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%.

中文翻译：

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窝沟封闭剂还是氟化物清漆？随机务实开口试验

本研究旨在比较树脂基窝沟封闭剂（FS）和氟化物清漆（FV）对高龋齿风险儿童的临床效果。在挪威的 9 家公共牙科服务 (PDS) 诊所进行了一项基于实践的分口随机临床试验。总共有 409 名 6 至 10 岁儿童患有高龋齿风险 (d3mft > 0) 符合纳入标准是由牙医和牙科保健员在常规检查期间招募的。资格标准是同一颌内有 2 颗第一恒磨牙 (FPM) 完全萌出，咬合面健全或有初始龋齿。参与是自愿的，照顾者和符合条件的儿童被告知该研究，并获得了家长的书面同意。 FS 和 FV 被随机应用于同一颌的对侧 FPM，每个参与者作为自己的对照。 FS 在基线时应用，此后根据临床医生的常规程序进行维持，而 FV 在基线、6 个月和 12 个月时应用。研究结果是成功，无需侵入性治疗（龋齿控制），而失败则定义为牙本质龋损或修复。使用两水平混合效应逻辑回归分析来比较 FS 和 FV 组。在 409 名招募的儿童中，369 名（90%）儿童/牙齿对在 36 个月后接受了检查。意向治疗分析显示，调整后的预测概率为 94.1%（AFS 组的成功率（95% 置信区间 [CI] 91.7 至 96.4）和 89.6%AFV 组的 PP（95% CI 86.5 至 92.7）。在调整后的分析中，与 FS 组相比，FV 组的成功 OR 较低（OR 0.54，95% CI 0.24 至 0.87）。在研究人群中，FS 的临床有效性在统计学上显着高于 FV，但低于估计的最小临床重要差异 10%。