CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review

Abstract

IntroductionThis study aimed to investigate methodological quality of clinical trials in regenerative endodontics and its compliance with the CONSORT statement. MethodsAn electronic search was performed in 8 electronic databases. Only clinical trials whose participants underwent regenerative endodontic treatment on necrotic permanent immature teeth were included. Quality assessment was performed using the Cochrane Collaboration’s Risk of Bias Tool (RoB, version 2.0). Compliance of articles with the CONSORT guidelines was assessed by a tool with scales: 0 = no description, 1 = deficient, and 2 = adequate description, totaling a maximum score of 32 points. The Mann-Whitney and Kruskal-Wallis tests were used to compare the scores among journals, studies, country, income levels, and publication periods. Spearman correlation analyses were performed between CONSORT compliance scores and 2019 journal CiteScore values, publication year, and quality assessment. ResultsTwenty studies were included. The average CONSORT compliance score was 20.95 (±6.19). The better reported items were the description of the interventions performed in the trials (100%), followed by the description of the number of patients analyzed, losses and exclusions (90%), and the hypothesis tested (85%). Within the 20 studies, 3 articles were classified as “low risk of bias,” 8 studies were classified as “some concerns,” and 9 studies were considered “high risk of bias.” Studies carried out in countries with higher income levels presented higher CONSORT scores. Significant moderate correlations were found between the CONSORT score and the percentage of risk of bias in low-risk domains (rs = 0.63; 95% CI, 0.31–0.94; P = .003) and the overall risk of bias categories (rs = 0.76; 95% CI, 0.54–0.98; P = .001). ConclusionsThe adequacy of reporting based on the CONSORT checklist items of regenerative endodontic trials was low with a moderate to high risk of bias.