Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.
Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.
Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Informed Consent from parents.
- Child assent
- High risk of dental caries
- At least one sound first permanent molar (ICDAS=0)
Exclusion Criteria:
- Bad behaviour
- Any systemic condition, disability
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Fluoride Varnish each 6 months
Fluoride Varnish application every 6 months.
|
Application of fluoride varnish every 3 and 6 months.
其他名称：
|
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实验性的：Fluoride Varnish each 3 months
Fluoride Varnish application every 3 months.
|
Application of fluoride varnish every 3 and 6 months.
其他名称：
|
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有源比较器：Fluoride tooth paste
Control group.
Twice a day brush with fluoride toothpaste.
|
Twice a day brush with fluoride toothpaste.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
大体时间：One year
|
We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.
|
One year
|
合作者和调查者
调查人员
- 首席研究员：Ninoska Abreu、Universidad Iberoamericana
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Fluoride Varnish的临床试验
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American College of Radiology - Image MetrixWorld Molecular Imaging Society未知