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临床试验/NCT06286995
NCT06286995已完成不适用

Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems (A Randomized Clinical Trial)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Level of post operative pain using 10-cm visual analogue scale ( VAS)

研究概览

简要总结

The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS)

详细描述

Patients : 20 patients with symptomatic apical periodontitis related to mandibular premolars were selected.after proper anathesia, Access cavity was ppreformed.The working length measured using apex locator.chemomechanical preparation was done .for trunatomy file group ,using file sequence according to manufacture's instructions until medium one .for edgeendo group ,using file sequence also according to manufacture's instructions until file size 35 taper4.Apical fluid samples was collected by paper point from the both preoperatively and before obturation and also pain was assessed pre and post opertively.finally,the root canal were filled by gutta-percha and resin based sealer.the access cavity was restored by glass ionomer restoration.

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 (Investigator, Outcomes Assessor)

盲法说明

A) Sequence generation: was done using random sequence number generated by computer software B) Allocation concealment Mechanism:folded,numbered papers were placed in tightly sealed envelopes containing patients' coding

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnoses of apical periodontitis related to single-rooted mandibular premolars
  • no evidence of excessive mobility

排除标准

  • presence of any systemic disease or allergic reaction
  • Incompletely formed root
  • Previously Endodontically treated teeth

结局指标

主要结局

Level of post operative pain using 10-cm visual analogue scale ( VAS)

时间窗: After 6 hours,24 hours, 48 hours and finally 72 hours

10-cm visual analogue scale (VAS) questionnaire.each patient reported their level of pain as follow: 0 no pain,1-3 mild pain,4-6 moderate pain,7-9 severe pain and 10 the worst pain

次要结局

  • Level of inflammatory mediators substance P in apical fluid samples(Preoperatively ( after working length determination) and before obturation after 3days)

研究者

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

Fatma Essam Badr El-din, Bachelor

Bachelor degree in Dental Medicine and Surgery,May 2017

Ain Shams University

研究点 (1)

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