Effect of Preoperative, Single-dose Diclofenac Potassium on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Postoperative endodontic pain
研究概览
简要总结
The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.
详细描述
Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •Patients with active pain (moderate-to-severe) in mandibular molars.
- •Patients with prolonged response to cold testing and electric pulp tester.
- •Patient with the ability to understand and use pain scales.
- •Patient with vital coronal pulp tissue on access.
- •Patient who accept to enroll to the study.
排除标准
- •Patients' allergies or any other contraindication to diclofenac potassium or articaine.
- •Pregnant and lactating females.
- •Patients having pain medication in the last 6 hours.
- •Patient has more than one symptomatic mandibular tooth in the same quadrant.
- •Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- •Patients with active peptic ulcer and gastrointestinal disorders.
- •Patients with history of bleeding problems or anticoagulant use within the last month.
研究组 & 干预措施
Diclofenac Potassium 50mg tab
Diclofenac Potassium 50mg tablet to be administered one hour before treatment.
干预措施: Diclofenac Potassium 50mg Tab. (Drug)
Placebo
Placebo to be administered one hour before treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative endodontic pain
时间窗: Up to 2 days after endodontic treatment
Pain after completion root canal treatment measured by Heft-parker visual analogue scale.
次要结局
- Analgesic intake(Up to 2 days after endodontic treatment)
研究者
Amatallah Hussein Nasser Al-Rawhani
Postgraduate Student in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University.
Cairo University