NCT01237795已完成不适用
A Randomized Trial of Experimental Dentifrices for Cleaning Dentures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Denture plaque coverage area (%)
研究概览
简要总结
This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous
- •Good general health
- •Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures)
- •Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years
- •Both denture bases and artificial teeth should be composed by acrylic resin
排除标准
- •Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
- •Absence of deposits of biofilm at baseline
结局指标
主要结局
Denture plaque coverage area (%)
时间窗: 7 days
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
次要结局
未报告次要终点
研究者
Raphael Freitas de Souza
Associate Professor
University of Sao Paulo
研究点 (2)
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