A randomized double-blind, multiple-arm trial comparing the efficacy of submucosal injections of hyaluronidase, dexamethasone, and combination of dexamethasone and hyaluronidase in the management of oral submucous fibrosis

Abstract

Numerous treatment modalities for oral submucous fibrosis (OSF) have been advocated over the years. However, its medical treatment is not yet fully standardized. This randomized double-blind trial assessed and compared the effects of two commonly used drugs, independently and in combination. Forty-five patients were staged clinically and histopathologically for OSF and were randomly divided into three groups of 15 each by permuted block randomization. Each group received biweekly submucosal injections of hyaluronidase (1500 IU), dexamethasone (8 mg) or a combination of both (750 IU and 4 mg), respectively, for a period of 5 weeks. Improvement in pain upon opening, burning sensation, and tightness of mucosa as perceived by the patient, as well as improvement in mouth opening measured clinically were determined at the end of week 2, months 1, 2, 3, and 6 after the final injection. Results were compared and statistically analyzed using analysis of variance. Submucosal injection of hyaluronidase gave a quicker and better improvement of measured symptoms. Biweekly submucosal injection of hyaluronidase over a period of 5 weeks appears to be a viable treatment option for OSF.