Guidelines for reporting randomized controlled trials in paediatric dentistry based on the CONSORT statement.

Abstract

The significance of randomized controlled trials (RCT) depends on how thoroughly the results were reported. Reporting of RCTs should be accurate and transparent and encompasses design, implementation, analysis, and results of the trial. The Consolidated Standards of Reporting Trials (CONSORT) statement and its extension were developed to guide the researchers to report clinical trials in a systematic manner. Despite this recommendation, the overall reporting quality of RCTs still remains suboptimal. To describe the relevance and importance of CONSORT reporting guidelines and explain the items using examples derived from randomized trials published in Paediatric Dentistry. This is a narrative review that illustrates the importance of reporting items in the CONSORT guidelines from relevant sources. RCTs published in the International Journal of Paediatric Dentistry between 2017 and 2020 were identified from PubMed and Scopus databases and through handsearching. An explanation has been provided for each of the 37 items in the 2010 CONSORT checklist and 17 items in the CONSORT extension for reporting abstracts. This explanation and elaboration document would enable investigators to report trials in Paediatric Dentistry with accuracy and transparency as well as for reviewers and editors in evaluating the suitability of RCTs for publication.