RU2708624C1 - Method of treating periodontitis - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention refers to dentistry and can be used for treating chronic periodontitis. What is presented is a method for treating periodontitis using a paste based on a biologically active additive "Yagel". Paste is prepared by simple mixing of components with the following composition, in wt%: "Yagel" biologically active additive, dry residue – 10–11; zinc oxide – 59–60; oil solution of vitamin "A" – 29–30. Pasta is introduced into the pathological periodontal pocket daily or every second day. Daily procedure includes no more than one paste application, the therapeutic course makes 7–10 procedures, and for its prevention it is repeated 3-4 times a year with interval of 2–3 months under indications.EFFECT: use of the method provides effective treatment of chronic localized and generalized periodontitis, provides secondary prevention of complications of pathological processes in periodontium tissues due to antibiotic properties of therapeutic paste produced based on dietary supplements "Yagel".1 cl, 4 tbl

Description

The invention relates to medicine, namely to dentistry, and can be used to treat periodontitis.

A known method of treating periodontitis using medical paste (see RU No. 2026062, class A61K 6/00, publ. 09/01/1995) containing antibacterial substances, oily 30% solution of vitamin "E", chymotrypsin, dibunol, zinc oxide , and as antibacterial substances, dioxidine, zinc sulfate and cobalt sulfate are additionally used in it.

The presence of antibacterial substances determines the achievement of a certain clinical effect in the known method, however, its local use can cause an allergic reaction in patients with a multifactorial form of sensitization and body allergy. In addition, there are difficulties in the preparation of this paste, which are associated with the presence of numerous constituent components. In this case, accidental ingestion or ingestion of certain active components (for example, dibunol, dioxidine, zinc sulfate and cobalt sulfate) into the gastrointestinal tract can cause dysfunction of the central nervous and cardiovascular systems, upset the gastrointestinal tract, as well as the urogenital and endocrine systems.

Known pharmaceutical composition for the treatment and prevention of dental diseases (see RU No. 2630612, class A61K 31/6615, publ. 09/11/2017) containing zinc oxide, phytic acid or its salts, glucosamine in salt form and excipients, also available in soft form in the form of a paste for the treatment of periodontitis.

Known dental paste is characterized by a complex composition, which limits its widespread use. Moreover, the local use of the paste significantly increases the likelihood of developing an allergic local and general reaction, especially in patients with a multifactorial form of allergy. Accidental ingestion or ingestion of certain active components (e.g., zinc oxide, phytic acid and its salts, glucosamine) into the gastrointestinal tract can cause dysfunction of the central nervous and urinary systems. In addition, there are relative contraindications for the use of therapeutic paste during pregnancy and lactation.

A known method using a medicinal product for the treatment of dental diseases (see RU No. 2148422, class A61K 41/00, publ. 05/10/2000), which is a composition for periodontal dressing, including zinc oxide, temppro paste, lorinden-C ointment, laser activated sea buckthorn oil.

The disadvantages of the treatment with the described drug include its preparation, which requires special medications (temppro ointment, lorinden-C ointment) and the use of laser radiation. The drug is intended for use with a bandage, which causes discomfort and negative consequences in the form of a gag reflex and salivation.

The problem to which the claimed invention is directed is expressed in achieving a significant reverse development of the inflammatory and destructive process of periodontal tissues with the disappearance of symptoms of bleeding and swelling of the gums in patients with chronic periodontitis.

The technical effect obtained when solving the problem is expressed in obtaining a method for the treatment of chronic periodontitis in patients with external use of a paste based on the “Yagel” dietary supplement from Cladonia lichen thallus extract containing usnic acid, which has an antibiotic effect.

