Ruff Ryan Richard, Gawande Aditi Ashish, Xu Qianhui, Barry Godín Tamarinda
Department of Epidemiology & Health Promotion, New York University, New York, New York.
JAMA Netw Open. 2025 Jun 2;8(6):e2513826. doi: 10.1001/jamanetworkopen.2025.13826.
Dental caries is a pervasive and inequitable chronic disease stemming from a lack of access to preventive and therapeutic care. Minimally invasive interventions may be provided in schools to treat caries in children.
To compare the effectiveness of silver diamine fluoride (SDF) with atraumatic restorative treatment (ART) in the control of dental caries among US schoolchildren.
DESIGN, SETTING, AND PARTICIPANTS: The CariedAway study was a cluster randomized clinical trial conducted from February 1, 2019, to June 1, 2023, in 48 primary schools in New York City. Participants were followed up for up to 4 years. Schools with a student population of at least 50% Black and/or Hispanic or Latino students and 80% receiving free or reduced-cost lunch were eligible. Within enrolled schools, any child with parental informed consent was eligible. Treatment was provided biannually. Analysis was restricted to children aged 5 to 13 years who completed at least 1 follow-up observation and had at least 1 tooth surface with dental caries.
Participants were randomized at the school level to receive SDF or ART.
Any surface lesion with an International Caries Detection and Assessment System score of 5 or 6 was recorded as caries. The primary outcome was the number of carious surfaces that had a recurrence of caries. Analysis was performed on an intent-to-treat basis.
Of the 17 741 children eligible, 7418 were randomized (mean [SD] age at baseline, 7.6 [1.9] years; 4006 girls [54.0%]), and 1668 were analyzed (mean [SD] age at baseline, 6.8 [1.5] years; 881 girls [52.8%]; 861 in the SDF group and 807 in the ART group). The total surface-level failure in the SDF group was 38.3% (2167 of 5651 carious surfaces) compared with 45.5% (2116 of 4647) in the ART group. There were 2167 surface failures observed among SDF participants over 1372 person-years compared with 2116 ART surface failures over 1291 person-years (incidence rate ratio, 0.96 [95% CI, 0.91-1.02]). At the person level, 45.5% of SDF recipients (392 of 861) experienced at least 1 surface failure compared with 53.3% of ART recipients (430 of 807; odds ratio, 0.51 [95% CI, 0.39-0.66]). There were no significant differences in the risk of recurrent surface failure between treatments (hazard ratio, 0.92 [95% CI, 0.82-1.04]).
In this study of treatments for caries, similar failures in surface control were observed among children receiving SDF or ART. These results support the use of secondary preventive therapies for caries in schools.
ClinicalTrials.gov Identifier: NCT03442309.
龋齿是一种普遍存在且不公平的慢性疾病，源于缺乏预防和治疗护理。可在学校提供微创干预措施来治疗儿童龋齿。
比较氟化银胺（SDF）与非创伤性修复治疗（ART）在美国学龄儿童中控制龋齿的效果。
设计、设置和参与者：“摆脱龋齿”研究是一项整群随机临床试验，于2019年2月1日至2023年6月1日在纽约市的48所小学进行。对参与者进行了长达4年的随访。学生中至少50%为黑人及/或西班牙裔或拉丁裔学生且80%接受免费或减价午餐的学校符合条件。在已入学的学校中，任何获得家长知情同意的儿童都符合条件。每半年进行一次治疗。分析仅限于5至13岁且至少完成1次随访观察且至少有1个牙面患龋齿的儿童。
参与者在学校层面被随机分配接受SDF或ART。
国际龋齿检测和评估系统评分为5或6的任何表面病变都被记录为龋齿。主要结局是发生龋齿复发的龋面数量。分析基于意向性治疗原则进行。
在17741名符合条件的儿童中，7418名被随机分组（基线时平均[标准差]年龄为7.6[1.9]岁；4006名女孩[54.0%]），1668名接受分析（基线时平均[标准差]年龄为6.8[1.5]岁；881名女孩[52.8%]；SDF组861名，ART组807名）。SDF组的总表面水平失败率为38.3%（5651个龋面中的2167个），而ART组为45.5%（4647个中的2116个）。在1372人年中，SDF参与者中有2167个表面失败，而在1291人年中，ART有2116个表面失败（发病率比，0.96[95%置信区间，0.91 - 1.02]）。在个体层面，45.5%的SDF接受者（861名中的392名）经历了至少1次表面失败，而ART接受者为53.3%（807名中的430名；优势比，0.51[95%置信区间，0.39 - 0.66]）。治疗之间表面复发失败的风险没有显著差异（风险比，0.92[95%置信区间，0.82 - 1.04]）。
在这项龋齿治疗研究中，接受SDF或ART的儿童在表面控制方面观察到类似的失败情况。这些结果支持在学校使用龋齿二级预防疗法。
ClinicalTrials.gov标识符：NCT03442309。
