Approximately a year and a half ago, the manufacturers of Vizilite applied to the ADA for the ADA Seal of Acceptance for their product. The official seal of acceptance is considered the ultimate in product recognition in terms of marketing a given product for use in dentistry in the United States. The Council on Scientific Affairs is charged with the review of all studies related to products requesting the seal. The companies are asked to submit all studies that support their claims. They are required to submit at least two credible clinical studies.
The usual requirement is that of two independent double blind clinical trials, each conducted at a separate site. In addition to the review of this data by the entire Council on Scientific Affairs, the studies are sent out to a number of outside reviewers. The conclusion on Vizilite was quite clear. Their submitted study data was extremely weak. All outside consultants were in agreement in not supporting the product for the seal. The Council was unanimous in not supporting the application.
As a number of you have mentioned, this technique has been employed in the study of uterine cervical epithelium. As has also been mentioned, this
epithelium is a non-keratinizing stratified squamous epithelium. I believe that all oral pathologists are in agreement that the progression of oral epithelial dysplasia to SCC is substantially different biologically from the progression of cervical epithelial dysplasia to SCC. Therefore, one cannot truly indicate that the data on the cervix is transferable to the oral cavity.
Many of you have mentioned economics. Unfortunately, I think that that is what is driving the desire to use this technique. The potential for inaccurate conclusions and greater cost to the patient appear to be the most likely outcomes to result from using the product at this point in time. In this era of evidence-based dentistry, who among us wants to support or use a technique in the absence of evidence?
Unfortunately, despite its failure to achieve the Seal of Acceptance, the manufacturers of Vizilite have increased their marketing, including a full page ad that runs in most issues of the Journal of the American Dental Association (JADA). I raised the question about whether we should be accepting ads concerning a product that we could not say was efficacious.
The bottom line given to me from the ad people is that there is no regulation of ads, JADA just needs the money from ads in order to publish (So buyer beware!).
I would hope that we educators have taught most of the practicing dentists how to examine and evaluate lesions by traditional critieria. I submit that those who do not feel confident to evaluate lesions by traditional examination parameters would probably not be adept at using Vizilite for early detection either.
The ADA informed the Vizilite manufacturers of the decision not to grant the seal and indicated that the application could be reconsidered if they wished to submit new data. It has been over one year and there has been no resubmission.
Valerie A. Murrah, D.M.D., M.S.
Representative to the ADA Council on Scientific Affairs from the 16th
District of the ADA
Professor and Chair
Department of Diagnostic Sciences and General Dentistry
Director, Oral and Maxillofacial Pathology
University of North Carolina School of Dentistry
Chapel Hill, NC 27516