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.
J Dent. 2024 Nov;150:105349. doi: 10.1016/j.jdent.2024.105349. Epub 2024 Sep 12.
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.
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.
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.
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.
The study provides clinicians with a cost-effective, safer, readily available, non-invasive treatment option (25% SN followed by 5% NaF) for caries management.
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。
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。
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。
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。
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。
