Fluoride Varnish Trial in High Caries Preschoolers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Number of decayed, missing, or filled surfaces
研究概览
简要总结
The aim of this study is to determine whether an annual application of three (3) fluoride varnish doses over two weeks is at least as effective in reducing cavities as the current semi-annual application.
详细描述
The study population will consist of pre-school aged children who are residents of Yakima County, in central Washington State. Children will be recruited from non-migrant Head Start programs for ethnic minority farmworker children in the Yakima Valley.
This study will be a randomized, double blinded trial with one experimental and one standard treatment group. Each participant will be randomly assigned to one of two study groups. The participant and the personnel conducting the study will not know to which study group the participant was assigned.
This trial has two study groups:
- Massive Dose (Experimental):
Annually for three years, children in the experimental group will receive three .30ml applications of 50mg NaF/mL fluoride varnish (CavityShieldÒ, Omni), followed 6 months later by three .30ml applications of placebo varnish in two weeks. There are 18 visits over the entire duration of the study. Each participant will receive a dental exam annually. 2. Semiannual Dose (Standard):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 36 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 36-71 months
- •Enrolled in participating Head Start Center
- •Plan to stay in Yakima County for duration of the study
- •One sound tooth surface present
排除标准
- •No teeth present
- •Developmentally unable to give oral assent
结局指标
主要结局
Number of decayed, missing, or filled surfaces
次要结局
未报告次要终点