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局部用氨丁三醇银氟化物预防学龄前儿童龋齿:一项随机对照试验及对与龋齿相关微生物和耐药基因表达的微生物分析。

Topical silver diamine fluoride for dental caries arrest in preschool children: A randomized controlled trial and microbiological analysis of caries associated microbes and resistance gene expression.

机构信息

Department of Oral Health Sciences, University of Washington, Box 357475, Seattle, WA 98195-7475 USA.

Department of Biochemistry, University of California San Francisco,1700 4th Street, QB3 Room 404, San Francisco, CA 94158 USA.

出版信息

J Dent. 2018 Jan;68:72-78. doi: 10.1016/j.jdent.2017.08.015. Epub 2017 Sep 1.

Abstract

OBJECTIVES

The Stopping Cavities Trial investigated effectiveness and safety of 38% silver diamine fluoride in arresting caries lesions.

MATERIALS AND METHODS

The study was a double-blind randomized placebo-controlled superiority trial with 2 parallel groups. The sites were Oregon preschools. Sixty-six preschool children with ≥1 lesion were enrolled. Silver diamine fluoride (38%) or placebo (blue-tinted water), applied topically to the lesion. The primary endpoint was caries arrest (lesion inactivity, Nyvad criteria) 14-21days post intervention. Dental plaque was collected from all children, and microbial composition was assessed by RNA sequencing from 2 lesions and 1 unaffected surface before treatment and at follow-up for 3 children from each group.

RESULTS AND CONCLUSION

Average proportion of arrested caries lesions in the silver diamine fluoride group was higher (0.72; 95% CI; 0.55, 0.84) than in the placebo group (0.05; 95% CI; 0.00, 0.16). Confirmatory analysis using generalized estimating equation log-linear regression, based on the number of arrested lesions and accounting for the number of treated surfaces and length of follow-up, indicates the risk of arrested caries was significantly higher in the treatment group (relative risk, 17.3; 95% CI: 4.3 to 69.4). No harms were observed. RNA sequencing analysis identified no consistent changes in relative abundance of caries-associated microbes, nor emergence of antibiotic or metal resistance gene expression. Topical 38% silver diamine fluoride is effective and safe in arresting cavities in preschool children.

CLINICAL SIGNIFICANCE

The treatment is applicable to primary care practice and may reduce the burden of untreated tooth decay in the population.

摘要

目的

《阻断龋损试验》研究了 38% 氟化银胺在阻止龋损方面的有效性和安全性。

材料和方法

这是一项双盲、随机、安慰剂对照的优效性试验,有 2 个平行组。研究地点为俄勒冈州幼儿园。共纳入 66 名患有≥1 个龋损的学龄前儿童。将 38%氟化银胺(银剂)或安慰剂(蓝色水)局部涂于病变处。主要终点为干预后 14-21 天的龋损静止(无龋,Nyvad 标准)。从所有儿童中收集牙菌斑,并对 2 个病变和 1 个未受影响的表面在治疗前和随访时进行 RNA 测序,以评估微生物组成,每组有 3 名儿童进行随访。

结果和结论

银剂组静止龋的比例(0.72;95%CI;0.55,0.84)高于安慰剂组(0.05;95%CI;0.00,0.16)。基于静止龋数量的广义估计方程对数线性回归的验证性分析,考虑了治疗表面数量和随访时间长度,表明治疗组静止龋的风险显著更高(相对风险,17.3;95%CI:4.3 至 69.4)。未观察到任何危害。RNA 测序分析未发现与龋相关微生物的相对丰度发生一致变化,也未发现抗生素或金属耐药基因表达的出现。局部应用 38%氟化银胺在阻止学龄前儿童龋齿方面是有效且安全的。

临床意义

该治疗方法适用于基层医疗实践,可能会减少人群中未经治疗的龋齿负担。

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