Oral diseases · 2026
Micro-Needle Assisted Transmucosal Delivery of Triamcinolone and Hyaluronic Acid for the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Zahed Maryam, Rezaee Mostafa, Sookhakian Asma, Sepaskhah Mozhdeh
Аннотация
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): G1, topical TA alone; G2, MN as an adjunct to the topical TA; G3, topical TA and HA; and G4, 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. G4 showed a significantly higher PHI compared to both G1 (p < 0.001) and G3 (p < 0.05) at all observation times. Regarding the REU score, G4 achieved significantly greater reductions compared to G1 at all observation times (p < 0.05), compared to G2 on Days 7, 28, and 56 (p < 0.05), and compared to G3 on Days 28 and 56 (p < 0.05). Regarding the VAS, both G2 and G4 showed a statistically significant reduction on Day 7 compared to G1 and G3 (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).
METHODS: Twenty volunteers with bilateral symptomatic OLP lesions were randomly assigned to the study involving four different treatment groups (G): G1, topical TA alone; G2, MN as an adjunct to the topical TA; G3, topical TA and HA; and G4, 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. G4 showed a significantly higher PHI compared to both G1 (p < 0.001) and G3 (p < 0.05) at all observation times. Regarding the REU score, G4 achieved significantly greater reductions compared to G1 at all observation times (p < 0.05), compared to G2 on Days 7, 28, and 56 (p < 0.05), and compared to G3 on Days 28 and 56 (p < 0.05). Regarding the VAS, both G2 and G4 showed a statistically significant reduction on Day 7 compared to G1 and G3 (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).