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临床试验/NCT02789202
NCT02789202Unknown不适用

Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月最近更新:
适应症
干预措施

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

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

Experimental

Control treatment

干预措施: Silver diamine fluoride (Other)

Fluoride Varnish

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Minatel Braga

PhD, Associate professor

University of Sao Paulo

研究点 (2)

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