Comparative Efficacy of Topical Pomegranate Peel Extract and Topical Corticosteroid in Management of Oral Lichenoid Lesions: A Research Protocol

Introduction: Oral Lichenoid Lesions (OLL) represent a group of oral lesions that share common clinical features and histological appearances but have different aetiologies. Lichenoid lesions may include oral lichen planus, lichenoid drug eruptions, lichenoid contact reactions, or lichenoid reactions of graftversus-host disease. A number of treatment opportunities have been reported in the literature for the management of lichenoid lesions. Need of the study: Among the various management options, corticosteroids are one of the drugs of choice. However, they are often known to cause various side-effects. Thus, it is reasonable to select a drug with minimal side-effect or the safest one. Pomegranate has been identified for its various health benefits and is expected to be helpful in the treatment of OLLs. Aim: To evaluate the comparative efficacy of topical pomegranate peel extract and topical corticosteroids in the management of OLLs. Materials and Methods: This randomised control trial doubleblind study will be conducted in the Department of Oral Medicine and Radiology at Sharad Pawar Dental College and Hospital, DMIHER, Maharashtra, India, for a duration of six months from September 2025 to March 2026 (CTRI/2024/10/075071). The study will comprise 28 patients, who will be equally divided into two groups through simple randomisation. Group A will be treated with topical corticosteroids, while Group B will receive 10% pomegranate peel extract. Treatment response will be monitored after seven days, 15 days, and one month from the initial visit using two clinical parameters: 1) Visual Analog Scale (VAS) score and 2) Sign score. All observations will be recorded and subjected to appropriate statistical tests. Inter and intragroup comparisons will be made by comparing the observations of various parameters at the second and third recalls with the first recall in both groups. We will also compare the findings of both parameters at the first, second, and third recalls between the groups using the Wilcoxon Signed Rank test and Mann-Whitney U test, respectively. A p-value of <0.05 will be considered significant.