SALIVARY EXOSOMAL MIRNA PROFILES IN EARLY DETECTION OF PEDIATRIC PREMALIGNANT ORAL LESIONS: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background

Pediatric premalignant oral lesions, though relatively uncommon, represent a significant clinical concern due to their potential for malignant transformation and the challenges associated with early diagnosis. Conventional diagnostic methods rely heavily on clinical examination and invasive biopsies, which are often impractical for routine screening in children. Salivary exosomes, enriched with microRNAs (miRNAs), have emerged as promising non-invasive biomarkers for early cancer detection.

Objective

This study aims to investigate the potential of salivary exosomal miRNA profiles as biomarkers for the early detection of pediatric premalignant oral lesions. By identifying specific miRNA signatures associated with oral dysplasia and leukoplakia in children, this study seeks to establish a non-invasive diagnostic approach for screening and monitoring at-risk pediatric populations.

Methods

A cross-sectional study was conducted involving 100 pediatric participants aged 5–18 years presenting with oral lesions at a tertiary care hospital in Khyber Pakhtunkhwa (KPK), Pakistan. Saliva samples were collected and processed for exosomal isolation using ultracentrifugation techniques. High-throughput sequencing was employed to perform comprehensive miRNA profiling. Participants were stratified into three groups: healthy controls, benign oral lesions, and premalignant oral lesions. Statistical analyses were conducted to identify miRNAs that were significantly differentially expressed among the groups.

Results

Distinct salivary exosomal miRNA expression patterns were observed across the study groups. miRNAs including miR-21, miR-155, and miR-196a were significantly upregulated in participants with premalignant oral lesions compared to those with benign lesions and healthy controls. The identified miRNA signature demonstrated a sensitivity of 85% and a specificity of 92% for the detection of oral dysplasia.

Conclusion

Salivary exosomal miRNA profiling shows considerable promise as a non-invasive, early diagnostic modality for pediatric premalignant oral lesions. The findings support the potential integration of miRNA-based salivary diagnostics into future pediatric screening and surveillance programs, offering a reliable alternative to invasive diagnostic procedures.