A prospective study to evaluate the efficacy of a fluorescence based hand-held device in the detection of malignant and potentially malignant disorders (PMD) of the oral cavity

Objective: Oral cancers have varied clinical presentations, often leading to repeated and multiple biopsies to establish diagnosis and formulate treatment. Use of portable, office- based tools to help in diagnosis and biopsies can result in early diagnosis. We used a fluorescence-based device to study its efficacy in malignant and potentially malignant disorders of oral cavity. Method: 50 individuals including 41 patients and 9 controls were enrolled. Following a thorough clinical examination, the Oralscan (R) device (with combined autofluorescence and diffuse reflectance) was used for characterization of these lesion and to assist in biopsy taking. The zones (red/yellow/green) in which the lesion(s) fell were noted. Punch biopsies were performed and pathological reports were compared with the zonal category as given by the device. Results: The most common site of involvement was buccal mucosa (70.7 %). The total number of lesions studied was 59, with 143 images captured in toto. 75.6 % of cases were malignant. The overall sensitivity, accuracy and PPV of the device was 43.24 %, 34.04 % and 61.54 % respectively. Conclusion: The present study showed that the use of the autofluorescence and diffuse reflectance handheld device had poor sensitivity and specificity for diagnosing oral lesions both malignant and potentially malignant disorders of oral cavity.