Fissure Sealants or Fluoride Varnish? A Randomized Pragmatic Split-Mouth Trial.

Journal of dental research Pub Date : 2024-07-01 Epub Date: 2024-05-08 DOI:10.1177/00220345241248630
M-M Uhlen-Strand, L Stangvaltaite-Mouhat, I Mdala, I Volden Klepaker, N J Wang, R Skudutyte-Rysstad
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Abstract

This study aimed to compare the clinical effectiveness of resin-based fissure sealants (FS) and fluoride varnish (FV) in children at high caries risk. A practice-based split-mouth randomized clinical trial was conducted at 9 Public Dental Service (PDS) clinics in Norway. In total, 409 children age 6 to 10 y at high caries risk (d3mft > 0) meeting inclusion criteria were recruited by dentists and dental hygienists during routine examination. Eligibility criteria were 2 fully erupted first permanent molars (FPMs) in the same jaw, with sound occlusal surfaces or with initial caries. Participation was voluntary, caregivers and eligible children were informed about the study, and written parental consent was obtained. FS and FV were randomly applied on contralateral FPMs in the same jaw, with each participant serving as their own control. FS was applied at baseline and thereafter maintained according to clinicians' conventional procedures, whereas FV was applied at baseline, 6 mo, and 12 mo. The study outcome was success, with no need for invasive treatment (caries control), while failure was defined as dentin carious lesion or restoration. Two-level mixed-effects logistic regression analysis was used to compare FS and FV groups. Of 409 recruited children, 369 (90%) children/tooth pairs were examined after 36 mo. Intention-to-treat analysis showed 94.1% adjusted predicted probability (aPP) of success (95% confidence interval [CI] 91.7 to 96.4) in the FS group and 89.6% aPP (95% CI 86.5 to 92.7) in the FV group. In the adjusted analysis, the FV group had a lower OR for success compared with the FS group (OR 0.54, 95% CI 0.24 to 0.87). In the population studied, the clinical effectiveness of FS was statistically significantly higher compared with FV but below the estimated minimal clinically important difference of 10%.

窝沟封闭剂还是氟化物清漆?随机务实分口试验
这项研究旨在比较树脂基窝沟封闭剂(FS)和氟化物清漆(FV)对高龋病风险儿童的临床效果。在挪威的9家公共牙科服务(PDS)诊所开展了一项基于实践的分口随机临床试验。牙医和牙科保健师在进行常规检查时,共招募了 409 名符合纳入标准的 6-10 岁龋齿高危儿童(d3mft > 0)。资格标准是同一颌骨内有两颗完全萌出的第一恒磨牙(FPM),咬合面完好或有初期龋齿。参与研究属自愿性质,护理人员和符合条件的儿童均已被告知研究内容,并已获得家长的书面同意。FS和FV随机应用于同一颌骨的对侧FPM,每个参与者作为自己的对照。FS在基线时使用,之后按照临床医生的常规程序进行维护,而FV则在基线、6个月和12个月时使用。研究结果为成功,即无需进行侵入性治疗(龋病控制),而失败则定义为牙本质龋损或修复。两级混合效应逻辑回归分析用于比较 FS 组和 FV 组。意向治疗分析显示,FS 组的成功调整预测概率(aPP)为 94.1%(95% 置信区间 [CI] 91.7 至 96.4),FV 组的成功调整预测概率(aPP)为 89.6%(95% 置信区间 [CI] 86.5 至 92.7)。在调整分析中,与 FS 组相比,FV 组的成功率较低(OR 0.54,95% CI 0.24 至 0.87)。在所研究的人群中,与 FV 相比,FS 的临床有效性在统计学上明显更高,但低于 10% 的最小临床重要性差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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