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局部应用 25%硝酸银溶液后再应用 5%氟化物漆与 38%氟化亚锡相比在阻止和预防β-地中海贫血症主要患者龋齿方面的效果:一项随机临床试验。

Effectiveness of topical 25% silver nitrate solution followed by 5% fluoride varnish compared to 38% silver diamine fluoride in arresting and preventing dental caries among beta-thalassemia major patients: A randomized clinical trial.

机构信息

Dept. of Public Health Dentistry, Post Graduate Institute of Dental Sciences, Rohtak, Haryana, India.

Dept. of Public Health Dentistry, Post Graduate Institute of Dental Sciences, Rohtak, Haryana, India.

出版信息

J Dent. 2024 Nov;150:105349. doi: 10.1016/j.jdent.2024.105349. Epub 2024 Sep 12.

Abstract

INTRODUCTION

This is the first randomized non-inferiority clinical trial in the evidence literature to examine the effectiveness of topical 25% silver nitrate (SN) followed by 5% sodium fluoride (NaF) varnish is not much worse or acceptable to 38% silver diamine fluoride (SDF) in preventing and arresting dental caries among Beta-Thalassemia Major (BTM) patients.

METHOD

170 BTM participants aged 18 years and older with at least 1 or more active carious lesions were randomly allocated into 2 groups (1:1). 25% silver nitrate solution application followed by 5% NaF varnish was administered to Group I, and Group II received 38% SDF. The Nyvad criteria and DMFT index were used to assess caries arrest and prevention among both groups at 3- and 6-months interval.

RESULTS

Caries arrest rate at 3 months was significantly higher in Group I (83.10%) when compared to Group II (76.16%) (p<0.05). While at 6 months, both the groups were comparable with arrest rate (76.16%) (p>0.05). The caries increment was comparable among both groups at 3 months, while at 6 months, caries increment was almost half in SN with NaF group compared to SDF group (p>0.05). Kaplan-Meir survival estimated the median survival time for caries increment was 17 and 39 weeks for Group I and 15 and 36 weeks for Group II at 3 and 6 months, respectively.

CONCLUSION

One time application of 25% SN followed by 5% NaF is no worse than a 38% SDF in arresting and preventing dental caries among Thalassemia Major participants at 3 and 6 months.

CLINICAL SIGNIFICANCE

The study provides clinicians with a cost-effective, safer, readily available, non-invasive treatment option (25% SN followed by 5% NaF) for caries management.

摘要

引言

这是首个在证据文献中进行的随机非劣效性临床试验,旨在检验局部应用 25%硝酸银(SN)后再涂 5%氟化钠(NaF)漆与应用 38% 氟化银(SDF)在预防和控制β地中海贫血(BTM)患者龋齿方面的效果,结果显示前者并不差于后者。

方法

将 170 名年龄在 18 岁及以上、至少有 1 个或多个活跃龋损的 BTM 参与者随机分为两组(1:1)。第 I 组给予 25%硝酸银溶液,再涂 5% NaF 漆,第 II 组给予 38% SDF。使用 Nyvad 标准和 DMFT 指数在 3 个月和 6 个月的时间间隔内评估两组的龋齿抑制和预防效果。

结果

第 I 组(83.10%)的龋齿抑制率在 3 个月时显著高于第 II 组(76.16%)(p<0.05)。而在 6 个月时,两组的抑制率相似(76.16%)(p>0.05)。两组的龋齿进展率在 3 个月时相似,而在 6 个月时,SN 加 NaF 组的龋齿进展率几乎是 SDF 组的一半(p>0.05)。Kaplan-Meier 生存分析估计,第 I 组和第 II 组的龋齿进展中位数生存时间分别为 17 和 39 周和 15 和 36 周,分别为 3 个月和 6 个月。

结论

在 3 个月和 6 个月时,单次应用 25% SN 后再涂 5% NaF 与应用 38% SDF 相比,在抑制和预防 BTM 患者的龋齿方面效果相当。

临床意义

该研究为临床医生提供了一种具有成本效益、更安全、易于获得、非侵入性的治疗选择(25% SN 后再涂 5% NaF),用于龋齿管理。

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