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采用银和氟化物产品抑制幼儿龋齿——一项随机试验。

Arresting early childhood caries using silver and fluoride products - A randomised trial.

机构信息

Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.

Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.

出版信息

J Dent. 2020 Dec;103:103522. doi: 10.1016/j.jdent.2020.103522. Epub 2020 Nov 6.

DOI:10.1016/j.jdent.2020.103522
PMID:33166594
Abstract

OBJECTIVE

The aim of this randomised non-inferiority clinical trial was to compare the effectiveness of semi-annual (every six months) applications of 25 % silver nitrate (AgNO) solution followed by 5 % sodium fluoride (NaF) varnish to semi-annual applications of 38 % silver diamine fluoride (SDF) solution in arresting early childhood caries (ECC).

METHODS

Three-year-old children with active cavitated carious lesions were recruited and randomly assigned to two intervention groups. Children in Group A received semi-annual applications of 25 % AgNO solution followed by 5 % NaF varnish on carious lesions. Children in Group B received semi-annual applications of 38 % SDF solution followed by a placebo varnish. One trained dentist assessed ECC status at baseline and in all follow-up examinations. An independent operator performed the interventions. The dentist, the children, and their caretakers were blinded to the intervention allocation. Data were analysed using a non-inferiority test. Group A's non-inferiority would be accepted if the lower limit of the 95 % confidence interval (CI) for the difference in the mean number of arrested decayed surfaces (ds) was greater than -0.5.

RESULTS

At baseline, 1,070 children were recruited, and 535 children were assigned to each group. After 30 months, the mean arrested ds in Groups A (n = 447) and B (n = 433) were 3.7 ± 3.6 and 3.6 ± 3.7, respectively (p = 0.694). The difference in the mean arrested ds between the two groups was 0.088 (95 % CI: -0.351 to 0.526).

CONCLUSION

Semi-annual application of 25 % AgNO followed by 5 % NaF is at least as effective as the semi-annual application of 38 % SDF in arresting ECC.

CLINICAL SIGNIFICANCE

Silver and fluoride products are effective in arresting caries. As a simple, non-invasive, and inexpensive strategy, it can be used in young children, elderly adults, and people with special needs.

摘要

目的

本随机非劣效临床试验旨在比较每半年(每六个月)应用 25%硝酸银(AgNO)溶液后再应用 5%氟化钠(NaF)漆与每半年应用 38%氟化银胺(SDF)溶液在抑制幼儿龋病(ECC)方面的疗效。

方法

招募了患有活动性龋损的 3 岁儿童,并将其随机分配到两个干预组。A 组儿童每半年应用 25%AgNO 溶液治疗龋损,再应用 5%NaF 漆。B 组儿童每半年应用 38%SDF 溶液,然后应用安慰剂漆。一名经过培训的牙医在基线和所有随访检查中评估 ECC 状况。一名独立操作人员实施干预措施。牙医、儿童及其照顾者均对干预分配不知情。使用非劣效性检验对数据进行分析。如果置信区间(CI)下限大于-0.5,则可接受 A 组的非劣效性。

结果

基线时,共招募了 1070 名儿童,每组 535 名。30 个月后,A 组(n=447)和 B 组(n=433)的平均龋齿静止数(ds)分别为 3.7±3.6 和 3.6±3.7(p=0.694)。两组之间平均龋齿静止数的差异为 0.088(95%CI:-0.351 至 0.526)。

结论

每半年应用 25%AgNO 后再应用 5%NaF 与每半年应用 38%SDF 一样有效,可以抑制 ECC。

临床意义

银和氟化物产品在抑制龋齿方面有效。作为一种简单、非侵入性和廉价的策略,可以在幼儿、老年人和有特殊需求的人群中使用。

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