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临床试验/NCT06106386
NCT06106386已完成不适用

The Impact of Using Cold Irrigation on Postoperative Endodontic Pain and Substance P Level: a Randomized Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Level of post operative pain

研究概览

简要总结

The aim of this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite

The main questions to answer are:

  1. Does Postoperative pain is different between the three groups?
  2. Does level of substance P different between the three groups ?

详细描述

  • The patients will be randomly divided into three groups Group 1: control group (n=25) Regular root canal treatment with regular irrigant will be used. Group 2: (n=25) Intraradicular cryotherapy will be performed where :
  • Normal root canal treatment will be done with irrigation using sodium hypochlorite cooled to 2°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes. Group 3: (n=25) Normal root canal treatment will be done with irrigation using sodium hypochlorite at room temperature during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes.

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 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients that will be diagnosed with symptomatic apical periodontitis
  • •Single-rooted premolars (radiographically and clinically assessed)
  • •Medically free patients.
  • •Teeth with mature apex

排除标准

  • •Patients with other pulpal diagnosis.
  • •Medically compromised patients.
  • •Pregnant females.
  • •Patients taking analgesics or anti-inflammatory drugs.

研究组 & 干预措施

Control Group

No Intervention

Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite

Cryotherapy Group

Experimental

Root canal treatment is done and irrigation is done with cooled sodium hypochlorite ( 2- 4°C) through out the visits and final flush with 2- 4°C cold saline will be used for 5 minutes.

干预措施: cryotherapy (Other)

Final Flush group

Active Comparator

Root canal treatment is done and irrigation is done with sodium hypochlorite at room temperature through out the visits then final flush with 2- 4°C cold saline will be used for 5 minutes.

干预措施: cryotherapy (Other)

结局指标

主要结局

Level of post operative pain

时间窗: after 6 hours, 24 hours, 48 hours, 72 hours

On visual analogue scale (VAS) questionnaire, patients will report their level of pain 0° refers for no pain, and the 100° degree refers for unbearable pain

次要结局

  • Level of substance P(After access cavity, after finishing mechanical perpetration, before obturation(after 3 days))

研究者

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

Maram Obeid

Professor of Endodontics

Ain Shams University

研究点 (1)

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