Medical adhesive tapes for fixing removable laminar dentures and method of their preparation

 

(57) Abstract:

The invention relates to dentistry, concerns the creation of a medical adhesive tapes for fixing laminar prostheses and method of their preparation. Film with double-sided adhesive contains one or more water-soluble polymer, a plasticizer, if necessary, partially water-soluble polymer, nonionic surface-active substances of the medicinal product. The method of preparation of the film involves the dissolution of water-soluble polymer and plasticizer in deionized water at 40-45oWith, if necessary, the temperature increased to 80-85oC, then cooled, filtered, the filtrate contribute optionally partially water-soluble polymer, is stirred at a temperature of 40-45oC, filtered, the filtrate is evenly dried on the surface at a temperature not exceeding 25oC in an atmosphere of inert gas until the water content in the film of 5-10%. The film serves for fixing dentures, does not cause adverse reactions when in contact with mucous, not denaturised drugs, does not cause allergic reactions. 3 S. and 6 C.p. f-crystals.

The invention relates to medicine, in particular dental, and described the prosthesis, and the method of their preparation.

Removable laminar dentures with plastic bases are the most common form of treatment of fully edentulous. Despite the advantages of this type of prosthesis, there are a number of problems associated with the period of patient adaptation to the prosthesis, fixation of prostheses under adverse morphological structure of the jaw, wearing dentures with the RUB sores, bedsores and other Long-term observations confirm that:

1. Up to 70% of those using permanent dentures, suffer from stomatitis and constantly emerging bedsores.

2. With the constant contact of the plastic with mucous often arise intolerance and allergic reactions.

3. There are cases of candidiasis, neuralgia of the trigeminal nerve.

Installing different kind of locking strips between the gum and denture today is the most common type of prostheses correction and elimination of these drawbacks.

For fixing dentures offers many tools - gels, powders, soft and elastomeric gaskets.

A brief introduction to the technology of their application shows that it includes all sorts of>/P>1. Molloy (Germany) - overlay denture carefully wash detergent, dehydrated with acetone or alcohol. The surface of the prosthesis is treated for roughening, then the entire surface of the prosthesis is covered with a layer of edge-Ziv, after which the prosthesis is left on the air. Is the polymerization of the adhesive layer under the influence of moisture in the air. The second stage of the individual tube squeeze 8-10 cm of paste to the bottom or 12-18 cm for the upper jaw, then add one drop of the catalyst. Mass with the catalyst are thoroughly mixed for 1 minute, after which it is ground in a thin layer, to remove air. The cooked mass is collected with a spatula and put first light pressure on the lingual and the cervical region, then cover with the weight of the entire surface of the prosthesis. The prosthesis is inserted into the oral cavity, and incubated for 8-10 minutes, remove from the mouth, correction, polishing and finally finished lining varnish.

In the packaging means includes:

1 bottle - 60 g

1 bottle of adhesive 5 ml.

1 vial of catalyst 6 ml.

1 bottle Lustrol* - 6 ml.

1 brush.

1 unit for mixing.

*) the lacquer coating and the second instruction.

2. JI si Relay

Multicomponent tool making gaskets associated with the use of liquid monomers, polymer powders, catalyst, fixing cream and other Technology similar technology Morosila.

3. a) SOS Reparfix (Switzerland): liquid methyl methacrylate powder of polymethyl methacrylate, cyanoacrylate adhesive, pigments and other source components. The multistage technology.

b) 1 Month Denture Stabilizer - butylphenylmethyl gluconate, ethanol, powder - methylmethacrylate polymer, alcohol, acetone, lacquer, cellulose derivatives and other multistage Technology.

4. Also apply powders (Protopic, NEOFIX R), fixing gels, creams.

Despite the large multistage instructions and operation, not always getting the gaskets described above technologies leads to satisfactory results. This is due to inaccuracies caused by dosing the starting components and their mixing, it is difficult adjustable time and temperature of polymerization and other uncontrolled factors.

