Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 2
- 主要终点
- Caries Incidence
研究概览
简要总结
The goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.
详细描述
Community-based, stratified (by location) randomized clinical trial (RCT) to determine the relative efficacy of topically applied fluoride varnish (FV) applications alone vs FV with fluoride-releasing glass ionomer (GI) sealants on occlusal surfaces of primary molars in reducing the caries incidence and increment in 3-6 year old children. A parallel groups design RCT stratified by study site (one dental and one non-dental location) will be conducted among 596 initially 2.5- to 3-year-old children. Those eligible will be randomized to one of 2 groups (FV or GIS+FV) and followed for 36 months. The RCT will take place at two sites serving primarily underserved, minority and low-income populations in Southern California: 1) the dental facility of the San Ysidro Health Center (SYHC) located near the U.S.-Mexican Border serves mainly Latino immigrants, and 2) the Comprehensive Health Center - Ocean View (CHC-OV), in a non-dental setting in close proximity to its dental clinic, which serves Latinos and African Americans. Both sites are part of a consortium of community clinics (SYHC Inc) and are located 15 miles apart from each other.
Annual study dental examinations will be performed by trained, calibrated, study dentists to determine caries (precavitated and cavitated) incidence and increment. Children identified as needing dental care will be referred for appropriate treatment.
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
- 2 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family resides in the South Bay or Central San Diego area
- •Parent/Guardian can consent in English or Spanish
- •Child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration)
- •Child is cooperative and behaviorally suited for the clinical trial interventions
- •Child is a registered patient at San Ysidro Health Center Inc.
排除标准
- •Any siblings of participants
- •Child with cavitated lesions
- •Child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period
- •Anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol
结局指标
主要结局
Caries Incidence
时间窗: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs \>0)
Caries Increment
时间窗: Assessed every 12 months (plus or minus 1 month); Month 36 reported
Caries increment by 36 months measured by the amount of change in dmfs index from baseline
次要结局
- Adverse Event(every 6 months; up to 7 days after application)
- Salivary Fluoride Level(Every 6 months (plus minus 1 month); Month 30 reported)
- Caries Patterns(Assessed every 12 months (plus or minus 1 month); Month 36 reported)
- Retention of Glass Ionomer Sealants(Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported)