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临床试验/NCT03006107
NCT03006107Unknown不适用

Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior Teeth

Cairo University0 个研究点目标入组 26 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
主要终点
The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.

研究概览

简要总结

to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

详细描述

The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

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
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Medically free patients
  • Patient's age between 25-50 years.
  • Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
  • Positive patient's acceptance for participation in the study.
  • Sex include both male and female.
  • Patients who can understand Numerical Rating Scale (NRS)
  • Patients able to sign informed consent.

排除标准

  • • Pregnancy or lactation in female patients
  • Medically compromised patients.
  • Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
  • Patient with fracture or mobile or mutilated teeth.

结局指标

主要结局

The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.

时间窗: up to 48 hours

Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Gamal Ahmed

principal investigator

Cairo University

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