ANTISEPTIC AND/OR ANTI-INFLAMMATORY GEL FOR TREATMENT OF ORAL CAVITY DISEASES COMPRISING POLYVINYL ALCOHOL AND POLYACIDS

Abstract

Product for the therapeutic treatment for the prevention and cure of oral cavity diseases of teeth and dental implants including a mixture in a polyvinyl alcohol aqueous solution, of one or more polyacids or their salts, of one or more antiseptics and/or anti-inflammatories, capable of obtaining in situ a protective and adhesive barrier, capable of facilitating the bioavailability of the aforementioned medicinal products, antiseptics and anti-inflammatories.

Claims

1. A product for hygiene, cosmetics, or oral or dental care comprising a mixture, in a polyvinyl alcohol aqueous solution, of one or more polyacids or their salts and one or more antiseptics and/or anti-inflammatories, wherein the antiseptic is selected from among the group consisting of chlorhexidine gluconate, chlorhexidine dihydrochloride, iodine, silver ions and any combination thereof.

2. The product according to claim 1, wherein the polyvinyl alcohol of the polyvinyl alcohol aqueous solution has a molecular weight comprised between 10 and 1,000,000, and a concentration comprised between 0.0001% and 30% w/w.

3. The product according to claim 13, wherein the one or more polyacids or their salts is selected from among the group consisting of polyacrylic acid and its monovalent salts and has a molecular weight comprised between 10 and 5,000,000 and a concentration comprised between 0.0001% and 30% w/w.

4. The product according to claim 1, wherein the one or more polyacids or their salts is selected from among the group consisting of alginic acid and its alginates of monovalent salts and has a concentration comprised between 0.0001% and 30% w/w.

5. The product according to claim 1, wherein the one or more polyacids or their salts is a polyacid salt in the form of a high molecular weight sodium alginate, with viscosity greater than 40 centipoises at 20° C. in solution at 1.5% w/w and with a concentration comprised between 0.0001% and 5% w/w.

6. The product according to claim 13, wherein the one or more antiseptics and/or anti-inflammatories is an antiseptic selected from among the group consisting of chlorhexidine gluconate, chlorhexidine dihydrochloride, iodine, silver ions and any combination thereof.

7. The product according to claim 1, wherein the one or more antiseptics and/or anti-inflammatories is an anti-inflammatory consisting of acetylsalicylic acid or a combination of acetylsalicylic acid and flurbiprofen.

8. The product according to claim 7, wherein said product is a gel which, from a fluid-viscous state, becomes a rubbery and elastic solid resistant against the perforation, penetration of food fragments and extension.

9. A method for in-situ formation of a protective and adhesive barrier in a patient requiring aseptic conditions and protection against bacterial infections or penetration of food fragments, comprising providing the product of claim 8, and applying said gel into the oral cavity or into an area surrounding the tooth or an implant of the patient.

10. The product according to claim 8, wherein the gel contains a factor stimulating tissue regeneration.

11. The product according to claim 10, wherein the factor stimulating tissue regeneration is hyaluronic acid.

12. The product according to claim 8, wherein the gel is used for cosmetic treatment.

13. The product according to claim 12, wherein the gel used for cosmetic treatment comprises whiteners for dental surfaces based on peroxides, oxygenated water and carbamide peroxide and any combination thereof.

14. The product according to claim 13, wherein the gel contains preservatives for the stability of the product over time.

15. The product according to claim 14, wherein the preservatives belong to the class of parabens, same case applying to propyl paraoxybenzoate and methyl paraoxybenzoate and any combination thereof.

16. The product according to claim 1, wherein said product is obtained extemporaneously by a health operator, by mixing all or part of the aforementioned constituents.

17. The product according to claim 1, wherein said product is obtained by using the one or more polyacids or their salts and the one or more antiseptics and/or anti-inflammatories are in form of a bi-component comprising a gel and cross-linking solution.

18. The product according to claim 1, wherein polyvinyl alcohol has a molecular weight greater than 10,000 and a concentration less than 4% w/w.

19. The product according to claim 13, wherein the one or more polyacids or their salts is selected from among the group consisting of polyacrylic acid and its monovalent salts and has a molecular weight comprised between 10 and 5,000,000 and a concentration comprised between 0.0001% and 30% w/w.

20. The product according to claim 2, wherein the one or more polyacids or their salts is selected from among the group consisting of alginic acid and its alginates of monovalent salts and has a concentration comprised between 0.0001% and 30% w/w.

Description

EXAMPLES

[0034] The examples below, which regard the preparation, characterisation and use of the product according to the invention, are provided solely for illustrative purposes and shall not be deemed to limit the scope of protection according to the present invention, as defined in the attached claims, in any manner whatsoever.

Example 1: Preparation

[0035] The gel was obtained by dissolving polyvinyl alcohol, with molecular weight equivalent to 90.000, at a concentration of 2% by weight, in water. The solution was stirred up to obtaining a homogeneous solution, followed by the addition of polyacrylic acid with molecular weight of 400,000 at the concentration of 0.5% w/w and sodium alginate at a concentration of 1.5% by weight. Chlorhexidine gluconate at a concentration of 2% by weight and, lastly, acetylsalicylic acid at the concentration of 10% w/w, was added to the entirety.

Example 2: Administration

[0036] The gel containing chlorhexidine gluconate, prepared according to Example 1, was introduced into the interdental spaces (or administered around dental implants) by means of a syringe with bevelled needle. Once solidified in loco, the gel prevented food residues from penetrating between the teeth or in the vicinity of the implant. Such treatment is recommendable after performing the radicular cleaning, polishing the roots, curettage, disinfection of periodontal pockets and/or scaling and root planing top avoid frequent recurrence of the disease.

[0037] Administration can be expanded by administering a thin layer of gel at the level of the gingival collar (between the gums and teeth) using a small brush, forming a sealing film and antiseptic sealing, for the restoration and maintaining the health conditions of the gums and the root of the tooth.

Example 3: Characterisation of the Plastic Film

[0038] The rubbery film obtained through the procedure described in Example 2 is characterised by elasticity and capacity to release the chlorhexidine gluconate contained therein. Measurements of the elastic elongation at fracture in gel samples were carried out, resulting greater than 100%. The release of chlorhexidine gluconate revealed a duration exceeding 7 days.

Example 4: Preliminary Clinical Studies

[0039] Preliminary clinical studies, carried out with the product of Example 1, revealed the maintenance of a longer optimal oral health after scaling and root planing sessions, radicular cleaning, polishing the roots, curettage, disinfection of the periodontal pockets, thus eliminating the need for repeating the treatment within a short time. The product also revealed to be useful for curing or preventing fistulas, cysts or dental infection after extracting a tooth or a major dentistry intervention, infections in carriers of fixed or moveable dental prosthesis.

Example 5: Alternative Preparation

[0040] The gel was obtained by dissolving polyvinyl alcohol, with molecular weight equivalent to 90.000, at a concentration of 2% by weight, in water. The solution was stirred up to obtaining a homogeneous solution, followed by the addition of hyaluronic acid at the concentration of 0.2% w/w, flurbiprofen at the concentration of 5% w/w and sodium alginate, with specific viscosity of 4,000 cP, at a concentration of 2% by weight. Chlorhexidine gluconate at a concentration of 2% by weight and, land chlorhexidine dichlorhydrate at a concentration of 3% by weight, was added to the entirety.

[0041] The administration of the product, according to Example 2, proved to prevent gingival recession and formation of periodontal pockets facilitating the resolution thereof after surgical treatment.

[0042] Though the present invention has been described by way of non-limiting example, according to some preferred embodiments, it should be observed that any variations and/or modifications may be carried out by a man skilled in the art without departing from the relative scope of protection, as defined by the following dependent claims.