Comparative Efficacy of Lycopene-Hyaluronidase Versus Hyaluronidase-Dexamethasone in Grade III Oral Submucous Fibrosis

​Background: Oral submucous fibrosis (OSMF) is a chronic, insidious, and debilitating disorder of the oral mucosa, primarily attributed to the habit of betel nut chewing. It is classified as a potentially malignant condition characterized by progressive juxta-epithelial inflammatory reactions followed by fibroelastic changes in the lamina propria. These changes result in epithelial atrophy and mucosal rigidity, leading to severe trismus and functional impairment. While various treatment modalities exist, medical management remains inconsistent. This study compares the efficacy of two common therapeutic combinations used to manage advanced stages of the disease. Methods: A prospective, randomized comparative clinical study was conducted in eighty patients clinically diagnosed with Grade III oral submucous fibrosis (OSMF). Patients were randomly allocated into two equal groups. Group A received weekly intralesional injections of hyaluronidase (1500 IU) combined with dexamethasone and lignocaine for 12 weeks, while Group B received oral lycopene twice daily along with weekly intralesional hyaluronidase injections. Clinical outcomes including maximum interincisal mouth opening and burning sensation (VAS) were assessed at baseline, 3 weeks, 6 weeks, 3 months, and 6 months. Statistical analysis was performed to compare intra- and intergroup outcomes. Results: Both groups showed clinical improvement, but Group A demonstrated superior results in mechanical function. At the 6-month follow-up, Group A showed a maximum mouth opening increase of 8 mm, compared to 5 mm in Group B. Burning sensation was significantly reduced in both cohorts, though partial remission persisted in more patients in Group B. Interestingly, Group B showed a more noticeable improvement in mucosal color and blanching reduction compared to Group A. Conclusion: The combination of intralesional hyaluronidase and dexamethasone significantly improves mouth opening and reduces burning sensation in Grade III OSMF. This regimen effectively reduces the morbidity associated with the condition and may decrease the necessity for surgical intervention. Keywords: Oral Submucous Fibrosis, Hyaluronoglucosaminidase, Dexamethasone, Lycopene, Trismus, Mouth Rehabilitation, Antioxidants, Precancerous Conditions