The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- to assess a visual analog scale (VAS)of the oral lichen planus lesion
研究概览
简要总结
evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.
详细描述
The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of OLP
排除标准
- •lichenoid reaction from medication ' .
- •any systemic autoimmune disease
研究组 & 干预措施
group I (triamcinolone)
ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks.
干预措施: Triamcinolone Acetonide 0.1% Oint (Drug)
group II (tacrollimus)
ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.
干预措施: Tacrollimus Topical (Drug)
group III (selenium)
ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.
干预措施: Selenium (Drug)
group IV (selenium + triamcinolone )
: ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks
干预措施: Selenium & Triamcinolone Acetonide 0.1% Oint (Drug)
group V ( selenium + tacrollimus)
ten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks.
干预措施: Selenium& Tacrollimus topical (Drug)
结局指标
主要结局
to assess a visual analog scale (VAS)of the oral lichen planus lesion
时间窗: baseline, 1, 3 and 6 months after treatment
qualitative
次要结局
- to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis(baseline, 1, 3 and 6 months after treatment)
- Biochemical evaluation of salivary Glutathione level using (ELISA)(baseline, 1, 3 months after treatment)
研究者
Shaymaa Hussein Rafat Kotb
Assistant lecturere of oral medicine ,periodontology departement
Sphinx university