Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Postendodontic pain using a pain-measuring scale
研究概览
简要总结
The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.
详细描述
- Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be 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)
盲法说明
The study will be participant and operator-blind where the participant and operator will not know the intervention done.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aging between 18-50 years old
- •Patients with mandibular molar with non-vital pulp.
- •Systemically- healthy patients (ASA I or II).
- •Patients who agree to attend for recall appointments and provide a written consent.
排除标准
- •Pregnant or lactating female patients.
- •Patients allergic to piroxicam.
- •History of peptic ulceration.
- •Periapical abscess, fistula.
- •Non-restorable teeth.
- •Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
研究组 & 干预措施
Piroxicam drug
20 mg piroxicam
干预措施: Piroxicam (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Postendodontic pain using a pain-measuring scale
时间窗: 7 days
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
次要结局
- Analgesic medication intake incidence(7 days)
研究者
Asmaa Fathelrahman Mohamed
Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University
Cairo University