Besides the technical difficulties of preparation, these strips have a number of other significant drawbacks:

and over time, the soft pads of Delta unpleasant mouth odor and often leads to inflammation of the lining;

b) lose their color, are rigid;

C) places around the base of the prosthesis material exfoliate.

The technical objective of the invention is the expansion of the means of local action in terms of creating funds intended for fixation of removable plastic dentures. The tool is intended for use in dentistry for both professional work and for independent use by patients using dentures at home.

The tool is made in the form of a soft film (strip) with double-sided adhesion. On both sides it can be pasted as the surface of a plastic prosthesis, and the surface of the mucous membrane of the gums, without the use of glue or other auxiliary components. When creating a film, special attention was paid to the fact, in order to create the most simple and convenient means for persons using removable dentures. On the other hand, that the film was non-toxic, biocompatible, did not cause allergies, did not support the growth of colonies of microorganisms and other Film is easy to use, does not require participation of a doctor (if not necessary) and can reduce the frequency of patient visits mouth or outside of it there is a transition film hydrocolloid state, due to which there is a complete exclusion of hollow spaces between the surfaces of the prosthesis and prosthetic bed, which are niches for the development of pathogenic microflora and weakening cohesion. The film is transparent, has no flavor characteristics and odor.

Biopolymer base allows you to enter in the composition of the films a number of drugs, so it is possible to deal with complications, without disturbing the normal rhythm of life and nutritional status of patients.

Another point in the prevention of complications in removable prosthetics using the proposed in this application film (strips) we consider some insulation mucous from the toxic effects of the material basis.

Thus, the proposed treatment and the adhesive film (strip) possess complex properties: prevention, treatment, isolation, redistributive masticatory loading and locking means for removable dentures. The proposed film (strip) consists of:

a) water-soluble polymer is one or a mixture of two or more polymers);

b) plasticizer (one or a mixture of two or more similar actions).

Additional the mayor;

b) drugs;

in other auxiliary components, in particular, nonionic surface-active substances (surfactants). Components:

1. Water-soluble polymers:

the base materials for the preparation of films are water-soluble, film-forming polymers of natural and synthetic origin, which do not cause adverse reactions when in contact with mucous, not denature drugs, does not cause allergic reactions.

These include polysaccharides and their derivatives, such as tragakant, gelatin resin, denatured gelatin, collagen and its derivatives - Arabian gum, agarose, agar-agar, xanthan gum, pectins, polymers, alginic acid, its salts and esters, chitin, chitosan and their derivatives, esters of cellulose carboxymethylcellulose, hydroxyethylcellulose, methylhydroxypropylcellulose, synthetic polymers and copolymers - polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, copolymers based on vinyl esters, vinyl acetate, maleina-howl acid, the polymers and copolymers of acrylic and methacrylic acids and their salts and esters, water-soluble polymers of lactic and glycolic acid, vodor the tx2">

2. Plasticizers.

Basically it is biocompatible substances such as esters of glycerine, polyoxyalkylene esters of fatty acids and alcohols and other plasticizers. Their content in the finished film should be no more than 10% by weight of the basic component.

3. Partially-soluble polymers is mainly Berasategui polymers as polyglycolic acid, polylactic acid, polytetramethylene, polydiethylsiloxane, polycaprolacton. Poly(DL - decanolactone), poly(alkanal imenti), their copolymers, ion-exchange resins and shellac, cellulose derivatives, as ethylcellulose, acetylcellulose, Boticelli, partially saponified derivatives of polyvinyl acetate.

Their content in the finished film (strip) must range between 0-30% by weight of the basic component.

4. As nonionic surfactants usually used polyoxyethylene derivatives of higher fatty biocompatible acids, alcohols, alkyl phenols, sorbitan etc.

Below is a General method and specific examples of the preparation of films (gaskets) for fixing dentures.

General method of preparation of films

Example 1.

