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Controlled Clinical Trials and Practice-based Research in DentistryProfessor and Academy 100 Eminent Scholar, University of Florida College of Dentistry, Gainesville, FL 32610, USA; imjor{at}dental.ufl.edu
Key Words: Clinical research • practice-based research • controlled clinical trials • RCT • CCT Controlled clinical trials have long been recognized as the ‘gold standard’ for evidence-based research related to clinical practice. They may be randomized (RCTs) to reduce or eliminate bias in patient selection, operator inclination, and other confounding factors. These trials have been funded by public and private institutions, including the dental industry. They form the basis for approval of clinical treatments and the introduction of new or modified dental materials prior to marketing. The RCTs also form the basis for meta-analysis, which is considered to be the optimal approach to evidence-based dentistry. Practice-based dental research (PBDR) networks have been in function in the UK for some time. They vary markedly in approach to the research, covering anything from product testing to educational networks, with emphasis on continuing and advanced education. Recently, practice-based clinical research formally entered the dental research arena in the US—much to the credit of an initiative by the NIDCR/NIH (National Institute of Dental and Craniofacial Research/National Institutes of Health), after the Institute announced, in 2003, the opportunity for funding practice-based research over a seven-year period. Three equal awards were funded in 2005, totaling $75 million. Since dental practice-based research networks are developing on a large scale in the US, it is timely to consider the potential advantages of PBDR. Much can be learned from the numerous medical practice-based research networks that have been in operation internationally for several years. However, it must be kept in mind that the outcomes of dental treatment differ from those in medical practice, in that the technical aspects of the treatment usually have more influence on the outcome in dental practice than in medical practice. The dentists in RCTs are established, recognized, experienced, and often specially trained clinicians. These trials have specific requirements for patient selection, including types of lesions to be treated, patient age, health status, and sometimes gender. The clinicians work without time constraints. The diagnostic criteria and the outcome measures are defined. They are followed up by standardization and calibration of the involved dentists. The clinicians evaluating the outcome are different from the operators performing the procedure, and they are blinded to the procedure whenever possible. These conditions may also apply to practice-based research, but there is more to practice-based studies than doing controlled clinical trials in general practice settings, including identification of recurring problems in dental practice. It has been suggested that the training of selected clinicians to conduct standardized procedures in their practices allows controlled clinical trials to be carried out in a practice setting. That is undoubtedly true, but it is unlikely that the outcome will be different from that in an academic setting. It is not the location where the controlled clinical trial is performed, but rather the additional training of the clinicians that is decisive for the outcome in RCTs. Practice-based research should focus on the identification and frequency of recurring clinical problems. A clinical problem that cannot be identified is unlikely to be resolved. The criteria used by clinicians in practice should be the same as those used for the treatment of patients. They are likely to be varied, because they are based on what was taught in dental school, supplemented by clinical experience and continuing dental education. Improvements in diagnosis, clinical procedures, and outcome assessment must start in dental schools, include all involved clinical faculty, and then become part of the dental curriculum and continuing education programs. This goal is a major endeavor, and we need to get started to obtain quality improvements in general dental practice. Few dental schools make a formal attempt to standardize or calibrate the faculty in clinical decision-making in the main area of dental practice, i.e., restorative/conservative dentistry. Great variations in diagnosis and outcome assessment in general dental practice have repeatedly been demonstrated and published. Detailed grading systems of evidence have been established based on scientifically sound studies (e.g., NICE guidelines). These guidelines may be helpful, but other factors may be equally important, i.e., when, in the caries process, restorative intervention is indicated (Mjör et al., 2008). A primary purpose of PBDR is to identify recurring problems in ‘real-life’ dental practice. As in medical practice (Mold and Peterson, 2005), PBDR is expected to lead to quality improvements, not only of the treatment performed in general dental practice, but also in the teaching at dental schools, by linking academia closer to clinical practice. Practice-based research in restorative dentistry has the potential to become as important for improvements in clinical practice as laboratory research is to enhancing knowledge in basic science (Green and Dowey, 2001). Thus, practice-based research will act as a ‘corrective’ to dental curricula and continuing dental education. In that way, PBDR will also have important educational implications. REFERENCES
Journal of Dental Research, Vol. 87, No. 7,
605 (2008)
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