瓶装化水对预防母牙 кариес的影响:为期3.5年的2期平行组随机对照临床试验 (waterBEST) 的研究方案
Anne E Sanders1, Kimon Divaris2, Tewodros R Godebo3
1The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. anne_sanders@unc.edu.
Trials
|March 5, 2024
概括
这项研究是对瓶装化水用于预防幼儿牙腐烂的首次随机试验. 它提供了一种新的方法,可以向没有公共水化设施的人群提供化物.
科学领域:
- 公共卫生 公共卫生
- 儿科牙科 儿科牙科
- 临床试验 临床试验
背景情况:
- 社区水的化是一种经过验证的空预防策略.
- 数百万人无法获得化水,或者避免使用自来水.
- 本研究方案解决了替代化物输送方法的需求.
研究的目的:
- 评估瓶装化水在预防幼儿牙损伤方面的有效性.
- 评估这种干预对没有公共水化的人群的潜力.
主要方法:
- 一个随机的,四重覆盖的,安慰剂控制的试验,涉及200名2-6个月龄的儿童.
- 参与者接受化 (0.7 mg/L F) 或非化瓶装水3.5年.
- 主要终点:到4岁时,缺失或填充的牙表面;通过指甲剪切物摄入化物的生物标志物分析.
主要成果:
- 这项研究正在进行中,结果尚未公布.
- 主要结果将使用通用线性模型进行评估,以估计疗效.
结论:
- 这是瓶装化水用于预防母牙虫的第一次随机干预研究.
- 这种输送方法可以显著影响儿童早期空的预防服务不足的人群.
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