RU2797139C1 - Self-hardening gel for the treatment of necrotic ulcer diseases of the periodontal and mucosa of the oral cavity - Google Patents

Abstract

FIELD: dentistry.

SUBSTANCE: invention relates to the field of dentistry and concerns an oral agent used to treat ulcerative necrotic diseases of the periodontium and oral mucosa, in particular ulcerative necrotic gingivitis, periodontitis, chronic recurrent aphthous stomatitis, herpetic stomatitis. The proposed product contains deproteinized dialysate obtained from the blood of dairy calves, polidocanol 600, peppermint oil, menthol, gelatin, pectin, liquid paraffin, trypsin, 5% hyaluronic acid gel (as a wound healing component), aluminum chloride hexahydrate (having a hemostatic effect), metronidazole (performing antiprotozoal and antimicrobial action) at a ratio of components, wt.%: 15 of deproteinized dialysate, 5 of polidocanol 600, 5 of peppermint oil, 5 of menthol, 5 of gelatin, 10 of pectin, 10 of liquid paraffin, 10 of metronidazole, 10 of aluminum chloride hexahydrate, 10 of trypsin, 15 of 5% hyaluronic acid gel. The proposed tool has a pronounced anti-inflammatory, wound healing, adhesive, hemostatic, antiseptic properties and dissolving necrotic plaque effect.

EFFECT: use of the product contributes to the painless dissolution of necrotic plaque from the surface of the lesion, stopping bleeding, antiseptic treatment and stimulating the epithelization of the lesion and the surface of the gingival margin.

1 cl, 3 ex

Description

The invention relates to medicine, namely to dentistry.

There are various treatment regimens for ulcerative necrotic gingivitis, periodontitis, chronic recurrent aphthous stomatitis, and herpetic stomatitis [1].

Currently, diseases of the periodontal and oral mucosa are quite common, and new methods of treatment are constantly being improved. Ulcerative-necrotic changes in periodontal tissues are accompanied by the formation of necrotic plaque, which requires its removal, after which a wound surface is formed. Treatment regimens for diseases of the oral mucosa are similar and require the following steps: antiseptic treatment, anesthesia, removal of necrotic plaque and stimulation of epithelialization [2].

Ulcerative gingivitis is inflammation of the gums, accompanied by necrosis and ulceration of its tissues. These processes are based on the predominance of tissue alteration. In the genesis of ulcerative gingivitis, the leading role belongs to a decrease in the resistance of the gingival mucosa to the fusospirochetary flora of the oral cavity. Clinically, necrotizing ulcerative gingivitis begins acutely and is characterized by bleeding gums, pain, and bad breath. With the progression of the pathological condition, bone tissue is involved in the process and ulcerative-necrotic periodontitis develops, requiring intensive treatment.

Diseases of the oral mucosa, accompanied by the formation of necrotic plaque on the surface of the elements of the lesion, include chronic recurrent aphthous stomatitis, herpetic stomatitis, the local treatment of which is reduced to anesthesia, drug treatment of the mucosal surface, removal of plaque and stimulation of epithelialization [3].

Methods and means of treatment of the listed nosological units are standard and have not been improved for a long time. Modern agents for local treatment of the oral mucosa and periodontal tissues have mainly antiseptic (Metrogil-gel, Kamistad, Cholisal) and wound healing (Asepta, Solcoseryl adhesive paste) action [4] .

For the treatment of ulcerative-necrotic diseases of the oral mucosa and inflammatory periodontal diseases, Dentamet gel is used, which contains metronidazole, chlorhexidine gluconate 20% solution and excipients. The drug has an antiseptic and antibacterial effect.

However, this gel does not have a wound healing effect and a component that dissolves necrotic plaque, covers the surface of the lesion and prevents its healing, and there is also no adhesive effect of this drug on the surface of the oral mucosa [5].

Known "Cholisal", which consists of choline salicylate and cetalkonium chloride. This drug also has a local anti-inflammatory effect, without a pronounced epithelial effect.

However, necrotic plaque from the surface of the lesion element has to be removed mechanically, and a bleeding wound surface is formed, the treatment of which requires, in addition to antiseptic, a hemostatic effect. Gel "Cholisal" does not have the above properties. Also, there is no effect of gel fixation on the lesion element [6].

