Available Evidence on the Diagnostic Accuracy of Chemiluminescence for Detecting Dysplasia or Malignant Transformation in Oral Potentially Malignant Disorders (OPMDs): A Systematic Review and Meta-Analysis

<b>Background</b>: Oral potentially malignant disorders (OPMDs) often exhibit heterogeneous clinical features, making the early detection of dysplasia very difficult. Several chemiluminescence-based devices, like ViziLite^®, have been suggested as non-invasive adjuncts that can enhance the visualization of suspicious mucosal changes. However, their true diagnostic value remains unclear. <b>Methods</b>: A systematic review and meta-analysis were conducted in line with PRISMA 2020 guidelines. Thirteen clinical studies met the inclusion criteria, necessitating chemiluminescence as index test and histopathology as reference standard, with extractable 2 × 2 diagnostic data. For all OPMDs and leukoplakia-only subgroups, pooled sensitivity and specificity, DOR, SROC curves, and device-specific diagnostic accuracy were determined. <b>Results</b>: Of all the OPMDs, chemiluminescence demonstrated a high pooled sensitivity of 0.82 and a low specificity of 0.48 with considerable heterogeneity among studies. The results in the leukoplakia subgroup improved sensitivity of 0.87 and a specificity of 0.51 were recorded with a more concave SROC curve, which illustrated a better discriminative ability in keratinized lesions. Comparison of devices illustrates accuracy was best for ViziLite + Lugol iodine (~0.82) followed by standard ViziLite (~0.62) and ViziLite Plus (~0.53). <b>Conclusions</b>: Chemiluminescence, while it may demonstrate good sensitivity, has repeatedly shown to have limited specificity in a consistent manner, particularly in populations with mixed OPMD where inflammatory and benign lesions inflate the false-positive rates. Notably, diagnostic performance was higher in leukoplakia, suggesting that keratinized lesions benefit most from this adjunctive tool. Overall, chemiluminescence may facilitate lesion visualization and biopsy site selection but cannot supplant histopathological examination as a definitive diagnostic modality.