(a) preparation and is intended for casting film (strip) and 12 g of plasticizer. The dissolution is conducted at a temperature of 40-45oC for 6 hours; if necessary, the mixing can be maintained for another 2 hours at 80-85oC, cool the solution to 25oC, filtered through nylon cloth. Impose additional 3.6 g of partially-soluble polymer is stirred for further 4 hours at 40-45oWith, again filtered through nylon cloth.

b) casting the film.

In a pre-siliconized surface of the glass size 30x40 cm put 60-70 cm3the prepared solution; the solution is evenly distributed over the surface and dried at a temperature not exceeding 25oWith the current of inert gas within 48 hours. The end of drying is controlled by the water content in the finished film; it must be in the range of 5-7%, but not above 10%. The thickness of the films regulate within 0.02 to 0.15 mm

C) estimated amount of other auxiliary components are solutions before applying.

Example 2. Analogously to example 1, 4 g of polyvinyl alcohol, 0.35 g of PEG 300 dissolved in 40 ml of deionized water, stirred for 2 hours at a temperature of 40oC, then 1 hour at 90oC, the mixture is cooled, add 0.1 g of partially saponified derivative of polyvinyl acetate, again nahrawan surface pre-siliconized glass described in example 1 technology. The film obtained in this example, named "Protoplasm".

Example 3. Analogously to example 1, 1 g of polyvinyl alcohol, 0.35 g of glycerin, 0.2 g of Triton X-100 (polyoxyethylene Nonylphenol) was dissolved in 40 ml of water, stirred at 40oWith 2 hours, then 2 hours at 90oC. is Cooled, filtered through nylon cloth and cast film on a pre-siliconized surface of the glass.

Example 4. Analogously to example 1 a film cast from a mixture of 4 g of polyvinyl alcohol, 0.35 g of glycerin, 0.2 g polyoxyethylene lauric alcohol in 40 ml of water.

Example 5. Analogously to example 1 film (strip) cast from water-alcohol solution of a mixture of 3.6 g of hydroxypropylcellulose (viscosity of 2% aqueous solution. 1000-4000 centipoise at 20oC), 0.5 ml of PEG-300, 0.18 g of shellac.

Example 6. Analogously to example 1 film (strip) cast from water-alcohol solution of a mixture of 3.6 g of hydroxypropylcellulose (viscosity of 2% aqueous solution. 1000-4000 centipoise at 20oC), 0.5 ml of PEG-300, 0.18 g of polylactic acid.

Example 7. Analogously to example 1 film (strip) cast from an aqueous solution of a mixture of 10 g of polyvinyl alcohol, 0.6 g of PEG-300 and 0.3 g polivinilatsetatftalat.

Example 8. 80 g of copolymerization, stirred at 40oWith 2 hours, filtered and cast film.

Example 9. 45,0 g of polyvinyl alcohol, 15 g of highly-substituted PCB derivative hydroxypropylcellulose, 20 g viscosimeter derived hydroxypropylcellulose, 4 g of PEG-300 dissolved in 1000 ml of ethanol and cast film.

Example 10. In 250 ml of ethanol was dissolved 50 g of polyvinylpyrrolidone, 5 g of propylene glycol, 5 g polyoxyethylene derived Nonylphenol (Triton X-100) and cast film.

Example 11. Analogously to example 1 a solution casting film (strip) is prepared from 0.5 g of hydroxypropylcellulose, 0.25 ml of PEG-400 and 0.25 g of shellac in 25 ml of ethanol.

Example 12. Solution casting is prepared analogously to example 1 from 3,5 g hydroxypropylcellulose and 0.5 ml of PEG-400 in a mixture of 63 g of ethanol and 10 g of water.

Example 13. Analogously to example 1, the film cast from a mixture of 50 g of polyacrylate Na, 40 g of starch, 9.0 g of glycerol dissolved in 500 ml of water.

Example 14. The film prepared analogously to example 1 from an aqueous solution of a mixture of 40 g of gelatin, 20 g of starch and 0.35 g of glycerin.

