Comparative assessment of the efficacy of lycopene alone to a combination of lycopene hyaluronidase for the treatment of oral submucous fibrosis

Background: OSMF is an oral precancerous condition with a high potential for malignant transformation. The main etiologic factor linked to OSMF is gutkha and tobacco chewing. Management of OSMF includes various therapies and drugs where the use of antioxidants has proven to be efficacious. Aim: The present study was conducted to compare and assess the efficacy of Lycopene antioxidant alone to its combination with intralesional injection of Hyaluronidase for managing the subjects with OSMF.Material and Method: The study included 54 subjects having stage 2 OSMF and were divided into 2 groups where the group I subjects were given lycopene daily in a dose of 8mg in two equal doses, whereas, group II subjects were given lycopene daily in a dose of 8mg combined with intralesional hyaluronidase injection of 1500 IU twice in a week for 3 months. VAS and inter-incisal mouth opening were assessed at baseline and 90th day after treatment completion.Results: At baseline, interincisal opening in Group I was 25.18±3.03mm and was 24.56±3.92mm in Group II. This difference was statistically non-significant with p=0.5184. On the 90th day, the last day of the study, interincisal opening in Group I was 29.34±3.19mm, whereas, in Group II was 32.39±3.24mm.