Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)
研究概览
简要总结
The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig metal-core interdental brush.
详细描述
Self-performed interdental cleaning is a crucial element in preventing gingival or periodontal diseases. Interdental cleaning is most efficiently performed through usage of interdental brushes. Commonly used metal-core interdental brushes can harbour the risk of hard tissue damage when used inappropriately.The aim of the study was to evaluate the clinical efficacy and patient satisfaction of a novel metal-free interdental brush. This was tested on healthy participants. The control group performed interdental cleaning with a commonly used metal-core interdental brush.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 是
入选标准
- •minimum age: 18 years
排除标准
- •allergy against one or more parts of the interdental brushes
- •non-treated periodontitis
- •soft-tissue changes of the mucosa
- •orthodontic treatment
- •removable prosthesis
- •pregnancy
- •anticoagulants
- •drugs causing gingivahyperplasia
- •indications for antibiotics
结局指标
主要结局
Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970)
时间窗: Beginning and after four weeks of use
次要结局
- Eastman Interdental Bleeding Index, questionnaire of patient acceptance(Beginning and after four weeks of use)
研究者
Johan Wölber, DDS, Principal investigator
Dr.
University of Freiburg