Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of caries lesions which progressed to dentine
研究概览
简要总结
This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies 1 to 3 years;
- •Babies with initial dental caries lesion.
排除标准
- •Parents who do not consent.
研究组 & 干预措施
Silver Diamine Fluoride
Control treatment
干预措施: Silver diamine fluoride (Other)
Fluoride Varnish
Test treatment
干预措施: Fluoride Varnish (Other)
结局指标
主要结局
Number of caries lesions which progressed to dentine
时间窗: 24 months
Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)
次要结局
- Parental acceptability to the treatment using a VAS scale(12 months)
研究者
Mariana Minatel Braga
PhD, Associate professor
University of Sao Paulo
