Ever hear these statistics?
- Every hour of every day 365 days a year someone dies in the United States resulting from oral cancer.
- The mortality rate at five years from oral cancer remains basically unchanged over the past thirty years at approximately 50%.
- Oral cancer now has a mortality rate higher than Hodgkin’s lymphoma, thyroid cancer, acute and chronic lymphocytic leukemia, non-epithelial skin cancer, and testicular cancer.
- Even though the majority of oral cancers occur in people over the age of 40 there is an alarming increase in orophayngeal cancer cases seen in the 18-40 age group. These oropharyngeal cancers are thought to be related to certain types of the Human Papilloma Virus (HPV 16/18).
- More than 25% of the oral cancers still occur in people who do not have the risk factors of tobacco or excessive alcohol consumption.
- Today, oral cancer affects approximately twice as many men as women today versus a 5:1 male to female ratio 50 years ago.
What can the dental team do?
Even though I have personally read and spoken about these statistics to many dental groups over the past two years or more, their reality is still personally chilling.
The good news is that today we have new technologies at our disposal that, along with a comprehensive visual and palpation screening for oral cancer under incandescent light, can significantly change this entire negative scenario. Effective early detection of oral cancer and follow-up can bring the 5-year survival rate from the current 50% to close to 90%! Now that is exciting and achievable if we all do our part!
So, I would like to broadly answer these key questions:
What are these new technologies currently available that will make such a difference?
- How do they work?
- What are their costs?
- Are they reliable
- What are their costs?
- What about patient acceptance?
- How about dentist/dental hygienist acceptance?
What are the new technologies currently available?
I like to group the new technologies into two groups:
- Detection technologies
- Brush biopsy technologies
It is critical to note that when reviewing the literature on this subject, the only ‘gold standard’ that exists to determine the exact nature of a suspicious malignant or pre-malignant lesion in the mouth is either a scalpel or laser biopsy. The detection devices as well as brush biopsy devices create increased evidence that moves us toward the performing of the definitive biopsy NOT in place of it.
DETECTION DEVICES
Considering that available information can change daily, as of right now, the two primary/leading detection technologies most commonly seen in the marketplace are ViziLite Plus and VELscope Vantage.
The Vizilite uses Direct Tissue Fluorescence Visualization (fluorescent bulb in hand-held device) and the VELscope uses an acetic acid rinse in combination with Chemiluminescent light or Speculite(chemically created illumination accomplished through a mixing of materials in a closed, thin, tube). The second is Direct Tissue Fluorescence Visualization (excitation and direct observation of natural tissue fluorescence).
Two other products on the market are MicroLux and Orascoptic DK which use the same basic approach as ViziLitePlus a mild acetic acid rinse and then a light source to visualize ‘acetowhite’ lesions. Both are significantly less expensive than ViziLite Plus. The Microlux DL representative contacted by this author stated that ‘the developer of the Microlux technology does not believe in the usefulness of toluidine blue stain (tol-blue) and thus does not include it in with the product when it is sold’. An Orascoptic DK representative did not return calls for product clarification regarding tol blue.
A multi-page review of the pros and cons of each technology could easily be accomplished, but is beyond the scope of this article. The literature is filled with articles both pro and con.
I encourage you to stay abreast of the literature as you normally do and make your own decisions for your own reasons. NOTE: Watch carefully for ‘product affiliation’ of the author(s) and study size when weighing the value of any study.
Below is my take on how the two most popular detection systems compare. NOTE: Both of these devices are adjunctive and require utilizing a clinical assessment to determine the appropriate course of action.
Effectiveness
VELscope Vantage shows high effectiveness in detecting both the existence AND extent of both white, white and mixed red/white lesions (leukoplakia and erythroplasia and eythroleukoplakia). ViziLite Plus identifies suspicious white areas, but not red areas.
