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

NCT06106386 | Completed

• 1 other identifier: 20720
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain; Inflammation

Keywords

Cryotherapy; Substance P; Apical periodontitis; Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of substance P

  After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)

Study Arms (3)

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.

Other: cryotherapy

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.

Other: cryotherapy

Interventions

cryotherapy OTHER

Cooling of irrigation

Cryotherapy Group; Final Flush group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• Sharaf RMA, Abdelrahman TY, Obeid MF. The impact of using cold irrigation on postoperative endodontic pain and substance P level: a randomized clinical trial. Odontology. 2025 Jun 18. doi: 10.1007/s10266-025-01131-3. Online ahead of print.

  PMID: 40533695 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Inflammation; Periapical Periodontitis

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Maram F Obeid, Professor

  Faculty of dentistry Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endodontics

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2025

Locations

EG (1)