Maryam Zahed, Mostafa Rezaee, Asma Sookhakian, Mozhdeh Sepaskhah
ABSTRACT Background The atrophic‐erosive forms of oral lichen planus (OLP) remain a major concern as these lesions can cause a wide range of symptoms leading to reduced quality of life. Nowadays, newer possibilities are offered by micro‐needles as an effective transmucosal drug delivery. The aim of this single‐blinded randomized clinical trial was to determine the therapeutic efficacy of micro‐needling (MN) as a novel technique for transmucosal delivery of triamcinolone acetonide (TA) and hyaluronic acid (HA) on symptomatic OLP lesions. Methods Twenty volunteers with bilateral symptomatic OLP lesions were randomly assigned to the study involving four different treatment groups (G): G 1 , topical TA alone; G 2 , MN as an adjunct to the topical TA; G 3 , topical TA and HA; and G 4 , MN as an adjunct to the topical TA and HA. Lesions were assessed at baseline, and on Days 7, 14, 28, and 56 using parameters including the percentage healing index (PHI), reticulation/erythema/ulceration (REU) score, and visual analogue scale (VAS). Statistical analysis was then performed using SPSS software. Results Twenty patients (40 lesions; 10 per group) were included. G 4 showed a significantly higher PHI compared to both G 1 ( p 0.001) and G 3 ( p < 0.05) at all observation times. Regarding the REU score, G 4 achieved significantly greater reductions compared to G 1 at all observation times ( p < 0.05), compared to G 2 on Days 7, 28, and 56 ( p < 0.05), and compared to G 3 on Days 28 and 56 ( p < 0.05). Regarding the VAS, both G 2 and G 4 showed a statistically significant reduction on Day 7 compared to G 1 and G 3 ( p < 0.05). Conclusion This study uncovered the advantages of MN in promoting healing, reducing severity, and alleviating pain in OLP patients. Therefore, MN has the potential to become an effective and well‐tolerated treatment modality for symptomatic OLP. Moreover, the adjunctive use of MN with topical application of both TA and HA demonstrated the most significant therapeutic benefits, suggesting a synergistic effect. Trial Registration irct.behdasht.gov.ir : IRCT20231213060357N1 (17 February 2024)