Efficacy of topical tulsi (Ocimum sanctum) paste for the management of oral submucous fibrosis - A clinical study

Context: Oral submucous fibrosis (OSMF) is a chronic insidious oral potentially malignant disorder characterized by increased collagen deposition and reduced collagen degradation causing burning sensation and difficulty in mouth opening. Aim: To assess the efficacy of topical Tulsi (Ocimum sanctum) paste for the management of OSMF. Settings and Design: Institution-based clinical trial. Materials and Methods: The study included a total of 60 OSMF patients categorized into three Groups A, B and C (20 in each) depending on the severity according to Lai DR et al. classification. The patients were advised for topical Tulsi paste application and were evaluated for the reduction in the burning sensation and improvement in mouth opening every month for 3 subsequent months using the numeric pain rating scale (NRS) and a Vernier calliper, respectively. Statistical Analysis: The baseline and 3-month recordings were subjected to inter- and intra-group statistical analysis using Kruskal-Wallis analysis of variance (ANOVA), Mann-Whitney U, one-way ANOVA, Tukey's multiple post-hoc and Wilcoxon matched-pairs tests. Results: There was a reduction in the burning sensation and improvement in the mouth opening in all three groups. The reduction in the burning sensation was statistically significant among all the groups (P < 0.05) and the NRS scores after 3 months among the three groups were not statistically significant (P > 0.05). There was a statistically significant difference (P < 0.05) in the improvement of mouth opening between Group A and B; A and C; but not between B and C. Conclusion: Tulsi paste showed a significant reduction in the burning sensation and improvement of the mouth opening thereby proving to be a safe and promising medicament for OSMF.