To solve this problem, a method for the treatment of periodontitis using paste based on the biologically active additives "Yagel", obtained by mixing the components with the following composition, in mass. %: BAA "Yagel", dry residue - 10-11; zinc oxide - 59-60; Vitamin A oil solution - 29-30, while the treatment is built taking into account the prevalence of periodontitis, the use of the method of increasing the effectiveness of treatment of inflammatory processes of periodontal tissues and includes daily or every other day after the paste is inserted into the pathological periodontal pocket with local and generalized tissue lesions periodontal inflammatory and destructive nature, while the daily procedure includes no more than one paste, the course of treatment is 7-10 procedures and for prevention and repeated 3-4 times a year with an interval of 2-3 months of testimony. For this, a disposable syringe with a disposable cannula is used, and the pathological periodontal pocket is introduced into the previously isolated cotton swabs with the paste. After the inflammatory process of periodontal tissues subsides, patients are treated according to indications with surgical methods of treatment, which include open curettage or patchwork operations. At the end of the procedure, recommendations are given on oral hygiene.

A comparative analysis of the characteristics of the claimed solution with the signs of analogues indicates the conformity of the claimed solution to the criterion of "novelty."

The features of the characterizing part of the claims provide an increase in the effectiveness of the treatment of chronic periodontitis due to the antibiotic effect of the components of the paste.

Yagel dietary supplement (BAA) was developed at the Institute of Biological Problems of Cryolithozone SBI SB RAS (Yakutsk) and has a certificate of state registration of the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being of the Russian Federation 77.99.23.3.U.3522.5 .08 dated 05/04/2008; TU 9219-002-36971185-08; sanitary-epidemiological conclusion of the Federal Service for Supervision of Consumer Rights Protection and Human Well-Being of the Russian Federation 77.99.03.003.T.000928.05.08 from 05/04/2008; certificate of state registration in the customs union of the Republic of Belarus, the Republic of Kazakhstan and the Russian Federation RU.77.99.11.003.E.051236.11.11 of 11.17.2011.

The drug "Yagel" is obtained from the extract of thalli of the lichens of the genus Cladonia and is recommended for use as a food supplement as a detoxifier of the body's internal media (blood, lymph, intercellular fluids, cell cytoplasm) from a wide range of endo- and exotoxins, as well as to reduce toxic , post-toxic, narcotic effect of vodka products, without reducing their euphoric effect, and as a corrector of metabolic disorders. At the same time, it normalizes blood sugar in patients with diabetes mellitus and cholesterol in patients suffering from atherosclerosis. In addition, the drug has a preventive effect against heart attacks and strokes, because exhibits antithrombin activity. Due to the high content in dietary supplements of derivatives of usnic and other lichen acids in the form of clathrate and lichen oligosaccharides, it has an antibiotic effect. Yagel contains: the main active substances — amino-oligosaccharides, which are formed from amino-polysaccharides when they are treated with water in a carbon dioxide medium in a supercritical fluid state, and in addition, a complex of antioxidant substances (orselic, lecnoric, grifforic, chiastic acids and quinones; vitamin B12, folic acid); natural antibiotics - usnic acids and their derivatives (see table 1).

The preparation of the paste is carried out by mixing the dry residue of the dietary supplement "Yagel" with zinc oxide and an oil solution of vitamin "A" to obtain a pasty consistency in the following percentage ratio (wt.%):

dry residue "Yagel" - 10-11;

zinc oxide - 59-60;

oily solution of vitamin "A" - 29-30.

A method for the treatment of chronic periodontitis using medical paste based on the dietary supplement "Yagel" consists of sequential measures. At the initial stage of treatment, a preliminary safety training is organized. Moreover, in order to increase the effectiveness of the antibiotic effect of the therapeutic paste based on the Yagel dietary supplement with respect to periodontopathogenic microorganisms, contingent is being monitored for cleaning, based on the removal of dental deposits, instructing in the selection of oral hygiene products, as well as on the method of brushing teeth.

Measures for the direct treatment of chronic periodontitis according to the claimed method consist in maintaining therapeutic paste in the periodontal pocket, while the course of treatment of chronic periodontitis is 7-10 daily or every other day the paste is introduced into the periodontal pocket. At the end of the procedure, recommendations are given in limiting food intake for 4-5 hours.

