Comparison of Postoperative Pain and Healing After Passive Ultrasonic Irrigation and Needle Irrigation in Patients With Apical Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 主要终点
- Postoperative pain
研究概览
简要总结
The aim of this study is to compare the effect of passive ultrasonic irrigation versus needle irrigation on post-operative pain and healing in patients with permanent posterior teeth with apical periodontitis treated in a single visit.
详细描述
Full medical and dental history using a dental chart for all patients treated in this study.
Clinical and radiographic examination will be done for all patients to verify the diagnosis of apical periodontitis with periapical radiolucency at least 2mm in diameter.
The treatment protocol and its associated risks and benefits will be explained to the eligible patients before obtaining informed consent. Endodontic procedures will be done in a single visit as follows: access cavity preparation using sterile round bur and Endo-Z bur, isolation using a rubber dam, canal preparation using a nickel-titanium rotary system then obturation. During mechanical preparation, irrigation will be done using passive ultrasonic irrigation (Experimental group) where ultrasonic activation will be done for irrigant-filled canals using the U- file tip (Varios NSK) in an ultrasonic device (P5 Newtron; Satelec Acteon) 1mm from the working length after each file change for 10 sec, or needle irrigation (Control group) where only the endodontic irrigation needle will be used; the irrigation protocol for each patient will be determined following a random-number sequence.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-55 years old.
- •Males and females.
- •Positive patient's acceptance to participate in the study.
- •Mature, permanent, mandibular, posterior teeth with apical periodontitis.
排除标准
- •Medically compromised patients so that no other pain source or drug interaction could interfere with pain resulting from the endodontic therapy.
- •Patients who had received analgesic treatment recently (past 8 hours) as it can affect the results
- •Pregnant females.
- •Teeth with previous root canal treatment.
结局指标
主要结局
Postoperative pain
时间窗: 7 days
postoperative pain will be assessed using numerical rate scale (NRS).
次要结局
- Periapical healing(12 months)
研究者
Noha Tawfik aly
postgraduate student, Department of Endodontics, Cairo University.
Cairo University