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Vizilite® TBlue

Vizilite TBlue
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Overview

ViziLite TBlue

Better screening saves lives.®

vizilite-and-tblueViziLite® TBlue® is used to help oral healthcare professionals identify, evaluate, monitor and mark abnormal oral cell lesions suspicious for pathology including precancerous and cancerous cells that may be difficult to see during a regular visual exam.

ViziLite TBlue Advantage:

  • Quick and easy-to use system that incorporates seamlessly into your standard visual examination – procedure only takes 2 minutes to complete
  • Small device size enables easier access to see and focus light inside the oral cavity
  • Disposable technology eliminates cross-contamination and improves infection control
  • Patented and clinically proven technology that has been helping healthcare professionals for more than a decade
  • A clinical study has shown that the use of ViziLite TBlue after a conventional visual examination resulted in1:
    • NO FALSE NEGATIVE OUTCOMES, meaning in this clinical study ViziLite TBlue identified every lesion that had precancerous or cancerous cells
    • SIGNIFICANTLY REDUCED the number of false positive lesions identified during standard visual examinations – limiting the number of biopsies that may have normally been performed

Below is an image of Squamous cell carcinoma – identified and stained with ViziLite TBlue

squamous_normal
What you see under normal light
squamous_vizilite
What you see using ViziLite Plus

For more information on ViziLite TBlue, download the package insert

Case Studies

Case Studies

The following case studies document how ViziLite® TBlue® has been used to help dental professionals identify suspicious oral tissue and to identify these tissues earlier than using a conventional visual exam alone.

Mark Levin, D.M.D., F.A.G.D.
Philadelphia, PA
51-year old white male, a tobacco user, was found to have hyperparakeratosis with focal dyskeratosis after initial visualization using ViziLite TBlue. This case report was submitted by Dr. Mark Levin and Nicole Nocille, R.D.H.
Download PDF

New York City Dental Clinic
New York, NY
35-year old white female was found to have a possible pre-malignant lesion using ViziLite TBlue.
Download PDF

New York City Dental Clinic
New York, NY
62-year old male, a moderate tobacco user, was found to have a possible pre-malignant lesion using ViziLite TBlue. In this case, the lesion was subsequently found to be oral cancer.
Download PDF

New York City Dental Clinic
New York, NY
47-year old male, a non-smoker, was found to have a pre-malignant lesion using ViziLite TBlue.
Download PDF

Clinical Studies

Clinical Studies

Download Summaries of Oral Cancer Clinical Studies

ViziLite® TBlue® is a clinically proven screening system that has been helping oral healthcare professionals identify and mark lesions for more than a decade. This system uses a chemiluminescent light source and a patented, GMP manufactured toluidine blue dye called TBlue. TBlue provides the deep blue staining that allows ViziLite TBlue identified lesions to be seen clearly under normal light.

ViziLite and ViziLite TBlue have had numerous clinical studies published supporting its ability to help oral healthcare professionals identify, evaluate, monitor and mark abnormal oral lesions suspicious for pathology including precancerous and cancerous cells that may be difficult to see during a regular visual exam.

Clinical Studies

Mojsa I, Zaleska M, Stypulkowska J, et al. Value of the ViziLite Plus System as a Diagnostic Aid in the Early Detection of Oral Cancer/Premalignant Epithelial Lesions. J Craniofacial Surg. 2012;23(2):e162-164.
http://www.ncbi.nlm.nih.gov/pubmed/22446458

Patton LL, Epstein JB, and Kerr AR. Adjunctive Techniques for Oral Cancer Examination and Lesion Diagnosis: A Systematic Review of the Literature. J Am Dent Assoc. 2008;139:896-905.
http://www.oralcancerfoundation.org/dental/pdf/Lauren_Patton-1.pdf

Epstein JB, Silverman S Jr, Epstein JD, et al. Analysis of oral lesion biopsies identified and evaluated by visual examination, chemiluminescence and toluidine blue. Oral Oncol. 2008;44(6):615.
http://www.ncbi.nlm.nih.gov/pubmed?term=17996486

Kerr AR, Sirois DA, Epstein JB. Clinical evaluation of chemiluminescent lighting: an adjunct for oral mucosal examinations. New York University College of Dentistry. J Clin Dent. 2006;17(3):59-63.
http://www.ncbi.nih.gov/pubmed?term=17022366

