A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Fluoride concentration in resting saliva
研究概览
简要总结
Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.
Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.
Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.
Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •10 natural teeth or more
- •willing to refrain from use of fluoride containing products
- •signed informed consent
排除标准
- •less than 10 natural teeth
- •reduced cognitive skills
- •does not speak and/or understand Swedish
- •ongoing oral or systemic infections
- •pregnancy
- •breast feeding
研究组 & 干预措施
placebo
干预措施: calcium lactate solution (Drug)
calcium lactate solution 75 mM
干预措施: calcium lactate solution (Drug)
calcium lactate solution 150 mM
干预措施: calcium lactate solution (Drug)
结局指标
主要结局
Fluoride concentration in resting saliva
时间窗: 12 hours after rinse
次要结局
- Discomfort by calcium lactate rinse(12 hours after rinse)
研究者
Gunilla Sandborgh Englund
professor
Karolinska Institutet