Studies of the effectiveness of therapeutic paste according to the claimed technical solution were carried out in a clinical setting.

The inventive method was carried out in a group of adults 35-50 years old: the first group (21 people) used medical paste based on the Yagel dietary supplement, and the second group (23 people) used medical paste "Vitadont" (registration certificate for a medical product from 10/02/2017 No. FSR 2011/10985, according to TU 9391-057-45814830-2001 registration dossier number RD-19394/54961 dated 09/25/2017, type of medical device 236160, potential risk class for using medical device 2a, code of the All-Russian product classifier by type of economic activity 32.50.50.000, by order of Roszdravnadzor dated 02.10.2017 No. 8376 approved for circulation on the territory of the Russian Federation).

To prepare therapeutic paste based on the dietary supplement "Yagel" 180 mg of the dry residue of the dietary supplement "Yagel" was mixed with 1 g. zinc oxide and 0.5 ml of an oil solution of vitamin "A" to obtain a pasty consistency.

The therapeutic antibacterial paste dressing “Vitadont” is a complex based on a wax-lecithin composition containing beta-carotene, vitamins E and C and is intended for a soothing and analgesic effect. Along with the vitamin complex, the composition of the paste includes a natural component - beeswax. The healing components of beeswax penetrate the gums and help relieve pain, disinfect the oral cavity, having a detrimental effect on germs and viruses, and harmful substances from the oral cavity are adsorbed on the wax.

A third control group of 14 people was also formed, where therapeutic measures were not carried out.

The treatment results were evaluated by clinical, laboratory, instrumental diagnostic research methods and examined in the dynamics of the prevalence and severity of the inflammatory and destructive process of periodontal tissues in patients.

Initial organizational activities included the analysis and assessment of the prevalence and intensity of periodontal diseases among the population of the Republic of Sakha (Yakutia) (see table 2).

For microbiological research, material from the pathological periodontal pocket (inflammatory focus) was obtained using a tampon that was placed in the Amiesa liquid transport medium. Initial inoculation of the material was carried out on anaerobic blood agar, Chocolate agar and Saburo medium. The incubation of crops was carried out at a temperature of 37 ⁰ C for 24-48 hours. At the same time, plates with anaerobic hemagar were incubated in sealed containers with gas generators to create an anaerobic atmosphere “GENbag Anaer” from BioMerieux (France). Crops on “Chocolate” agar were also placed in airtight containers, but with gas generators for microbagophiles GENbag Microaer from BioMerieux (France). To count the number of microorganisms in the material, the sowing was carried out according to the method of Melnikov-Tsarev: a tampon was used to sow the test material on the 1st sector of the Petri dish with nutrient medium. After this, a d3 mm bacteriological loop performed 4 line seeding from the 1st sector to the 2nd, similarly from the 2nd sector to the 3rd, burning the loop after reseeding of each sector. The number of bacteria in the material was determined using the table (see table 3).

The average number in statistical processing was expressed in lg CFU, where 10 ¹ CFU = 1 lg CFU (CFU - colony forming unit, microbial cell). Identification of the selected cultures was carried out by time-of-flight mass spectrometry on a Vitek-MS analyzer (BioMerieux, France).

As the results of the studies show, the microbiological characteristics of the microflora of the pathological periodontal pocket are represented by gr (+), gr (-) by microorganisms and fungal flora of the genus Candida. Moreover, before treatment, the quantitative and qualitative composition of microorganisms in the gum tissue did not differ in all groups (P> 0.05). As the test-cultures were used microorganisms isolated from periodontal pockets with periodontitis Streptococcus oralis, Streptococcus suis, Streptococcus sanguis , Streptococcus constellatus, Streptococcus vestibularis, Streptococcus cristatus, Rothia mucilaginosa, Streptococcus parasanguinis, Candida dubliniensis, Neisseria flava, Neisseria sicca, Veillonela parvula.

