The use of biologic response modifiers in human clinical trials.
To optimize regeneration of the periodontium, new cementum, periodontal ligament, and bone must be formed. Conventional periodontal surgery decreases the likelihood of continued progressive periodontal disease however, it does not lead to significant periodontal regeneration. In vitro studies have identified a class of biologic response modifiers loosely referred to as growth factors, which stimulate the cellular events of tissue regeneration. The most promising are mitogenic and differentiation factors. Based on promising results from animal studies, the application of growth factors to predictably stimulate periodontal regeneration is entering human clinical trials. This manuscript deals with several important considerations in testing biologic response modifiers in humans. Suggestions are made regarding the following parameters: 1) selection of the unit of measurement; 2) patient and lesion selection; 3) identification of controls; 4) selection of outcome parameters; 5) statistical approach; and 6) considerations in treatment regimens.
Graves
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Department of Periodontology and Oral Biology, Boston University School of Graduate Dentistry, Massachusetts, USA.
D000818:Animals; D019485:Bone Morphogenetic Proteins; D002986:Clinical Trials as Topic / Q000379:methods*; D004341:Drug Evaluation; D006133:Growth Substances / Q000627:therapeutic use*; D016557:Guided Tissue Regeneration, Periodontal; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007167:Immunotherapy / Q000379:methods; D017063:Outcome Assessment, Health Care; D010347:Patient Care Planning; D018579:Patient Selection; D010510:Periodontal Diseases / Q000276:immunology / Q000601:surgery / Q000628:therapy*; D010519:Periodontium / Q000502:physiology; D012038:Regeneration; D012107:Research Design
D019485:Bone Morphogenetic Proteins; D006133:Growth Substances; D007155:Immunologic Factors