Introduction: Oral Submucous Fibrosis  is a premalignant condition involving the oral cavity & pharynx. It predominantly occurs in the Indian subcontinent where the habit is more prevalent. The malignant potential and the origin of cancer were attributed to the generalized epithelial atrophy associated with OSMF. Carotenoids & lycopene has antioxidant activity which proved to be efficient in the management of premalignancy.

Materials & Methods: 25 patients were included in the study who were clinically and histopathologically diagnosed as oral submucous fibrosis. They were supplemented with capsule Lycobig 5mg in BID dosage for 90 days along with  mouth exercises and complete withdrawal of oral chewing habits.           

Results: The 25 OSMF subjects were divided into 3 clinical stages.  In stage I with mouth opening of > 36 mm there were 3 (12%) subjects, stage II with mouth opening of 35–26 mm had 10 (40%) subjects, stage III with mouth opening of 25–15 mm had  12 (48%) subjects.

Aims & Objectives:  The main of this study is to determine the effect of lycopene on the clinical stages of Oral Submucous Fibrosis.