Comparative evaluation of Aloe vera, curcumin, and lycopene in oral submucous fibrosis patients – A randomized controlled trial

Background: Oral submucous fibrosis (OSMF) is a potentially malignant disorder characterized by fibrosis of the oral mucosa. Various treatment modalities, including conventional interventions and natural products, have been explored for managing OSMF. This study aimed to compare the efficacy of Aloe vera, curcumin, and conventional intervention in Grade II OSMF patients. Materials and Methods: A randomized controlled trial was conducted with a total of 120 Grade II OSMF patients. They were randomly assigned to three treatment groups: A. vera group (n = 40), curcumin group (n = 40), and lycopene intervention group (n = 40). The primary outcomes assessed were mouth opening, symptom relief, and improvement in quality of life. Baseline measurements were recorded, and the interventions were administered for 12 weeks. Follow-up assessments were conducted at the end of the intervention period. SPSS 25.0 was used for data analysis. Results: All three treatment groups showed significant improvements in mouth opening and symptom relief. The lycopene group exhibited the highest mean increase in mouth opening, though not significant. There were no significant differences among the groups in terms of symptom relief. The interventions were generally well-tolerated, with no serious adverse events reported. Conclusion: The findings of this study suggest that A. vera, curcumin, and conventional intervention are effective in improving the primary outcomes in Grade II OSMF patients. Both curcumin and A. vera showed promising results in terms of mouth opening and reduction in fibrotic bands. These natural products can be considered adjunctive therapies to conventional interventions for managing Grade II OSMF. Further research with larger sample sizes and longer follow-up periods is warranted to confirm these findings and optimize the treatment approach for OSMF.