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Clinical Trials/NCT06106386
NCT06106386
Completed
Not Applicable

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

Ain Shams University1 site in 1 country135 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Operative Pain
Sponsor
Ain Shams University
Enrollment
135
Locations
1
Primary Endpoint
Level of post operative pain
Status
Completed
Last Updated
last year

Overview

Brief Summary

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 ?

Detailed Description

* 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
March 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maram Obeid

Professor of Endodontics

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Level of post operative pain

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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