RU2703530C2 - Dental gel for treating and preventing periodontitis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine and can be used as an agent for treating and preventing periodontal disease. Disclosed dental gel for treating and preventing periodontitis contains juice of medicinal plants - Kalanchoe and nettle, melaxen, anesthesin, glucosamine hydrochloride, dimethylsulphoxide and a gel base - an alloy of polyethylene oxides PEO-400 and PEO-4000 in a mixture with glycerol, with the following ratio of components, wt. %: melaxen 3–5, anesthesin 3–5, Kalanchoe juice 10–20, nettle juice 10–20, glucosamine hydrochloride 5–15, dimethylsulphoxide 1–5, gel base making the rest.

EFFECT: said gel is a highly effective agent for treating periodontitis of any severity, damage to the oral mucosa of the odontogenic and non-odontogenic nature (ulcers, burns), having pronounced clinical effect and having wide functional capabilities for practical medicine.

1 cl, 9 ex

Description

The invention relates to medicine and dentistry, in particular to medicines, made in the form of a gel, and can be used as a means of treating periodontitis.

A number of medicinal formulations are known from the state of the art for use as local treatment for periodontitis. A known composition based on dimexide and chlorhexidine bigluconate, used in dentistry for the treatment of periodontal diseases [1] and a therapeutic and prophylactic gel containing a biologically active component of plant origin - dry oak bark extract, formative component - sodium carboxymethyl cellulose, water-retaining - glycerin, stabilizing - propylene glycol cleansing - sodium lauryl sulfate and distilled water. The gel has anti-inflammatory, antimicrobial and analgesic effects and can be used in the treatment of diseases of the oral mucosa and periodontium [2].

The disadvantage of these funds is the inclusion of a wide range of strong antiseptics, which have limitations for use due to their individual intolerance, as well as the risk of side effects with prolonged use - reducing the sensitivity of the microflora of the oral cavity, impaired function of internal organs.

Known wound healing agent based on Kalanchoe juice [3]. Ointment is used in dentistry as a wound healing and anti-inflammatory agent.

Kalanchoe ointment contains 40.0 ml kalanchoe juice, furazolidone 0.25 g, novocaine hydrochloride 0.25 g, anhydrous lanolin 60.0 g. The ointment is applied in a thin layer on the mucous membrane and the affected areas of the gums.

Advantages of the ointment: the presence of a wound healing (colanchoe juice), antibacterial (furozalidone) and anesthetic agent in the composition.

Disadvantages: a short period of therapeutic effect, a protective dressing is required to correlate the therapeutic effect. The ointment contains furazolidone and novocaine hydrochloride in its composition, the use of which may be accompanied by a contact or systemic allergic reaction in sensitized people.

The prior art method for the treatment of inflammatory periodontal diseases (RU 2372949, publ. 20.11.2009, abstract, claims, D1).

The method combines the simultaneous effect on the periodontium with a low-frequency magnetic field and a composition of medicinal substances deposited in a gingival dressing.

The principle of the method according to D1: a gingival dressing is applied to the treated area, which is a gauze impregnated with gel, which is treated with a waveguide from the Pole-1 apparatus, affecting the periodontium / gingival complex with a low-frequency magnetic field with an intensity of 12-17 MT for 20 minutes.

One of the components of the known method D1 is a gingival dressing containing a gel of 2% solution of calcium chloride, colanchoe juice and nettle, glucosamine hydrochloride, dimethyl sulfoxide, and the PEO-400 and PEO-4000 polyethylene oxides with glycerin are the closest technical gel essence of the invention, therefore, adopted as a prototype.

Advantages of the prototype: effectiveness in the treatment of generalized periodontitis. Exposure to periodontal tissues with a low-frequency magnetic field improves metabolic processes, reduces tissue hypoxia, and reduces inflammation in the periodontium.

