Assessment of the Efficacy of Orally Administered Lycopene in Improving the Mean Maximum Incisal Opening in Individuals Suffering from Oral Submucous Fibrosis

Objective: To compare the effectiveness of orally administered lycopene versus a placebo in increasing mean maximum incisal opening in patients with oral submucous fibrosis (OSF). Methodology: This randomized controlled trial, conducted at the Oral and Maxillofacial Surgery Department of Lahore Medical and Dental College from January to July 2020, enrolled 68 eligible patients. Two groups were formed: Group 1 (received oral lycopene) and Group 2 (received placebo). A block size of 4 was utilized for patient allocation, alternating between groups until the sample size was met. Both groups underwent a comprehensive 3-month treatment plan, including habit cessation and daily physiotherapy involving tongue spatula insertion between teeth (with spatula replacement). Only Group 1 received an additional 40mg oral lycopene daily. Follow-up appointments occurred monthly for 3 months, measuring maximal incisal opening with a Vernier Caliper. Results: Baseline incisal opening was 25.39 ± 2.92 mm in Group 1 and 25.23 ± 3.03 mm in Group 2. At the 3-month mark, Group 1 showed an incisal opening of 31.71 ± 2.84 mm, while Group 2 had 28.31 ± 2.98 mm. The mean change in incisal opening was 6.32 ± 0.96 mm for Group 1 and 3.08 ± 0.90 mm for Group 2. Group 1 exhibited a significantly higher mean change in incisal opening compared to Group 2 (p=<0.001). Conclusion: Lycopene administration is more effective than a placebo in improving mouth opening in OSF patients. Therefore, lycopene should be considered as a treatment option to enhance maximal incisal opening and improve the quality of life for individuals with OSF. Keywords: Maximum incisal opening, Oral submucous fibrosis, lycopene orally, Nutt eating