COMPLIANCE OF RANDOMIZED CLINICAL TRIALS ON DENTAL CARIES PREVENTION METHODS WITH THE CONSORT STATEMENT: A SYSTEMATIC REVIEW.

Objective: Reporting of randomized controlled trials (RCTs) in dentistry remains suboptimal. Considering the positive impact of the Consolidated Standards of Reporting Trials (CONSORT) guidelines on the quality of evidence in RCTs, the main objective of this systematic review was to determine whether RCTs on dental caries prevention conform to these guidelines. The secondary objective was to assess the association between CONSORT adherence and the year and impact factor of the journal in which the study was published.

Methods: A systematic search was conducted in different databases using appropriate terms to retrieve RCTs that assessed the caries-preventive effect of at least 2 of the following materials-fluoride varnish, resin-based fissure sealants, and ionomer-based fissure sealants-on the occlusal surfaces of permanent molars. Since the first CONSORT statement was published in 1996, a time frame from 1997 to 2020 was established for the identification of studies. Selected articles were assessed according to their adherence to the CONSORT statement, risk of bias (Cochrane risk of bias tool, RoB 2.0), and journal impact factor based on the InCites Journal Citation Reports. The year of publication and other relevant data were also recorded. SPSS (SPSS Statistics 25.0, IBM©) was used to perform the linear correlation analyses to determine the relationship between the article CONSORT score (previously determined) and the year of publication and journal impact factor. A significance level of 5% was established for all analyses.

Results: Of 3196 references retrieved, 30 articles were selected and evaluated. Using RoB 2.0, 8 studies were classified as having a high risk of bias, 16 as having some concerns about the risk of bias assessment, and 6 as having a low risk of bias. Concerning CONSORT adherence, 77% of the studies adequately reported the intervention domain, since the methodology for the application of fluoride varnish or sealant materials was thoroughly described. However, the participants' setting and location, random sequence generation, randomization, and the flowchart description of the losses/exclusions domains were poorly reported. Meanwhile, the allocation concealment process was not reported in 83% of the articles. Correlation analyses indicated a positive relationship between CONSORT adherence and the year of publication, as well as the journal impact factor.

Conclusion: When assessing clinical trials on the prevention of occlusal caries, most RCTs examined followed the CONSORT statement. However, some methodological domains remain poorly reported, demonstrating the need to improve CONSORT compliance in these RCTs.