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
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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