A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- dental caries
研究概览
简要总结
Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •school children in good general health
- •have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries
排除标准
- •children with major systemic disease or taking long-term medications
- •not cooperative or refuse dental treatments
研究组 & 干预措施
fissure sealant
single placement of resin fissure sealant on tooth surface
干预措施: placement of fissure sealant (Other)
fluoride varnish
application of a 5% sodium fluoride varnish every 6 months
干预措施: fluoride varnish (Other)
control
application of water onto tooth surface every year
干预措施: placebo control (Other)
SDF solution
application of a 38% silver diamine fluoride solution onto tooth surface every year
干预措施: silver fluoride (Other)
结局指标
主要结局
dental caries
时间窗: 3 years
tooth decay appearing as a cavity on tooth surface
次要结局
未报告次要终点
