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Reported methodological quality of split-mouth studies
Emmanuel Lesaffre1, Maria-José Garcia Zattera, Carol Redmond
1Biostatistical Centre, Catholic University Leuven, Leuven, Belgium. emmanuel.lesaffre@med.kuleuven.be
Journal of Clinical Periodontology
|August 25, 2007
Summary
This review found that many split-mouth dental studies in 2004 lacked essential methodological reporting. Improvements are needed in study design rationale, statistical analysis, and sample size calculations for split-mouth clinical trials.
Area of Science:
- Dental research methodology
- Clinical trial design
Background:
- Previous work questioned the quality of split-mouth studies.
- Limited subsequent investigation into split-mouth study methodology occurred.
- This study systematically reviewed split-mouth clinical trials from 2004.
Purpose of the Study:
- To systematically review the reported methodology of split-mouth clinical studies.
- To assess the quality of reporting in dental journals.
- To identify areas for improvement in split-mouth study design and analysis.
Main Methods:
- A systematic review of split-mouth studies published in 2004.
- Utilized an extension of CONSORT guidelines for cluster-randomized designs for quality evaluation.
- Assessed methods and reporting quality of included studies.
Main Results:
- Thirty-four split-mouth studies were included.
- Many studies lacked essential reporting qualities.
- Few studies provided rationale for design (5/34), used appropriate statistics (19/34), or sample size calculations (1/34).
- None of the five studies using survival analysis employed a paired approach.
Conclusions:
- Despite statistical analysis advancements, reporting quality remains a concern.
- Key aspects of split-mouth study design and analysis require further development.
- Improved reporting is crucial to reflect actual trial methodology accurately.
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