Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.
Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.
F1000Res. 2020 Jun 26;9:650. doi: 10.12688/f1000research.23801.3. eCollection 2020.
The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.
龋损周围修复体的检测具有挑战性。因此，为了使诊断过程更具客观性，提出了一些标准。其中两个是国际牙科联合会（FDI）和龋病相关修复体和封闭剂（CARS）标准。这两种方法对龋病的处理方式不同，无法确定在临床实践中使用哪种方法来评估儿童的修复体更好。因此，本方案旨在评估 FDI 和 CARS 标准在评估儿童乳牙修复体周围龋损时对儿童口腔健康相关结局和评估成本的影响。
共对 626 名 3 至 10 岁儿童的修复体进行了随机评估，根据 FDI 标准（FDI 组）或 CARS 标准（CARS 组）进行治疗。参与者将在 6、12、18 和 24 个月后进行随访。主要结局是评估修复体需要新的干预。该结局由几个组成部分组成，这些事件中的每一个都将作为次要结局单独进行分析。儿童口腔健康相关生活质量的变化和修复牙治疗的成本也将作为次要结局进行分析。将使用具有共享脆弱性的 Cox 回归模型比较这些方法。所有统计分析的显著性水平均设为 5%。
这将是首次针对乳牙修复体周围龋损检测的随机临床研究。该研究于 2018 年 5 月 9 日在 Clinicaltrials.gov（NCT03520309）上进行了注册。
