Supplementary Material for: Clinical accuracy of two different criteria for the detection of caries lesions around restorations in primary teeth

This is a delayed-type cross-sectional prospective accuracy study nested in a randomized clinical trial. The aim was to investigate the diagnostic accuracy of two visual criteria for caries lesions detection around restorations in primary teeth: the International Dental Federation (FDI) criteria, considering adaptation, staining and presence of caries, and the Caries Associated with Restorations and Sealants (CARS) system. For this, one examiner made the diagnosis and subsequent treatment decision using visual assessment in 163 children (3 to 10 years old) with both FDI and CARS criteria. The order of criteria used was defined by randomization. The reference standard was composed of two approaches: (i) presence of carious tissue after restoration removal or (ii) presence of caries lesions after six and 12 months of follow-up. Sensitivity, specificity, and accuracy parameters were calculated at the dentin threshold. Poisson multilevel regression analyses were performed to evaluate the association of the diagnostic methods and other explanatory variables with the outcomes. Of the 651 restorations included, 480 were evaluated by the reference standard methods and were analyzed. The CARS system presented higher accuracy (0.721) than those obtained with FDI recurrence of caries (0.702), FDI marginal adaptation (0.700) and FDI marginal staining criteria (0.681). The FDI marginal staining showed the study’s lowest sensitivity (0.280) and accuracy (0.681) values. The specificity values of FDI recurrence of caries and FDI marginal adaptation were lower than the CARS system. Restorations assessed after the follow-up period resulted in lower sensitivity but higher specificity than those replaced after initial evaluation. In conclusion, the CARS system is more accurate in detecting caries around restorations in primary teeth than the FDI system, in general. However, the FDI recurrence of caries and FDI marginal adaptation present similar performance to the CARS system when the dentin threshold is considered. On the other hand, marginal staining is not an accurate parameter to evaluate caries around restorations.

本研究为一项嵌套于随机临床试验的延迟型横断面前瞻性准确性研究，旨在探究两种视觉诊断标准在乳牙修复体周围龋损检测中的诊断准确性：其一为考量适配性、着色与龋坏存在情况的国际牙科联合会（International Dental Federation, FDI）标准，其二为龋坏相关修复体与封闭剂（Caries Associated with Restorations and Sealants, CARS）系统。
为此，一名检查者采用视觉评估法，同时依据FDI与CARS标准对163名3~10岁儿童完成诊断及后续治疗决策，检查所用标准的顺序通过随机化方式确定。
本研究的参考标准由两种方案构成：(i) 移除修复体后龋坏组织的存在情况，或(ii) 随访6个月与12个月后龋损的存在情况。
研究人员在牙本质阈值下计算灵敏度、特异度与准确度参数，并采用泊松多水平回归分析，评估诊断方法及其他解释变量与研究结局的关联。
纳入研究的651件修复体中，共480件经参考标准方法评估并纳入最终分析。结果显示，CARS系统的准确度（0.721）高于FDI龋复发标准（0.702）、FDI边缘适配性标准（0.700）及FDI边缘着色标准（0.681）。FDI边缘着色标准为本研究灵敏度（0.280）与准确度（0.681）最低的指标。FDI龋复发与FDI边缘适配性的特异度值均低于CARS系统。相较于初始评估后即行更换的修复体，经随访期后评估的修复体灵敏度更低，但特异度更高。
综上，总体而言，CARS系统在乳牙修复体周围龋损检测中的准确度优于FDI标准。但当以牙本质为阈值时，FDI龋复发标准与FDI边缘适配性标准的诊断性能与CARS系统相当。另一方面，边缘着色并非评估修复体周围龋坏的准确指标。