We thank Dr. Huff for his interest in and commitment to early detection of oral premalignant and malignant lesions (OPMLs) in his practice and community. Dr. Huff has found the use of several of these adjunctive techniques in conjunction with conventional examination to be of perceived value in his practice. This personal experience follows Ismail and colleagues,1 who stated that "in developing appropriate treatment plans, dentists should combine the patient’s treatment needs and preferences with the best available scientific evidence, in conjunction with the dentist’s clinical expertise."
Systematic reviews have become the cornerstone of evidence-based dentistry. They are a method for summarizing empiric research data and guiding practice and further research directions. Such systematic reviews, when well-conducted and transparent,2 can provide guidance of greater impact than individual studies, opinion pieces and case reports.
Interested readers are encouraged to review the search strategy, quality rating scale and data tables related to this systematic review that were published online as supplemental data at "http://jada.ada.org/cgi/content/full/139/7/896/DC1" owing to print space limitations. Our goal was to provide dentists with a rigorous approach to summarizing the evidence on the performance of the adjuncts to oral cancer examination available on the U.S. market, in order to inform their decision-making process on the use of these adjuncts based on the best evidence to date.
The devices reviewed are "cleared" through the U.S. Food and Drug Administration’s devices branch; Dr. Huff is correct in stating they are not diagnostic tests, but are adjunctive techniques promoted to improve the clinician’s ability to detect OPMLs. Our review required that all lesions identified upon examination with or without use of the adjunct be assessed by the gold standard of tissue biopsy. Our inclusion criteria were aimed at identifying the most rigorously conducted studies with defined endpoints, thus limiting the number of studies that could be included.
We agree that visualization technologies and brush sampling are to be used as adjunctive tools, to guide the need for biopsy, and do not replace biopsy. We found no studies in the literature to support any conclusion about the use of the VELscope as an oral cancer screening adjunct in general dental practice. As Dr. Huff emphasized, precise mechanisms for loss of fluorescence are variable and application of diascopy to help the clinician identify the nature of lesions with loss of fluorescence should be objectively explored in future clinical studies using this adjunct.
Medical-grade toluidine blue is available as a part of the ViziLite Plus with TBlue system. The ViziLite is not available as a stand-alone device. As stated, toluidine blue is the best-documented adjunctive technique studied in high-risk populations in mucosal disease clinics. It is uncertain whether the differential ability of toluidine blue and autofluoresence to delineate lesion margins has an impact on their relative accuracy as examination adjuncts, although there are implications for surgical treatment approaches.
We believe adjunctive techniques will continue to be developed with additional clinical studies in high-risk and general-patient populations, and they may evolve with the advent of molecular markers to improve the identification of mucosal lesions at risk for malignancy and to potentially predict patients who are at an elevated risk of developing malignant disease.
Currently, toluidine blue has been shown in a cross-sectional and in a longitudinal study to predict lesions with molecular changes and to characterize pre-malignant lesions at increased risk of progressing to cancer. We agree that definitive histopathologic diagnosis based on tissue biopsy remains the gold standard, although new and improved therapies for oral premalignant lesions are needed to have an impact on the progression of premalignant to malignant disease, and to advance early-stage cancer to definitive therapy.
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