龋齿是世界上最普遍的非传染性疾病,也是健康不平等的根源;学校牙科密封剂计划是一种常见的预防措施。如果显示不劣于密封剂治疗,则氟化银二胺(SDF)可以提供预防和控制龋齿的替代疗法。
■确定在龋齿的患病率中,基于学校的SDF应用是否不劣于牙齿密封剂和无创伤修复治疗(ART)。
■氟化银胺与治疗性密封剂在低收入少数民族儿童中的逮捕和预防龋齿(CariedAway)研究是一项务实的非劣效性集群随机临床试验,于2018年2月至2023年6月进行,比较氟化银胺与治疗性密封剂在阻止和预防龋齿中的作用。纽约小学的孩子们,纽约,包括至少50%的学生人口报告为黑人或西班牙裔,至少80%的学生接受免费或减少的午餐。选择该人群是因为他们在纽约患龋齿的风险最高。学生被随机分配接受SDF或ART密封剂;那些5至13岁的人被包括在分析中。每次就诊都根据需要提供治疗,访问的次数因儿童而异。已有口腔健康计划的学校被排除在外,和不会说英语的孩子一样。在评估资格的17741名学生中,7418个随机分组,4100人完成了随访并纳入最终分析.
■参与者在学校水平随机接受38%浓度的SDF溶液或玻璃离聚物密封剂和ART。每位参与者还接受了氟化物清漆。
■主要研究结果是龋齿的患病率和发病率。
■共有7418名儿童(平均[SD]年龄,7.58[1.90]岁;4006[54.0%]女性;125[1.7%]亚洲,1246[16.8%]黑色,3648[49.2%]西班牙裔,153[2.1%]白色,114[1.5%]多个种族或民族,90[1.2%]其他[未指定],2042[27.5%]未报告)被纳入并随机接受SDF(n=3739)或ART密封剂(n=3679)。初步治疗后,4100名参与者(55.0%)完成了至少1次随访观察。龋齿的总体基线患病率约为27.2%(95%CI,25.7-28.6)。衰减流行的几率纵向下降(优势比[OR],0.79;95%CI,0.75-0.83)和SDF与密封剂和ART(OR,0.94;95%CI,0.80-1.11)。在接受SDF治疗的儿童中,龋齿的发生率为10.2/1000牙齿年,而在接受密封剂和ART治疗的儿童中,龋齿的发生率为9.8/1000牙齿年(比率,1.05;95%CI,0.97-1.12)。
■在这项以学校为基础的实用随机临床试验中,与牙科密封剂和ART相比,SDF的应用导致龋齿发生率几乎相同,并且龋齿的纵向患病率也不差。这些发现表明,SDF可能为学校龋齿预防提供有效的替代方法。
■ClinicalTrials.gov标识符:NCT03442309。
UNASSIGNED: 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.
UNASSIGNED: To determine whether school-based application of SDF is noninferior to dental sealants and atraumatic restorative treatment (ART) in the prevalence of dental caries.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Primary
study outcomes were the prevalence and incidence of dental caries.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03442309.