Determination of a Threshold for Mouth Rinse Induced Discoloration of Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Time point (day) when delta E > 2
研究概览
简要总结
The purpose of this study is to daily monitor the discoloration of teeth when participants rinse with a mouth rinse and black tea and to determine the time point when unacceptable discoloration occurs.
详细描述
Tooth discoloration is a side effect of most mouth rinse solutions. It impairs the aesthetic appearance especially of the front teeth. The aim of this pilot study is to determine a time point when visible discoloration appears in the front teeth. Therefore, participants of this study will rinse twice daily with chlorhexidine mouth rinse for 10 days. To elicit a more pronounced discoloration, participants will rinse with black tea right after the chlorhexidine rinse. Discoloration will be measured daily by discoloration index, by spectrophotometry, and by the use of a digital photo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •persons aged 18 to 30 years
- •written informed consent
- •healthy participants
- •participants who have no or mild gingivitis
- •participants who have all incisors and canines in the upper and lower jaw
排除标准
- •participants who have severe general diseases
- •participants who have allergies against the ingredients of the mouthrinse
- •participants who are enrolled in another clinical study
- •participants who are not able to oversee the consequences of the study
- •female participants who are pregnant or breast feeding
- •participants who have impaired compliance
- •participants who have moderate or severe gingivitis
- •participants who have fillings in the incisors and canines
- •participants who smoke
结局指标
主要结局
Time point (day) when delta E > 2
时间窗: 11 days
次要结局
- Time point (day) when discoloration index changes compared to baseline(11 days)
- Time point (day) when changes in the photo evaluation occur compared to baseline(11 days)
- Time point (day) when discoloration occurs subjectively (questionnaire) compared to baseline(11 days)