Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Pain
研究概览
简要总结
The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.
详细描述
This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.
Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presented with painful oral lichen planus lesions
- •Free of any visible oral lesions other than oral lichen planus
- •Free of any systemic diseases
排除标准
- •Topical treatment or systemic therapy of OLP for one month before starting the study
- •Pregnant or breast feeding women
- •Use of corticosteroids or other immunosuppressive drugs
研究组 & 干预措施
OLP and corticosteroid
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.
干预措施: Triamcinolone Acetonide (Drug)
OLP and corticosteroid and green tea
15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Pain
时间窗: one month after treatment
pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
次要结局
- Salivary Total Oxidative Capacity(one month after treatment)
研究者
Noha Ayman Ghallab
Associate Professor of periodontology and Oral Medicine, faculty of oral and dental medicine
Cairo University