Reported methodological quality of split-mouth studies
: Emmanuel Lesaffre
: Blackwell Synergy
Background/Aim: Hujoel & Moulton previously questioned the reported quality of
split-mouth studies. Since then, there has been little enquiry into the methodology of
this study design. The aim was to conduct a systematic review of the reported
methodology of clinical studies using a split-mouth design published in dental journals
over a 1-year period (2004).
Material and Methods: An extension of the CONSORT guidelines for clusterrandomized
designs was used to evaluate quality. We evaluated the methods used and
quality of reporting split-mouth studies.
Results: Thirty-four studies were eligible for this review. The results showed that
many papers lack essential qualities of good reporting, e.g. five of 34 papers gave the
rationale for choosing a split-mouth design, 19 of 34 (56%) used appropriate analytical
statistical methods and only one of 34 presented an appropriate sample size
calculation. Of the five studies that used survival analysis, none of them used a paired
Conclusions: Despite some progress in statistical analysis, if the reporting of studies
represents the actual methodology of the trial, this review has identified important
aspects of split-mouth study design and analysis that would benefit from development.
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