The Effect of Different Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P

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

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 ?

Study Overview

• Status: Completed
• Conditions: Inflammation; Post Operative Pain
• Intervention / Treatment: Other: cryotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite
Experimental: Cryotherapy Group; 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.	Other: cryotherapy; Cooling of irrigation
Active Comparator: Final Flush group; 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.	Other: cryotherapy; Cooling of irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of post operative pain	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	after 6 hours, 24 hours, 48 hours, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of substance P	apical fluid sample will be taken using sterilized, medium sized paper point (Diadent Korea, Seoul, Korea) will be inserted into the periapical area and left in place for 30 seconds and the sample will be placed into a 1.5-mL Eppendorf tube containing 100 _L of Tris-HCl buffer, pH 7.5, with 0.15 M NaCl and 1 mM CaCl2; the tubes will be placed on a shaker at room temperature for 3 hours and then stored at -70°C	After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Maram F Obeid, Professor, Faculty of Dentistry Ain Shams university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cryotherapy; Substance P; Apical periodontitis; Post Operative Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Inflammation
• Other Study ID Numbers: 20720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2025
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No