Efficacy of self-nano-emulsifying curcumin oral gel as an adjunct to triamcinolone acetonide in the management of erosive oral lichen planus: A Randomized Controlled Trial.

This randomized clinical study aims to evaluate the efficacy of topical nano-emulsified curcumin as an adjunct to topical corticosteroids in the management of erosive Oral Lichen Planus (OLP), a chronic inflammatory mucocutaneous disorder with malignant potential. Although corticosteroids are the standard therapy, their limitations and side effects necessitate alternative adjunctive approaches. Curcumin, a natural antioxidant and anti-inflammatory agent, may help modulate oxidative stress, which plays a central role in OLP pathogenesis. The study will include clinically and histologically confirmed erosive OLP patients, randomized into two groups: Group A will receive topical corticosteroids alone, while Group B will receive topical corticosteroids combined with nano-emulsified curcumin. Clinical outcomes such as mouth opening, burning sensation (VAS score), and mucosal flexibility will be assessed at baseline and follow-up visits. Additionally, salivary Malondialdehyde (MDA) levels will be measured as a biomarker of oxidative stress modulation. The findings are expected to provide insights into the potential role of curcumin as a safe, effective adjunct in OLP management.

This double-blinded randomized controlled trial will be conducted at the Department of Oral Medicine and Radiology, Government Dental College, Kottayam, in collaboration with the College of Pharmaceutical Sciences, Government Medical College, Kottayam for placebo gel preparation. Patients above 18 years with newly diagnosed erosive Oral Lichen Planus (OLP) will be enrolled. Participants will be randomized into two groups: Group 1 will receive Triamcinolone acetonide 0.1% buccal paste twice daily with Self Nano-Emulsifying Curcumin gel, while Group 2 will receive Triamcinolone acetonide with placebo gel. Both groups will be instructed on oral hygiene and diet, and followed up at baseline, 2 weeks, and 4 weeks. The primary outcome will be reduction in lesion severity using the REU scoring system. Sample size was calculated as 12 per group accounting for dropouts. Randomization will use computer-generated sequences with allocation concealment, and blinding will be maintained for both patients and outcome assessors.

This study aims to determine whether adjunctive use of nano-emulsified curcumin enhances treatment outcomes of erosive OLP while minimizing steroid-associated risks. If effective, this could provide a safer, evidence-based adjunctive therapy in OLP management.