Fluoride Administered and Retained After Topical Fluoride Varnish
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Urinalysis for fluoride levels
研究概览
简要总结
The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration that will allow an estimate of the margin of safety of the procedure.
详细描述
Fluoride varnish painted on the teeth is the standard method dentists use to prevent tooth decay (cavities) in preschool children in the United States. Fluoride varnish is not FDA approved specifically for prevention of cavities, but dentists may legally use it for this purpose. We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety. The fluoride varnish is being used for research purposes for this study by permission of FDA (IND #110869).
Premier Dental Product Company's Enamel Pro Varnish will be used. Up to six children aged 12-15 months will be enrolled in this study. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth. Baseline levels were measured on a separate day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •consent obtained from parent or legal guardian of participant
- •children aged 12 - 15 months
- •at least 1 erupted tooth
- •in general good health
排除标准
- •known allergy to any drug, latex, nuts, or resin components or components of toothpaste/dental prophylaxis product
- •participant has stomatitis or other oral conditions that preclude applying fluoride varnish comfortably
研究组 & 干预措施
Fluoride varnish
Topical fluoride
干预措施: Fluoride varnish (Device)
结局指标
主要结局
Urinalysis for fluoride levels
时间窗: 2 days
We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety.
次要结局
未报告次要终点
研究者
Peter Milgrom
Professor
University of Washington