NCT04616469已完成4 期
Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Post operative pain using visual analogue scale
研究概览
简要总结
The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:
- Post operative pain: incidence and intensity
- Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor
- Time needed for the instruments to reach to the full working length
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.
- •Age between 30-60 years old.
- •Males & Females.
- •Patients' acceptance for participating in the trial through an informed consent
- •Maxillary permanent premolar teeth:
- •Diagnosed clinically and radiographically with pulp necrosis
- •With or without periapical radiolucency
- •Negative response of pulp tissue to thermal and electric pulp tester
- •Possessing two independent roots each having a type I canal
- •Patent canals with no internal calcification or resorptive lesions
- •Fully formed roots
- •Root curvatures less than 30
排除标准
- •Patient with contributory medical condition
- •Badly destructed teeth
- •Patients with pre-operative pain
- •Patients having significant systemic disorders
- •Patients with two or more adjacent teeth requiring root canal therapy
- •Patients who had received antibiotics in the last month
- •Teeth presenting with:
- •Positive response to thermal or electric pulp tester
- •History of trauma or previous endodontic treatment
- •Immature or open apices
- •Association with acute periapical abscess and swelling or fistulous tract
- •Fused roots at any level
- •Canals larger than size 15# K-file
- •Periodontonal/ endodontic lesions
- •Mobility higher than grade I
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
- •Severe root curvature (>30)
结局指标
主要结局
Post operative pain using visual analogue scale
时间窗: at 1 week post treatment
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
次要结局
- time required for the instrument to reach the full working length(during treatment)
- operative torque generated during instrumentation(during treatment)
研究者
Tarek Ali El Mosalamy
Doctor
Cairo University
研究点 (2)
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