Predictive value of tissue p53 protein expression and serum p53 antibodies in oral potentially malignant disorders: Relative to oral squamous cell carcinoma

Objective: This study aims to assess and report the predictive value of tissue p53 protein expression and serum p53 antibodies as a screening tool for oral potentially malignant disorders (OPMDs) cases with risk of malignant transformation. Methods: A case-control study was jointly conducted at the Department of Pathology and Oral and Maxillofacial Surgery in several dental institutes in the country from April 2016 to March 2017. A total of 180 eligible subjects (60 cases of OPMDs, 60 cases of oral squamous cell carcinoma, and 60 controls) were included in the study. Tissue p53 immunoreactivity was determined by immunohistochemistry, and serum concentrations of p53antibodies were determined by enzyme-linked immunosorbent assay. Specimens were collected for laboratory investigations after obtaining written consent from both patients and controls. Results: Among the study participants, the recorded male to female ratio was close to 2:1, and most participants fell in the age range of 41-60 years and above. Of the 60 cases of OPMDs, the observed tissue p53 immunopositivity was 73.3% (n = 44) while for the p53 antibody, the seropositivity was 96.7% (n = 58). The sensitivity for p53 immunoreactivity was 73%, and specificity was 98.3% between OPMDs and healthy individuals. Conclusion: The present study provides evidence (for OPMDs) that serum p53 antibodies and p53 immunoreactivity could be used as a sensitivity test and a specific test, respectively, and may contribute to determining the potential of OPMD for malignant transformation risk.