The closest in technical essence is "Solcoseryl dental adhesive paste" containing deproteinized dialysate and Polidocanol 600 - a local anesthetic, pectin, gelatin, menthol, peppermint oil. The agent has a membrane-stabilizing, cytoprotective and analgesic effect. The paste forms a protective therapeutic layer on the affected area of the oral mucosa and protects it from mechanical and chemical damage for 3-5 hours, acting as a medicinal dressing.

However, this drug does not have antiprotozoal, hemostatic and liquidating necrotic plaque action [7].

The task was set to increase the effectiveness of the treatment of ulcerative-necrotic periodontal diseases and diseases of the oral mucosa, the development of a drug that has a pronounced anti-inflammatory, wound healing, adhesive,

hemostatic, antiseptic properties and dissolving necrotic plaque action.

The task is achieved by using the developed self-hardening gel for the treatment of ulcerative necrotic diseases of the periodontium and oral mucosa, consisting of deproteinized dialysate, polidocanol, peppermint oil, menthol, gelatin, pectin, liquid paraffin, as a dissolving necrotic plaque and wound healing component includes trypsin and gel 5% hyaluronic acid, with the addition of aluminum chloride hexahydrate for hemostatic action, metronidazole for antiprotozoal action, at a ratio of components, wt. %:

Deproteinized dialysate 15 Polidocanol 5 Peppermint Oil 5 Menthol 5 Gelatin 5 Pectin 10 liquid paraffin 10 Metronidazole 10 Aluminum chloride hexahydrate 10 trypsin 10 Hyaluronic acid gel 5% 15

The proposed ratio of components, selected empirically, is optimal and allows you to achieve convenient for application to the pathological elements of the lesion or periodontal tissue. All components of the composition are compatible with each other in chemical composition and do not cause precipitation of any of the components.

The main advantage of the described gel composition is that, when compared with Solcoseryl Dental Adhesive Paste, applied by application, the effect of dissolving necrotic plaque is achieved by adding the trypsin enzyme, wound healing effect due to the influence of 5% hyaluronic acid gel, aluminum chloride hexahydrate for hemostatic and metronidazole for antiprotozoal action.

Rationale for the choice of gel components for the treatment of ulcerative necrotic diseases of the periodontium and oral mucosa.

Deproteinized dialysate obtained from the blood of dairy calves has a cytoprotective and membrane stabilizing effect [8]. Polidocanol 600 is a local anesthetic for superficial anesthesia. Its action is due to the blockade of sodium channels, which prevents the generation of impulses at the endings of sensory nerves and the conduction of pain impulses along the nerve fibers. Does not have a local irritating effect. It has an analgesic effect [9].

Menthol and peppermint oil act as a fragrance and local antiseptic [10].

Gelatin is a protein containing amino acids and collagen. Added to composition for stabilization [11].

Pectin - is a water-soluble fiber ("rolled" or "gelatinized") contained in the cell walls of fruits and vegetables, promotes "adhesion" to the surface of the oral mucosa of the gel-like composition [12].

Paraffin was also added to the composition to stabilize it and prolong the action of the collected substances [13].

Metronidazole is an antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group by intracellular transport proteins of anaerobic microorganisms and protozoa. Indicated in the treatment of ulcerative necrotic changes in the oral cavity. Ulcerative-necrotic changes in periodontal tissues indicate the presence of fusospirochetary microflora of the oral cavity. Metronidazole, which is part of the gel, has an antiprotozoal effect [4].

Aluminum chloride hexahydrate - is an aluminum salt, and has a hemostatic effect. It is known that after the removal of necrotic plaque, bleeding often occurs, to stop which a hemostatic fluid based on aluminum chloride hexahydrate was added to the composition [14].

Trypsin is an enzyme that has pronounced anti-inflammatory and decongestant properties, is able to break down dead tissue, fibrinous formations, viscous secrets and exudates. In relation to healthy tissues, the enzyme is inactive and safe due to the presence of trypsin inhibitors in them [15].

