Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Number of Caries Incident Cases
研究概览
简要总结
The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).
详细描述
This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 36 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children < 44 months old
- •Caries-free
- •4 erupted maxillary incisors
- •Residing in fluoridated community (San Francisco)
- •Cleft Palate
- •Developmental or learning disabilities
- •Children with transient residence (homeless, migrant, foster home)
- •Children with an another household member participating in the study
排除标准
- 未提供
研究组 & 干预措施
Counseling Only
Counseling Only
FV every 12mo for 24mo + Counsel
Preventive fluoride varnish every 12mo for 24mo plus Counseling
干预措施: Fluoride Varnish (Device)
FV every 6mo for 24mo + Counseling
Preventive fluoride varnish every 6mo for 24mo plus Counseling
干预措施: Fluoride Varnish (Device)
结局指标
主要结局
Number of Caries Incident Cases
时间窗: two years
A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.
次要结局
未报告次要终点
