COMPOSITION AND METHOD FOR THE TREATMENT OF MUCOUS MEMBRANE INFLAMMATION

Abstract

A method for treating mucous membrane inflammation in a patient is provided. The method includes administering an effective amount of a composition containing sodium salts to the patient. Preferably, the composition contains a sodium concentration of less than or equal to 125 mM, and contains sodium hypochlorite and a sodium salt of N-chlorotaurine.

Claims

1. A method of treating mucous membrane inflammation in a subject, comprising administering an effective amount of a composition comprising sodium salts, with a sodium concentration less than or equal to 125 mM, wherein said composition is a mixture of: (i) sodium hypochlorite (NaOCl) at a concentration of between 30 and 45 mM, and (ii) sodium salt of N-chlorotaurine (NCT) at a concentration of more than 0.5 mM.

2. The method according to claim 1, wherein the composition has a concentration of sodium salt of N-chlorotaurine of more than 10 mM.

3. The method according to claim 1, wherein the composition has a concentration of sodium salt of N-chlorotaurine between 20 and 50 mM.

4. The method according to claim 1, for treating periodontitis and the composition is administered within the periodontal pocket of the subject.

5. The method according to claim 1, wherein the composition is administered within an exudate of the subject.

6. The method according to claim 1, wherein the composition further comprises a pharmaceutically acceptable carrier.

Description

[0036] The following examples detail the invention with reference to various methods. No limitation of the invention must be considered in the light of these detailed examples. The invention includes all embodiments which would include details not explicitly mentioned in the following examples, but would be readily understandable to those skilled in the art.

[0037] A controlled prospective, randomized, multicentric and unblinded phase I-II clinical study is realized with randomization, which study includes the following 4 groups:

[0038] i. A “T” or control group, in which the patients with periodontitis were treated with the current standard treatment corresponding to a scaling/root planing without subgingival irrigation.

[0039] ii. A group named “D.sub.k” in which patients are treated with a scaling/root planing with subgingival irrigation by a Dakin's solution diluted with a Na+ concentration of 154 mM.

[0040] iii. A group named “S1-154” in which patients are treated with scaling/root planing with subgingival irrigation with a solution of sodium hypochlorite and sodium salt of N-chlorotaurine with an Na.sup.+ concentration of 154 mM.

[0041] iv. A group named “ irrigation S1-55” in which patients are treated with scaling/root planing with subgingival irrigation with a solution of sodium hypochlorite and sodium salt of N-chlorotaurine with an Na.sup.+ concentration of 55 mM.

[0042] In the study, the inclusion criteria include any consulting adult in one of the research centers if it has (i) at least 20 teeth, (ii) an advanced chronic periodontitis defined by periodontal sites with depth pocket sample of ≧6 mm and a clinical periodontal attachment loss ≧5 mm and (iii) affecting at least 30% of teeth, including at least 3 teeth with one or several radicles. Naturally, written and signed consent will be obtained prior to inclusion of the patient.

[0043] This study will not include pregnant women, those with valvular or severe heart disease, immunodeficients, drug abusers, subjects that have been treated in the last three months with antibiotic, anti-inflammatory, or immunomodulatory drugs.

[0044] Within the study, the principal criteria will be the reduction of periodontal attachment loss clinic at 70.sup.th day compared to the loss before treatment. The secondary criteria will be, i)—for the systemic safety, methemoglobinemia and impaired creatinine and transaminases; ii)—for local effects, periodontal pocket depth, indicators of bleeding on probing and tooth mobility; and iii)—for the assessment of periodontal immune effects, the dosage in the periodontal crevicular fluid of cytokines IL-1β, TNF-α and IL-17.

[0045] Concerning the conduct of the study, patients included will be required to make six visits during the first two weeks and then two further visits during the following eight weeks. The initial consultation will include a detailed medical questionnaire, 30 preoperative evaluation of oral pain, indicators of gingival bleeding, tooth mobility and 8 a blood sample. Scaling/root planing with or without accompanying irrigation will be done to the group randomly. The clinical periodontal attachment level will be measured by electronic survey with constant force at D0 and then every four weeks from D14 to D70.

[0046] In terms of the statistical method, the total number of subjects included therein 188: with 47 patients in each of the four groups T, D.sub.k, S1-55 and S1-154. The total duration of the study will be 30 months. We will test the benefit of irrigation with a solution of HS-CT compared to non-surgical treatment without irrigation (comparing two groups S1 versus T) in relation to non-surgical treatment with irrigation (comparison of two groups S1 versus group D.sub.k), the specific effect of irrigation with Dakin (comparison of group D.sub.k versus T) and finally the anti-exudate effect (comparison of group S1-55 versus S1-154). Being used for the comparison analysis of variance with Dunnett post-tests at α-risk of 0.05

[0047] It is expected to demonstrate a significant improvement in the periodontal healing (disappearance of periodontal pockets and optimal gain in clinical attachment) through the subgingival irrigation with a solution of sodium hypochlorite and sodium salt of N-chlorotaurine (HS-CT) with reduction of complaints in cases of advanced periodontitis. The right tolerance of HS-CT solutions for local use will also be analyzed. Thus, periodontal care accessibility should be vastly improved and strengthened.