Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent from parents.
- •Child assent
- •High risk of dental caries
- •At least one sound first permanent molar (ICDAS=0)
排除标准
- •Bad behaviour
- •Any systemic condition, disability
研究组 & 干预措施
Fluoride Varnish each 6 months
Fluoride Varnish application every 6 months.
干预措施: Fluoride Varnish (Drug)
Fluoride Varnish each 3 months
Fluoride Varnish application every 3 months.
干预措施: Fluoride Varnish (Drug)
Fluoride tooth paste
Control group. Twice a day brush with fluoride toothpaste.
干预措施: Control Group (Drug)
结局指标
主要结局
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
时间窗: One year
We are going to measure changed to decay surfaces in first permanent molars = ICDAS \> 0 in a year.
次要结局
未报告次要终点