Epstein JB, Gorsky M, Lonky S, et al. The efficacy of oral lumenoscopy (ViziLite) in visualizing oral mucosal lesions. College of Dentistry and Illinois Cancer Center. Spec Care Dentist. 2006;26(4):171-4.
http://www.ncbi.nlm.nih.gov/pubmed/16927741

Ram S, Siar CH. Chemiluminescence as a diagnostic aid in the detection of oral cancer and potentially malignant epithelial lesions. Int J Oral Maxillofac Surg. 2005;34(5):521-7.
http://www.ncbi.nlm.nih.gov/pubmed/16053872

Zhang L, Williams M, Poh CF, et al. Toluidine blue staining identifies high-risk primary oral premalignant lesions with poor outcome. University of British Columbia. Cancer Res. 2005;65(17):8017-21.
http://www.ncbi.nlm.nih.gov/pubmed?term=16140975

Huber MA, Bsoul SA, Terezhalmy GT. Acetic acid wash and chemiluminescent illumination as an adjunct to conventional oral soft tissue examination for the detection of dysplasia: a pilot study. University of Texas Health Science Center of San Antonio. Quintessence Int. 2004;35(5):378-84.
http://www.ncbi.nlm.nih.gov/pubmed/15130078

Patient News

ViziLite® Plus Patient News

Across the U.S., reporters have picked up on the importance of oral cancer screenings to raise awareness with local viewers. Look through these clips to watch news stories about the impact oral cancer screenings made in a treatment program.


News Clips

KENS5 – San Antonio, Texas

KSBY – San Luis Obispo, California

KVAL – Portland, Oregon

WWLTV 4 – New Orleans, Louisiana

WATE – Knoxville, Tennessee

How It Works

How ViziLite® TBlue® Works

When cells mutate from normal to becoming cancerous they go through many changes. One change that occurs within the cell is the replication of nuclear DNA at an accelerated rate. The DNA takes up a greater percentage of the total cell volume as shown in the illustration below. The ratio between the nucleus and the cytoplasm can increase until the nucleus takes up nearly 100% of the cell volume.

progression

With ViziLite TBlue, oral healthcare professionals now have an adjunctive screening system that helps to identify, evaluate, monitor and mark abnormal oral lesions that may be going through these dysplastic changes. The pre-rinse solution in ViziLite TBlue desiccates the cells to make the nuclei more prominent and; therefore, more visible. The low intensity light from the handheld light source is reflected off of these abnormal cells down to the basement membrane where the nuclei have been rendered more prominent and appear to “glow” – making abnormal cells easier to see.

vizilite how illustration

TBlue®

TBlue is a toluidine blue-based metachromatic dye used to mark ViziLite identified lesions for further evaluation and monitoring of changes. TBlue, packaged in an easy-to-use three-swab system, provides the blue staining that allows ViziLite identified lesions to be seen clearly under normal light.

How to Use

How to Use ViziLite® TBlue®

ViziLite TBlue is an easy-to-use system that takes just 90 seconds to perform. It incorporates seamlessly into your existing visual oral cancer screening examinations. Below are the simple-to-use steps when conducting a ViziLite TBlue screening exam. For specific details on each step, please download the ViziLite TBlue Instructions for Use.

  • ViziLite TBlue contains:
  • Pre-Rinse Solution
  • Disposable Retractor
  • Handheld Light Stick
  • Mirror Attachment
  • TBlue® Marking System

How to conduct a ViziLite® TBlue® Exam:

Insurance Coverage

Insurance Coverage

Patient medical and dental insurance benefits should not dictate the standard of care that is provided. This is especially important for screening procedures, such as the ViziLite® TBlue® examination. Practices that offer ViziLite TBlue exams to their patients want their patients to receive the highest quality standard of care available.

CDT Code: D0431

In 2005, the American Dental Association approved a CDT code for adjunctive tests intended to aid in oral mucosal examinations. The relevant passage reads: “Adjunctive pre-diagnostic test that aids in the detection of mucosal abnormalities including pre-malignant and malignant lesions not to include cytology or biopsy procedures.” The ViziLite TBlue screening examination falls under this definition.

Increasing numbers of dental and medical insurance plans are covering CDT code D0431. While not all insurance companies are currently reimbursing for it, many insurance carriers are seeing the value and cost savings of early detection and diagnosis. Please check with your patient’s individual plan for policy coverage. We recommend that you submit every ViziLite TBlue exam to the patient’s insurance company for payment. Even if the insurance company does not reimburse at this time, your submittal is what influences insurance companies to begin covering CDT code D0431.

