The reporting and methodological quality of split-mouth trials in oral implantology: A methodological study.

Abstract

The objective of this study is to assess the reporting and methodological quality of split-mouth trials (SMTs) in oral implantology published during the past 10 years, and to investigate whether there was any improvement over time. We searched PubMed for SMTs in oral implantology published during 2011-20. We used CONSORT 2010, its extension for within-person trial (WPT), and an SMT-specific methodological checklist to assess trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Binary scores were given to each item, and total scores of TRQ (range 0-32), WRQ (0-15), and SMQ (0-3) were calculated for each study. Multivariable regression analyses were performed to compare the quality of SMTs published before (2011-17) and after (2018-20) the release of CONSORT for WPT. Seventy-nine SMTs were included. The mean TRQ, WRQ, and SMQ were 16.4, 6.7, and 1.3, respectively. Less than one-third (n=25, 31.6%) reported the rationale for using split-mouth designs. Only 4 (5.1%) trials adequately conducted sample size calculation, and 40 (50.6%) used appropriate statistical methods that considered dependency and clustering of data. In multivariable analyses, compared with 2011-17, studies published in 2018-20 had significantly higher TRQ (p=.044), while WRQ and SMQ did not show improvement. The reporting and methodological quality of SMTs in oral implantology need to be improved. Joint efforts are needed to improve the reporting and methodology of SMTs in this field.