Efficacy and Safety of Intralesional Xantinol Nicotinate in the Treatment of Various Stages of Oral Submucous Fibrosis.

INTRODUCTION

Oral Submucous Fibrosis (OSMF) is one of the most prevalent potentially malignant disorders seen in South east population since ages. Despite the extensive amount of research held in this field, its treatment still remains a challenge. In this study, we present our experience in successfully managing OSMF with intralesional injections of a peripheral vasodilator namely xantinol nicotinate.

AIM: To determine the efficacy and safety of intralesional xantinol nicotinate in the treatment of various stages of OSMF.

MATERIALS AND

METHODS

This parallel, prospective, clinical study included 60 patients clinically diagnosed with oral submucous fibrosis divided into two groups. Group I patients were subjected to intralesional xantinol nicotinate injections bi-weekly for a period of four months while Group II patients were given intralesional saline injections biweekly for four months. All the patients were instructed to perform home mouth opening physiotherapy exercises. At each visit, parameters like increase in interincisal distance, cheek flexibility, tongue protrusion and relief from burning sensation and any side effects were measured and recorded. The drop out figure was zero.

RESULTS

At the end of four months, in Group I, there was an increase in mean values of interincisal distance, cheek flexibility and tongue protrusion (p<0.001). For burning sensation a significant decrease in mean value was observed (p<0.001). Whereas, in Group 2 the difference between pre-treatment and post-treatment values was not statistically significant (p>0.001). On comparing the results of Group 1 and Group 2, statistically significant difference was observed (p<0.001).

CONCLUSION

Xantinol nicotinate, a peripheral vasodilator, when injected intralesionally in OSMF patients not only provides relief from burning sensation but also results in increased mouth opening, tongue protrusion and cheek flexibility.