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VIZILITE ORAL CANCER SCREENING CAN SAVE YOUR LIFE

ViziLite Plus makes oral screening more comprehensive than ever before.

VIZILITE PLUS ABOUT ORAL CANCER
About Oral Cancer
Most people are surprised to learn that one American dies every hour from oral cancer; a death rate that has remained virtually unchanged for more than 40 years. In fact, recent statistics published by the American Cancer Society indicate that while the incidence and death rates for cancers overall has decreased, the incidence of oral cancer has increased by 5.5% and the death rate has increased by 1.5%
Oral cancer is far too often discovered in late stage development, the primary reason for the consistently high death rate. Oral cancer treatment often results in disfiguring effects on patients, and can seriously compromise their quality of life. Early detection and diagnosis can make a tremendous difference in life expectancy; oral cancer is 90% curable when found in its early stages. Unfortunately, 70% of oral cancers are diagnosed in the late stages, III and IV, leading to a five-year survival rate of 57%.
THE DEADLY STATISTICS
•    Every hour of every day, one American dies of oral cancer.
•    The mortality rate associated with oral cancer has not improved significantly in the last 40 years.
•    The death rate in the United States for oral cancer is higher than that of cervical cancer, Hodgkin’s disease, cancer of the brain, liver, testes, kidney, or ovary.
•    More than 30,000 Americans will receive an oral cancer diagnosis this year. In five years, only 57% will still be alive.

How ViziLite Plus Works
ViziLite Plus with TBlue630 is an oral lesion identification and marking system that is used as an adjunct to the conventional head and neck examination. It is comprised of a chemiluminescent light source (ViziLite) to improve the identification of lesions and a blue phenothiazine dye to mark those lesions identified by ViziLite. ViziLitePlus with TBlue630 is designed to be used in a patient population at increased risk for oral cancer.
ViziLite Oral Lesion Identification System
In clinical trials involving 13,000 female patients, abnormal squamous epithelium in the cervical complex appears acetowhite after rinsing with a dilute acetic acid solution and viewed under chemiluminescent light (Speculite®). Similarly in the oral cavity, after rinsing with a dilute acetic acid solution, abnormal squamous epithelium tissue will appear acetowhite when viewed under ViziLite’s diffuse low-energy wavelength light. Normal epithelium will absorb the light and appear dark. ViziLite can assist a dentist or hygienist in identifying an abnormality in the oral cavity.

ViziLite Plus  and TBlue630 Oral Lesion Marking System

TBlue630 is a patented, pharmaceutical-grade toluidine blue-based metachromatic dye. It is used to further evaluate and closely monitor changes in ViziLite-identified lesions. It has been proposed that living cells will differentially accumulate toluidine blue based on parameters related to metabolic activity. TBlue630, packaged in an easy to use 3-swab system, provides the deep blue staining that allows ViziLite-identified lesions to be seen clearly under normal light.

Why ViziLite Plus is Important
Early Detection is Critical
Your patients rely on you to be an expert in oral health. Dentists and hygenists are the best overall defense against oral cancer — you are, in fact, a lifesaver. No other medical professionals are as well positioned to address this potentially deadly disease at its earliest stage. The key is to identify oral abnormalities at their most easily treated stage of development.
Fortunately, there’s a simple technology to help in your fight against oral cancer. ViziLite Plus aids in the early identification of oral abnormalities that can lead to cancer. Cleared by the FDA, ViziLite Plus allows dentists to offer superior care to patients. Annual ViziLite Plus exams can be integrated with exsisting patient services, improving patient care and creating a positive financial impact in dental practices.
ViziLite Plus Oral Screening Protocol
ViziLite Plus should be offered annually to all new and re-care adult patients following the standard head and neck exam. Patients with a history of oral cancer should receive at least semi-annual ViziLite Plus exams.
As is the case with most cancers, age is the primary risk factor for oral cancer. Approximately 90% of oral cancer victims are age 40 and older, recent studies indicate that increasingly, patients younger than age 40 are being diagnosed with oral cancer. Though tobacco and alcohol use are the primary lifestyle risk factors that contribute to the development of oral cancer, 27% of oral cancer victims do not use tobacco or alcohol, and have no lifestyle risk factors. Oral cancer affects men more than women, 2:1, but oral cancer in women is on the rise nationwide.
WHO’S AT RISK?
Fact: 27% of oral cancers occur in people who don’t smoke and have no other risk factors.
Increased risk
•    Patients age 18-39
High risk

•    Patients age 40 and older
•    Tobacco users (any type, any age, within 10 years)
Highest risk
•    Patients age 40 and older with lifestyle risk factors
(Tobacco, alcohol, HPV)
•    Patients with history of oral cancer

FDA Clearance
ViziLite Oral Lesion Identification System
In November of 2001 the U.S. Food and Drug Administration cleared ViziLite as an adjunctive screening technology for use in the oral cavity, thus making it the only FDA-cleared medical device for such an application. The technology to identify submucosal dysplastic tissue in non-keratinizing stratified squamous epithelium has been available since 1995.
Chemiluminescent light technology was originally tested on 13,000 cervical cancer patients and obtained FDA clearance for use as a visual screening device for cervical cancer.  Clinical research demonstrated that the illumination device doubled cervical cancer detection. It is the same technology used in ViziLite.
TBlue630 Oral Lesion Marking System
In January of 2005 the U.S. Food and Drug Administration cleared the TBlue630 oral lesion marking system as an adjunctive technology for use with the ViziLite oral lesion identification system.
ViziLite Plus with TBlue630™ is the only FDA-cleared oral lesion identification and marking system available.

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