Effect of trans retinoic acid on patients with oral submucous fibrosis-randomized single-blind monocentric study

Various treatment modalities have been practiced for the suppression of premalignant conditions such as oral submucous fibrosis (OSMF) to prevent their differentiation into malignant lesions. Conventional treatment includes steroids, enzymes like hyaluronidase, trypsin, chymotrypsin and placental extracts which are advocated intralesionally and oral drugs like carotenoids, alpha lipoic acid, lycopene, vitamins, microelements and tea pigments have also been advocated.In this study, a total number of 30 patients with OSMF were taken and randomly divided into two groups with 15 patients each according to Khanna and Andrade group of classification 1995. Group 1 (test group) received the test drug Tretiome 20 mg, whereas Group 2 (control group) received an antioxidant lycopene 20 mg/day for a period of 1 month and the effect of the therapy with the changes in the symptoms was recorded every 1 week, 15 days and 30 days of follow-up. The result of this study showed an improvement in the mouth opening of the patients of test Group with a significant decrease in the burning sensation as compared to the control group (P < 0.05). Xerostomia and headache were the two most commonly seen side effects which were reported in the patients of the test group, of which headache was associated with the withdrawal symptom of habit cessation and xerostomia was taken care by increase in hydration.