The disadvantages of the prototype: the gingival dressing is made in the form of gauze soaked with gel, which is extremely inconvenient to use at home and requires specialized conditions for a dental office for each procedure, the same applies to periodontal tissue exposure to a low-frequency magnetic field with an intensity of 12-17 MT from the apparatus Pole-1 "for 20 minutes.

The method does not provide analgesia during the procedure, however, inflammatory periodontal diseases are accompanied by extremely unpleasant pain, which requires the introduction of a local anesthetic substance in the gingival dressing.

The composition of the gingival dressing declared in D1 is not an independent method of treating periodontitis, since its effectiveness is determined by a combination of 2 methods of different effects on living tissues - chemical (gingival dressing) and physical (low-frequency magnetic field with an intensity of 12-17 MT from the Polyus apparatus -one"). The effectiveness of each of the methods for influencing periodontal tissues claimed in D1 is not considered separately; therefore, it is not possible to evaluate the bioavailability of the medicinal components of the gingival dressing in periodontal tissues and the oral mucosa when applied according to D1.

The task: to ensure the bioavailability of drugs in the periodontal tissue and the oral mucosa for the most effective relief of pain, swelling and bleeding gums with periodontitis, which will reduce the treatment time and the period of epithelization of the oral mucosa.

The problem is solved by introducing into the composition containing the juice of medicinal plants and a gel base, antioxidant "Melaxen", anestezin, colanchoe juice and nettle, glucosamine hydrochloride, dimethyl sulfoxide, as a gel base - an alloy of polyethylene oxides PEO-400 and PEO-4000 in mixture with glycerin in the following ratio, wt. %:

Melaxen 3-5 Anesesin 3-5 Kalanchoe juice 10-20 Stinging nettle juice 10-20 Glucosamine hydrochloride 5-15 Dimethyl sulfoxide 1-5 Gel base rest

An alloy of polyethylene oxides PEO - 400 and PEO - 4000 mixed with glycerin was used as a gel base.

Stinging nettle juice was chosen as a hemostatic, Kalanchoe juice as a remedy, anesthesin as an anesthetic, glucosamine hydrochloride as an anti-inflammatory and chondroprotective property, dimethyl sulfoxide was used as a conductor and a weak antiseptic. The components of the gel have pharmacological synergies.

The technology for producing the gel is as follows: polyethylene oxide 4000 (PEO 4000) and polyethylene oxide 400 (PEO 400) were fused in an evaporation cup, melaxen, anestezin, Kalanchoe juice was mixed with dioica nettle juice, dimethyl sulfoxide and glycerin. Glucosamine hydrochloride was dissolved in this mixture, then a PEO alloy was introduced in parts into the solution with constant stirring.

The proposed ratio of therapeutic substances and gel base is optimal and provides a therapeutic effect of the drug. Doses of medicinal substances are established experimentally. The introduction of components below the lower or higher than the upper limit does not provide optimal exposure, and also worsens the presentation.

The drug "Melaxen" (a chemical analogue of the biogenic amine Melatonin) is selected as an effective antioxidant. This antioxidant eliminates oxygen and nitrogen radicals, including OH, O2-, and NO. It is twice as active as vitamin E, which is an effective lipophilic antioxidant that is able to protect mitochondria from oxidation, which, in conditions of periodontal inflammation, acquires a key role as the main pathogenetic therapeutic factor. It more effectively neutralizes the highly toxic hydroxyl and peroxyl radicals formed in the processes of free radical oxidation than the widespread natural antioxidants.

Anestezin is an effective pain reliever.

Colanchoe juice is a transparent or slightly opalescent liquid with a fine suspension, with shaking it is easily broken, yellow in color with an orange tint and aromatic odor [5]. The juice contains flavonoids, organic acids (malic, acetic, citric), tannins, polysaccharides, enzymes, vitamin C, micro and macro elements - aluminum, iron, magnesium, calcium, copper, silicon and manganese. In dentistry, it is used for gingivitis, periodontal disease of II and III degrees and for aphthous stomatitis, applying to the oral mucosa in the form of applications or aerosol inhalations.

