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得到测试 （随机对照试验），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 世纪的许多公共供水系统中添加氟化物是合理的，并捍卫 然而，加氟公共供水系统的增长已经停滞，只剩下 100 个。 数以百万计的美国人生活在没有氟化水的地方，而且可能永远不会有氟化水。 问题是，在全国范围内，15% 的儿童不喝自来水，原因包括消费 一种解决方案是利用消费者对瓶装水的需求。 然而，RCT 证据表明，增加氟化瓶装水的消耗对牙齿健康有益。 如果公共卫生部门要将其作为扩大氟化的策略，那么氟化瓶装水将是必不可少的。 缺乏先例，并且面临合规性和可能影响大小的不确定性 干预，全面的随机对照试验还为时过早，我们建议进行第二阶段概念验证随机对照试验。 评估氟化瓶装水在没有供水的社区中预防龋齿的效果 主要招募人群是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，该地区的龋齿患病率超过 对于自来水中氟化物含量低于 0.2 ppm 的家庭，我们将 以 1:1 的比例随机分配 200 名婴儿/家庭二人，分别接受氟化或非氟化瓶装水。 两种 5 加仑瓶装的商用水将被重新贴上标签，以供婴儿、家庭和儿童使用。 研究人员确定了氟化物含量 在随机分组后的 3.5 年内，将为每个家庭提供氟化物含量。 水、分配器和其他用品，以鼓励符合营养的用水 将监测瓶装水的消耗量并收集指甲屑，以提供建议。 氟化物摄入量的生物标志物测量。在儿童 48 至 3 个月大时进行的牙科检查。 将使用腐烂、缺失和填充的牙齿表面指数 (dmfs) 来衡量龋齿经历。 分析将比较研究组之间的平均 DMF，以生成效应大小估计值和标准误差 需要计算未来多中心第三期随机对照试验的样本量要求。 在儿童牙科职业的观察和介入研究方面取得了良好的成就记录，并且 在规划（在 UG3 阶段）和执行（在 5 年 UH3 阶段）所需的工作方面具有经验 地方、州和国家利益相关者已表示支持 PAR-18-547 的要求。 拟议的研究，指出其通过严格应用来改善服务不足的社区的口腔健康的潜力。 一项安慰剂对照的随机对照试验设计，该研究将解决阻碍该研究的证据严重不足的问题 国家预防龋齿的主要公共卫生战略。