Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1)
试验速览
- 阶段
- 不适用
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Clinical-effectiveness (will be measured with DFS
研究概览
简要总结
The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.
详细描述
A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.
This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.
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
- None
盲法说明
No one is blinded ( unfortunately) as fissure sealant will be obvious
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).
排除标准
- •Teeth will be excluded from the study if they had any of the following:
- •Dental caries in dentine
- •History of pain or swelling. Parents refused their children participate in the trial
结局指标
主要结局
Clinical-effectiveness (will be measured with DFS
时间窗: Through study completion, an average of one year
Clinical-effectiveness (will be measured by DFS) Clinical effectiveness (continuous outcome will be measured with DFS D Decayed in permanent molar Filling in permanent molar S Surface
次要结局
- adverse effect will be measured by questionnaire(through study completion, an average of one year)
- Cost-effectiveness (will be measured with Incremental cost effective ratio ICER(through study completion, an average of one year)
- acceptability will be measured by questionnaire(through study completion, an average of one year)
- Time of application (continuous outcome, (minutes) will be measured with stopwatch.(Through application of interventions in treatment visit( baseline))
研究者
Esraa Mohamed Zaghloul
principal investigator
Cairo University