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临床试验/NCT02645617
NCT02645617已完成1 期

Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish

Advantage Dental Services, LLC1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年3月30日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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