The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
研究概览
简要总结
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
排除标准
- 未提供
研究组 & 干预措施
Low ppm fluoride dentifrice
Low ppm fluoride as sodium fluoride in a silica base dentifrice
干预措施: sodium fluoride (Drug)
Medium ppm fluoride dentifrice
Medium ppm fluoride as sodium fluoride in a silica base dentifrice
干预措施: sodium fluoride (Drug)
High ppm fluoride dentifrice
High ppm fluoride as sodium fluoride in a silica base dentifrice
干预措施: sodium fluoride (Drug)
No fluoride dentifrice
no added fluoride in a silica base dentifrice
干预措施: no added fluoride in a silica base (Drug)
结局指标
主要结局
Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
时间窗: Baseline to 4 hours
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 erosive challenge (E1) using formula: \[(E1-R)/ (E1-B)\]\*100.
次要结局
- Enamel Fluoride Uptake (Corrected Data)(Baseline to 4 hours)
- %SMHR(Baseline to 4 hours)
- Percentage Relative Erosion Resistance(Baseline to 4 hours)