Reduction of the gingival inflammation by V0109 DI. MedDRA version: 9.1 Level: HLT Classification code 10012325 Term: Dental and periodontal infections and inflammations
Conditions
Interventions
Trade Name: ARTHRODONT
Product Code: V0109 DI
Pharmaceutical Form: Gingival paste
INN or Proposed INN: ENOXOLONE
CAS Number: D03AX10
Concentration unit: % percent
Concentration type: equal
Concentrati
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Will be eligible patients (male or female) who meet the following criteria: - age between 18 and 45 years inclusive, - negative urine pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (oral contraception, intrauterine device, tubal ligature) since at least 2 months before the screening and until 1 month after the end of the study, - stable hormonal contraception since least 2 months before the screening visit and not start it during the study, - be non smoker, - have a minimum of 20 natural teeth ( excluding wisdom teeth) and good dental health (except gingivitis), - have a toothbrush and toothpaste, - have gingivitis (Gingival Index > or equal to 1,5), - willing and able to understand and sign an approved Informed Consent Form, - able to understand the protocol and to attend the control visits, - registered with a social security or health insurance system if required by law. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Will not be included patients who have one of the following criteria: * Criteria related to pathology - periodontitis, - history of periodontitis or acute necrotizing ulcerative gingivitis, - history of severe medical or psychiatric disease/disorder which, in the judgement of the investigator, puts the patient « at risk » or is likely to modify the handling of the study drug, - epilepsy, - any coagulation disorder, - hyposialia or asialia, - caries with cavities and ill-fitting restorations, - lichen planus, - current signs or symptoms of mucosal tissue ulcerations, or canker sores, *Criteria related to treatments - currently undergoing orthodontic treatment, - extensive interproximal restorations, crowns, bridges or implants, - treatment within the six weeks preceding inclusion with either :· antibiotics· corticosteroids· non-steroidal anti-inflammatory drugs· immunosuppressive drugs, immunostimulant drug, antimitotic drug, - start or change within the preceding month of any drug which could interfere with salivary flow: anticholinergic drug, atropine, scopolamine, quaternar amoniums, imipraminic antidepressives, sedative antihistamines, phenothiazines neuroleptics, disopyramide, - treatment with any other topical product (i.e. mouthwashes, gels,…) which could interfere with the study treatment, * Criteria related to the way of life - Drinking excessive amounts of alcohol (more than 2 glass of wine (>2) per day or equivalent), - history of drug addiction, * Criteria related to the population - female who is pregnant or breast feeding or not using contraception, or planning to become pregnant, - participation to an other clinical trial in the previous month before the inclusion visit or during the study, - patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, - patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of V0109 DI in reducing gingival inflammation in patients with gingivitis.;Secondary Objective: - To assess the effect of V0109 DI on gingival bleeding, - To assess the activity of V0109 DI on dental plaque, - To assess the local and general tolerance. ;Primary end point(s): Efficacy Primary criterion The main criterion will be the evolution of the Loe and Silness Gingival Index (GI) during the study: mean change between D0 and D14 calculated on 6 sites (3 vestibular and 3 palatin) around 6 target teeth, excluding wisdom teeth. Safety - local tolerance: aspect of the mouth mucosa, - general tolerance (adverse events), Statistical analysis - efficacy:non-parametric analysis of covariance, -safety: descriptive analysis. | — |
Countries
Estonia, Latvia
Outcome results
None listed