Abstract
INTRODUCTION: This clinical randomized controlled trial evaluates the effectiveness of prednisolone mouthwash as a treatment modality for moderately advanced cases of oral submucous fibrosis. MATERIALS AND METHOD: Sixty-four patients were enrolled for the study and randomized into two groups (n = 32 in each group). The experimental group was treated with prednisolone mouthwash and antioxidant capsule as per GDCH Nagpur protocol, and control group was treated with antioxidant capsule only. The primary outcome variables were interincisal mouth opening, burning sensation, and recurrent ulceration. Clinical responses were obtained at the time of the allocation, at 1, 3, 6, and 9 months into the intervention, and 6 months thereafter. RESULTS: The average increased mouth opening achieved was 10.46 mm (p < 0.5) in group A (experimental group) and only 1.04 mm (p < 0.5) mm in group B (control group). In addition, there was a significant difference in relief of burning sensation and recurrent ulceration. Relief of burning sensation and recurrent ulceration was within 12.81 and 10.93 days, respectively, in group A when compared to group B which was within 21.56 and 20.06 days, respectively. CONCLUSION: We conclude that in our trial, prednisolone mouthwash with antioxidants was seen to be efficacious, safe, and reliable in the management of oral submucous fibrosis.