Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Dental Caries Activity
研究概览
简要总结
This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.
详细描述
Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nyvad criteria 3
- •Active carious lesion
排除标准
- •Allergy to silver
- •Stomatitis or oral ulcerative condition
- •Weight less than 15 kg
研究组 & 干预措施
Water
Topical application of fluoride free water to active cavity
干预措施: Water (Other)
38% diamine silver fluoride
Topical application of 38% diammine silver fluoride to active cavity
干预措施: 38% diammine silver fluoride (Drug)
结局指标
主要结局
Dental Caries Activity
时间窗: 14-21 days
Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change
次要结局
未报告次要终点