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CONTROLLED CLINICAL TRIALS AND PRACTICE-BASED RESEARCH IN DENTISTRY
1 Executive Associate Dean for Research and Academic Affairs, University of Washington, Seattle, USA
To the Editor: In his recent editorial (Mjör, 2008), Ivar Mjör extolled the virtues of practice-based research, but seemed to suggest that practice-based settings may not be conducive to the conduct of randomized clinical trials (RCTs). His point depends on the perception of a RCT as done to demonstrate efficacy in a very controlled environment by one or two highly trained and calibrated expert clinicians who are able to devote extraordinary time and attention to it. However, there is no reason why RCTs cannot be used in a practice-based setting to demonstrate effectiveness (the outcome in practice). One would focus on the intervention as used in practice, with simple clinical outcomes. Variations of participating dentists in background and skill would be present, but are part of the background noise. If the outcome is not significantly greater than the background noise, then it won’t have any impact on practice. An example is an upcoming RCT in NW PRECEDENT in which we will compare mineral trioxide aggregate (MTA) and calcium hydroxide as pulp-capping materials in member practices. Each dentist will be randomized to use only one of the two for all pulp caps needed over a specified period. Outcomes after two years will be whether the treated tooth required endodontic treatment or extraction, or if it remains vital. This addresses the kind of "identified" and "recurring" clinical problem Dr. Mjör suggests should be pursued in dental practice-based research networks, but does so with a RCT design that should produce the highest-quality evidence of effectiveness. FOOTNOTES Co-Directors, Northwest PRECEDENT Dental Practice Based Research Network References
The author replies:3 Academy 100 Eminent Scholar, College of Dentistry, University of Florida, PO Box 100415, Gainesville, FL 32610, USA Thank you for the opportunity to comment on the Letter to the Editor from Drs. DeRouen and Ferracane at the NW PRECEDENT practice-based network. I am pleased to note that we agree that RCTs can be done in practice-based research (P-BR), as expressed in my Guest Editorial. The network’s pulp study referred to is an example of a RCT design carried out in practice. However, there is more to P-BR than training clinicians to do RCTs in their practices, and that is to identify recurring problems encountered in practice. Many examples can be quoted. I will mention two. When resin-based materials came into common use 30–40 years ago, marginal staining was a major problem. As the problem was identified, it was solved by introducing acid etching as part of the restorative procedure. The clinical diagnosis of secondary (recurrent) caries is a frequent reason for replacement of restorations. It dates back a century, when G.V. Black identified it as a major problem associated with amalgam restorations. Since P-BR has shown this diagnosis to be the most common reason for replacement of all types of restorations, it calls for research to solve the recurring problem. Progress has been made, and more needs to be done. I maintain that a recurring clinical problem must be identified or it will not be resolved. It is unlikely that P-BR will solve the problem per se, but it will allow the dental research community to focus on problems relevant to dental practice.
Journal of Dental Research, Vol. 87, No. 9,
800-801 (2008)
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