Hyaluronic acid gel 5% - is a natural polysaccharide that is part of the group of glycosaminoglycans. Due to its physicochemical properties: high viscosity, specific hydrophilic properties and the ability to form proteoglycan aggregates, hyaluronic acid promotes the manifestation of numerous functions of connective tissue: trophic, barrier, plastic. Hyaluronic acid provides an active exchange between blood and tissues, facilitates the supply of nutrients to cells and the removal of metabolic products, modulates the functional state of phagocytes and other local immunocompetent cells. Interacting with cell surface receptors, hyaluronic acid stimulates fibroblast migration and cell proliferation. All these properties are especially important for tissue regeneration. Thus, hyaluronic acid has the following actions: preventive, anti-inflammatory, bacteriostatic. Its influence on the reduction of the terms of tissue repair during progressive inflammatory-dystrophic processes in the periodontium was noted. Hyaluronic acid is a hydrophilic polymer and forms gels in the presence of water, binding up to 10,000 times the volume of fluid, preventing reinfection of the lesion. Due to this property, hyaluronic acid improves the fixation of the gel-like self-hardening composition in the case of its use for the healing of the lesion, while maintaining the stability and volume of the product.

An important property of hyaluronic acid is its anti-inflammatory effect, expressed by blocking the arachidonic acid cascade, slowing down the production of cytokines and reducing the permeability of the vascular wall and tissue permeability to various harmful substances. [2].

Thus, the introduction of the above components into the composition makes it possible to achieve the best effect in the local treatment of ulcerative necrotic diseases of the periodontium and oral mucosa.

A distinctive feature of the composition is the combination of an enzymatic component and wound healing substances, as well as a hemostatic substance, which makes it possible to eliminate necrotic plaque, stop bleeding, at the same time maintain the stability of the substrate applied to the lesion element and stimulate epithelization in the area of pathological formation for a long time.

The preparation of self-hardening gel is carried out as follows.

In a sterile Petri dish, deproteinized dialysate from the blood of dairy calves (15 mg), polidocanol (5 mg), peppermint oil (5 ml), menthol (5 ml), gelatin (5 g), pectin (10 g), liquid paraffin (10 ml), metronidazole (10 mg), aluminum chloride hexahydrate (10 ml), then trypsin (10 g) and hyaluronic acid gel (15 ml).

The quantitative composition of the composition was determined experimentally, the selection of mass fractions of the components used was also carried out experimentally. The use of components before the specified proportions and after the specified proportions does not give the desired effect.

Treatment of ulcerative necrotic diseases of the periodontium and oral mucosa using the proposed gel is as follows.

After antiseptic treatment of the oral cavity with an antiseptic (rinsing with a 0.02% solution of furacilin), a self-hardening gel prepared by mixing in a Petri dish is applied to the surface of the aphthae and / or marginal periodontium using a spatula. The patient is advised not to eat for an hour, for a prolonged effect on the lesion element of the listed gel components.

The therapeutic effect of the proposed self-hardening gel has been tested in the entire range of the quantitative content of the components. Complications and side effects during its use have not been identified.

The effectiveness of the practical use of the developed gel for the treatment of ulcerative-necrotic lesions in the oral cavity is confirmed by specific clinical examples.

Practical application of the gel.

Clinical example No. 1.

Patient Z., 52 years old, amb. card No. 3487 complained of inflammation in the gums, bad breath, whitish plaque on the gums.

An objective examination in the oral cavity: the gingival margin is covered with a gray coating, after removing which, a sharply painful bleeding surface was exposed. The tops of the gingival papillae are cut off, their contour is broken. Abundant dental deposits, tartar are determined. Regional lymph nodes are enlarged and painful on palpation.

Diagnosis: generalized ulcerative necrotic gingivitis.

Treatment. After professional oral hygiene, medical treatment of the surface of the mucous membrane and the gingival margin was carried out. Using a spatula, a gel is applied to the surface of the marginal gum. The patient was prescribed general therapy, including metronidazole 0.5 mg 2 times a day, kestin - 1 tablet at night, multivitamins, a sparing diet and plenty of fluids. Locally - after each meal, it is recommended to apply the gel on the ulcerated gingival margin for a week.

One week after the treatment, there was a clear improvement in the condition of the oral cavity, the absence of painful ulcerations, and an unpleasant odor.

Clinical example No. 2 Patient P., 49 years old, amb. card No. 6547 complained of the appearance of painful formations on the cheeks and palate.

