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临床试验/IRCT2014080416090N5
IRCT2014080416090N5已完成未知

Comparison the efficacy of Triamcinolone Acetonide 0.1 % in Orabase with it's nanoliposomal carriers formulation on oral Lichen Planus patients

Dental Branch Islamic Azad University of Tehran0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

Abstract:
Background and Aim: Lichen planus (LP) is a chronic mucocutaneous disease, with different clinical subtypes. The erythematous-ulcerative type is accompanied by pain and burning sensation. Topical or systemic corticosteroid therapy is among the common treatments. No evidence is available supporting the superiority of any specific type or dose of treatment. Nano-drugs are recently used for the management of oral lesions. This study sought to compare the anti-inflammatory effects of 0.1% triamcinolone acetonide in Orabase® with and without nanoliposomal carriers on oral lichen planus (OLP).
Materials and Methods: This randomized clinical trial was performed on 40 patients with erythematous-ulcerative OLP. Formulations of 0.1% Triamcinolone acetonide with and without nanoliposomal carriers in Orabase were used 3 times a day for a month in case and control groups, respectively. Pain intensity by linear Visual Analog Scale (0-10) and cross sectional area of the lesions by a grid paper (mm2) were measured before and one, two and four weeks after treatment. Data were analyzed using t-test, chi-square, Fisher’s Exact, Mann-Whitney and Wilcoxon Singed-Rank tests.
Results: Although the pain intensity and size of oral lesions decreased statistically by each drug formulation (P=0.001), there were no significant differences between the two formulations after one, two and four weeks of treatment (P >0.05).
Conclusion: Based on the results, the efficacy of the two formulations is similar for OLP. More investigations are required on topical drugs to obtain more efficient formulations.
Keywords: Oral lichen planus, Triamcinolone acetonide, Nanoliposomal carriers, Orabase, Pain, area of lesion, Formulation

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 no limit(—)
性别
All

入选标准

  • Inclusion Criteria: All referral patients to Oral Medicine Department of Dental Branch, Islamic Azad University of Tehran with symptomatic oral lesions suspected of Lichen Planus; with confirmed diagnosis clinically and histologically of atrophic or erosive oral Lichen Planus.

排除标准

  • presence of dysplasia on histological examination; pregnancy; nursing; dysfunction of immune system(organ transplantation, lupus erythematous, ulcerative colitis); hematologic diseases; systemic diseases; history of systemic or topical corticosteroid therapy for Lichen Planus in the past month; Lichenoid reactions due to drug use or restorative materials.

研究者

发起方
Dental Branch Islamic Azad University of Tehran

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