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临床试验/NCT02453503
NCT02453503已完成2 期

Comparison of Triamcinolone Acetonide Mucoadhesive Film and Licorice Mucoadhesive Film Effect on the Duration and Symptoms of Lesions That Caused by Symptomatic Oral Lichen Planus

Isfahan University of Medical Sciences0 个研究点目标入组 60 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
主要终点
VAS

研究概览

简要总结

Introduction :Oral lichen planus (OLP) is one of the most common disorders of the oral cavity which is basically a chronic and inflammated mucocutaneous .There is no cure for OLP currently. The main focus of treatment is to reduce the duration and severity of the symptoms. This study was designed to determine and compare the parameters of improvement in patient symptoms and lesions caused by oral lichen planus by using triamcinolone acetonide mucoadhesive film and licorice mucoadhesive film.

Methods and materials :The study was randomized by double-blind clinical trial . Patients with symptomatic OLP who referred to the Oral Medicine School of Dentistryin Medical Sciences in Isfahan University participated voluntarily. The patients were divided into two groups that were including 30 samples in each group. The first group was treated with triamcinolone mucoadhesive film and the second group were treated with licorice mucoadhesive film. Data were analyzed by using the Mann-Whitney test and t-test in SPSS software.

详细描述

Introduction OLP is a chronic and inflammatory disease that frequently involves the oral mucosa. Clinical symptoms of OLP are various from white keratotic lesions without pain to erosion and painful injury (1). OLP episodic symptoms range from pain and irritation of the mouth that can affect the normal function and causes physical and mental pressure to patients.OLP can be seen in two main forms of reticular and erosive. Erosive OLP have been seen as injured Arytmatozo that enclosed by keratotic striae .These lesions are often follow by episodic symptoms of pain and irritation to severe discomfort and can cause a major negative impact on performance of oral system and l quality of life .So, being aware of the Clinical symptoms and management of these lesions are very important for the clinician. (4,3,2,1)

Although, these lesions rarely are life-threatening , discomfort and pain associated with abnormal caloric intake lead to nervosa, dehydrated in short order and malnutrition. It also increases the risk of infection and reduce the quality of life in patients greatly.(2,3). The main treatment for symptomatic OLP is prescribing systemic or topical corticosteroids . (1,3) and its strong type like triamcinolone has been increasingly used in the treatment of OLP (4).

Lichen planus is a chronic mucocutaneous disease and relatively common in middle-aged that affected 2- 0.2% of the population. Men and women are almost equally affected. In the mouth, white bilatera lesions sometimes cause wound The most common clinical pattern is linear (9-5) .There is a limited study in the frequency and clinical forms of OLP.

It can be mention to Esmaeili etal study that patients in men and in fourth decades is most common and Hypertrophic and classic type are more and the type of reticular in oral lesions is more prevalent (10)and in another study by Khalili etal reported that the most common form of clinical lesion is ulcerated lesion and the average time spend 18.4 months, most commonly involving mucosa is the buccal and then the tongue and gums .White spots, lines Wickham and mucosal erythema are the most common clinical features of the lesion (11).

There is currently no cure for OLP. The main focus of treatment is to reduce the duration and severity of symptoms. The most common and acceptable treatment for symptomatic OLP lesions and systemic corticosteroids or topical is to modulate the host immune response .In mild to moderate lesions the main treatment is by topical corticosteroids such as clobetasol gel, betamethasone gel and triamcinolone ointment (2, 3, 12). Due to the persistence of the drug at the site of the lesion may be used new dosage form of mucoadhesive such as tablets or film. Films are from mucoadhesive drug delivery systems that have been used in the manufacture of mucoadhesive polymers and have received considerable attention in recent years .The films can be attached on the oral wound healing and cause to reduce pain and inflammatory diseases. (4, 13)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients over 18 years old
  • All non pregnant women

排除标准

  • 未提供

研究组 & 干预措施

Triamcinolone acetonide

Active Comparator

Triamcinolone acetonide mucoadhesive films 1 mg every 6 hours for two weeks.

干预措施: Triamcinolone Acetonide (Drug)

Licorice

Experimental

Licorice mucoadhesive films 1 mg every 6 hours for two weeks.

干预措施: Licorice (Drug)

结局指标

主要结局

VAS

时间窗: 12 months

Pain severity was measured by visual analogue scale : 0 for no pain and 10 for most painful experience

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehdi Nasr Isfahani

Director

Isfahan University of Medical Sciences

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