On the positive side, ViziLite Plus can bring to the attention of the clinician white areas possibly missed in their initial clinical examination. With ViziLite Plus, if a suspicious white area is detected, tol blue stain (T-blue) is then applied to mark the position of the lesion to assist the clinician to visualize the area under incandescent light.
According to the Summary of Safety and Effectiveness for ViziLite available on the FDA’s website,
“The marking system is not intended to be used as an indicator of lesions warranting further study, including biopsy. Whether a lesion is marked or not should not alter the clinician’s clinical behavior as dictated by the results of the Vizilite examination.”
The use of natural tissue fluorescence to help in disease diagnosis and detection (in the lung, colon, skin, cervix, oral cavity…) has been well studied and reported in the scientific literature over the past two decades. The fluorescence technique as employed by the VELscope system is thought to be sensitive to the involvement of all of the oral mucosal tissues from the surface of the epithelium down to the basement membrane and into the underlying connective tissue. When viewed through the VELscope handpiece, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal, green fluorescence pattern of surrounding healthy tissue. In addition to being used as a tool for the general practitioner to aid in the discovery of abnormal tissue, VELscope is also being used successfully to help clinicians to determine biopsy site selections and help delineate surgical margins around dysplastic and cancerous lesions.
Ease of use
VELscope is arguably more user-friendly when judged by the lack of pre-screening rinses and absence of restrictive time limits for use with any given patient. ViziLite Plus requires an acetic acid drying rinse prior to using the chemilumiscent light and has a 5 minute window of use until the ‘light’ created by the mixed chemicals goes out.
Cost
VELscope is a ‘unit’ that is purchased ($6995 retail price when purchased in the new VELscope Vantage package) with minimal cost in disposables per patient (@$2.50). The manufacturer, using very conservative figures, states that it will take two to four months to totally recoup the cost of the unit. Once owned outright, the ‘hard cost’ is only the disposables. Potential financial gain for the practice is then measured against the disposables cost only. The cost to the patient is typically somewhere in the range $10.00-$65.00 (average @$35.00).
For ViziLite Plus, it is purchased on a ‘one patient/one use’ basis therefore no equipment need be purchased which is a plus for some practitioners. The cost of disposables per patient is @$20.00-$25.00 (double if it is necessary to use two ‘lights’ for a patient). These costs always remain the same no matter how long the practice uses the product. Cost to the patient is @$50.00-$80.00 (average @$70.00).
Both are submitted under ADA code D0431 which a growing amount of dental insurance carriers now accept.
Patient acceptance
The increased cost factor and the need for a rinse that, to some patients is unpleasant, makes patient acceptance of the VELscope likely higher than ViziLite Plus. Controlled non manufacturer-supported studies need to be undertaken to clarify this point.
Dentist/team acceptance
As a clinician of over thirty years, for me the cost factor as well as the need for a possibly unpleasant patient rinse could lead to frustration among dentists and team members if their attempts to gain patient acceptance for ViziLite were consistently rejected. These later two factors are not issues with VELscope. Also, I personally, feel that the added ability to take an intra-oral photo of exactly what the clinician sees through the VELscope unit for documentation using a relatively inexpensive camera attached via a supplied adapter is a significant plus for the VELscope technology. Once again, a controlled, non-manufacturer-supported studies need to be undertaken to clarify these aspects of concern.
Don’t take my word for it. Make it your own responsibility to learn then incorporate one or both of these technologies when screening EVERY preventive recare patient and EVERY new patient in your practice. The critical point here is that there ARE effective and proven methods/technologies available to each of us that are adjunctive to our incandescent light visual/palpation screening exam. It is our responsibility and duty to use the best technology available to provide the best care for our patients.
BRUSH BIOPSY
Brush "biopsy" techniques, as well, have had some recent additions. To clarify, the OralCDx BrushTest is a sampling technique which captures cells and cell clusters and is NOT a scalpel or laser biopsy. If the report comes back positive for dysplastic cells, a scalpel/laser biopsy MUST be performed to make a definitive diagnosis.
The BrushTest is a simple and easy tool to screen any ‘suspicious patch’ in the mouth for abnormal cells inexpensively, quickly, and with excellent patient compliance. Once the cells (transepithelial cells) are removed in the suspicious area down to the basement membrane with the brush supplied, the material gathered is wiped on a slide, fixed, and sent off for evaluation.
The ADA code for this procedure is D7288 which is accepted by most dental insurance companies. The cost is approximately $125.00-$210.00 to the patient with a cost to the office of $10.00. Most medical insurance plans cover the cost of the biopsy test.
(Note: For an excisional biopsy of oral soft tissue the ADA code is D7286 when performed by scalpel or laser with an associated patient cost of for the procedure in the range of @$225.00-$300.00. There is an additional pathology cost that is usually submitted and covered by the patient’s medical insurance.)
Liquid-based cytology
Another brush “biopsy” technique that is available in some areas in the United States (e.g. Tufts Oral Pathology Services, Boston MA) is ‘liquid-based cytology’ which is believed to improve the effectiveness of standard brush “biopsy” techniques. With this approach, the cells and material gathered along with the brush are placed in a sealed vial with a fixing solution before being transported for evaluation. The vial’s liquid is then filtered of all blood and debris and then used to prepare a superior cytological slide specimen where the vast majority of cells are distributed uniformly in a monolayer with minimal clumping or undesirable multilayer overlap.
Experts agree that the liquid-based cytological samples lend themselves to a more accurate and reproducible analysis. This ‘liquid-based cytology’ technique is now the standard of care when doing ‘pap smears,’ a type of brush “biopsy” of the cervix.
Once again, look up the options that you have for this most important follow-up step and learn the pros and cons. The critical point is getting our patients to do the necessary follow-up to improve their chances of survival based on good clinical judgment beginning with a thorough visual/palpation examination. The earlier an oral cancer is definitively diagnosed AND treated, the better our patient’s chances of survival.
A word about ‘false positives’
What percent of all Pap smears are ‘false positives?’ The answer: A very significant percent. BUT, does that negate the importance or the need to do Pap smears? Of course not!
Lives are saved every day of patients whose smears were, indeed, positive--with intervention/treatment started immediately.
With a visual/manual examination under incandescent light, have all dentists had ‘false positives’ in the form of finding white areas or abnormal looking tissues that did not turn out to be malignancies? Of course! Do we decide to stop doing our incandescent light/visual examination based on that? Of course not! For many years, I and my colleagues have saved many lives from diagnosing those areas that were indeed dysplastic or a frank malignancy prior to the advent of these new adjunctive technologies.
So, if we have more ‘false positives’ from the use of one of the new adjunctive technologies, do we decide that these technologies are not useful? To me, the answer is a resounding, OF COURSE NOT! Through these new technologies, more areas of concern are discovered and, yes, a percent of them are indeed ‘negative’ BUT a percent of them are malignant or pre-malignant.
What would you rather have for you or your family, loved ones, or friends: The potential of a ‘false positive’ or the chance to save a life if you or they are among the small percent that are, indeed, a ‘true positive’ for dysplasia or carcinoma? Think about it.
Summary
I firmly believe that our focus in the dental profession, as a whole, and the dentist and team, specifically, needs to provide the best patient care possible. In this area of early oral cancer detection, this patient-centered focus will save lives through performing an ‘effective’ visual and manual oral cancer screening plus adopting adjunctive technologies in order to better detect oral cancer. The new technologies can greatly enhance the currently used visual and palpation examination/screening under incandescent light.
Also, I cannot overstate the critical importance of managing our patients so that the necessary follow-up with appropriate biopsy techniques to determine a definitive diagnosis is accomplished. NOW is the time for more effective early oral cancer detection! Together, the dentist and all team members can save lives.
(DISCLOSURE: This author does not work for nor has gained any financial benefit from any manufacturer of adjunctive screening or biopsy technologies mentioned here.)