Phase II Study to Assess Bacterial Count Reduction of Three Octenidine Mouthwash Concentrations in Comparison to a Placebo in Patients With Mild Gingivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
研究概览
简要总结
The objective of this clinical trial is to identify the most efficacious octenidine dihydrochloride concentration regarding bacterial count reduction in comparison to a placebo in the oral cavity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild gingivitis (mean GI: 0.2 - 1.0)
- •Patients with complete natural "Ramfjord-teeth" or their replacement teeth
- •Caucasian
- •Signed Informed Consent
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
- •Patients who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure
- •Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- •Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism)
- •Pregnant or breastfeeding women
- •Women with childbearing potential except those who fulfill the following criteria:
- •Post-menopausal (12 month of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
- •Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- •Continuous and correct application of a contraception method with a Pearl Index < 1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD)
研究组 & 干预措施
OCT 0.1% vs. Placebo
0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
干预措施: Octenidine dihydrochloride (Drug)
OCT 0.1% vs. Placebo
0.1 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
干预措施: Placebo (Drug)
OCT 0.15% vs. Placebo
0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
干预措施: Octenidine dihydrochloride (Drug)
OCT 0.15% vs. Placebo
0.15 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
干预措施: Placebo (Drug)
OCT 2.0% vs. Placebo
0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
干预措施: Octenidine dihydrochloride (Drug)
OCT 2.0% vs. Placebo
0.2 % Octenidine dihydrochloride vs. Placebo (0.9 % sodium chloride solution)
干预措施: Placebo (Drug)
结局指标
主要结局
Bacterial count reduction in saliva after a single application of OML in comparison to placebo application
时间窗: After 1 minute of rinsing
Bacterial count reduction is measured at V1 (Verum/Placebo) and V3 (Placebo/Verum) in a blinded cross-over design
次要结局
- Mean plaque index (PI)(After 5 days of application)
- Change in mean gingival index (GI)(After 5 days of application)
- Evaluation of taste and flavour (questionnaire)(After 5 days of application)
- AEs and SAEs(4 weeks)