Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.
详细描述
Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.
Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.
Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment).
Root canal treatment will then be carried out in a single visit.
Each patient will receive a 7-day diary to record postoperative pain and swelling. In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome.
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
- 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 symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
- •Mandibular posterior teeth.
- •Patients with non-contributory systemic condition.
- •Patients who can understand pain scales and able to sign informed consent.
排除标准
- •Patients allergic to penicillin.
- •Patients who have a draining sinus tract.
- •Retreatment cases.
研究组 & 干预措施
Amoxicillin/Clavulanate Potassium
Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment
干预措施: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet (Drug)
Placebo
placebo 30 minutes before root canal treatment
干预措施: Oral placebo (Drug)
结局指标
主要结局
Postoperative pain
时间窗: Up to 7 days after endodontic treatment
Postoperative pain will be measured by a numerical rating scale (NRS).
次要结局
- Swelling(Up to 7 days after endodontic treatment)
研究者
Nermeen Naser Taleb Moushtaha
Principal Investigator
Cairo University