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

Abstract

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 a 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-square 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 be low, with some RoB concerns that can be improved.

Clinical Implications: Adherence to the CONSORT statement when reporting a clinical trial of tooth-supported FDPs has been proven to reduce the risk of bias.