Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for 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
- 22
- 试验地点
- 1
- 主要终点
- Change in oral lesions
研究概览
简要总结
Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder.
Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity.
Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9).
Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.
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
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients involved in this clinical trial will have symptomatic OLP
排除标准
- •Smokers or tobacco users will be excluded from this clinical trial.
- •Pregnant and lactating females.
- •Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study.
- •Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded.
- •Any patients presenting with extra oral lichen planus lesions will be excluded.
- •Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded.
- •Vitamin administration intake within the last 3 months
研究组 & 干预措施
Test group
干预措施: Oral zinc supplement (Drug)
control group
干预措施: triamcinolone acetonide Oral paste (Drug)
结局指标
主要结局
Change in oral lesions
时间窗: Baseline, 6 weeks, 12 weeks
Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas \>1 cm2, score 4 assigned to patients with white striae and erosive areas \<1 cm2, score 3 assigned to those having white striae and atrophic areas \>1 cm2, score 2 assigned to those having white striae and atrophic areas \<1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.
Change in MMP-9 level
时间窗: Baseline, 6 weeks, 12 weeks
Whole unstimulated saliva will be collected from all participants
次要结局
- Change in pain(Baseline, 6 weeks, 12 weeks)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University