Vitamin A loaded Bioadhesive Patches for Oral Mucosal Delivery in Treatment of Potentially Malignant White Lesions: A Placebo-Controlled Study

Abstract

Introduction: This randomized controlled trial aimed to evaluate the efficacy of Vitamin Aloaded bioadhesive patches for the treatment of potentially malignant white lesions of the oral mucosa. Materials and Methods: A total of 100 participants with clinically diagnosed oral leukoplakia were randomly assigned to receive either Vitamin A-loaded bioadhesive patches (n=50) or
placebo patches (n=50) for 8 weeks. The primary outcome was the reduction in lesion size, while secondary outcomes included histopathological improvement, patient-reported pain levels, and adverse effects. Participants were followed up for 36 months to assess long-term efficacy and lesion recurrence.