A Novel Non-invasive Approach, “DrOroscope,” for Early Detection of Dysplasia in Oral Mucosal Lesions: A Cross-sectional Study

Background: Oral cancer is a significant global burden in the present scenario, and early detection has critical importance in improving the survival rate. Devices which aid in the early diagnosis of dysplastic lesions non-invasively are necessary to reduce the oral cancer burden and improve the quality of life of the patients. Objectives: To evaluate the efficacy of DrOroscope in diagnosing dysplasia in oral mucosal lesions. Methodology: A cross-sectional study was conducted among 40 individuals clinically diagnosed with oral mucosal lesions from various demographics in Hyderabad. Participants were screened using the DrOroscope device, which detects dysplastic changes via fluorescence imaging analyzed by artificial intelligence algorithms. Based on the image analysis, lesions were categorized as variable, borderline, or severe. Confirmatory biopsies were performed on all examined lesions, with histopathological results as the gold standard. Statistical analyses, including Chi-square tests, Fisher’s exact test, Cohen’s kappa, and receiver operating characteristic (ROC) curve analysis, were conducted using SPSS version 26.0 with a confidence interval at 95% and p < 0.05 significance. Results: DrOroscope exhibited a sensitivity of 100.00% and a specificity of 69.23%. Positive predictive value was 87.10%, negative predictive value was 100.00%, and overall diagnostic accuracy was 90.00%. Cohen’s kappa value for agreement between DrOroscope and biopsy results was 0.752, indicating substantial agreement, and 0.539 for detecting dysplasia levels, indicating moderate agreement. The ROC curve analysis supported these findings, demonstrating excellent diagnostic performance. Conclusion: The DrOroscope device is highly sensitive and accurate in detecting dysplastic changes in oral lesions, making it a promising adjunctive non-invasive diagnostic tool, especially in screening larger populations. This aids in the early diagnosis of dysplasia and thus reducing patients’ morbidity. However, further refinement and larger studies are needed to improve agreement with biopsy for grading of dysplasia. Clinical Significance of the Study: DrOroscope plays a promising role in the early diagnosis of dysplasia. This can have a huge impact on the treatment plan, thereby improving the quality of life of the patient. Such devices play a crucial role in oral cancer screening programs, thus promoting awareness on early detection of oral cancer and also enhancing the effectiveness of oral cancer prevention.