RU2847407C2 - Method for treating moderate chronic periodontitis with second-degree dysbiosis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: the invention relates to medicine, specifically dentistry, and can be used in the treatment of moderate chronic periodontitis with second-degree dysbiosis. The method involves the administration of a medicinal product in the form of a therapeutic paste based on the synbiotic Bificin Forte 20 billion CFU, an oil solution of vitamin A, and zinc oxide, obtained by mixing the components. The prepared paste is injected directly into the periodontal pocket, with the daily procedure involving a single injection of the paste. The course of treatment consists of 8-10 daily and/or every other day procedures, followed by fixation of the therapeutic paste with a Parasept protective bandage. At the end of the procedure, food intake is restricted for 3-5 hours. Additionally, take the synbiotic Bificin Forte 20 billion CFU orally, 1 capsule per day for 3-4 weeks.

EFFECT: effective treatment of chronic periodontitis by stimulating the growth of beneficial bacteria and reducing the number of pathogenic microflora in the periodontal pocket, followed by a reduction in the intensity of the inflammatory process, swelling and bleeding of the periodontal tissues.

5 dwg, 2 tbl

Description

The invention relates to medicine, namely to dentistry, and can be used in the treatment of moderate chronic periodontitis with second-degree dysbiosis.

A method is known for a probiotic agent in the form of an ointment for the treatment of dental diseases (see RU No. 2352345, cl. C1, published 04/20/2009) a probiotic agent is used for the treatment of dental diseases, made in the form of an ointment, which contains base components, for example, petroleum jelly, paraffin, palm fat, a microbial mass of probiotic microorganisms of the genus Bifidobacterium and Lactobacillus in an effective amount, from which conglomerates are prepared with the help of a sorbent, an adhesive component, a surfactant, as well as fatty oils of plant origin, for example, sea buckthorn oil, rosehip oil or oil solutions of vitamins, for example, a solution of retinol acetate in oil, a solution of tocopherol acetate in oil (Mashkovsky M.D. "Medicines. A Manual for Doctors." Publ. 14, Moscow, 2001, Volume 2, pp. 68, 105). When treating chronic periodontitis, the ointment is injected into the periodontal pocket.

The disadvantage of this method is the complexity of preparation and dosage of the ointment components, which limits its widespread use in practical dentistry.

A known method for treating periodontal disease using bacteriophages (see RU No. 2165766, class C1, published April 27, 2001) involves the use of a bacteriophage concentrate, such as a gel base, or applicators of various modifications (threads, plates, gels, sprays). Carbomer (BP93) and cellulose derivatives are used as gelling agents. The final concentration of each phage is 108 PFU/ml. To improve the organoleptic and anti-inflammatory properties of the preparation, essential oils and alcoholic extracts of medicinal plants are added to the composition. The preparation has the appearance of a translucent gel with a faint yellow or greenish tint. The gel is intended for the treatment of purulent-septic periodontal diseases caused by staphylococcus, streptococcus, Staphylococcus aureus, Streptococcus pyogenes, Wolinella sp. and Actinobacillus actinomicetemcomitans.

The disadvantage of this method is the need to use high concentrations of each phage, the long duration of treatment courses, and the need to use additional means for rehabilitation and correction of microflora imbalances.

A known method for treating periodontitis (see RU No. 2400243, cl. A61K 35/74, A61K 31/4146, A61K 31/345, A61P 1/02, A61K 6/00, published 09/27/2010) includes antimicrobial treatment with local application of antiseptics by instillation of 1% hydrogen peroxide solution, 0.06% chlorhexidine solution, 0.02% furacilin solution into periodontal pockets; applications to the gums and introduction of metronidazole (Metrogyl Denta gel) into periodontal pockets; Oral administration of metronidazole according to the following regimen: Day 1 - 0.5 g 2 times a day, Day 2 - 0.25 g 3 times a day, and the following 4 days - 0.25 g 2 times a day. Starting from the 15th day of treatment, conservative removal of pathological periodontal pockets, sclerotherapy, and closed curettage (as indicated) are performed. Starting from the second week of treatment (after antimicrobial therapy), the liquid synbiotic Normoflorin D is prescribed locally in the form of instillations into periodontal pockets at a dose of 0.2 ml daily, 5 procedures, then applications to the entire gum for 10 minutes, 5 days, daily, once; orally from the first day of treatment, Normoflorin D is taken morning and evening 20-30 minutes before meals for 30 days.

The disadvantages of the known method include the duration of treatment using several types of antiseptics, due to the need for conservative treatment, including sclerotherapy and local application of a liquid synbiotic.

