Fluoride Varnish to Prevent Caries in Toddlers - An Expanded Immunization Program

描述（由申请人提供）：这是对申请R21 DE017117-01A1的修订，以响应NIDCR临床试验计划拨款PAR-06-026（原PAR-03-042），目的是规划一个明确的III期多中心随机临床试验（RCT），以确定氟清漆（FV）在3至36个月大的儿童牙齿上应用时是否有效减少幼儿的龋齿。儿童（包括学步儿童）的口腔健康差距和龋齿仍然是主要的公共卫生问题。《2010年健康人》再次强调其目标是改善口腔健康差距和龋齿，特别是在幼儿中。氟化物清漆已被证明是一种有效的预防恒牙龋齿的工具。两项小型研究表明，在3岁的学龄前儿童中也有类似的效果。然而，目前还没有发表的关于FV对6-36个月儿童的影响的研究，这一时期是乳牙长出的时期。牙齿长出后很容易出现蛀牙。虽然FV对3岁及以下儿童的初级牙列的有效性在文献中得到了建议，并得到了生物学原理的支持，但这种有效性仍然不确定。需要在这一特定年龄人群中进行随机对照试验。本提案旨在开发必要的工具，进行多中心随机对照试验，以确定6-36个月大的儿童使用氟化物清漆是否能有效减少初级牙列的龋齿。具体而言，该提案旨在：(1)制定RCT的结构，包括行政协调中心、数据协调中心、现场中心、顾问、数据安全监测委员会等，以及指导、执行、咨询等委员会；(2)制定随机对照试验的流程，包括完善假设、终点、研究设计、方案、程序以及招募和保留策略；(3)制定程序手册（MOP），为所有研究活动制定分步协议，包括组建委员会、招聘、保留和遵守方法、表格和问卷的实施、程序培训手册和程序认证过程。该研究采用两组随机安慰剂对照设计，将招募1600至2000名3-6个月大的儿童，并在他们6个月的健康儿童访问之前进行。每个参与诊所将招募150-200名参与者。两个研究网络，一个HMO和一个大学机构已经同意参与计划拨款并为随机对照试验提供诊所地点。关键词：氟化物清漆，龋齿，口腔健康，早期预防，多中心，幼儿

DESCRIPTION (provided by applicant): This is a revision of application R21 DE017117-01A1 in response to the NIDCR Clinical Trial Planning Grant, PAR-06-026 (formerly PAR-03-042), with the objective of planning for a definitive phase III multi- center randomized clinical trial (RCT) to determine if fluoride varnish (FV) is effective in reducing dental caries among toddlers when it is applied to children's teeth from 3 to 36 months of age. Oral health disparity and dental caries in children, including toddlers, continue to be major public health concerns. Healthy People 2010 re-emphasized its goals to improve both oral health disparity and dental caries, particularly among young children. Fluoride varnish has been shown to be an effective preventive tool against caries in permanent teeth. Two small studies have demonstrated similar effectiveness in preschool children young as 3 years of age. However, there is no published study of FV effect in children age 6-36 months, the period when primary dentition erupts. Teeth are vulnerable to develop caries immediately after teeth eruption. Although the effectiveness of FV on primary dentition of children 3 years and younger is suggested in the literature and is supported by biological rationale, this efficacy is still uncertain. A RCT among this specific age population is needed. This proposal aims to develop the tools necessary to carry a multi-center RCT to determine if fluoride varnish is effective in reducing caries in primary dentition when applied from 6-36 months of age. Specifically, the proposal aims to: (1) develop the structure of an RCT including the Administrative Coordinating Center, Data Coordinating Center, Field Centers, Consultants, Data Safety Monitoring Board etc., and committees such as Steering, Executive, Advisory, etc.; (2) develop the process for an RCT including refinement of the hypotheses, end points, study design, protocol, procedures, and recruitment and retention strategies; (3) develop the manual of procedures (MOP) with step-by-step protocols for all study activities including the formation of committees, the recruitment, retention, and adherence methods, the conduct of forms and questionnaires, and the procedures training manual and procedures certification process. The proposed study is a two-group randomized placebo control design and will enroll between 1600 to 2000 children age 3-6 months and prior to their 6 months well-child visit. Each participating clinics will recruit between 150-200 participants. Two research networks, an HMO, and a university institution have agreed to participate in the planning grant and provide the clinic sites for the RCT. Keywords: fluoride varnish, dental caries, oral health, early prevention, multi-center, toddlers.