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The reporting and methodological quality of split-mouth trials in oral implantology: A methodological study
Danchen Qin1, Fang Hua1,2,3, Haoze Yue4
1Hubei-MOST KLOS & KLOBM, School & Hospital of Stomatology, Wuhan University, Wuhan, China.
Objectives:
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.
Materials And Methods:
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.
Results:
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.
Conclusions:
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.
