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Title ViziLite Plus TBlue System is Not a Replacement for Comprehensive Oral Screening Examinations with Surgical Biopsy/Definitive Histopathology
Clinical Question In patients with a suspicious oral lesion, how does the ViziLite Plus TBlue oral cancer screening system compare to comprehensive oral screening examination and surgical biopsy/definitive histopathology in identifying precancerous and cancerous lesions?
Clinical Bottom Line The ViziLite Plus TBlue Screening System appears to be a questionably useful adjunct in the oral cancer screening process, and as such its use does not replace a comprehensive oral screening examination and surgical biopsy/definitive histopathology.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 22446458Mojsa/201230 patients with 41 visually identified suspected premalignant oral lesionsComparison with Gold Standard
Key resultsChemiluminescence (ViziLite) may assist the visualization oral pathologies that are not readily detectable by conventional visual examination. The use of toluidine blue (TBlue) reduced the number of false positive biopsies by 3% compared with conventional visual examinations. 100% of serious pathology was positively identified using the ViziLite Plus TBlue system. Sensitivity: 81.8%, specificity: 37.5%, NPV: 33.3%, PPV: 84.4% [5 false positives, 27 true positives, 6 false negatives, and 3 true negatives]
#2) 20123872Mehrotra/2010102 patients with visually identified clinically innocuous oral lesionsComparison with Gold Standard
Key resultsThe use of the ViziLite Plus TBlue system was ineffective in identifying innocuous dysplasia or cancer. Its use resulted in high false positive rates potentially causing a large percentage of precancerous and cancerous lesions to go undiagnosed or potentially resulting in delayed diagnosis. Sensitivity: 0%, specificity: 75.5%, PPV: 0%, NPV: 94.8%
#3) 17996486Epstein/200884 patients with 97 visually identified clinically suspicious oral lesionsComparison with Gold Standard
Key resultsChemiluminescence (ViziLite) may assist the identification of mucosal lesion by increasing the brightness and outlining margins while the addition of toluidine blue (TBlue) reduced the number of false positive biopsies by 55.26% compared with conventional visual examinations. Sensitivity: 100%, NPV: 100% [34 false positives, 20 true positives, 0 false negatives, and 42 true negatives (1 missing)]
Evidence Search ViziLite toluidine blue
Comments on
The Evidence
Validity: The use of the surgical biopsy with histologic diagnosis was the valid gold standard for all three studies. While the histologic diagnosis was blinded to the target test for all three studies, due to the vast differences in the diagnostic tests, researchers and patients were unable to be blinded on the individual screening devices being tested. Additionally, there were some concerns regarding the inherent validity of two of the above study's results. The 2008 Epstein et al. study was funded by the Trylon Corp Inc. (licensing company for ViziLite) and two of the five authors were members of the Medical Advisory Board for Zila, Inc. (makers or ViziLite) while an additional author was a Zila Inc. employee. In the refuting 2010 Mehrotra study, the authors remark that none of their examiners were calibrated, which could potentially have had a significant impact on the interpretation of visually subjective results. Perspective: The patients included in all three studies were selected for inclusion because they were previously identified, via conventional visual examination, to have presented with a clinically suspicious oral lesion that warranted biopsy and histologic diagnosis. None of the studies tested the ViziLite Plus TBlue system's ability to identify occult lesions or lesions that were not previously identified by conventional visual examination. Additionally, the clinicians who performed the studies were generally clinical experts in fields outside of general dentistry (pathology, oral surgery, etc.) leading to concerns that screening results may not be generalizable to general practitioners with less experience in identifying pathologic lesions. Finally, all three studies concluded that further research is required and that regardless of results, suspicious lesions should be examined by experienced providers for definitive diagnosis and treatment.
Applicability At this time the comprehensive visual examination remains the gold standard for oral cancer screenings in the dental field. There is inadequate clinical evidence that the ViziLite Plus TBlue system identifies potential oral lesions over conventional methods alone. As such, its use does not replace a comprehensive examination and definitive histopathology. There was limited evidence to suggest that its use could be a useful adjunct to obtain better visualization of the lesion/margins, but not enough to offset the additional financial cost to the patient with its use. Further well designed clinical studies are needed on the utility of this system in the general dental setting.
Specialty/Discipline (Public Health) (Oral Medicine/Pathology/Radiology) (General Dentistry) (Oral Surgery)
Keywords oral cancer, oral dysplasia, detection, diagnosis
ID# 2523
Date of submission: 08/03/2013spacer
E-mail wyrick@livemail.uthscsa.edu
Author Erin Wyrick
Co-author(s) Wan Zaripah Wan Bakar
Co-author(s) e-mail WanBaker@uthscsa.edu
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