The results shown in the group with the therapeutic paste based on the Yagel dietary supplement indicate its antibiotic effect in relation to Streptococcus oralis, Streptococcus suis, Streptococcus sanguis, Streptococcus constellatus, Streptococcus vestibularis, Streptococcus cristatus, Rothia mucilocinibida Candida, Neisseria flava, Neisseria sicca, Veillonela parvulla, which determine the basis of clinical efficacy (see table 4). Due to this, starting from 2 days, the reverse development of the inflammatory process of the marginal gum was determined, which is characterized by a significant decrease in edema and hyperemia of the mucous marginal gum section, which confirms its pronounced clinical effect.

In the group with therapeutic paste “Vitadont” during the microbiological study, quantitative and qualitative changes in the types of microorganisms were also determined. This, in turn, is due to the antibiotic effect of the Vitadont paste (see table 4). At the same time, starting from the 3rd day, the inflammatory process of the periodontal pocket is reversed, which is clinically characterized by a significant decrease in edema and hyperemia of the mucous membrane of the marginal gingival region, which also confirms its clinical effect.

The satisfactory results of the therapeutic measures taken in the treatment of chronic periodontitis are explained by the positive effect of the antibiotic components contained in the therapeutic paste based on the Yagel dietary supplement. In this case, an increase in the rate of salivation by 0.18 ml / min, normalization of viscosity by 0.21 units. and saliva pH at 0.10 (P <0.05).

For comparison, the clinical effectiveness of the group with therapeutic paste based on the Yagel dietary supplement is characterized by a similar antimicrobial effect of the Vitadont therapeutic paste, dynamic changes in periodontal tissues in the form of a reverse development of the inflammatory process are noted starting from 2 days and obtained by the studied parameters in comparison with the control group significant significant differences (P <0.05).

Thus, the good antibiotic properties of the “Yagel” dietary supplement allow it to be used in dentistry, in particular, during the treatment of periodontitis.

Table 1

The dry residue composition of the product "Yagel" based on the extract of thalli of the lichens of the genus Cladonia

№№ The name of indicators Concentration (%) one Amino Oligosaccharides 89,99916 2 Vitamin B 12 0.00004 3 Folic acid 0,0008 4 Usnic Acid Salt 10.0

table 2

The prevalence and intensity of periodontal disease in the population of the Republic of Sakha (Yakutia)

Age
groups Distributed
% CPI% healthy bleeding supra and subgingival
howling stone pathologist. periodontal pocket 15-19 91.26 ± 0.05 8.74 ± 0.59 36.23 ± 2.46 48.23 ± 0.43 6.80 ± 0.60 20-34 95.14 ± 0.03 4.86 ± 0.62 29.13 ± 0.46 47.69 ± 0.34 18.32 ± 0.53 35-44 97.43 ± 0.01 2.57 ± 0.63 15.50 ± 0.55 42.21 ± 0.37 39.72 ± 0.39 45-54 98.88 ± 0.007 1.12 ± 0.64 6.07 ± 0.61 31.41 ± 0.44 61.40 ± 0.25 65-74 62.42 ± 0.24 0.17 ± 0.65 4.71 ± 0.62 12.22 ± 0.57 45.32 ± 0.35 Age groups CPI (SEXTANT) healthy bleeding sup- and subdesn.
a rock pathologist.
periodontium
pocket unaccounted for
sextants 15-19 0.42 ± 0.03 2.22 ± 0.02 2.87 ± 0.02 0.45 ± 0.03 0.04 ± 0.03 20-34 0.20 ± 0.03 1.80 ± 0.02 2.80 ± 0.02 1.09 ± 0.03 0.11 ± 0.03 35-44 0.11 ± 0.03 1.05 ± 0.03 2.37 ± 0.02 2.14 ± 0.02 0.33 ± 0.03 45-54 0.03 ± 0.03 0.37 ± 0.03 1.27 ± 0.03 3.04 ± 0.01 1.29 ± 0.03 65-74 0.01 ± 0.03 0.13 ± 0.03 0.60 ± 0.03 3.10 ± 0.01 2.16 ± 0.02

