E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative care for patients having periodontal surgery with gingival suture. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of DC071BB08b mouthwash for controlling the evolution of plaque index in per-surgical area during the post-operative period. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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,
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evolution of the plaque index in the peri-surgery area. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last patient undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |