Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 主要终点
- Post-operative pain
研究概览
简要总结
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin 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.
Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed.
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)
盲法说明
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 and do not have evidence of spreading infection or systemic involvement.
- •Mandibular posterior teeth.
- •Patients in good health.
- •Patients who can understand pain scales (NRS).
- •Patients able to sign informed consent.
排除标准
- •Patients who have draining sinus tract.
- •Retreatment cases
- •Patients with weeping canals.
研究组 & 干预措施
Clindamycin
600 mg of Clindamycin orally 30 minutes before root canal treatment
干预措施: 600 mg Clindamycin orally (Drug)
Placebo
placebo 30 minutes Orally before treatment
干预措施: Oral Placebo (Drug)
结局指标
主要结局
Post-operative pain
时间窗: Up to 7 days after endodontic treatment
Post-operative pain will be measured by a numerical rating scale (NRS)
次要结局
- Swelling(7 days)
研究者
Nermeen Saeed Abdel Ghany El Sedawy
principal Investigator
Cairo University