EUCTR2005-000869-20-ESActive, not recruitingPhase 1
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.Cuidado post-operatorio mediante un colutorio de clorhexidina tras una cirugía periodontal. Estudio ciego, en grupos paralelos, aleatorizado, DC071BB versus placebo, en pacientes que presenten cirugía periodontal con sutura
Pierre Fabre Médicament0 sites200 target enrollmentStarted: June 9, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Regular user of manual toothbrush (at least once a day),
- •- who have a periodontitis,
- •- who have 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
- •- 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,
- •- smokers.
Investigators
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