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临床试验/EUCTR2013-002708-14-DE
EUCTR2013-002708-14-DE进行中(未招募)不适用

Phase II study to assess bacterial count reduction of three Octenidine mouthwash concentrations in comparison to a placebo in patients with mild gingivitis - OML-Study

Schülke & Mayr GmbH0 个研究点开始时间: 2013年7月23日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)

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

  • Adult male and female patients (aged 18 and older)
  • Patients who have mild gingivitis (mean GI: 0.2 - 1.0)
  • Patients with complete natural Ramfjord-teeth” or their replacement teeth
  • Patients must have signed the informed consent form.
  • 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 88
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • Patients with severe systemic diseases (diabetes, hepatitis, HIV, tuberculosis, cancer)
  • Patients who require endocarditis prophylaxis for dental examination and treatment
  • Caries requiring treatment (e.g. caries with cavity) or other oral diseases (incl. gingival hyperplasia, diseases of the oral mucosa, periodontal screening index PSI > 2)
  • Patients with orthodontic appliances and removable dentures
  • Patients treated with antibiotics less than 3 months prior to the baseline examination at V1 and/or such a treatment planned for the duration of the trial
  • Patients chronically treated with steroids
  • Patients who suffer from xerostomia
  • Patients who regularly smoke more than 10 cigarettes per day

研究者

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