Illuminating Dysplasia: A Novel Approach using DrOroscope for Early, Non-invasive Detection - A Prospective Cohort Study

Background: Early detection of oral cancer plays a pivotal role in improving patient outcomes, as identifying the disease at an early stage markedly increases survival rates. Given the rising incidence of oral cancer in India, there is a growing need to prioritise the implementation of regular screening programs and public awareness campaigns. Educating the community about the signs and symptoms can lead to earlier consultations with healthcare professionals. Additionally, promoting healthy lifestyle choices may help reduce the risk factors associated with oral cancer, ultimately contributing to better overall health outcomes. Non-invasive diagnostic tools are utilised for the screening and early diagnosis of dysplasia and malignancies within the oral cavity. The study aims to evaluate the diagnostic efficacy of a novel device, DrOroscope, in the early diagnosis of dysplasia. Methodology: A prospective cohort study was conducted among 200 participants with the presence of oral mucosal lesions in Hyderabad, India. We selected participants based on the clinical oral examination and documented data on behavioural risk factors such as smoking, tobacco, and alcohol use. We correlated DrOroscope analysis, which uses autofluorescence to detect dysplastic lesions, with DNA ploidy analysis using image cytometry. Statistical analysis was performed using SPSS version 26.0 to assess sensitivity, specificity, and overall diagnostic accuracy. The agreement between the two methods was analysed using Cohen’s Kappa, and the receiver operating characteristic (ROC) curve was used to evaluate the overall diagnostic performance of DrOroscope. Results: The sensitivity and specificity of the DrOroscope were 92.73% and 86.90%, respectively, with a positive predictive value (PPV) of 72.86% and a negative predictive value (NPV) of 96.92%. The overall diagnostic accuracy was 88.50%. Cohen’s Kappa value of 0.276 indicated a fair level of agreement between the two methods. The ROC curve revealed an AUC of 0.898 for the DrOroscope, demonstrating its excellent discriminatory ability. Conclusions: DrOroscope exhibited high diagnostic potential in the early diagnosis of dysplasia. The fact that DrOroscope and DNA ploidy agree on a lot of things suggests that using them together could make diagnoses more accurate. The DrOroscope’s non-invasive nature and real-time analysis make it a promising tool for widespread oral cancer screening.