Reduction of the gingival inflammation by V0109 DI. Randomised, parallel groups, double blind study, V0109 DI versus placebo, in patients presenting gingivitis.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 54

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

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,

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - To assess the effect of V0109 DI on gingival bleeding,<br>- To assess the activity of V0109 DI on dental plaque,<br>- To assess the local and general tolerance. ;Main Objective: To assess the efficacy of V0109 DI in reducing gingival inflammation in patients with gingivitis.;Primary end point(s): Efficacy<br>Primary criterion<br>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.<br>Safety<br>- local tolerance: aspect of the mouth mucosa, <br>- general tolerance (adverse events),<br>Statistical analysis<br>- efficacy:non-parametric analysis of covariance,<br>-safety: descriptive analysis.

Secondary Outcome Measures

Name	Time	Method

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