Recommended revisions to American Dental Association guidelines for acceptance of chemotherapeutic products for gingivitis control |
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| Authors: | P. B. Imrey N. W. Chilton B. L. Pihlstrom H. M. Proskin A. Kingman M. A. Listgarten S. O. Zimmerman S. G. Ciancio M. E. Cohen R. B. D'Agostino S. L. Fischman J. L. Fleiss J. C. Gunsolley R. L. Kent W. J. Killoy L. L. Laster R. G. Marks A. O. Varma |
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| Affiliation: | Task Force on Design and Analysis in Dental and Oral Research, and the Depts. of Medical Information Science, Community Health, Statistics, and Center for Research in Oral Molecular Biology, University of Illinois, Urbana, IL (PBI);School of Dental and Oral Surgery (NWC) and Division of Biostatistics (JLF), Columbia University, New York, NY;Minnesota Clinical Dental Research Center, University of Minnesota, Minneapolis, MN (BLP);Division of Biostatistics, Eastman Dental Center, Rochester, NY (HMP);Epidemiology and Oral Disease Prevention Program, National Institute for Dental Research, Bethesda, MD (AK);Dept. of Periodontics (MAL) and Epidemiology Section (LLL), University of Pennsylvania, Philadelphia, PA;Dept. of Biomathematics, University of Texas M.D. Anderson Cancer Center, Houston, TX (SOZ);Depts. of Periodontology (SGC) and Oral Medicine (SLF), State University of New York at Buffalo, Buffalo, NY;Naval Dental Research Institute, Great Lakes, IL (MEC);Dept. of Mathematics, Boston University, Boston, MA (RBD);Dept. of Periodontics, Virginia Commonwealth University, Richmond, VA (JCG);Forsyth Dental Center, Boston, MA (RLK);Dept. of Periodontics, University of Missouri-Kansas City, Kansas City, MO (WJK);Division of Biostatistics, Dept. of Statistics, University of Florida, Gainesville, FL (RGM);and Dept. of Preventive Medicine, State University of New York at Stony Brook, Stony Brook, NY (AOV), USA. |
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| Abstract: | This paper presents suggested revisions to the American Dental Association's 1985 guidelines for acceptance of anti-gingivitis chemotherapeutic agents. The areas of study design, choice and quality control of clinical gingivitis measurements, statistical analysis, and minimum strength of effect, are addressed. The revisions articulate certain aspects of study design which were implicit in the 1985 guidelines, clarify language on cross-over designs and independence of studies, and recommend use of a United States population in at least one trial supporting a product. Separate recording and analysis of a product's effect on gingival bleeding is proposed, and quality control of clinical measurements receives enhanced emphasis. Modestly elaborated statistical reporting guidelines and strengthened approval criteria, based on size of estimated effect as well as statistical significance, are advocated. |
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| Keywords: | gingivitis American Dental Association efficacy clinical trials |
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