Another resource for coverage is to include a reimbursement narrative letter with each D0431 claim. To download an Insurance Reimbursement Narrative template, click here.

Medical Insurance

Patient medical insurance may also cover the ViziLite TBlue exam. Several medical insurance codes have been used to obtain insurance reimbursement for ViziLite TBlue exam. These codes are as follows:

Dental professionals can provide necessary information to patients so that they can submit a medical claim to their medical insurance company, or dental professionals may submit a medical claim on behalf of their patient. Below are links to prepared, downloadable and printable medical claim forms containing the three code combinations listed above and a blank standard medical claim form.

Download the 82397/V76.42 form (Recommended)

Download the 99211/V76.42 form

Download the 99201/V76.42 form

Download a blank standard medical claim form

Patient medical insurance companies can also provide plan-specific forms.

MSA/HSA Option

Medical Spending Accounts (MSAs), if offered by patient employers, are an excellent option for patients to use for reimbursement of a ViziLite TBlue examination. Healthcare Savings Accounts (HSAs), can also be an option for reimbursement of the annual ViziLite TBlue exam. In any case, it is important to provide patients with documentation of the ViziLite TBlue exam for submittal, along with payment receipt, for reimbursement.

What if a patient claim is denied?

Zila, Inc. has also prepared sample practice appeal letters for to be sent to insurance companies in the event that a submission for reimbursement has been denied. Simply download the letter here, fill in practice information, and mail to the insurance company.

Disclaimer – The reimbursement information contained here is provided to help you understand the reimbursement process. It is intended to assist providers in accurately obtaining reimbursement for dental health care services. It is not intended to increase or maximize reimbursement by any payer. We strongly suggest that you consult your payer organization with regard to local reimbursement policies. The information contained here is provided for information purposes only and represents no statement, promise or guarantee by DenMat, Inc., concerning reimbursement, payment or charge. Similarly, all CDT, CPT/HCPCS and ICD-9 codes are supplied for information purposes only and represent no statement, promise or guarantee by DenMat that these codes will be appropriate or that reimbursement will be made.

ViziLite In STM

ViziLite® TBlue® in Soft Tissue Management®

In Early Detection of Oral Cancer

Soft Tissue Management (STM) includes the early detection of premalignant and malignant lesions in the oral cavity.

The most common type of head and neck cancer is oral squamous cell carcinoma (OSCC). Cancer of the head and neck area is the sixth most common neoplastic disease in the developed world, representing one of the most serious health problems in this part of the body based on annual morbidity and mortality rates.2

Cancer, which is a major cause of morbidity and disability, is second only to heart disease as the leading cause of death among Americans.3 In the U.S., oral cancer accounts for nearly three percent of all cancers and approximately two percent of all cancer-related deaths.3 Additionally, it is estimated that oral cancer will kill 24 people per day in the U.S.4

What is disturbing is that the average five-year survival rate of oral cancer has not changed significantly in the last few decades because oral cancer is typically not diagnosed until it is in later stages.3 Unfortunately, studies indicate that only a small number of Americans report having been examined for oral cancer, suggesting that the current oral cancer screening protocol needs to be improved.3

FAQ

Frequently Asked Questions

Oral Cancer Risk Factors

Q: Which patients should receive a ViziLite® TBlue® examination?

Approximately 25% of oral cancers are discovered in patients once believed to have no lifestyle risk factors.5 Because the incidence of human papillomavirus 16/18 (HPV 16/18) related cancers are rising in young patients, it is recommended a practitioner perform ViziLite TBlue exams on all adult patients ages 18 and older.6,7

  • Oral Cancer Relative Risk Profile1,3,4,5:
  • Increased Risk
  • Patients age 40 and older (95% of all cases)
  • 18-39 years of age combined with the following:
  • Tobacco use
  • Chronic alcohol consumption
  • Oral HPV 16/18 infection

Highest Risk

  • Patients age 65 and older with lifestyle risk factors
  • Patients with history of oral cancer

Q: Why shouldn’t I offer ViziLite TBlue exams to tobacco users only?

The demographics for oral cancer are changing and 25% of oral cancers are discovered in patients once believed to have no lifestyle risk factors.5 Additionally, the incidence of human papillomavirus 16/18 (HPV 16/18) related cancers are rising in young patients. Therefore, it is recommended a practitioner perform ViziLite TBlue exams on all adult patients.5,6

ViziLite TBlue Product Information

Q: What is ViziLite®?

