Introduction: A New and Innovative Implant Design

Usual progression of research. Basic research identifies a treatment/product that has the potential to improve the quality of dental health. This promising new treatment/product is then subjected to a well-controlled clinical trial, and the results are then observed. The last step in the research sequence is to subject the new treatment/product to an effectiveness-type clinical trial to determine its “true impact” on clinical care (it is this step that is generally omitted largely because of costs of conducting such studies)

Basic research and efficacy-type clinical trials introduce an intervention to observe its effect (result) on the variable of interest. It is important to eliminate as many other variables (represented by multicolored arrows) from acting on the variable being studied. Under actual (real world) clinical conditions, controlling many of the variables may not be possible. Eliminating or controlling 1 or any combination of these variables may produce an entirely different result than that found in basic or efficacy-type clinical trials. Effectiveness-type clinical trails attempt to study the same variable(s) of interest, but under actual clinical conditions
Contributor Notes
Harold F. Morris, DDS, MS, is the codirector of the Dental Clinical Research Center; project codirector for the Ankylos Implant Clinical Research Group (AICRG), Department of Veterans Affairs Medical Center (VMAC), Ann Arbor, Mich; clinical professor, Department of Restorative Dentistry, Temple University, School of Dentistry, Philadelphia, Penn; visiting clinical researcher, University of Otago, Dunedin, New Zealand; and senior associate editor, Journal of Oral Implantology. Correspondence may be addressed to Dr Morris at DVA Dental Clinical Research Center (154), VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105.
Shigeru Ochi, PhD, is the codirector of the Dental Clinical Research Center, and the project codirector for the AICRG, VMAC, Ann Arbor, Mich.
Sheldon Winkler, DDS, is a professor in the Department of Restorative Dentistry, Temple University, School of Dentistry, Philadelphia, Penn; president, American Academy of Implant Prosthodontics, Voorhees, NJ, and senior executive editor, Journal of Oral Implantology.