Table 3

Calculation table for determining the number of bacteria in the test material

The number of colonies by sector Quantity, CFU Sector 1 Sector 2 Sector 3 1-6 No growth No growth <1000 (up to 10 ³ ) 8-20 No growth No growth 1000 (10 ³ ) 21-30 No growth No growth 5000 (10 ^3-4 ) 31-60 No growth No growth 10.000 (10 ⁴ ) 70-80 No growth No growth 50,000 (10 ^4-5 ) 100-150 5-10 No growth 100,000 (10 ⁵ ) A very large number 20-30 No growth 500,000 (10 ^5-6 ) Very large number 40-60 No growth 1,000,000 (10 ⁶ ) Very large number 100-140 10-20 5.000.000 (10 ^6-7 ) Very large number Very large number 30-40 50,000,000 (10 ⁷ ) Very large number Very large number 60-80 100,000,000 (10 ⁸ ) A very large number A very large number 80-140 1,000,000,000 (10 ⁹ )

Table 4

Comparative characteristics of the antimicrobial activity of the drug "Yagel" in the treatment of periodontitis

Types of microorganisms Quantity, CFU before treatment The number of CFU after treatment Reindeer moss Vitadont Reindeer moss Vitadont Streptococcusoralis ⁵ 10 ⁵ 10 ⁵ 10 ³ 10 ³ Streptococcusoralis ⁶ 10 ⁶ 10 ⁶ 10 ⁵ 10 ⁵ Streptococcusoralis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁵ Streptococcusoralis ⁸ 10 ⁸ 10 ⁸ 10 ⁵ 10 ⁵ Streptococcusoralis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁵ Streptococcusoralis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁶ Streptococcusoralis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁶ Streptococcusoralis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁵ Streptococcusoralis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁶ Streptococcussanguis ⁷ 10 ⁷ 10 ⁷ 10 ⁵ 10 ⁵ Streptococcussanguis ⁷ 10 ⁷ 10 ⁶ 10 ⁵ 10 ⁴ Streptococcussuis ⁶ 10 ⁶ 10 ⁵ 10 ⁵ 10 ³ Streptococcusconstellatus ⁷ 10 ⁷ 10 ⁷ - - Streptococcusvestibularis ⁷ 10 ⁷ 10 ⁷ - - Streptococcusparasanguinis ³ 10 ³ 10 ³ - - The average concentration for the genus Streptococcus 10 ^6.53 10 ^6.4 10 ^3.8 10 ^3.8 Candida dubliniensis ⁷ 10 ⁷ 10 ⁷ 10 ³ 10 ⁴ Candida dubliniensis ⁵ 10 ⁵ 10 ⁵ 10 ³ 10 ³ Average concentration for the genus Candida 10 ⁶ 10 ⁶ 10 ³ 10 ^3,5 Neisseriaflava ⁴ 10 ⁴ 10 ⁴ - - Neisseriasicca ⁹ 10 ⁹ 10 ⁹ 10 ⁴ 10 ⁶ Neisseriasicca ⁸ 10 ⁸ 10 ⁸ 10 ⁴ 10 ⁵ Average concentration for the genus Neisseria 10 ⁷ 10 ⁷ 10 ⁴ 10 ^5.5 Veillonela parvulla 10 ³ 10 ³ - 10 ² Rothia mucilaginosa 10 ³ 10 ³ 10 ³ - -

Claims (5)

A method for the treatment of periodontitis with the use of medical paste based on the "Yagel" dietary supplement, obtained by mixing the components in the following composition, in mass. %: BAA "Yagel", the dry residue is 10-11, zinc oxide - 59-60, oil solution of vitamin "A" - 29-30, including daily or every other day intervals the paste is inserted into the pathological periodontal pocket, while the daily procedure includes no more than one paste, the treatment course is 7-10 procedures, and for prevention it is repeated 3-4 times a year with an interval of 2- 3 months according to indications.