Compliance of randomized controlled trials in posterior restorations with the CONSORT statement: a systematic review of methodology.

Abstract

This study aims to investigate the compliance of randomized controlled trials (RCTs) in posterior restorations with the Consolidated Standards of Reporting Trials Statement (CONSORT) statement and to analyze the risk of bias (RoB) of these studies. A systematic search was performed in PubMed, Scopus, Web of Science, LILACS/BBO, and Cochrane Library. Only RCTs published in peer-reviewed journals were included. The compliance with the CONSORT was evaluated in a 0-2 scale where 0 = no description, 1 = poor description and 2 = adequate description. Descriptive analyses of the CONSORT mean score by journal, country, and RoB were performed. The RoB in RCTs was evaluated by using the Cochrane Collaboration's tool version 1.0. A total of 15,476 studies were identified after duplicates removal. O only 202 meet the eligibility criteria, among which 31 were follow-up studies. Concerning the overall RoB, only 29 out of 171 were classified as low risk of bias. The overall mean CONSORT score was 19 ± 5.4 points, which means compliance of approximately 59%. Significant differences among countries, publication period, and RoB were observed (p < 0.001). The journal's impact factor was not correlated with the overall CONSORT score (p = 0.36). The adherence of RCTs conducted in posterior restorations to the CONSORT Statement is still low. In addition, most studies were classified as at unclear risk of bias. These results call up an urgent need for improvement. Most RCTs conducted in posterior teeth have poor reporting and are mainly classified as having an unclear risk of bias.