Dioecious nettle leaves contain up to 270 mg% vitamin C, carotene and other carotenoids, up to 5% chlorophyll, more than 2% tannins, and organic acids. Along with this, in the aerial part of the plant, essential oil, sitosterol, phenolcarboxylic acids, porphyrins, starch, flavonoids, vitamins B ₁ , B ₁₂ , E, PP, pantothenic acid, glycoside urgicin, iron, manganese, sulfur, copper, silicon, boron were found , nickel, titanium, calcium, potassium, mineral salts, tannins, acetylcholine, histamine, volatile.

The plant has anti-inflammatory, antiseptic, wound healing, hemostatic, general strengthening, multivitamin properties. In scientific and folk medicine, nettle is used in the form of a decoction, infusion, fresh juice and powder as a hemostatic agent.

Glucosamine (2-deoxy-2-amino-D - (+) - glucose) is an active chondroprotective agent and is used, as a rule, in the form of salts of sulfuric or hydrochloric acids. Glucosamine hydrochloride has a stimulating effect on reparative processes in structures of connective tissue origin, and also contributes to the inhibition of dystrophic post-traumatic processes in them. The mechanism of the reparative action of glucosamine is to stimulate the synthesis of glycosaminoglycans and collagen [6].

Dimethyl sulfoxide - DMSO, (dimexide) is an antiseptic that has anti-inflammatory and antimicrobial effects, and also exhibits local anesthetic properties in pain syndromes of various etiologies, has a wide range of effects on the sources of inflammatory processes, as it penetrates well with substances dissolved in it through skin and mucous membranes without damage to the latter, acting as a factor enhancing the penetration of drugs through epithelial barriers [7]. Examples of gel preparation.

Example 1

Melaxen - 3.0

Anestezin - 3.0

Kalanchoe juice - 10.0

Stinging nettle juice - 10.0

Glucosamine hydrochloride - 5.0

Dimethyl sulfoxide - 1.0

Gel base up to 100.0

Polyethylene oxide 4000 (PEO 4000) and polyethylene oxide 400 (PEO 400) were fused in an evaporation cup, 3.0 mg of melaxen, 3.0 mg of anestezin, 10.0 mg of Kalanchoe juice were mixed with 10.0 mg of nettle juice, 1.0 mg dimethyl sulfoxide and glycerin. 5.0 mg of glucosamine hydrochloride was dissolved in this mixture, then a PEO alloy was introduced in parts into the solution with constant stirring.

Glucosamine hydrochloride is taken in this recipe in a minimum amount, since a glucosamine content of less than 5% does not have a therapeutic effect. Dimethyl sulfoxide is used in the minimum dose since dimethyl sulfoxide solutions use from 1-25% in the composition of dental preparations for the prolonged action of the active substances of Kalanchoe and nettle juices, and also promotes more intensive diffusion of drugs into the periodontal tissues and the oral mucosa.

Example 2

Melaxen - 3.0

Anestezin - 3.0

Kalanchoe juice - 15.0

Stinging nettle juice - 15.0

Glucosamine hydrochloride - 8.0

Dimethyl sulfoxide - 2.0

Gel base up to 100.0

Polyethylene oxide 4000 (PEO 4000) and polyethylene oxide 400 (PEO 400) were fused in an evaporation cup, 3.0 mg of meloxene, 3.0 mg of anestezin, 15.0 mg of Kalanchoe juice were mixed with 15.0 mg of nettle juice, 2.0 mg dimethyl sulfoxide and glycerin. 8.0 mg of glucosamine hydrochloride was dissolved in this mixture, then a PEO alloy was introduced in parts into the solution with constant stirring.