An objective examination in the oral cavity revealed aphthae on the surface of the mucous membrane of the cheeks (in the amount of 5 pieces) and on the hard palate (2 pieces), painful when touched, covered with fibrinous plaque. Regional lymph nodes are enlarged, mobile, not soldered to the skin, painful on palpation.

Diagnosis: chronic recurrent aphthous stomatitis of moderate severity (7 aft).

Treatment. The patient was prescribed general therapy, sanitation of chronic foci of infection, antihistamine therapy. Locally: after each meal, it is recommended to use the developed gel for the treatment of ulcerative necrotic diseases of the periodontium and oral mucosa. A control examination conducted a week later showed complete healing of 5 aphthae, 2 aphthae were in a state of epithelialization. There were no pain sensations. Organized food intake.

2 weeks after the local treatment, a complete restoration of the surface of the oral mucosa was noted.

Clinical example No. 3.

Patient M., 37 years old, amb. card No. 6589 complained of pain, on the tongue, inner surface of the lip and palate, painful "wounds" according to the patient, and bad breath. Such rashes have happened before.

An objective examination in the oral cavity marked swelling of the oral mucosa. On the inner surface of the lower lip, on the left, there is a single aphthae with bubbles; on the hard palate along the median suture, 2 grouped aphthae are covered with a gray coating and are sharply painful when touched. The general condition is not broken.

Diagnosis: mild chronic herpetic stomatitis (3 aphthae).

Treatment. The patient was prescribed a high-calorie diet, antihistamine, vitamin therapy, immunostimulating therapy.

Local treatment: application of Solcoseryl adhesive dental paste gel 3-5 times a day. Control examination in a week. At the control examination after 7 days, incomplete epithelialization of three aphthae was noted. The general condition has improved. Eating normalized. But there were single non-epithelialized aphthae.

Total for the period from 2019 to 2021. 48 patients were under observation. In the main group (24 patients, including 10 patients diagnosed with chronic recurrent aphthous stomatitis, 8 patients with herpetic stomatitis and 6 patients with ulcerative necrotic gingivitis), local treatment was carried out in the form of application of the developed gel. The results of treatment showed that within a week all aphthous, herpetic and ulcerative-necrotic formations underwent complete epithelialization, that is, healing. In the control group (24 patients, including 12 patients diagnosed with "chronic recurrent aphthous stomatitis", 7 patients with "herpetic stomatitis" and 5 patients with "ulcerative necrotic gingivitis"), traditional local treatment was carried out with the appointment of the gel "Dentamet", " Stomagel" and "Kholisala". The results of the treatment showed that on the 7th day after the application of the indicated agent, single painful non-epithelial formations remained in the oral cavity on the surface of the mucous membrane.

The claimed technical solution fully satisfies all the main criteria for evaluating patentability, has - novelty, inventive step and industrial applicability.

Thus, the use of the developed "Self-hardening gel for the treatment of ulcerative-necrotic diseases of the periodontium and oral mucosa" showed its high efficiency compared to "Solcoseryl dental adhesive paste" and contributed to the painless dissolution of necrotic plaque from the surface of the lesions, stopping bleeding, antiseptic treatment and stimulation of epithelialization of the elements of the lesion and the surface of the gingival margin.

The obtained results of the study allow us to recommend the proposed self-hardening gel for the treatment of necrotic ulcers of the periodontium and oral mucosa in dental clinics, clinics and dermatovenerological dispensaries, in the practice of a dentist.

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Claims (2)

An agent for the treatment of ulcerative necrotic diseases of the periodontium and oral mucosa, containing deproteinized dialysate obtained from the blood of dairy calves, polidocanol 600, peppermint oil, menthol, gelatin, pectin, liquid paraffin, characterized in that it contains trypsin, which dissolves necrotic plaque , 5% hyaluronic acid gel as a wound healing component, aluminum chloride hexahydrate, which has a hemostatic effect, metronidazole, which has an antiprotozoal and antimicrobial effect, at a ratio of components, wt.%: Deproteinized dialysate 15 Polidocanol 600 5 Peppermint Oil 5 Menthol 5 Gelatin 5 Pectin 10 liquid paraffin 10 Metronidazole 10 Aluminum chloride hexahydrate 10 trypsin 10 Hyaluronic acid gel 5% 15