Comparison of efficacy of lycopene and lycopene–hyaluronidase combination in the treatment of oral submucous fibrosis

Background: Oral submucous fibrosis (OSMF) is a chronic progressively scarring disease of the oral cavity. Lycopene is a powerful antioxidant obtained from tomatoes and has the highest singlet oxygen quenching capacity and a high capacity of quenching other free radicals in vitro among dietary carotenoids. Hyaluronidase is a substance prepared from the testes and semen of mammals that modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid. Objective: To evaluate the efficacy of lycopene and lycopene−hyaluronidase combination, and to compare the efficacy of lycopene and lycopene−hyaluronidase combination in the treatment of OSMF. Study Design: The study consisted of 45 patients with OSMF divided into three equal groups. Patients in Group A were given Lycored 16mg daily in two equally divided doses for 3 months. Patients in Group B were given LycoRed along with hyaluronidase intralesional injection of 1500 IU twice weekly for 3 months. Patients in Group C were given placebo capsules. Patients were evaluated after 3 months. The following parameters were recorded: mouth opening, visual inspection, palpatory findings, and burning sensation. Results: There was statistically significant change in mouth opening and burning sensation for lycopene and lycopene–hyaluronidase combination than in the placebo group in the treatment of OSMF, but the lycopene–hyaluronidase combination did not show any statistically significant change when compared with lycopene alone. Conclusion: Lycopene appears to be a very promising antioxidant in the management of oral submucous fibrosis, both in clinical and symptomatic improvement.