Post-operative care by chlorhexidine mouthwash after periodontal surgery. Randomised, parallel groups; blind study, DC071BB versus placebo, in patients presenting with periodontal surgery with suture.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

- Regular user of manual toothbrush (at least once a day),
- Patient having a periodontitis,
- Patient having a periodontal surgery (flap, debridment with access flap, complicated tooth extraction, alveolectomy) with a gingival suture or several sutures on the same area, concerning one or several teeth

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Smokers,
- Dental surgery such as: grafting of bone substitute material, membrane, gingivectomy, non complicated tooth extraction, scaling – root planning alone,
- any surgery that requires an antibiotic cover during or after the surgery,
- who have more than two teeth missing between the suture and an existing tooth,
- who have in the same time surgical procedures on different areas of the mouth,
- medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug,
- severe acute or chronic systemic disease or disorder that should interfere with treatment or evaluation,
- any coagulation disorder,
- any buccal disorder which could interfere with the treatment or the evaluation (hyposalivation or asialia, aphtha, ulceration, lichen planus, stomatitis),
- history of alcohol or drug addiction.
- use of local antiseptics (mouthwash) within the 7 previous days,
- use of antibiotics (any route of administration) within the 7 previous days.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of DC071BB08b mouthwash for controlling the evolution of plaque index in peri-surgical area during the post-operative period.;Secondary Objective: To evaluate the patient's satisfaction and the investigator's global judgement during the post-operative period.<br>To evaluate the suture healing.<br>To document the local and general tolerance.<br>;Primary end point(s): Evolution of the plaque index in the peri-surgery area.

Secondary Outcome Measures

Name	Time	Method

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