Post-operative care for patients having periodontal surgery with gingival suture.
Conditions
Interventions
Trade Name: ELUDRIL mouthwash
Product Code: DC071BB08b
Pharmaceutical Form: Mouth wash
INN or Proposed INN: Clorherxidrina digluconato
Concentration unit: % percent
Concentration type: equal
Concentra
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of DC071BB08b mouthwash for controlling the evolution of plaque index in per-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. To evaluate the suture healing. To document the local and general tolerance. ;Primary end point(s): Evolution of the plaque index in the peri-surgery area. | — |
Countries
Estonia, Latvia, Spain
Outcome results
None listed