Evaluating the quality of activecontrol trials in periodontal research
: Blackwell Synergy
Aim: The increasing popularity of randomized-controlled trials (RCTs) has raiseed
the issue of their quality. Frequently overlooked are the differences between
superiority and equivalence trials. The purpose of this study was to apply specific
methodological criteria to evaluate the quality of active-control trials using studies that
compared guided tissue regeneration (GTR) with enamel matrix derivatives (EMD).
Materials and Methods: Seven RCTs were identified in the literature. Standard
methodological criteria and seven additional criteria for trials using active-control
groups were used to evaluate the quality of the seven RCTs.
Results: Two trials were considered as superiority trials. The remaining five provided
no clear statement of their research aim. However, two claimed that EMD and GTR
were equally effective, because their results failed to show a significant difference
between EMD and GTR. Most trials did not meet the majority of the design criteria.
Conclusions: The general lack of compliance with quality criteria might place doubt
on the value of these trials and may render any conclusions questionable. It is therefore
important to distinguish clearly between superiority trials and equivalence trials, and to
incorporate appropriate additional criteria in the design of future RCTs with activecontrol
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