A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
研究概览
简要总结
An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
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
- Single (Investigator)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).
排除标准
- 未提供
研究组 & 干预措施
1000 ppm Fluoride Toothpaste
Experimental toothpaste containing 1000 ppm Fluoride
干预措施: Fluoride (Drug)
500 ppm Toothpaste
Experimental toothpaste containing 500 ppm Fluoride
干预措施: Fluoride (Drug)
Fluoride free toothpaste
toothpaste with no fluoride
干预措施: Placebo (Drug)
1426ppm Fluoride Toothpaste
Experimental toothpaste containing 1426 ppm Fluoride
干预措施: Fluoride (Drug)
结局指标
主要结局
Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
时间窗: Baseline to 4 hours
Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation 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.
次要结局
- Enamel Fluoride Uptake(Baseline to 4 hours)
- Percent Net Acid Resistance (%NAR) of Enamel Specimens(Baseline to 4 hours)
- %SMHR of Enamel Specimens Exposed to Test Treatments(Baseline to 4 hours)