Example 15. The film prepared analogously to example 1 from a solution of a mixture of 90 g of phthalate hydroxypropylmethylcellulose, 10 g of triacetin, and 5 g of polyvinyl acetate, 2 g of polyacrylic acid, 3 g of hydroxypropylcellulose.

Example 17. The toxic properties of the obtained films was studied on the example of the film obtained in example 2. Her registered name OVERHEATED. For example OVERHEATED conducted clinical trials.

For Toxicological tests of the film OVERHEATED prepared aqueous extract of calculating 1.6 cm film/1 ml of water; the mixture was stirred over night at 37oC. Toxicological studies included an assessment of the biological effect of the film on biochemical, immunological, hematological, histological, physiological indicators, the coefficients change weight of internal organs and micronuclear test results (Handbook edited by Menshikov Century A. "Laboratory methods in the clinic", Moscow, 1987). As an integral indicator of the health of animals used indicator of musculoskeletal health, as defined by the time the motion to rotary setting company Ugo-Basile, Italy). The Central nervous system was assessed by the ability to summation of subthreshold pulses SPP (Elizarova O. N. and other "Handbook on the toxicology for technicians", Moscow, Honey the activity of chemicals microkernel method", Moscow, 1984).

The results of Toxicological and hygienic tests.

The study of chronic toxicity studies conducted under repeated intragastric administration of the extract of the film OVERHEATED white rats. Throughout the period of observation there were no deaths in experimental animals, changes in appearance, behaviour, food consumption, locomotor activity compared to control group animals. At the necropsy of animals not detected macroscopically pathological changes of internal organs and tissues of experimental animals. The ratios of the masses of internal organs of experimental animals do not have statistically significant differences from those of control animals. According to the results of the experiment using provokating intradermal tests, sensitizing actions of the drawing, the existence of which was judged by the reaction of degranulation, mast cells are not found. Basic biochemical indicators of function of a liver, kidneys, redox processes, as well as hematological, immunological parameters and mutagenic test laboratory animals do not have statistically significant differences from those figures, the contours of the internal organs. Extracts from samples of the film did not have any negative impact on the viability of the biological cell test object: index of toxicity 103,0% at the rate of not less than 70%. Extraction of the samples was not hemolytic effect in experiments in-vitro with isolated rabbit erythrocytes hemolysis 0% when the acceptable value is less than 2%.

Conclusions test results:

film OVERHEATED

on the Toxicological-hygienic and sanitary-chemical indicators meet the requirements of the medical products, short-term contact with mucous membranes.

Film OVERHEATED non-toxic, meets the requirements of normative documents.

EXAMPLES OF CLINICAL TRIALS.

Patient P. , 73 years, was to conduct the correction after the full removable prosthesis. Complaints arose pain when biting under the prosthesis and difficulty chewing hard food. The mucous membrane of the alveolar ridge in the area of the missing 11, 21, 24, 31, 41 and 46 teeth inflamed. Carried out the correction of the prosthesis. At the same time, teaching the patient to use, the surface of the prosthesis facing the mucous membrane, covered with a film "Overheated" and put in the traditional recommendations. The next day the patient was noted that the film was resorbed after 4 hours on the bottom and after 6 hours on the upper jaw prosthesis according to our recommendations outside of mealtimes were not, in the evening without the "Overheated" chewing remained painful. Objectively hyperemia areas has decreased. Repeated correction and layering film "Overheated". During the next reception of complaints from the patient was not, objectively - inflammation of the mucous membrane asleep. "Protoplasm" the patient continues to use it.

