In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
研究概览
简要总结
In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens [required dimensions 12 x 7 millimeters (mm)].
排除标准
- 未提供
研究组 & 干预措施
CSP/SMFP Dentifrice
Dentifrice containing high fluoride content as SMFP and CSP
干预措施: Calcium sodium phosphosilicate (Drug)
CSP/SMFP Dentifrice
Dentifrice containing high fluoride content as SMFP and CSP
干预措施: Sodium monoflurophosphate (Drug)
SMFP Dentifrice Prototype 1
Dentifrice containing high fluoride content as SMFP and no CSP
干预措施: Sodium monoflurophosphate (Drug)
SMFP Dentifrice Prototype 2
Dentifrice containing low fluoride content as SMFP and no CSP
干预措施: Sodium monoflurophosphate (Drug)
CSP Dentifrice
Dentifrice containing CSP but no fluoride
干预措施: Calcium sodium phosphosilicate (Drug)
Placebo Dentifrice
Dentifrice containing no CSP and no fluoride
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
时间窗: Baseline to 21 days
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
次要结局
- Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.(Baseline to 21 days)
- Enamel Fluoride Uptake (EFU)(Baseline to 21 days)