One year Survival Rate of Ketac Molar versus Vitro Molar for Occlusoproximal ART Restorations: a RCT

Abstract Good survival rates for single-surface Atraumatic Restorative Treatment (ART) restorations have been reported, while multi-surface ART restorations have not shown similar results. The aim of this study was to evaluate the survival rate of occluso-proximal ART restorations using two different filling materials: Ketac Molar EasyMix (3M ESPE) and Vitro Molar (DFL). A total of 117 primary molars with occluso-proximal caries lesions were selected in 4 to 8 years old children in Barueri city, Brazil. Only one tooth was selected per child. The subjetcs were randomly allocated in two groups according to the filling material. All treatments were performed following the ART premises and all restorations were evaluated after 2, 6 and 12 months. Restoration survival was evaluated using Kaplan-Meier survival analysis and Log-rank test, while Cox regression analysis was used for testing association with clinical factors (α = 5%). There was no difference in survival rate between the materials tested, (HR = 1.60, CI = 0.98–2.62, p = 0.058). The overall survival rate of restorations was 42.74% and the survival rate per group was Ketac Molar = 50,8% and Vitro Molar G2 = 34.5%). Cox regression test showed no association between the analyzed clinical variables and the success of the restorations. After 12 months evaluation, no difference in the survival rate of ART occluso-proximal restorations was found between tested materials.

摘要 已有研究报道单面无创修复治疗（Atraumatic Restorative Treatment，ART）修复体的存活率较高，但多面ART修复体未取得相近效果。本研究旨在评估两种不同充填材料——Ketac Molar EasyMix（3M ESPE）与Vitro Molar（DFL）——用于咬合邻面ART修复体的存活率。研究共纳入巴西巴韦里市4至8岁儿童的117颗患咬合邻面龋损的乳磨牙，每名儿童仅纳入1颗患牙。按照所用充填材料将受试者随机分为两组。所有操作均严格遵循ART操作规范，分别于修复后2、6及12个月对修复体进行评估。采用Kaplan-Meier生存分析与对数秩检验评价修复体存活率，采用Cox回归分析检验修复体存活率与临床因素的关联（检验水准α=5%）。两种受试充填材料的修复体存活率无显著差异（风险比HR=1.60，置信区间CI=0.98~2.62，p=0.058）。修复体总体存活率为42.74%，两组存活率分别为Ketac Molar组50.8%与Vitro Molar组34.5%。Cox回归分析显示，所分析的临床变量与修复体成功率无显著关联。12个月随访评估结果表明，两种材料的咬合邻面ART修复体存活率无显著差异。