Patient K. , 62 years old, came with complaints inflammation of the mucous membrane by a removable denture on the upper jaw and tenderness. According to the patient full removable laminar dentures made of plastic on the upper and lower jaws are made about 8 months ago. Objectively atrophy of the alveolar ridge of the upper jaw 2 class, and the alveolar part of the lower - class 3 classification of Oksman. Mucous 3 type in the upper jaw (nonfunctional, malopodatliva, dry) and 2 type at the bottom of Supply. Lots hyperemic mucosa on the vestibular side of the alveolar ridge in the area of the missing 16, 24, 36 and 43 teeth. Dentures in a satisfactory condition. Carried out the correction of the prosthesis. The FR is mendacii. On your next visit, had no complaints, the prosthesis is, objectively - mucosa pale pink color, without inflammatory changes.

Patient S., 56, at the stage of submission of complete removable laminar dentures was used in the film "Overheated". The patient is trained in the use of film and scheduled for correction of prostheses. Given the traditional recommendations. The next day was brought complaint a slight increase in sensitivity of the transition fold to the right, an objective examination using a solution Schiller-Pisarev detected locations of congestion in the mucosa and the correction of denture bases. The guidelines are the same, a few films issued to the patient. On the appointed day at the reception was not reported to the administrator about the absence of complaints.

1. Medical adhesive tape for fixing a removable laminar dentures, characterized in that it is made of elastic with double-sided adhesion and contains one or a mixture of two or more water-soluble polymers and one or a mixture of two or more plasticizers, and the content of the plasticizer in the film is not more than 1% by weight of the basic component.

2. Medical adhesive film under item 1, distinguished by Alacant, gelatinous resin, denatured gelatin, collagen and its derivatives, Arabian gum, agarose, agar-agar, xanthan gum, pectins, polymers, alginic acid, its salts and esters, chitin, chitosan and their derivatives, cellulose ethers, as carboxymethylcellulose, hydroxyethylcellulose, methylhydroxypropylcellulose, synthetic polymers and copolymers, as polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, copolymers based on vinyl esters, vinyl acetate, maleic acid, polymers and copolymers of acrylic and methacrylic acids and their salts and esters, water-soluble polymers of lactic and glycolic acid, water-soluble polyurethanes, polyesters organic duotronic acids, polysaccharides and their derivatives.

3. Medical adhesive film under item 1, characterized in that the plasticizer is chosen from the group of esters of glycerol, polyoxyalkylene esters of fatty acids and alcohols.

4. Medical adhesive film under item 1, characterized in that it further comprises partially water-soluble polymer that is compatible with the basic polymer selected from the group polyglycolic acid, polylactic acid, polytetramethylene, polydiethylsiloxane, polycaprolacton, the cellulose, as ethylcellulose, acetylcellulose, butyltoluene, partially saponified derivatives of polyvinyl acetate, the content of polymer in the film is not more than 30%.

5. Medical adhesive film under item 1, characterized in that it further comprises neionogennye surfactant selected from the group polyoxyethylene derivatives of higher fatty besomething acids, alcohols, alkyl phenols, sorbitan.

6. Medical adhesive film under item 1, characterized in that it additionally contains medicines anti-inflammatory, wound-healing action.

7. Method of preparation of medical adhesive tapes for fixing removable laminar dentures, characterized in that the water-soluble polymer and plasticizer are dissolved in deionized water at a temperature of 40-45oWith, then the solution is cooled, filtered, the filtrate is injected, if necessary, partially water-soluble polymer, is stirred at a temperature of 40-45oWith, re-filtered, a uniform layer is dried on the surface at a temperature not exceeding 25oC in an atmosphere of inert gas until the water content in the formed film of 5-10%.

8. The method according to p. 7, characterized I commit removable plastic dentures, characterized in that a water-soluble polymer and plasticizer are dissolved in deionized water at a temperature of 40-45oSince, then, the solution is stirred while heating to a temperature of 80-85o, Then cooled, filtered, the filtrate if necessary, make a partially water-soluble polymer, is stirred at a temperature of 40-45oWith, again filtered and the filtrate is evenly dried on the surface at a temperature not exceeding 25oC in an atmosphere of inert gas until the water content in the formed film of 5-10%.

 

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