Next stop for AI Tools and remote Clinical decision and support.
The first medical device to bring the advantages of oral mucosal fluorescence visualization (FV) to dentistry was the VELscope system (LED Dental, Vancouver BC), launched in 2006. In 2023, fluorescence is being increasingly used as part of comprehensive oral soft tissue evaluations in dentistry as an adjunctive aid in patient assessment. VELscope’s use as an oral mucosal screening tool has been extensively reported in the scientific literature. A review of the literature found 38 reviews and or meta-analyses1–38 involving VELscope, 49 papers evaluating the VELscope as an oral mucosal screening tool in clinical or case studies39–87 and another 11 studies/reviews88–98 related to VELscope helping to delineate surgical margins.
The utility of VELscope fluorescence visualization has been extended to other areas, most notably in identifying necrotic vs viable bone during surgical treatment of Medication Related Osteonecrosis of the Jaw99–114; although from a commercial and regulatory perspective, this is strictly off-label use.
by David Morgan, BSc, MSc, PhD.; Edmond Truelove, DDS, MSD. Professor Emeritus, Dept. of Oral Medicine, University of Washington
FV in oral mucosal screening is mainstream although a debate has developed regarding the appropriate uses of FV. FV devices, including the VELscope are, by definition and regulatory approval, adjuncts to the traditional oral exam. They are designed as supplementary visual aids that complement the visual and tactile exam by making abnormalities visually apparent that might otherwise have been overlooked. They help to visualize tissue changes that are suggestive not only of malignancy or potential malignancy but also a multitude of other potential diseases. The subsequent process of investigating these findings, identifying and removing proximate causes, and assessing the need for biopsy and definitive treatment, involves a clear protocol that is well-defined.
Concern has been expressed about “false positives” incorrectly attributed to FV-based devices when their use is treated as providing a definitive diagnostic outcome (positive or negative) for cancer or other diagnoses. Such findings are not false positives but mucosal conditions that merit further consideration since some may represent signs of significant local or systemically initiated mucosal change that require definitive diagnosis and management.
The authors have been closely involved with a Clinical Decision Support Service (CDSS) instituted by LED Dental Inc. (LED) for its VELscope customers to provide remote support to the dental practices in their efforts to make appropriate decisions in the management of the soft tissue lesions. This first, commercially-based, widely marketed service has been available to VELscope customers for more than 10 years, significantly predating a teledentistry-based program that helps in managing soft tissue lesions based on white light and fluorescence images.115
Practitioners are clearly advised that LED’s CDSS clinical case comments are in no way intended to be viewed as a definitive diagnosis and/or action plan but should be seen as suggestions that the clinician may consider in managing the patient. CDSS requirements include anonymous patient data, lesion history, prescribed medications, and white light reflectance and fluorescence photographs of the tissue of concern.
This information is forwarded to a highly qualified oral medicine specialist (Dr. Edmond Truelove) who reviews the information, and provides observations and suggestions based on the submitted information. The report contains the following elements:
- Description of the findings from examination of the supplied white light and fluorescence photographs.
- A summary of the patient and lesion history as provided by the practice.
- A list of clinical conditions that are recommended to be included as part of the differential diagnosis of the referring clinician.
- A discussion of the above listed conditions in the context of the findings and the patient and lesion history.
- Some suggestions to help guide the management of the patient moving forward (e.g. suggestions for lesion resolution, follow-up recommendations, etc.).
A clinical example (Image Smiles Dental – Dr. Jim Yeganegi Inc. & Associates, Vancouver, BC, Canada) is illustrative of the value provided by the service.
A 72 yr. old female presented for routine dental recall examination. She reported no oral symptoms or changes. Her medical history was negative for significant risk of mucosal disease and was only positive for hypothyroidism and rheumatoid arthritis. Medications in use at the time included Synthroid and Hydroxychloroquine. The area viewed with traditional white light illumination is shown in Fig. 1 and the fluorescence response is shown in Fig.2.
