Testing of a Candy in Five Different Versions for the Additional Humidification of the Oral Cavity (DESERTO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- dryness of mouth- sensation
研究概览
简要总结
This study is to investigate whether a candy can increase moisture of the oral cavity and reduce dryness of mouth.
详细描述
A candy (available on the market from a Swiss manufacturer (Ricola)), free of ingredients that could interfere with the investigation, is tested in five different versions on different days. It is to analyse whether these candies can increase moisture of the oral cavity and reduce dryness of mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- 是
入选标准
- •non- smoker
- •no allergies
- •no drug- use (except for contraception)
- •healthy volunteers (no disease/infection 4 weeks before study participation)
排除标准
- •pregnant women
结局指标
主要结局
dryness of mouth- sensation
时间窗: one point assessment following consumption of candy (approx 5 minutes)
dryness of mouth- sensation by Visual analogue scale (VAS); 0 = does not apply; 10 = is absolutely true.
Change in salivary flow rate (ml/min)
时间窗: before and after consumption of candy (approx 5 minutes for each salivary flow measurement)
Change in salivary flow rate (ml/min) before and after stimulation (mechanical and gustatory) by consumption of candy
次要结局
未报告次要终点
