Comparative evaluation of the efficacy of systemic levamisole and antioxidant in the management of oral submucous fibrosis – A randomized control trial

Background: Oral submucous fibrosis (OSF) is a chronic, disabling disease involving the entire oral mucosa, mainly reported in Indian population. A number of treatment modalities have been tried, but none of these have been completely therapeutic. Levamisole, an immunomodulator, has been reported to be beneficial in oral mucosal lesions, but there are hardly any studies reported in literature for OSF patients, and hence, the study was taken up. Aim: This study aims to compare the efficacy of levamisole with antioxidant for the assessment of burning sensation and mouth opening in OSF patients. Materials and Methods: A total of 60 patients clinically diagnosed of OSF were selected for the study. We assessed patients for burning sensation and mouth opening. Patients were divided into four groups according to staging of OSF (More et al., classification), then randomly subdivided into three groups to dispense medicines. Group I patients received levamisole, 150 mg once daily for 3 alternate weeks, Group II patients received antioxidant BID for 6 weeks, and Group III patients received levamisole and antioxidant both. The patients were followed up for 2 months. Results and Conclusion: The results proved that levamisole, antioxidant, and the combination of both showed significant improvement in mouth opening and reduction in burning sensation.