ViziLite Plus with TBlue

Background and FDA Clearance

Since 1995, technology to identify submucosal dysplastic tissue in nonkeratinizing stratified squamous epithelium has been available. The technology used in ViziLite has been used successfully to identify cervical intraepithelial neoplasia and cervical cancer. According to the manufacturer, the advantage of using the toluidine blue marking dye is that the precise location for additional examination and biopsy can be clearly noted and more accurately and quickly communicated to the oral surgeon.

In November 2001, the US Food and Drug Administration (FDA) cleared ViziLite as an adjunctive oral cancer screening tool. In January 2005, the FDA cleared the TBlue oral lesion marking system as an adjunctive technology for use with ViziLite.

Instructions and Training Materials

All 6 of the dentists who evaluated ViziLite Plus with TBlue gave it high marks for instructions and training materials, rating them very good to excellent. One evaluator said about both, “Very clear!” The training materials that accompany ViziLite Plus with TBlue include step-by-step instructions that guide the clinician from patient consent through explanations of how to use the product to a protocol for what do to if suspicious lesions are detected.

Ease of Use

When asked about ease of use when purchasing an intraoral cancer detection system, all 6 of the dentist evaluators said it was important to very important. When asked how ViziLite Plus with TBlue rated with regard to ease of use, 2 evaluators rated it as excellent and 4 rated it very good. One of the dentists commented, “Very simple system to use and understand.”

Packaging

The one area where the evaluators thought that the product could be improved was packaging. Two gave it an excellent rating, 1 said it was very good, 2 said it was good, and 1 rated it as fair. The concern regarding packaging and disposable product design focused on environmental issues. One evaluator noted that there is “too much disposable stuff. Not eco-friendly.” They went on to say that “really conscious patients even ask how we recycle the plastic products.”

Overall Satisfaction

The evaluators were asked if they would recommend ViziLite Plus with TBlue to colleagues in the dental profession and if they would purchase the product in the future. To both questions, 5 of the 6 evaluators said definitely or probably. When asked about overall satisfaction, 5 evaluators rated the product good to excellent.