Beena George, Shital Kharat, Roopan Prakash, Omkar Eswara B Danda, Rachna Raj, Chintan M Upadhyay, Sajidali S Saiyad
Background Oral potentially malignant disorders (OPMDs) represent precursor conditions that carry an elevated probability of progressing to oral squamous cell carcinoma (OSCC). Despite ongoing research efforts, identifying dependable, non-invasive markers that can detect early molecular changes linked to malignant conversion continues to present a significant clinical obstacle. Objective To evaluate the diagnostic utility of salivary inflammatory cytokines (IL-10 and IL-17) and microRNAs (miR-21, miR-138, and miR-184) in healthy individuals, patients with OPMDs, and patients with OSCC, and to assess the performance of a combined biomarker panel for oral cancer clinical stratification. Methods A cross-sectional analytical study was conducted involving 150 participants categorized into healthy controls (n=50), OPMD patients (n=50), and histopathologically confirmed OSCC patients (n=50). Salivary IL-10 and IL-17 concentrations were quantified using enzyme-linked immunosorbent assay (ELISA), whereas miR-21, miR-138, and miR-184 expression levels were measured using quantitative reverse-transcription polymerase chain reaction (qRT-PCR). Relative miRNA expression was calculated using the 2^-ΔΔCt method. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis. Results Significant alterations in salivary cytokine and microRNA expression were observed across the disease spectrum. miR-21 and miR-184 demonstrated progressive upregulation, whereas miR-138 showed progressive downregulation from healthy controls to OPMD and OSCC patients (all p<0.001). Both IL-10 and IL-17 were significantly elevated in OPMD and OSCC patients compared with healthy controls (both p<0.001). Biomarker expression profiles were significantly associated with dysplasia severity and tumor stage. Among individual biomarkers, miR-138 demonstrated the highest diagnostic accuracy (AUC=0.84), followed by IL-17 (AUC=0.82), miR-21 (AUC=0.80), miR-184 (AUC=0.76), and IL-10 (AUC=0.74). The combined cytokine-microRNA panel achieved superior performance, with an AUC of 0.93, sensitivity of 90%, and specificity of 88%. Conclusions The findings support the potential utility of integrated salivary biomarker profiling as a non-invasive approach for early detection, clinical stratification, and disease monitoring in oral carcinogenesis. The combined biomarker panel highlights the potential of integrated salivary diagnostics for improving the non-invasive detection and clinical assessment of OPMDs and OSCC.