Outcome measurements and quality of randomized controlled clinical trials of tooth-supported fixed dental prostheses: A systematic review and qualitative analysis

Statement of problem. The lack of consensus regarding a standardized set of outcome measurements and noncompliance with current reporting guidelines in clinical trials of tooth supported fixed dental prostheses (FDPs) hamper interstudy comparability, compromise scientific evidence, and waste research effort and resources in prosthetic dentistry. Purpose. The primary objective of this systematic review was to identify all primary and secondary outcome measurements assessed in randomized controlled trials (RCTs) of tooth-supported FDPs. Secondary objectives were to assess their methodological quality by using the Cochrane Collaboration's risk of bias tool (RoB, v2.0) and their reporting quality by means of standardized 16-item CONSORT assessment tool through published reports. Material and methods. An electronic search was conducted in MEDLINE, EMBASE, and Cochrane library to identify all RCT-related articles published in the past 10 years. Differences in RoB were tested with the Pearson chi-squared test, and those in CONSORT score with the Student t test. Results. A total of 64 RCTs from 79 publications were deemed eligible. The diversity of outcome measures used in the field is apparent. Twenty percent of the included studies had a low RoB, 79% showed some concerns, and 1% had a high RoB. The mean +/- standard deviation CONSORT compliance score was 22.56 +/- 3.17. Trials adhered to the CONSORT statement reported lower RoB than those that did not adhere (P<.001). RCTs with a low RoB reported more comprehensive adherence to CONSORT guidelines than those with some concerns (MD 4 [95% CI 1.52-6.48]; P=.004). Conclusions. A standardized core outcome reporting set in clinical research on tooth supported FDPs remains evident. Adherence to the CONSORT statement continues to low, with some RoB concerns that can be improved. (J Prost het Dent 2024;132:326-36)