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

氟化物清漆可预防幼儿龋齿 - 扩大免疫计划

基本信息

批准号：
7442217
负责人：
Peter M Milgrom
金额：
$ 26.33万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-07-01 至 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7442217
关键词：
Address Adherence Adverse effects Age Age-Months Age-Years Biological Certification Child Clinic Clinical Trials Clinical Trials Data Monitoring Committees Consent Forms Contracts Data Data Coordinating Center Dental caries Effectiveness End Point Enrollment Fluoride Varnishes Goals Grant Health Maintenance Organizations Healthy People 2010 Immunization Programs Institution Interview Literature Manuals Methods Monitor Oral cavity Oral health Participant Phase Placebo Control Population Preschool Child Prevention Preventive Primary Dentition Procedures Process Production Protocols documentation Public Health Publications Publishing Questionnaires Randomized Randomized Clinical Trials Recruitment Activity Reporting Research Research Design Role Site Structure Surveys Toddler Tooth eruption Tooth structure Training Universities Visit data management design health disparity improved organizational structure permanent tooth prevent response symposium tool

项目摘要

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.

描述（由申请人提供）：这是申请R21 DE017117-01A1的修订，以响应NIDCR临床试验计划赠款，PAR-06-026（以前是PAR-03-042），目的是计划确定确定阶段III多中心随机临床试验（RCT）确定氟化物清漆（FV）是否有效地减少幼儿中的龋齿，当它应用于3至36个月大的儿童牙齿。包括幼儿在内的儿童的口腔健康差异和龋齿仍然是主要的公共卫生问题。 2010年健康的人重新强调了改善口腔健康差异和龋齿的目标，尤其是在幼儿中。氟化物清漆已被证明是一种有效的预防性工具，可以防止在恒牙中龋齿。两项小型研究表明，在3岁的年龄幼儿儿童中有相似的效率。但是，在6-36个月的儿童中没有公开的FV效应研究，即初级牙列爆发的时期。牙齿爆发后牙齿很容易立即发育。尽管文献中提出了FV对3岁及以下儿童初级牙列的有效性，并得到了生物学原理的支持，但这种疗效仍然不确定。需要在该特定年龄人群中的RCT。该提案旨在开发携带多中心RCT所需的工具，以确定氟化物清漆是否有效减少6-36个月大时使用的龋齿。具体而言，该提案的目的是：（1）开发RCT的结构，包括行政协调中心，数据协调中心，现场中心，顾问，数据安全监控委员会等，以及诸如转向，高管，咨询等委员会。 ; （2）开发RCT的过程，包括对假设，终点，研究设计，协议，程序以及招聘和保留策略的改进；（3）制定程序手册（MOP），并通过逐步协议为所有研究活动制定，包括委员会成立，招聘，保留和依从方法，表格和问卷的行为以及培训手册和手册的程序和程序认证过程。拟议的研究是一项两组随机安慰剂控制设计，将在1600至2000名儿童3-6个月及其6个月之前招募。每个参与诊所将招募150-200名参与者。两个研究网络，一个HMO和一个大学机构已同意参加计划赠款，并为RCT提供诊所地点。关键字：氟化物清漆，龋齿，口腔健康，早期预防，多中心，幼儿。