A method is known for using a dental gel modified with a synbiotic for the treatment of oral dysbiosis and inflammatory diseases of periodontal tissues (see RU No. 2760267, cl. C1, published 11/23/2021), where a dental gel with a symbiotic is used for the treatment of inflammatory diseases of periodontal tissues and oral dysbiosis, including Asepta gel with propolis and the symbiotic Bifistim in the following ratio: water - 5 ml; Bifistim - 2 g; Asepta gel with propolis - 2 g. Bifistim in powder form is combined with boiled water at room temperature, left to swell for 2-3 minutes until a homogeneous suspension is formed and mixed with Asepta gel. Next, a prepared suspension of "Bifistim" mixed with 2 g of "Asepta" gel is applied to a silicone mouth guard for the upper and lower jaws. The mixture is placed in the cavity of the mouth guard over the alveolar process of the upper jaw or the alveolar portion of the lower jaw. The modified gel is left on for 30 minutes, with the treatment course lasting 14 days.

The disadvantage of this method is the multi-component composition of the dental gel and the production of individual dental mouth guards for the upper and lower jaw, which limits the practical application of this method. 66C1

The problem, which the claimed invention is aimed at solving, is determined by the restoration of the microbiota of the periodontal pocket and a decrease in the number of pathogenic microbial associations in the gum biotope, causing the reverse development of the pathological process of the periodontal tissues of an inflammatory-destructive nature and the disappearance of the main clinical symptoms of bleeding, hyperemia and swelling of the gums in patients.

The technical effect obtained by solving the set problem is expressed in obtaining a method for treating moderate chronic periodontitis in patients with an established diagnosis of stage II dysbiosis with the combined effect of local application of a medicinal paste based on the synbiotic "Bificin Forte" 20 billion CFU, an oil solution of vitamin "A" and zinc oxide, which promotes stimulation of the growth of beneficial bacteria and a decrease in the number of pathogenic microflora in the periodontal pocket with a subsequent decrease in the intensity of the inflammatory process, swelling and bleeding of periodontal tissues.

To solve the set problem, a method for treating moderate chronic periodontitis with stage 2 dysbiosis, including the administration of a medicinal product in the form of a therapeutic paste based on the powder of the synbiotic "Bificin Forte" 20 billion CFU, an oil solution of vitamin "A", obtained by mixing the components, is distinguished by the fact that the drug additionally contains zinc oxide to form the constituent components in a pasty state with the following composition, in wt. %: powder of the synbiotic "Bificin Forte" 20 billion CFU - 54-55; oil solution of vitamin "A" - 33-35; zinc oxide - 10-13, for which, the prepared paste is introduced directly into the periodontal pocket, where it is fixed with a protective dressing "Parasept". In this case, the daytime procedure includes a single administration of the paste, the course of treatment is 8-10 procedures. Additionally, the patient was prescribed the synbiotic "Bificin Forte" (20 billion CFU) orally, one capsule daily for 3-4 weeks. After the periodontal inflammation subsides, the patient undergoes surgical treatment, as indicated, which may include open curettage or flap surgery. After the procedure, oral hygiene recommendations are given. For preventive purposes, the course is repeated 3-4 times a year at 3-month intervals, as indicated.

A comparative analysis of the features of the claimed solution with known features indicates that the claimed solution meets the “novelty” criterion.

The distinguishing features of the invention formula enhance the effectiveness of treating moderate chronic periodontitis with stage 2 dysbiosis using a therapeutic paste based on the synbiotic "Bificin Forte" powder (20 billion CFU), an oil solution of vitamin A, and zinc oxide. This paste is injected into the periodontal pocket and secured with a protective "Parasept" dressing. The synbiotic "Bificin Forte" (20 billion CFU) is additionally administered orally, 1 capsule daily, for 3-4 weeks. This promotes the restoration of the periodontal pocket microbiota and a reduction in pathogenic microbial associations in the gingival biotope, which are responsible for the reversal of the inflammatory and destructive pathological process in periodontal tissue. Furthermore, the claimed treatment method is simple to perform and requires no special training, which is important for patients and novice practitioners.

The claimed technical solution is illustrated, where in Figure 1. - the components of the medicinal paste: powder of the synbiotic "Bificin Forte" 20 billion CFU, oil solution of vitamin "A" and zinc oxide; in Figure 2. - the finished medicinal paste for the treatment of chronic periodontitis of moderate severity with dysbiosis of the second degree; in Figure 3. - a patient with chronic generalized periodontitis of moderate severity before treatment with dysbiosis of the second degree; in Figure 4. - introducing the medicinal paste into the periodontal pocket with fixation with a protective dressing "Parasept" in chronic generalized periodontitis of moderate severity with dysbiosis of the second degree; Figure 5 shows the condition of periodontal tissues after a course of treatment with the medicinal paste containing the synbiotic "Bificin Forte" 20 billion CFU for chronic generalized periodontitis of moderate severity with second-degree dysbiosis.