Example 3

Melaxen - 4.0

Anestezin 4.0

Kalanchoe juice - 20.0

Stinging nettle juice - 20.0

Glucosamine hydrochloride - 10.0

Dimethyl sulfoxide - 4.0

Gel base up to 100.0

Polyethylene oxide 4000 (PEO 4000) and polyethylene oxide 400 (PEO 400) were fused in an evaporation cup, 4.0 mg of melaxen, 4.0 ml of anestezin, 20.0 mg of Kalanchoe juice were mixed with 20.0 mg of dioica nettle juice, 3.0 mg dimethyl sulfoxide and glycerin. 10.0 mg of glucosamine hydrochloride was dissolved in this mixture, then a PEO alloy was introduced in parts into the solution with constant stirring.

Example 4

Melaxen - 5.0

Anestezin - 5.0

Kalanchoe juice - 20.0

Stinging nettle juice - 20.0

Glucosamine hydrochloride - 15.0

Dimethyl sulfoxide - 5.0

Gel base up to 100.0

Polyethylene oxide 4000 (PEO 4000) and polyethylene oxide 400 (PEO 400) were fused in an evaporation cup, 5.0 mg of melaxen, 5.0 mg of anestezin, 20.0 mg of Kalanchoe juice were mixed with 20.0 mg of nettle juice, 5.0 mg dimethyl sulfoxide and glycerin. 15.0 mg of glucosamine hydrochloride was dissolved in this mixture, then a PEO alloy was introduced in parts into the solution with constant stirring.

The introduction of glucosamine hydrochloride in an amount of 15% is considered optimal for use in dentistry, because a good therapeutic effect is observed and the pH of the gel medium corresponds to the pH of the oral cavity (on average, at pH = 7.4). An amount of glucosamine hydrochloride in excess of 15% can create a more acidic environment (for example, up to pH = 5-6.0) and have an irritating effect on the oral mucosa.

The gel of example 1 should be used to prevent inflammatory complications of periodontal tissues after dental procedures, such as the preparation of hard tooth tissues under a stamped or cermet crown, curettage, to adapt a complete removable prosthesis to the oral mucosa.

The gel according to examples 2 and 3 should be used to prevent inflammatory periodontal diseases (periodontitis) - in case of traumatic damage to the mucous membrane or burns, including the mucous membrane of the oral cavity, lips, the inventive gel according to example 4 - directly in the treatment of inflammatory periodontal diseases (periodontitis) ) The shelf life of the funds received is at least 1 year. The parameters of the tool are stable during storage. The product is a light yellow mass with a pleasant herbal odor. The inventive gel is very plastic, easily applied to the gum and mucous membrane, has a high penetrating ability in the tissue.

The therapeutic effect of the proposed drug is tested in the entire range of the quantitative content of the components. Complications and side effects when using this tool were not identified. The method of applying the product to the oral mucosa is simple and affordable. The tool is well fixed even on a moistened oral mucosa. The breadth of its use is explained by the medicinal value of the product due to the optimal combination of biologically active substances in it.

Examples of specific performance.

Example 1. Patient S., 55 years old, amb. map number 433260. She complained of unpleasant sensations in the area of the mucous membrane of the oral cavity of the upper jaw after a recent denture prosthesis, pain during eating and talking.

Objectively: the mucous membrane in the region of the upper jaw is hyperemic, there are painful abrasions in the contact area of the clasps of the partial denture and abutment teeth. Interdental papillae are slightly hypertrophied, not enlarged, do not bleed when touched.

Diagnosis: damage to the oral mucosa in the upper jaw after removable prosthetics.

Treatment. Instrumental correction of the prosthesis basis was performed. In addition, daily applications of the developed gel on the mucous membrane of the oral cavity of the upper jaw are prescribed. A day after the start of treatment, according to the patient, a decrease in pain during eating and talking was noted. On the 3rd day from the start of treatment, the patient noted a significant improvement in the general condition, the mucous membrane of the upper jaw in the contact area of the clasps of the partial denture and abutment teeth was epithelized.

