2005D-0240 Guidance for Industry on Development and Evaluation of Drugs for Treatment or Prevention of Gingivitis; Availability
FDA Comment Number : EC13
Submitter : Dr. Mark Mallatt Date & Time: 11/03/2005 10:11:22
Organization : Indiana State Department of Health
Category : State Government
Issue Areas/Comments
I have been doing clinical research in the oral health field for 30 years. Over the years, I have performed approximatly 9000 gingivitis exams with an index that did not use bleeding as a criteria and probably 30,000 exams using the GI criteria. It is my belief that the bleeding aspect of the exam is much more important as an indicator of early inflammation than color change alone. The gingivae can assume color changes that do not have anything to do with inflammation caused by plaque; such as the case with pregnancy gingivitis, erythema caused by mild trauma, allergic response to flavoring agents (plasma cell gingivtis from chewing gum a few years ago),or color change of the gingivae from systemic conditions unrelated to bacterial infection, etc. In my opinion, if you are going to go through all the steps necessary to undertake a clinical trial, obtain informed consent, have the patient in the chair after having performed the necessary infection control preparation, then you might as well use the index that can give you the most information which includes color, swelling, AND bleeding. Using the GI, you can break out the the data for any one of the three separately if you want (bleeding sites alone) or all three collectively. I think the GI is still a very good index but I have repeatedly stated that I believe it should be expanded to at least 0-4 and maybe even 0-5.