The Efficacy of Adjunctive Oral Systemic Vitamin E Therapy on Salivary Nitric Oxide Level In Patients With Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in oral lesion
研究概览
简要总结
Oral lichen planus (OLP) is a chronic inflammatory disease affecting the skin, mucous membranes,s and rarely scalp and nails. It is a T-cell-mediated autoimmune disease. Traditional treatment for OLP is topical steroids commonly used to treat mild to moderately symptomatic lesions. Recent treatment modalities for oral lichen planus include micronutrients such as antioxidants including vitamin E that modify the immune system function. The aim of this study is to evaluate the efficacy of adjunctive oral systemic vitamin E therapy on salivary nitric oxide levels in patients with erosive oral lichen planus.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are clinically and histopathologically confirmed of having erosive OLP according to modified WHO criteria.
- •Patients with erosive OLP patients who will agree to take supplied medications.
- •Ability to complete this trial.
排除标准
- •OLP patients receiving any systemic treatment such as systemic steroids, other immunosuppressive drugs, or non-steroidal anti-inflammatory drugs on past 3 months.
- •Pregnant and breast-feeding females.
- •Patients suffering from systemic diseases.
- •Patients with lesions showing any dysplastic changes in the biopsy specimen.
- •Patients who are smoking and tobacco users in any form, will not be included.
- •Patients with both lichenoid contact reaction and lichenoid drug reactions.
- •Patients with cutaneous lichen planus lesions
研究组 & 干预措施
Topical corticosteroid and Vitamin E
干预措施: Topical corticosteroid and Vitamin E (Drug)
Topical corticosteroid
干预措施: Topical corticosteroid (Drug)
结局指标
主要结局
Change in oral lesion
时间窗: At baseline,4th week and 8th week
whole treatment response and the size of the oral lesions will be recorded using Thongprasom et al. scoring system, score 5 was assigned to patients having white striae with erosive areas \>1 cm2, score 4 for patients with white striae and erosive areas \<1 cm2, score 3 for those having white striae and atrophic areas \>1 cm2, score 2 for those having white striae and atrophic areas \<1 cm2, score 1 for those having only white striae, and score 0 for normal mucosa
Change in pain score
时间窗: At baseline,4th week and 8th week
At baseline, 4th week and 8th week after the treatment, burning sensation using Visual Analogue Scale (VAS) will be measured on a 10-point (0 = no symptoms, 10 = severe pain)
次要结局
- Change in salivary nitric oxide(At baseline,4th week and 8th week)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University