and a lipophilic extract of aspen bark (the composition of the toothpaste corresponds to sample 4 disclosed in Example 3); A second group performed oral hygiene using a toothpaste containing only an aqueous extract of aspen bark (the composition of the toothpaste corresponds to sample 1 disclosed in Example 4); The third group (control) performed oral hygiene using a toothpaste that did not contain an extract of aspen bark and did not focus on the specific composition of the toothpaste.

[0087] The patient's initial examination involves determining the hygiene effectiveness index (O'Leary) and the periodontal status index (PMA), which make it possible to assess the severity of gingivitis, the rate of salivary secretion, the viscosity of saliva and the buffering capacity of the oral fluids.

[0088] All patients treated with fixed orthodontic appliances were found to have poor oral hygiene indices. On average, the hygiene index for the three groups was 87.96 ± 1.33%. All patients had lower saliva viscosity than the average age, buffer capacity shifted to the acidic range, and saliva secretion rate lower than the baseline.

[0089] After 3 months, these indices were assessed in the patients. Below is the data from the study results for each group.

[0090] [Table 5]

[0091] [Table 6]

[0092] [Table 7]

[0093] The carried out study is shown below. During the study period, there was no significant change in the rate of saliva secretion for all groups of patients. In the subjects of the first and second groups, hygiene indexes are significantly reduced, which corresponds to a reduction in the amount of plaque and tartar. There is also a slight reduction in the O'Leary index in the patients of the control group. The subjects of the first and second groups also have a significant improvement in the condition of the gums. There is also a reduction in the viscosity of saliva in the patients of the first and second groups, which leads to a more complete cleaning of the tooth surface and the oral cavity, contributing to an increase in remineralization capacity. The use of the paste containing the extract of aspen bark leads to a shift in the pH of saliva to a more neutral range.

[0094] At the same time, based on the data in Tables 3 and 4, it can be seen that the composition characterized by the presence of two extracts of aspen bark, namely a lipophilic extract and an aqueous extract, demonstrates superior properties not only when compared to the control composition but also when compared to the paste containing only an aqueous extract of aspen bark.

[0095] In general, the method for preventing and treating oral diseases using the composition of the present invention comprises applying the composition to the tooth surface and finding the composition in the oral cavity and on the tooth surface for a period of 5 seconds to 5 minutes, preferably 30 seconds to 4 minutes, and preferably 1 minute to 4 minutes. In this case, a brush may also be used.

[0096] Thus, the compositions proposed within the scope of the present invention can be used for providing health care, effective prevention and / or treatment of oral diseases.

Claims

1. A composition for treating and / or preventing oral diseases, comprising an effective amount of an aqueous extract and a lipophilic extract of aspen bark, and at least one or more auxiliary substances for treatment and / or prevention.

2. The composition of claim 1, wherein one or more of the following substances are used as auxiliary substances: thickeners, binders, abrasives, wetting agents, foaming agents, flavoring agents, sweeteners, stabilizers, preservatives.

3. 3. The composition of claim 1 or 2, further comprising an anti-cavity additive.

4. 2. The composition of claim 1, wherein the weight ratio of the aqueous extract of aspen bark and the lipophilic extract is from 1:1 to 100:

1.

5. 2. The composition of claim 1, wherein the weight ratio of the aqueous extract of aspen bark and the lipophilic extract is from 1:10 to 100:

1.

6. 2. The composition of claim 1, wherein the weight ratio of the aqueous extract of aspen bark to the lipophilic extract is 1:1, 2:1, 5:1, 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1 or 100:

1.

7. The composition according to claim 1, wherein the therapeutic and / or preventive action is directed to acute and chronic stomatitis, periodontal diseases such as gingivitis, periodontitis or periodontitis, dental caries, and pulpitis.

8. 2. The composition of claim 1, wherein the therapeutic and / or preventive action is directed to burning foods, oral injuries caused by sharp objects, and chemical burns.

9. 2. The composition of claim 1, wherein the components are as follows: 【Table 1】

10. 2. The composition of claim 1, wherein the components are as follows: 【Table 2】

11. 2. The composition of claim 1, wherein the components are as follows: 【Table 3】

12. 2. The composition of claim 1, wherein the components are as follows: 【Table 4】

13. 2. The composition of claim 1, wherein the aqueous extract of aspen bark comprises up to 95% by weight water and volatile materials.

14. 2. The composition of claim 1, wherein the lipophilic extract of aspen bark contains up to 60% by weight of water and volatile materials.

15. Use of a composition according to any one of claims 1 to 14 for the manufacture of a product for the treatment and / or prevention of oral diseases.

16. 16. The use according to claim 15, wherein the product is a toothpaste, a mouthwash or a non-abrasive gel.

17. Use of a composition according to any one of claims 1 to 14 for treating and / or preventing oral diseases.

18. 15. A method for treating and / or preventing oral diseases, comprising applying a composition according to any one of claims 1 to 14 to a tooth surface and allowing said composition to remain in the oral cavity for a period of time ranging from 5 seconds to 5 minutes.

19. 20. The method according to claim 19, wherein the residence time of the composition is between 30 seconds and 5 minutes, preferably between 1 minute and 5 minutes.