Example 2. Patient K., 35 years old, amb. card number 21098. The patient complained of bleeding gums when eating and brushing, bad breath, dental deposits in the region of the central teeth of the lower jaw. Objectively: the mucous membrane in the region of the front teeth of the lower jaw is hyperemic, swollen, cyanotic. Interdental papillae are hypertrophied, edematous to 1/3 of the height of the tooth crown, bleed when touched. When probing, periodontal pockets up to 4-5 mm deep were found. Hygiene Index (IG) 2.6-3.8 - bad.

Diagnosis: generalized periodontitis 31, 32, 33, 34, 35, 41, 42, 43, 44, 45 teeth. Treatment. Used complex treatment. The removal of supra- and subgingival dental deposits was carried out, rinsing of the oral cavity with decoctions of herbs (chamomile, sage, mint) was prescribed. In addition, daily applications of the inventive gel on the oral mucosa and gel administration on cotton turundas into periodontal pockets for 1-2 hours for 7 days are prescribed. Immediately after the start of treatment (within 1-2 days) by the claimed composition, a decrease in edema of the interdental gingival papillae was noted by 50-60% and the bleeding of the gums disappeared. On the 3rd day from the start of treatment, the patient noted a significant improvement in general condition, 6 days after the start of treatment with the claimed agent, the patient completely disappeared from the mouth, the gums and mucous membrane were epithelized, the edema completely disappeared.

Example 3. Patient S., 45 years old, amb. card number 17013. The patient complained of bleeding gums, bad breath. In the oral cavity: hypertrophied mucous membrane and gums of the teeth in the region of 11, 12, 13, 21, 22, 23, 31, 32, 33, 34, 41, 42, 43, 44 teeth, gum erosion in the cervical part of the teeth. Diagnosis: generalized periodontitis. According to the patient, the patient considers himself to be about 2 months, the wound healing and anti-inflammatory ointments used by him did not bring any effect.

Treatment. Appointed local use of the inventive gel in the complex therapy of the disease. 4 days after the start of treatment, epithelization of the mucous membrane in the area of causal teeth was noted, a decrease in bleeding was noted, the patient noted the disappearance of fetid odor from the oral cavity.

Example 4. Patient W., 29 years old, amb. card number 29412. He complained of burning of the mucous membrane of the oral cavity when eating, a feeling of soreness in the teeth when cold air enters the mouth. From the anamnesis, it was noted that the patient works in the production of batteries.

Diagnosis: chronic burn of the oral mucosa, hyperesthesia of the hard tissues of the tooth. Treatment: after applying the claimed gel for 5 days, the patient reported a significant improvement in his condition, no complaints.

Example 5. Patient K., 26 years old, amb. card number 14801, complained of non-healing wounds of the oral mucosa in the lower jaw area on the left, bad breath. The used ointments for the oral cavity and other therapeutic agents did not bring any effect. Diagnosis: periodontitis of moderate severity in the area of 44, 45, 46, 47 teeth.

The patient was prescribed the claimed gel. After applying the gel, recovery came after 5 days, the patient no longer noted bleeding gums when brushing teeth and eating, bad breath disappeared completely, wounds of the mucous membrane were epithelized.

Thus, the data obtained in the clinic allow us to recommend the developed wound healing, anti-inflammatory, hemostatic and antimicrobial gel as a highly effective treatment and prevention of periodontitis of any severity, damage to the oral mucosa of odontogenic and non-odogenic nature (ulcers, burns) with a pronounced clinical effect and having wide functionality for practical medicine.

Claims (2)

A dental gel for the treatment and prevention of periodontitis containing the juice of medicinal plants and a gel base, characterized in that it additionally contains melaxen, anestezin, Kalanchoe juice and nettle, glucosamine hydrochloride, dimethyl sulfoxide, and the PEO-400 and PEO- polyethylene oxides are used as the gel base 4000 mixed with glycerin in the following ratio, wt. %: Melaxen 3-5 Anestezin 3-5 Kalanchoe juice 10-20 Stinging nettle juice 10-20 Glucosamine hydrochloride 5-15 Dimethyl sulfoxide 1-5 Gel base Rest