The treatment method for moderate chronic periodontitis with stage 2 dysbiosis involves the use of a medicated paste based on the synbiotic powder "Bificin Forte" (20 billion CFU), an oil solution of vitamin A, and zinc oxide, followed by fixation with a protective dressing "Parasept" in the periodontal pocket. At the initial stage of treatment, preliminary instructions are provided on the technological features of using the medicated paste and observing safety precautions. In addition, the examined patients undergo a controlled cleaning based on the removal of supragingival and subgingival deposits, after which recommendations are given on the selection of oral hygiene products and the brushing technique.

The preparation of the medicinal paste according to the declared technical solution is carried out by simply mixing the powder of the synbiotic "Bificin Forte" 20 billion CFU (state registration certificate AM.01.11.01.003.R.000001.01.24), an oil solution of vitamin "A" (state register of medicines Reg. No. PN 001778/01) and zinc oxide (state register of medicines Reg. No. FS-001204, safety data sheet in accordance with GOST 30333-2007 ROTI®nanoMETIC ≥99%, 25 nm, article number: 8278, Version: GHS 1.0 ru) until a thick, creamy consistency is obtained, with the following percentage ratio (mass %):

synbiotic powder "Bificin Forte" 20 billion CFU 54-55 oil solution of vitamin A 33-35 zinc oxide 10-13

Next, the treatment of chronic periodontitis begins. The prepared medicated paste is injected into the periodontal pocket, for example, using a dental spatula. After the medicated paste is injected, it is secured with a Parasept protective dressing (registration certificate for a medical device issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) dated November 16, 2020, No. FSR 2007/00142, TU 9391-067-45814830-2002). Thus, the course of treatment for chronic periodontitis consists of 8-10 daily and/or every other day injections of the medicated paste into the periodontal pocket. After the procedure, the patient is advised to limit food intake for 3-5 hours. Additionally, the synbiotic "Bificin Forte" 20 billion CFU is prescribed orally, 1 capsule per day for 3-4 weeks.

The study of the effectiveness of the claimed technical solution was conducted in clinical conditions (see Fig. 1-5). The claimed method was implemented in the age group of 35-45 years: the first group - 73 people were treated with a medicinal paste based on the powder of the synbiotic "Bificin Forte" 20 billion CFU, an oil solution of vitamin "A" and zinc oxide by introducing it into the periodontal pocket and fixing it with a protective dressing "Parasept" for 3-5 hours with an additional prescription for taking the synbiotic "Bificin Forte" 20 billion CFU orally, 1 capsule per day for 3-4 weeks; The second group - for treatment they used the liquid synbiotic "Normoflorin®-D" 1 billion CFU (Registration record of the state registration certificate No. RU.77.99.11.003.E.006229.05.15, TU 9229-002-18840410-05 with amendments No. 1,2,3), which was introduced into each periodontal pocket at a dose of 0.2 ml daily, once, 12-14 procedures, then supragingival applications of the synbiotic were applied in the area of each tooth for 15 minutes with oral administration of 20 ml in the morning and evening 20-30 minutes before meals for 30 days - 19 people. A third control group was also formed, where no treatment and preventive measures were carried out - 14 people.

For microbiological examination, material from the periodontal pocket (inflammatory lesion) was obtained using a swab placed in Amies liquid transport medium. Initial cultures were placed on anaerobic blood agar, Chocolate agar, and Sabouraud medium. The cultures were incubated at 37°C for 24-48 hours. The anaerobic blood agar plates were incubated in sealed containers with GENbagAnaer gas generators (BioMerieux, France) to create an anaerobic atmosphere. The Chocolate agar cultures were also placed in sealed containers but with GENbagMicroaer gas generators (BioMerieux, France).

To quantify the number of microorganisms in the material, inoculation was performed using the Melnikov-Tsarev method: the test material was inoculated with a swab onto sector 1 of a Petri dish containing nutrient medium. Four streaks of inoculation were then performed using a 3 mm bacteriological loop from sector 1 to sector 2, and similarly from sector 2 to sector 3, burning the loop after inoculation of each sector. The number of bacteria in the material was determined using the table (see Table 1). The average count for statistical processing was expressed as lg CFU, where 101 CFU = 1 lg CFU (CFU is a colony-forming unit, a microbial cell). Identification of the isolated cultures was performed using time-of-flight mass spectrometry on a Vitek-MS analyzer from BioMerieux (France).