ViziLite is an FDA cleared medical device that emits a chemiluminescent light at the 430-580nm wavelengths.8 It is used for the identification, evaluation, and monitoring of oral mucosal abnormalities in populations at increased risk for oral cancer.9

Q: What is ViziLite TBlue?

ViziLite TBlue is an oral lesion identification and marking system that is used as an adjunct to conventional visual examination. It is comprised of a chemiluminescent light source (ViziLite) to identify oral mucosal abnormalities and a blue metachromatic vital tissue dye (TBlue) to mark those lesions differentially identified by ViziLite TBlue. ViziLite TBlue is designed to be used as the standard of care adjunctive screening for the identification of oral mucosal abnormalities.8

Q: What is the purpose of the Acetic Acid rinse?

The Acetic Acid rinse prepares the mouth for the ViziLite TBlue examination by desiccating the cells and changing the retractile properties of potential abnormalities.8

Q: How long does the ViziLite TBlue light-stick glow?

Once activated, the examination must be completed within 5-10 minutes. While the light will continue to glow, it is maximally effective for up to 10 minutes.9

Q: Do I need a completely dark operatory to use ViziLite TBlue?

Optimally, the field of view for chemiluminescent light would be as dark as possible. For offices that are unable to dim or turn out the lights, eyewear is supplied that eliminates ambient light and enables easier visualization of the wavelength range that ViziLite TBlue uses: 430-580nm.8

How ViziLite TBlue Works

Q: Who administers the ViziLite TBlue exam?

The Food and Drug Administration cleared the ViziLite TBlue device for use by “trained healthcare professionals.” This includes dentists, registered dental hygienists, physicians and nurses. Check with your state board for specific state requirements.

Q: What am I looking for?

During an examination, a practitioner will look for areas in the mouth that reflect white and become visually differentiated from the surrounding “normal” tissue. Normal tissue will absorb the chemiluminescent light and abnormal tissues will reflect the light. DenMat provides ViziLite TBlue users with a Visual Guide containing photos of abnormalities identified using the chemiluminescent light.

Q: What should I do when I see a suspicious lesion or when a lesion retains TBlue?

Please refer to the following protocol:

  1. Document the clinical appearance and location of the lesion on the ViziLite TBlue mouth map. If possible, photograph the lesion.
  2. If trauma or inflammation cannot be ruled out, have the patient return for re-evaluation in 7-14 days.
  3. At re-evaluation, if the lesion persists, document recheck and note any deviations.
  4. Proceed to apply TBlue oral lesion marking system. Document results on the mouth map. If possible, photograph the lesion.
  5. If TBlue retention is present, biopsy the lesion or refer the patient to a specialist for further assessment.

Q: I’ve used ViziLite TBlue 25 times, but I haven’t found anything abnormal. Is something wrong?

ViziLite TBlue is a wellness exam. It is very likely that none of these patients presented with an abnormality. Each year, approximately 40,000 new people will be diagnosed with oral cancer, so not every patient you see will present with a suspicious lesion.10 Check for the following to ensure optimal screening results.

Patient should vigorously rinse with the solution for 30-60 seconds
Ambient light needs to be reduced
The ‘open’ side of the retractor is facing the tissues being examined

Q: My practice uses Oral CDx. Why should I use ViziLite TBlue?

ViziLite TBlue is used as an adjunct to the visual examination to identify oral lesions. Oral CDx is a pre-diagnostic test performed on clinically evident lesions. These are two different, yet complimentary, types of products. ViziLite TBlue can guide you to a location to perform a brush biopsy or any other biopsy method of choice.

Q: Do I need to use another ViziLite TBlue exam when I re-appoint the patient to re-evaluate the lesion?

If the lesion is visible and believed to be clinically suspicious, re-apply TBlue only. If the lesion is no longer visible under normal lighting, then repeat the ViziLite exam prior to applying TBlue.

Q: When I see a suspicious lesion visually, is the ViziLite TBlue exam still necessary?

Yes, you would still want to assess the entire mouth with a ViziLite TBlue exam. Worldwide clinical studies have shown that the use of ViziLite TBlue following your conventional examination can improve the net yield of suspicious lesions (suspicious lesions missed during visual examination).

Q: Is there a dental code I can use for reimbursement?

