Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 主要终点
- visual analogue scale
研究概览
简要总结
Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants.
详细描述
Double randomized clinical trial study using two parallel group suffer from oral aphthous ulcer one take antioxidant topical q10gel and other group take placebo carpabol gel two times per day for seven days measuring outcome at fourth and seventh day including pain; healing period and clinical parameters.
Sample size of study include 26 in each group.
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)
盲法说明
double blind
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with free medical history and no systemic diseases
- •Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers.
- •Patients who agreed to take medications.
排除标准
- •Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others.
- •Anemic and leukemic patients (using complete blood count investigation)
- •Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy.
- •Patients treated with any oral topical medications 48h before the study
- •Pregnant and lactating mothers.
研究组 & 干预措施
topical coenzyme Q10 gel
Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
干预措施: topical coenzyme Q10 gel (Drug)
carbapol gel
placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.
干预措施: Carpabol gel (Drug)
结局指标
主要结局
visual analogue scale
时间窗: 7 days
pain
次要结局
- scoring system(0-3)(7 days)
- cross sectional area William periodontal probe/mm(7 days)
研究者
Mostafa Abdelsamie Bakry Nafie
Principal investigator
Cairo University