The results of the study show that the microbiological characteristics of the periodontal pocket microflora are represented by gram (+), gram (-), and anaerobic microorganisms. Moreover, before treatment, the quantitative and qualitative composition of microorganisms in the gum tissues in all groups did not differ (P> 0.05). Microorganisms isolated from the periodontal pocket in periodontitis were used as test cultures: Fusobacterium nucleatum, Tannerella forsythensis, Treponema denticola, Streptococcus oralis, Streptococcus sanguis, Neisseria flava, Neisseria sicca, Candida dubliniensis, Neisseria elongata, and Neisseria mucosa. The results obtained in the group using the medicinal paste according to the claimed invention indicate restoration of the periodontal pocket microbiota and a reduction in opportunistic microflora in the oral cavity (see Table 2), followed by relief of periodontal inflammation, manifested by a reversal of the pathological process starting within 2-3 days of combination treatment. Furthermore, a significant reduction in swelling and hyperemia of the marginal gingival mucosa was observed, increasing the effectiveness of therapeutic and preventive measures and eliminating the potential for side effects from the components. This is characterized by ease of implementation and ease of use, regardless of the specialist's professional experience.

The comparison group underwent treatment with the liquid synbiotic Normoflorin®-D. 0.2 ml was administered to each periodontal pocket daily, once a day, for 12-14 treatments. Supragingival applications of the synbiotic were then applied to each tooth for 15 minutes, followed by oral administration of 20 ml morning and evening, 20-30 minutes before meals, for 30 days. During the treatment stages with the synbiotic Normoflorin®-D, quantitative and qualitative changes in the types of microflora in the periodontal pocket were studied, which were associated with a reduction in periodontopathogenic microorganisms and the restoration of a normal oral microbiocenosis.

In the third control group, where no treatment or preventive measures were carried out, the presence of an inflammatory process in the periodontal tissues was determined, which remained at the same level during dynamic observation.

The results of the clinical effectiveness of the conducted treatment measures for chronic periodontitis make it possible to reduce the duration of the treatment courses and the development of a long-term remission phase of the disease due to a combination of systemic (orally 1 capsule per day for 3-4 weeks) and local use of a medicinal paste with the synbiotic "Bificin Forte" 20 billion CFU, an oil solution of vitamin "A" and zinc oxide according to the specified scheme help to reduce the number of pathogenic microbial associations in the gum biotope and restore the microbiocenosis of the oral cavity (see Fig. 5).

The conducted comparative analysis confirms the presence of clinical efficacy in the main group treated with a paste based on the synbiotic "Bificin Forte" 20 billion CFU, an oil solution of vitamin "A", zinc oxide and the appointment of its oral administration of 1 capsule per day for 3-4 weeks, characterized by the restoration of normal microbiocenosis with a decrease in the amount of periodontopathogenic microflora and the subsequent manifestation of positive changes in the periodontal tissues at the stages of the complex treatment already on the 3rd day in the form of a reverse development of the inflammatory process with a subsequent decrease in swelling of the periodontal tissues and the disappearance of bleeding gums.

Thus, the pronounced properties of the medicinal paste according to the claimed invention allow its use in dentistry, in particular, in the treatment of chronic localized and generalized periodontitis of moderate severity with second-degree dysbiosis, contributing to an increase in the effectiveness of the treatment of inflammatory periodontal diseases and the prevention of complications associated with the development of a chronic source of infection in the oral cavity.

Claims (3)

A method for treating moderate chronic periodontitis with second-degree dysbiosis, comprising administering a medicinal product in the form of a medicinal paste based on the synbiotic Bificin Forte 20 billion CFU, an oil solution of vitamin A obtained by mixing the components, characterized in that the product additionally contains zinc oxide in the following composition, wt.%: synbiotic powder Bificin Forte 20 billion CFU 54-55 oil solution of vitamin A 33-35 zinc oxide 10-13, For this purpose, the prepared paste is injected directly into the periodontal pocket. The daily procedure involves a single injection of the paste. The course of treatment consists of 8-10 daily and/or every other day procedures, followed by fixation of the medicinal paste with a protective Parasept dressing. After the procedure, food intake is restricted for 3-5 hours. Additionally, the synbiotic Bificin Forte 20 billion CFU is taken orally, 1 capsule per day for 3-4 weeks.