Phase II, proof-of-concept randomized controlled trial to evaluate dental caries preventive effects of fluoridated bottle water

第二阶段，概念验证随机对照试验，评估氟化瓶装水的龋齿预防效果

• 批准号: 10472070
• 负责人: Gary Douglas Slade
• 金额: $ 106.48万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-17 至 2026-09-16
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10472070
• 关键词: 3 year old; 4 year old; Achievement; Address; Affect; Age; American; Area; Biological; Biological Markers; Caries prevention; Child; Communities; Confidence Intervals; Consumer Preferences; Consumption; Data; Decayed, Missing, and Filled Teeth; Dental; Dental Anesthesia; Dental caries; Diffusion; Disease; Enrollment; Family; Fluorides; Future; General Anesthesia; Growth; Health Benefit; Home; Household; Income; Inequality; Infant; Ingestion; Intake; Intervention; Intervention Studies; Intervention Trial; Masks; Measures; Mediation; Medicaid; Methods; Modeling; Monitor; Nutritional; Observational Study; Oral health; Participant; Phase; Placebo Control; Population; Prevalence; Preventive; Primary Prevention; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research Design; Research Personnel; Safety; Sample Size; Sampling; Side; Site; Statistical Data Interpretation; Structure of nail of finger; Sum; System; Testing; Treatment Efficacy; Uncertainty; Water; Water Supply; Water consumption; Water fluoridation; Work; Writing; aged; base; biomarker validation; cohort; community intervention; consumer demand; deciduous tooth; distrust; drinking water; experience; follow-up; group intervention; improved; indexing; infancy; intervention delivery; intervention effect; novel strategies; phase 2 study; phase II trial; premature; prevent; recruit; sex; systematic review; tooth surface; trial design; underserved community

Dental health benefits of fluoride in drinking water have never been tested in a randomized controlled trial (RCT). Instead, results from observational studies and a few non-randomized, community intervention studies were sufficient to justify addition of fluoride to many public water systems during the 20th century and to defend against fluoridation’s critics. However, growth in fluoridated public water systems has stalled, leaving 100 million Americans living in places that do not have fluoridated water and which probably never will. A related problem is that, nationwide, 15% of children do not drink tap water for reasons ranging from consumer preference to distrust of public water. One solution, capitalizing on consumers’ demand for bottled water, is to increase consumption of fluoridated bottled water. However, RCT evidence of dental health benefits of fluoridated bottled water will be essential if public health is to embrace it as a strategy to extend fluoridation. In the absence of a precedent, and in the face of uncertainty as to compliance and likely effect size of the intervention, a fully powered RCT is premature. We instead propose a phase II, proof-of-concept RCT to evaluate dental caries preventive effects of fluoridated bottled water in a community not served by water fluoridation. The primary recruitment population is ~470 babies born during a one-year period in Kinston, NC, the state’s community with the largest non-fluoridated public water system where caries prevalence exceeds the state average. In households where measured content of fluoride in tap water is <0.2 ppm, we will randomize 200 infant/family dyads in a 1:1 ratio to receive either fluoridated or non-fluoridated bottled water. The two types of commercially water in 5-gallon bottles will be relabeled to mask infants, families and researchers as to the fluoride content. For 3½ years after randomization, each household will be provided with water, dispensers and other supplies to encourage water consumption consistent with nutritional recommendations. Bottled water consumption will be monitored and fingernail clippings collected to provide a biomarker-measure of fluoride intake. A dental examination conducted when children are aged 48?3 months will measure caries experience using the index of decayed, missing and filled tooth surfaces (dmfs). Statistical analysis will compare mean dmfs between study-groups to generate effect size estimates and standard errors needed to calculate sample size requirement for a future, multi-site, Phase III RCT. The investigative team has a strong record of accomplishment in observational and interventional studies of dental caries in children, and is experienced in work needed to plan (during the UG3 phase) and conduct (during the 5-year UH3 phase) the study as required by PAR-18-547. Local, state and national stakeholders have expressed support for the proposed study, noting its potential to improve oral health in underserved communities. By applying the rigor of a placebo-controlled RCT design, the study will address a serious shortfall in the evidence that hampers the nation’s primary public health strategy for dental caries prevention.

饮用水中氟化物对牙齿健康的益处从未在随机对照试验中进行过测试 (RCT)。相反，来自观察性研究和一些非随机的社区干预研究的结果 足以证明在20世纪向许多公共供水系统中添加氟化物是合理的，并 反对氟化的批评者。然而，含氟公共供水系统的增长已经停滞不前，只剩下100 数百万美国人生活在没有氟化水的地方，而这些地方可能永远不会有氟化水。A相关 问题是，在全国范围内，15%的儿童不喝自来水，原因有很多，比如消费者 而不是不信任公共用水。利用消费者对瓶装水的需求，一种解决方案是 增加含氟瓶装水的消费量。然而，RCT证据表明， 如果公共卫生要将含氟瓶装水作为延长氟化的一种策略，那么它将是必不可少的。在……里面 没有先例，面对《公约》的遵守情况和可能产生的影响大小的不确定性 在干预方面，一项全面的随机对照试验为时过早。相反，我们提出了第二阶段概念验证RCT，以 在无水供应的社区评价含氟瓶装水预防龋齿效果 氟化作用。在北卡罗来纳州金斯顿，主要的招募人口是在一年期间出生的大约470名婴儿， 该州拥有最大的无氟公共供水系统，其龋齿患病率超过 州平均水平。对于自来水中氟化物含量为0.2ppm的家庭，我们将 按1：1的比例随机选择200名婴儿/家庭成员，接受加氟或不加氟的瓶装水。 这两种5加仑瓶装的商用水将被重新贴上标签，以掩盖婴儿、家庭和 研究人员对氟化物含量进行了调查.在随机化后的三年半内，每户将获得 水、饮水机和其他用品，以鼓励与营养相一致的用水 建议。将监测瓶装水的消费情况，并收集指甲切片，以提供 生物标记物-氟化物摄入量的测量。儿童在48？3个月大时进行的牙科检查 将使用龋齿、缺失和充填牙面(DMF)的指数来测量龋齿体验。统计 分析将比较研究组之间的平均DMF，以产生效应大小估计和标准误差 需要计算未来多地点第三阶段随机对照试验的样本量要求。调查组已经 在儿童龋齿的观察性和干预性研究方面取得了很好的成绩，以及 在计划(在UG3阶段)和实施(在5年UH3阶段)所需的工作方面经验丰富 按照PAR-18-547的要求进行研究。地方、州和国家利益攸关方已表示支持 拟议的研究，指出其在服务不足的社区改善口腔健康的潜力。通过应用严谨的 这是一项安慰剂对照RCT设计，该研究将解决阻碍 这是国家预防龋齿的主要公共卫生战略。