I read with great interest Dr. Joel Epstein and colleagues’ December JADA article, "A Survey of the Current Approaches to Diagnosis and Management of Oral Premalignant Lesions" (Epstein JB, Gorsky M, Fischer D, Gupta A, Epstein M, Elad S. JADA 2007;138[12]:1555–1562). The authors succinctly summarized our limitations in predicting which suspicious lesion will progress to cancer. Reference was made in the article to various adjunctive procedures and devices such as the brush biopsy, toluidine blue staining and two light-based devices available to the dentist to assess oral mucosal lesions. While the authors expressed no firm recommendations regarding their use, I believe further clarification on their yet-to-be-proven applicability in dental practice is in order.
Practitioners often ask me, "Should I use product ‘X’?" or, "Do you use product ‘Y’ routinely?" My current answer is that, given the present lack of scientific study validating their application as routine screening adjuncts, I can neither recommend nor discourage their use. The response from the inquiring practitioner is often, "But they are FDA approved."
The reality is none of these procedures or devices have been vetted through the U.S. Food and Drug Administration (FDA) approval process for a new device. It should be noted here that the brush biopsy procedure (OralCDx, CDx Laboratories, Suffern, N.Y.) is a refined and improved cytology assessment accomplished by a centralized laboratory and not subject to FDA regulation.
To illustrate the FDA’s true involvement concerning these devices, let us look at some of the light-based products available: ViziLite Plus with TBlue630 (Zila Pharmaceuticals, Phoenix), Microlux/DL (AdDent, Danbury, Conn.) and the VELscope (LED Dental, White Rock, British Columbia, Canada). They have all been cleared for use based on their equivalency to a predicate light source marketed in interstate commerce before May 28, 1976.
Essentially, the first such product cleared as equivalent by the FDA was the Speculite Disposable Vaginal Light (Trylon Associates, Harbor City, Calif.) in 1985. These devices are not considered as standard of care in either the gynecological or dental professions, and generally are considered experimental, investigational or unproven by insurance carriers.1–4
Similar concerns about the routine use of toluidine blue staining and brush biopsy to assess oral lesions in dental practice also exist. It may very well be that one or all of these adjunctive techniques may eventually serve an integral role in our ability to identify suspicious oral lesions in dental practice. Let me also emphasize that these products are being legally marketed to the dental profession, and the manufacturers are to be commended for their efforts to promote oral cancer awareness. However, for now, the operative word regarding their routine use is "may."
Until properly designed clinical studies to determine such issues as sensitivity and specificity, ease of use and cost benefit, the uncertainty about the true value of these techniques will continue.5–6
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