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.

在随机对照试验中，氟化物在饮用水中的牙齿健康益处从未进行过测试 （RCT）。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20世纪为许多公共供水系统添加氟化物并捍卫 反对氟化的关键。但是，氟化的公共供水系统的增长已经停滞不前，剩下100 数百万的美国人居住在没有氟化水且可能永远不会的地方。一个相关 问题是，在全国范围内，有15％的儿童因消费者的原因不喝自来水 偏爱不信任公共水。利用消费者对瓶装水的需求的一种解决方案是 增加氟化瓶装水的消耗。但是，RCT证据证明了牙科健康益处 如果将公共卫生作为扩展氟化的策略，则必须将氟化的瓶装水作为一种必要。 缺乏先例，面对不确定性的依从性，可能的效果大小 干预，完全动力的RCT为时过早。相反，我们提出了II期，概念证明RCT 在不被水提供的社区中评估龋齿预防性的预防作用 氟化。主要招聘人口约为470个婴儿，在北卡罗来纳州金斯顿的一年中出生 该州的社区是最大的非氟化公共供水系统，该系统的患病率超过了 州平均水平。在自来水中测量的氟化物含量的家庭中，我们将 以1：1的比例随机将200个婴儿/家庭二元组随机，以接收氟化或非氟化瓶装水。 5加仑瓶中的两种商业水将被重新标记为面具婴儿，家庭和 研究人员关于氟化物含量。随机化3。2.5年，每个家庭都将被提供 水，分配器和其他供应，以鼓励与营养一致的水消耗量 建议。瓶装水消耗将受到监控，并收集指甲剪剪以提供 氟化物摄入的生物标志物。儿童48岁3个月时进行的牙科检查 将使用腐烂，缺失和填充的牙齿表面（DMF）的索引来测量龋齿体验。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 需要计算未来多站点，III期RCT的样本量需求。调查团队有 在儿童牙齿携带牙齿的观察和介入研究中，有很强的成就记录 在计划（在UG3阶段）并进行（在5年UH3阶段）的工作中经验丰富 根据Par-18-547的要求进行研究。地方，州和国家利益相关者已表示支持 拟议的研究指出，其潜力可以改善服务不足的社区。通过应用严格 该研究是安慰剂对照的RCT设计，将解决严重的缺口，以抑制这种证据 国家预防龋齿的主要公共卫生战略。