Comparative study for safety and efficacy of a novel folic acid formulation gel with 0.1% triamcinolone acetonide paste in experimentally induced oral ulcer

Objectives: The objective of the present study was to evaluate the efficacy and safety of 0.1% novel folic acid gel in blunt dental instrument-induced oral ulcer in animal models (both rats and rabbits). Materials and Methods: The study was conducted in the Experimental Laboratory, Department of Pharmacology, Jawaharlal Nehru Medical College, Aligarh Muslim University. Animals were randomly divided into three interventional groups, namely Group 1 (folic acid gel), Group 2 (triamcinolone oromucosal paste) and Group 3 (control). We created a linear oral ulcer of 5 mm with the blunt dental instrument in both rats and rabbits. Each group consists of 10 animals (6 rats + 4 rabbits). Group 1 received test drug 0.1% novel folic acid gel formulated by us, Group 2 was positive control and received standard local drug 0.1% Kenacort triamcinolone oromucosal paste and Group 3 served as a negative control group where no treatment was given. Results: No untoward reaction was observed on the irritancy test. Kruskal–Wallis test applied for comparison of results. After 1 week of post-ulcer induction, there was a marked improvement in healing of oral ulcers in both Group 1 and Group 2, but more statistically significant healing was seen in Group 1 (folic acid gel). Both Groups 1 and 2 showed steady improvement in the healing of oral ulcers as compared to their pre-treated values and again were more marked in Group 1. Conclusion: Local folic acid gel supplementation was safe and had shown to augment oral ulcer healing in rats and rabbit’s animal models.