Overview of efficacy outcome variables for the evaluation of periodontal disease treatment.

Since the late 1980s, numerous new products for the prevention, diagnosis, and treatment of periodontal disease have been developed. These products have required randomized clinical trials to provide proof of efficacy and safety prior to marketing. Originally, no consensus existed in the scientific community, regulatory agencies, or industry as to the appropriate design, conduct, and methods of analyses of clinical trials in periodontics. However, in 1967, the Task Force on Design and Analysis in Dental and Oral Research was formed. This task force held three conferences to address specific issues in clinical oral health research; these meetings provided the foundation for the development of guidelines for clinical trials by the Subcommittee on Clinical Trials in Periodontics of the American Academy of Periodontology. Members of the subcommittee held an international symposium in 1996. Following this meeting, 4 working groups were convened and charged with the development of guidelines for the design and conduct of clinical trials in periodontics. These working groups developed guidelines for periodontal clinical trials in the areas of chemotherapeutic agents to slow or arrest periodontitis, products and methods for diagnosis and/or management of periodontitis, products designed to regenerate periodontal tissues, and clinical trials on endosseous dental implants. These guidelines have been published and approved or accepted by the American Academy of Periodontology and the Council on Scientific Affairs of the American Dental Association.