Department of Epidemiology & Health Promotion, New York University College of Dentistry, New York.
New York University School of Global Public Health, New York.
JAMA Pediatr. 2024 Apr 1;178(4):354-361. doi: 10.1001/jamapediatrics.2023.6770.
Dental caries is the world's most prevalent noncommunicable disease and a source of health inequity; school dental sealant programs are a common preventive measure. Silver diamine fluoride (SDF) may provide an alternative therapy to prevent and control caries if shown to be noninferior to sealant treatment.
To determine whether school-based application of SDF is noninferior to dental sealants and atraumatic restorative treatment (ART) in the prevalence of dental caries.
DESIGN, SETTING, AND PARTICIPANTS: The Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-Income Minority Children (CariedAway) study was a pragmatic noninferiority cluster-randomized clinical trial conducted from February 2018 to June 2023 to compare silver diamine fluoride vs therapeutic sealants for the arrest and prevention of dental caries. Children at primary schools in New York, New York, with at least 50% of the student population reporting as Black or Hispanic and at least 80% receiving free or reduced lunch were included. This population was selected as they are at the highest risk of caries in New York. Students were randomized to receive either SDF or sealant with ART; those aged 5 to 13 years were included in the analysis. Treatment was provided at every visit based on need, and the number of visits varied by child. Schools with preexisting oral health programs were excluded, as were children who did not speak English. Of 17 741 students assessed for eligibility, 7418 were randomized, and 4100 completed follow-up and were included in the final analysis.
Participants were randomized at the school level to receive either a 38% concentration SDF solution or glass ionomer sealants and ART. Each participant also received fluoride varnish.
Primary study outcomes were the prevalence and incidence of dental caries.
A total of 7418 children (mean [SD] age, 7.58 [1.90] years; 4006 [54.0%] female; 125 [1.7%] Asian, 1246 [16.8%] Black, 3648 [49.2%] Hispanic, 153 [2.1%] White, 114 [1.5%] multiple races or ethnicities, 90 [1.2%] other [unspecified], 2042 [27.5%] unreported) were enrolled and randomized to receive either SDF (n = 3739) or sealants with ART (n = 3679). After initial treatment, 4100 participants (55.0%) completed at least 1 follow-up observation. The overall baseline prevalence of dental caries was approximately 27.2% (95% CI, 25.7-28.6). The odds of decay prevalence decreased longitudinally (odds ratio [OR], 0.79; 95% CI, 0.75-0.83) and SDF was noninferior compared to sealants and ART (OR, 0.94; 95% CI, 0.80-1.11). The crude incidence of dental caries in children treated with SDF was 10.2 per 1000 tooth-years vs 9.8 per 1000 tooth-years in children treated with sealants and ART (rate ratio, 1.05; 95% CI, 0.97-1.12).
In this school-based pragmatic randomized clinical trial, application of SDF resulted in nearly identical caries incidence compared to dental sealants and ART and was noninferior in the longitudinal prevalence of caries. These findings suggest that SDF may provide an effective alternative for use in school caries prevention.
ClinicalTrials.gov Identifier: NCT03442309.
重要性：龋齿是世界上最普遍的非传染性疾病，也是健康不平等的一个根源；学校口腔封闭剂计划是一种常见的预防性措施。如果证明银胺氟（SDF）在预防和控制龋齿方面不逊于封闭剂治疗，它可能提供一种替代疗法。
目的：确定基于学校的 SDF 应用在龋齿的流行率方面是否不劣于牙封闭剂和无创伤性修复治疗（ART）。
设计、设置和参与者：银胺氟化物与治疗性封闭剂在低收入少数民族儿童中的龋齿（CariedAway）研究是一项实用的非劣效性聚类随机临床试验，于 2018 年 2 月至 2023 年 6 月进行，比较了银胺氟化物与治疗性封闭剂在预防和控制龋齿方面的效果。研究对象为纽约市小学的儿童，学生人群中至少有 50%报告为黑人或西班牙裔，至少 80%的学生接受免费或减价午餐。选择这一人群是因为他们是纽约州患龋齿风险最高的人群。学生随机接受 SDF 或封闭剂加 ART 治疗；年龄在 5 至 13 岁的儿童纳入分析。根据需要，在每次就诊时提供治疗，就诊次数因儿童而异。有预先存在的口腔卫生计划的学校被排除在外，不接受英语的儿童也被排除在外。在评估合格的 17741 名学生中，有 7418 名被随机分配，有 4100 名完成了随访并纳入了最终分析。
干预措施：参与者在学校层面随机接受 38%浓度的 SDF 溶液或玻璃离子封闭剂和 ART。每个参与者还接受了氟化物漆。
主要结果和措施：主要研究结果是龋齿的流行率和发生率。
结果：共有 7418 名儿童（平均[标准差]年龄，7.58[1.90]岁；4006[54.0%]女性；125[1.7%]亚洲人，1246[16.8%]黑人，3648[49.2%]西班牙裔，153[2.1%]白人，114[1.5%]多种族或族裔，90[1.2%]其他[未指定]，2042[27.5%]未报告）被纳入并随机分配接受 SDF（n=3739）或封闭剂加 ART（n=3679）。在初始治疗后，有 4100 名参与者（55.0%）完成了至少一次随访观察。龋齿的总体基线流行率约为 27.2%（95%CI，25.7-28.6）。龋齿的发生几率纵向下降（比值比[OR]，0.79；95%CI，0.75-0.83），SDF 与封闭剂加 ART 相比是非劣效的（OR，0.94；95%CI，0.80-1.11）。接受 SDF 治疗的儿童的龋齿发生率为每 1000 颗牙 10.2 例，而接受封闭剂加 ART 治疗的儿童的龋齿发生率为每 1000 颗牙 9.8 例（比率，1.05；95%CI，0.97-1.12）。
结论和相关性：在这项基于学校的实用随机临床试验中，SDF 的应用在龋齿的发生率方面与牙封闭剂和 ART 几乎相同，并且在龋齿的纵向流行率方面是非劣效的。这些发现表明，SDF 可能是一种有效的替代方法，可用于学校龋齿预防。
试验注册：ClinicalTrials.gov 标识符：NCT03442309。
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