A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Caries status (dmfs)
研究概览
简要总结
Objective:
The aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC).
Methods:
The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil. Twenty-four public health centres (clusters) were randomly selected and assigned to intervention or control group (12 clusters per intervention group). In each center, up to 30 children/mothers were selected and invited to participate in the trial. Each mother was interviewed in order to collect socio-economic and demographic variables. The intervention group received by means of a pamphlet the oral health instructions, which were emphasized with verbal instructions. Dental examination will be carried out after 1 year for all teeth surfaces to determine caries status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with 0 to 12 months
排除标准
- •Children with teeth in mouth at the time of enrollment
- •Children not living in Pelotas
- •No sufficient information provided by the mother at the time of enrollment
- •Systemic diseases
结局指标
主要结局
Caries status (dmfs)
时间窗: after 12 months
Number of carious lesions, including intial lesions (white spot), per surface teeth. Also missed and filled surfaces due to caries will be included.
次要结局
- dental plaque index(after 12 months)
研究者
Maximiliano Sergio Cenci
PhD, Associate Professor
Federal University of Pelotas