Yes, CDT D0431 can be used to submit insurance claims for reimbursement. There are also alternative codes, including medical insurance codes that have been successfully applied to receive reimbursement. Visit the “Insurance Coverage” tab for detailed coding information.

Q: Does my OS/H&N specialist need ViziLite TBlue if I’m using it?

It is recommended that all dental practitioners utilize ViziLite TBlue to identify any cell abnormalities and qualify the extent of the lesion with TBlue. It is important, however, for a copy of the ViziLite TBlue mouth map to accompany the patient to the specialist appointment.

TBlue Questions

Q: What is TBlue?

TBlue is a patented, metachromatic vital tissue dye known as toluidine blue. It is used to differentially mark and qualify suspicious lesions identified during a ViziLite TBlue exam.9,11

Q: Why should I use TBlue?

A lesion stained by TBlue allows the practitioner to clearly visualize the extent of the lesion after removal of the ViziLite TBlue light source. The practitioner can now take an intraoral photograph for inclusion in the patient record, submission to the patient’s insurance carrier or as an invaluable tool for referral to a specialist. In one study, TBlue was shown to have an 80% predictive value of the transformation of benign to malignant lesions.12

Q: When should I use TBlue?

TBlue should be used after trauma, inflammation and benign ulcerative conditions have been eliminated as a cause of the abnormality. TBlue should be used to mark suspicious lesions identified during the ViziLite TBlue exam. As such, you should perform a thorough visual examination followed by a ViziLite examination prior to the application of TBlue.

Q: What types of lesions will TBlue mark (stain)?

Clinical studies have demonstrated that TBlue will stain nearly 100% of several dysplasia, carcinoma in situ and cancer. It will also stain approximately 60-70% of less serious pathology (mid and moderate dysplasia as well as traumatic, ulcerative and inflammatory lesions.

Q: Can I use TBlue to mark lesions I’ve identified visually, without ViziLite TBlue?

Instructions for use require the use of TBlue in conjunction with a ViziLite TBlue examination. This ensures the abnormality is differentially identified as compared to normal. TBlue was not investigated on lesions other than those that were identified by ViziLite TBlue.

Q: Should I brush biopsy a lesion marked by TBlue?

Some practitioners feel as though this is an unnecessary step prior to scalpel biopsy. If a brush biopsy is performed after TBlue application, TBlue will not affect the results of the brush biopsy.

Q: What do I do when a lesion stains with TBlue?

The protocol for a suspicious lesion is as follows:

1. Rule out trauma (some providers will reassess the patient after 7 days).

2. If the lesion stains with TBlue, it is in the patient’s best interest for the practitioner to continue to the next step of their oral cancer diagnostic protocol, or refer to a specialist for further evaluation and treatment if required.

Q: Are there ViziLite TBlue-identified lesions that TBlue won’t stain?

The package insert includes information on the step-by step procedure to ensure proper application of the stain. The insert also includes clinical data that shows what lesions could yield a TBlue negative result. However, it is best to follow the recommended procedure: When in doubt, send it out to a specialist for evaluation.

Q: What are the contraindications of TBlue9?

  • TBlue is not intended to be used without prior traditional oral visual examination using ambient projected light.
  • TBlue is contraindicated in patients with known history of hypersensitivity to any of the ingredients or their analogs
  • TBlue is contraindicated in patients who are pregnant or lactating
  • TBlue should not be used in children or patients with liver or renal insufficiency
  • TBlue should not be used in patients who are unable to control swallowing or follow directions

Q: Does TBlue stain anything other than soft tissue lesions? How long will the stain last?

TBlue may stain the dorsum of the tongue, around the margins of dental restorations, inflammatory and ulcerative lesions and dental plaque. TBlue stain will remain present for 2-6 hours after application.9

Q: If TBlue gets on my clothes, will it come out?

The type of fabric will dictate how much, if any, of the stain can be removed. A diluted solution of Acetic Acid (vinegar) should be applied immediately after the stain occurs for best removal.

Q: Are there other uses for TBlue?

DenMat’s patented TBlue is currently only cleared by the FDA for use within the oral cavity. Generic toluidine blue has been used for decades as a hemostatsis agent in the identification of gastrointestinal neoplasms on the female cervix for lesion identification. It has also been used to stain the parathyroid gland during thyroid surgery.13

Q: Do I charge a patient separately to use the TBlue Marking System?

This is a practice decision and every practice is different. Typically dentists don’t charge for TBlue itself, but may charge for an office visit.

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