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.