Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- change in VAS score
研究概览
简要总结
The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.
详细描述
Among patients refer to endodontics department of Zahedan Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 2 groups of saffron and placebo. After root canal therapy each patient in each group will receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment completion and then each 6 hours up to 48 hours. Patients will record their pain intensity in each time period according to Visual Analog Scale(VAS)and finally mean pain intensity will be compared between 2 groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who have at least one vital tooth with one root canal and moderate to severe pain
排除标准
- •teeth with periapical lesions
- •patients with history of:
- •allergy to saffron
- •diabetes mellitus
- •cardiovascular disorders
- •kidney and liver diseases
- •blood and hormonal disorders
- •electrolyte imbalance
- •women in pregnancy or breast feeding period and
- •use of analgesics or opioids during 4 hours before treatment
结局指标
主要结局
change in VAS score
时间窗: Every 6 hours after treatment completion up to 48 hours
Patients will record their pain intensity in each time period according to Visual Analog Scale (VAS)
次要结局
未报告次要终点
研究者
Kaveh Oloomi, DDS, MS
Assistant Professor
Zahedan University of Medical Sciences