NCT05611736

Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain

Completed NA Last updated 6 February 2024

What this trial tests

NA trial testing cold saline in Dental Pulp Necroses in 302 participants. Completed in 14 January 2024.

Timeline

1 June 2022

Primary endpoint
14 January 2024

14 January 2024

Quick facts

Lead sponsor	Qassim University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	302
Start date	1 June 2022
Primary completion	14 January 2024
Estimated completion	14 January 2024
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• cold saline — full drug profile →
• saline

Conditions studied

• Dental Pulp Necroses — all drugs for Dental Pulp Necroses →
• Apical Periodontitis — all drugs for Apical Periodontitis →
• Post Operative Pain — all drugs for Post Operative Pain →

Sponsor

Qassim University

Who can join

18 and older, any sex, with Dental Pulp Necroses or Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to evaluate the effect of cold saline (2.5 degrees Celsius) irrigation on postoperative pain in patients who require root canal treatment in molar teeth because of dead dental pulp and infection around the apex of the root of the involved teeth. This cold saline irrigation will be done after standard irrigation of the canal using a 5.25% sodium hypochlorite solution. The main questions it aims to answer are:

* Is there any difference in postoperative pain when final irrigation is performed using a cold saline solution compared to the irrigation using the saline solution at room temperature in patients who require dental root canal treatment of molar teeth?
* Because of cold saline irrigation, what type of adverse event/s may result?

Participants will be asked to fill out a questionnaire before the start of the root canal treatment and record the preoperative pain using the visual analog scale (VAS). Root canal treatment will be completed in one visit. The standard procedure of root canal treatment will be followed, including irrigation of the canal using 5.25% sodium hypochlorite. As a final irrigation, either cold saline solution or a normal saline solution at room temperature will be used. The participants will be asked to fill out another questionnaire and record the presence, duration, and intensity of postoperative pain, and if painkiller medicine was taken immediately after completion of root canal treatment and at 6 hours, 12 hours, 72 hours, and 1-week intervals.

The researcher will compare the effect of the final irrigation of a cold saline solution with that of a normal saline solution at room temperature on postoperative pain.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of intracanal cryotherapy on postoperative pain in necrotic teeth with symptomatic apical periodontitis: a randomized controlled clinical trial.
   Ahmad MZ. · · 2025 · cited 1× · PMID 40297278 · DOI 10.3389/fdmed.2025.1543383