The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Number of healthy occlusal tooth surfaces of primary molars
研究概览
简要总结
Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition.
The aim of this study is to measure the caries preventive effect of sealants in primary molars. The specific objectives are: 1) to compare the number of new caries experience teeth and surfaces among the intervention group of 4-years old pre-school children during the 1 year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish on the caries experience on the occlusal surfaces of the primary molars and on the total caries experience of all the primary and permanent teeth, 3) to test the feasibility of the sealant program in one kindergarten in Kuwait city.
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
- 42 Months 至 52 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •positive written informed consent received from parents
排除标准
- •if caries lesions in primary molars are so extensive that restorative treatment is needed
研究组 & 干预措施
Preventing occlusal caries
Comparing preventing effect of fissure sealants vs. fluoride varnish
干预措施: Fissure sealant (Other)
Preventing occlusal caries
Comparing preventing effect of fissure sealants vs. fluoride varnish
干预措施: Fissure sealants and fluoride varnish (Other)
结局指标
主要结局
Number of healthy occlusal tooth surfaces of primary molars
时间窗: up to 1 year
Outcome will be measured by a clinical examination (dental caries status/ICDAS) one year after the fissure sealants and fluoride varnish have been applied. When a child has intact occlusal surfaces on primary molars in the baseline examination, s/he will get a fissure sealant on the other side of the mouth and fluoride varnish on the other side.
次要结局
- Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish(up to 1 year)
研究者
Sisko Honkala
Associate Professor
Kuwait University