Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Soft Tissue
研究概览
简要总结
The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
详细描述
This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride [Therametrics Technologies, Inc, Noblesville, IN, USA]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 36 Months 至 60 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Weight less than 15 kg or hypersensitivity to iodine
研究组 & 干预措施
Varnish
Dental varnish containing povidone iodine and sodium fluoride
干预措施: Varnish (Drug)
结局指标
主要结局
Soft Tissue
时间窗: within 48 hours
Proportion of participants with any oral ulcerations OR inflammatory response
次要结局
- Adverse Events(within 48 hours)
