Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain

February 2, 2024 updated by: Muhammad Zubair Ahmad, Qassim University

Effects of Intracanal Cryotherapy on Postoperative Pain in Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain in root canal therapy is multifactorial in nature, including changes in periapical pressure, microbial factors, inflammatory mediators, and psychological factors. Postoperative pain in endodontics between visits or after completion of the treatment is a major concern to both patients and operators. Teeth presented with preoperative pain, irreversible pulpitis, pulp necrosis, and apical periodontitis are the most susceptible to postoperative pain The pharmacological management of pain using medications such as nonsteroidal anti-inflammatory drugs, paracetamol, or corticosteroids, despite being relatively safe, can have side effects such as gastrointestinal intolerance and renal, hepatic, and respiratory disorders such as asthma which have been reported in the literature. To avoid these secondary effects, intracanal medications, laser, and cryotherapy have been suggested in the literature.

Physical and clinical evidence suggests that the application of cold may decrease pain through the mechanism of decreasing the conduction velocity of nerve signals, hemorrhage, edema, and local inflammation. An in vitro study showed that intracanal irrigation with cold saline at 2.5 degrees Celsius reduced the external root surface temperature by more than 10 degrees Celsius, which would be enough to produce the anti-inflammatory effect in peri-radicular tissues.

There are very few studies done to evaluate the effect of intracanal cryotherapy on postoperative pain in root canal therapy.

This clinical trial aims to assess if final irrigation using cold saline solution after standard chemo-mechanical preparation (root canal instrumentation and irrigation using 5.25% sodium hypochlorite) procedures results in any difference in the incidence and intensity of postoperative pain in patients presenting with molar teeth with necrosis of pulp and symptomatic apical periodontitis. This clinical trial will also assess the incidence of any adverse event as a result of cold saline irrigation.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Qassim
      • Ar Rass, Qassim, Saudi Arabia, 58883
        • Muhammad Zubair Ahmad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy patients
  • Patients with maxillary or mandibular molar teeth that require root canal treatment
  • The diagnosis of pulp necrosis
  • The presence of symptomatic apical periodontitis
  • The presence of normal occlusion

Exclusion Criteria:

  • Previously done root canal treatment
  • Pregnancy
  • Presence of any systemic disease or allergic reactions
  • Use of any analgesic or antibiotic medications within the past three days
  • Sinus tract or local gingival swelling around the affected tooth
  • Periodontal pocket greater than 3 mm around the affected tooth
  • Severe periodontal disease
  • Internal or external root resorption
  • Broken files
  • Over instrumentation
  • Incomplete filling of the root canal
  • Overfilling of the root canal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cold saline
After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.
Other: cold saline
After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.
Other Names:
  • cold normal saline
Active Comparator: saline
After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal system will be performed using 20 milliliters of normal saline solution at room temperature.
Other: saline
After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal will be done using normal saline solution at room temperature
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 6 hours postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
6 hours postoperatively
Postoperative pain
Time Frame: 24 hours postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
24 hours postoperatively
Postoperative pain
Time Frame: 72 hours postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
72 hours postoperatively
Postoperative pain
Time Frame: 1 week postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
1 week postoperatively
adverse event
Time Frame: during the irrigation procedure
If any adverse event will occur, it will be recorded
during the irrigation procedure
adverse event
Time Frame: immediately after the irrigation procedure
If any adverse event will occur, it will be recorded
immediately after the irrigation procedure
adverse event
Time Frame: 6 hours postoperatively
If any adverse event will occur, it will be recorded
6 hours postoperatively
adverse event
Time Frame: 24 hours postoperatively
If any adverse event will occur, it will be recorded
24 hours postoperatively
adverse event
Time Frame: 72 hours postoperatively
If any adverse event will occur, it will be recorded
72 hours postoperatively
adverse event
Time Frame: 1 week postoperatively
If any adverse event will occur, it will be recorded
1 week postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qassim University

Investigators

  • Principal Investigator: Muhammad Zubair Ahmad, BDS, FCPS, Qassim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

January 14, 2024

Study Completion (Actual)

January 14, 2024

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-19-08

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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