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临床试验/EUCTR2005-000869-20-LV
EUCTR2005-000869-20-LV进行中(未招募)1 期

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.

Pierre Fabre Médicament0 个研究点目标入组 200 人开始时间: 2005年7月26日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - 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

排除标准

  • - 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.

研究者

发起方
Pierre Fabre Médicament

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