Conditions suggested by the CDSS to be considered in the clinician’s differential diagnosis included:
- Epithelial dysplasia/carcinoma
- Chronic infection with fistula from adjacent odontogenic or periodontal infection
- Malignant tumor of accessory salivary gland
- Unintended factitial trauma
The discussion section of the report provided the following guidance: “Lack of symptoms increases odds that the lesion represents significant risk of disorders included in the differential diagnosis. The loss of fluorescence could represent inflammatory or dysplastic change. Careful follow up to rule out local odontogenic infection and assessment to determine if risk of dysplastic change or progressive mucosal disease is significant enough that biopsy and other testing be initiated.”
This service is currently offered at no charge for VELscope users. The increasing costs of maintaining the service and expanding it may require a review of this policy. More than 15,000 dental practices in North America have purchased VELscope units. In 2022, a total of 237 clinical cases were processed through the service. Only a small minority of VELscope users take advantage of the CDSS consulting service. Those that do generally find it has great value.
The current submission process is email-based. By late 2023, the submission process for clinical cases will become cloud-based. To submit a case, a clinician will complete an online submission form which will be viewed, and responded to, by an oral medicine specialist. An important characteristic of this new form will be the use of fields with predefined selection choices as opposed to free-form text fields. This will make it easier to submit the case and the specialist should be able to respond more quickly. A comprehensive PDF report, containing all the submitted information and specialist case comments in one document, will be automatically emailed to the patient’s clinician.
LED intends to grow the service through ease-of-use and automation. They will conduct an outreach to their existing customers to significantly increase participation in the program. LED will recruit additional oral medicine specialists to increase capacity.
An additional motivation for moving to a predefined choices format is to facilitate the development of an AI-based algorithm that can provide automated guidance. AI-based algorithms based on analysis of reflectance and/or autofluorescence images of oral mucosal lesions are being explored.116–122 LED and its partner, KELLS (www.getkells.com), are working on a comprehensive AI approach based on image data plus patient and lesion history information.
Initially, the algorithm will be based on historical data obtained through:
a) Clinical cases processed through the LED’s CDSS service to date. Algorithm training will be based on the clinical case data, the oral medicine specialists’ proposed differential diagnosis and suitably categorized, recommended actions for follow-up with the patient.
b) Clinical case histories supplied by specialists with white light and fluorescence photographs and patient data where biopsies have been performed and histopathological diagnoses obtained.
Moving forward, LED plans to incentivize practices to provide follow-up information on the final resolution of a case including histopathology diagnosis if a biopsy was performed. Referencing the final diagnostic outcomes of cases will strengthen the development of an AI-based algorithm.
It is not anticipated that an AI algorithm could replace clinical case support by an oral medicine specialist. However, its very valuable role could be:
a) A precursor step to 1) submitting a case through the service to engage an oral medicine specialist, or 2) referral and/or consultation with a specialist.
b) Integration into the CDSS through oral medicine specialists to facilitate and streamline their own analysis of the case.
The final form of the AI-algorithm’s deployment will depend upon its performance once it has been sufficiently trained, but LED is certain that it will contribute value to the dental community in helping to identify and manage oral soft tissue lesions.
Oral Health welcomes this original article.
Authors Disclaimer: David Morgan is Chief Technology Officer at LED Dental Inc, manufacturer of the VELscope system. Edmond Truelove receives remuneration from LED Dental Inc. for his role as a clinical consultant in LED’s Clinical Decision Support Service.
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About the Author
David Morgan PhD (physics) graduated the University of British Columbia. After research positions at Cambridge University and BC Cancer Research Centre, he began a 25-year career in medical device research and product development. He is currently the Chief Technology Officer at LED Dental Inc.
Dr. Truelove graduated in Oral Medicine, Indiana University. Now Professor Emeritus, he established the Department of Oral Medicine, University of Washington, and was Department Chair until 2010. He has published 200+ scientific articles, earned numerous research grants, and was appointed Chair, American Board of Oral Medicine and Council of Scientific Affairs at the ADA