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: 10458235
• 负责人: Gary Douglas Slade
• 金额: $ 104.92万
• 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/10458235
• 关键词: Phase; II; proof; concept; randomized

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 （随机对照试验）。相反，观察性研究和一些非随机社区干预研究的结果 足以证明在世纪向许多公共供水系统中添加氟化物是合理的， 反对氟化的批评者。然而，氟化公共供水系统的增长已经停滞， 数以百万计的美国人生活在没有氟化水的地方，而且可能永远不会。一个相关 问题是，在全国范围内，15%的儿童不喝自来水的原因，从消费者 对公共水源的不信任。一个解决方案是利用消费者对瓶装水的需求， 增加瓶装含氟水的消费量。然而，RCT证据表明， 如果公共卫生要将瓶装水作为推广氟化的战略，那么瓶装水氟化将是必不可少的。在 由于没有先例，而且在遵守情况和可能的影响程度方面存在不确定性， 但是，全面的RCT还为时过早。相反，我们提出了一个II期概念验证RCT， 评价瓶装含氟水在无水社区预防龋齿的效果 氟化主要招募人群是在北卡罗来纳州金斯顿一年内出生的约470名婴儿， 该州拥有最大的非氟化公共供水系统的社区， 国家平均水平。如果自来水中的氟化物含量低于0.2 ppm，我们将 将200名婴儿/家庭按1：1的比例随机分配，接受氟化或非氟化瓶装水。 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 研究人员对氟化物的含量。在随机化后的3年半内，将为每个家庭提供 水、饮水机和其他用品，以鼓励符合营养标准的水消费， 建议.监测瓶装水的消耗量，并收集指甲屑， 氟化物摄入量的生物标志物。儿童48岁时进行牙科检查？3个月 将使用龋坏、缺失和填充牙面指数（dmfs）来测量龋齿经历。统计 分析将比较研究组之间的平均dmfs，以生成效应量估计值和标准误 需要计算未来多中心III期RCT的样本量要求。调查小组已经 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， 在计划（UG 3阶段）和实施（5年UH 3阶段）所需的工作方面经验丰富， 根据PAR-18-547的要求进行研究。地方、州和国家利益攸关方表示支持 建议的研究，注意到它的潜力，以改善口腔健康在服务不足的社区。通过应用严格的 安慰剂对照随机对照试验设计，该研究将解决严重缺乏证据，阻碍 国家预防龋齿的主要公共卫生战略。