Ultrasonic Activated Irrigation and Intracanal Cryotherapy for Reducing Pain After Root Canal Treatment

June 17, 2026 updated by: Dr Arsalan Ali Khan

Effect of Using Ultrasonic Activated Irrigation, With and Without Intracanal Cryotherapy, on Post-Operative Pain After Single Visit Root Canal Treatment of Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of ultrasonic activated irrigation with and without intracanal cryotherapy on postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.

Participants requiring root canal treatment will be randomly allocated into two groups. One group will receive ultrasonic activated irrigation alone, while the other group will receive ultrasonic activated irrigation followed by intracanal cryotherapy. Postoperative pain will be assessed at predetermined time intervals using a standardized pain assessment scale.

The findings of this study may help identify effective strategies for reducing postoperative pain after root canal treatment and improving patient comfort and treatment outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Postoperative pain remains one of the most common complications following root canal treatment and may negatively affect patient comfort and treatment acceptance. Various factors, including preoperative status, instrumentation techniques, and irrigation protocols, influence the incidence and severity of post-endodontic pain.

Ultrasonic activated irrigation (UAI) enhances the effectiveness of irrigants by generating acoustic streaming and cavitation, thereby improving debris removal, smear layer elimination, and disinfectant penetration into the root canal system. Intracanal cryotherapy, which involves the application of cold saline as a final irrigant, has been proposed as a non-pharmacological method to reduce postoperative pain by decreasing tissue temperature and exerting anti-inflammatory effects.

This study is a single-center, parallel two-arm, single-blinded randomized controlled trial conducted at the Department of Operative Dentistry and Endodontics, Sardar Begum Dental College, Peshawar, Pakistan. A total of 60 patients aged 20 to 50 years diagnosed with symptomatic irreversible pulpitis in mandibular first or second molars will be enrolled.

Eligible participants will be randomly allocated into two groups using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes. Group A (control group) will receive ultrasonic activated irrigation without intracanal cryotherapy, whereas Group B (intervention group) will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes.

All treatments will be performed in a single visit under local anesthesia and rubber dam isolation using standardized clinical protocols. Root canal preparation will be carried out using the ProTaper Universal rotary system. Ultrasonic activation will be performed for one minute per canal. Following obturation and permanent restoration, postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS).

Pain scores will be recorded at 12, 24, 48, and 72 hours postoperatively through telephone follow-up by a blinded assessor. The primary outcome measure is postoperative pain intensity. Analgesic consumption and adverse events will also be documented.

The findings of this study may provide evidence regarding the effectiveness of intracanal cryotherapy as an adjunct to ultrasonic activated irrigation for reducing postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients who are medically fit (ASA Physical Status I) and aged between 20 and 50 years will be recruited for the study.

    2. Mandibular first or second molars exhibiting signs of symptomatic irreversible pulpitis, identified through an extended sensitivity to cold testing and/or a positive electric pulp test.

    3.Vital pulp with no signs of apical pathology (normal periapical radiograph, no swelling, sinus tract, or mobility).

    4. Mature roots with closed apices and no prior root canal treatment. 5. Willing to undergo single-visit treatment and comply with follow-up.

Exclusion Criteria:

  • 1.Use of analgesics or NSAIDs within 12 hours prior to treatment. 2.Pregnant or lactating women. 3.Presence of systemic illness or allergy to any materials used in the study. 4.Teeth with:

    • Non-vital pulp, periapical radiolucency, or sinus tract.
    • Mobility > Grade I or periodontal pockets > 5 mm.
    • Resorption, calcification, or non-restorable crown structure. 5.Third molars (wisdom teeth). 6.Endodontically treated tooth. 7.Inability or unwillingness to follow study instructions or complete follow-up.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ultrasonic Activated Irrigation Without Intracanal Cryorherapy
Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of room-temperature 0.9% saline will be delivered over 5 minutes. The canals will then be obturated and permanently restored in the same visit.
Procedure: Ultrasonic Activated Irrigation
Ultrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement.
Experimental: Ultrasonic Activated Irrigation With Intracanal Cryotherapy
Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of cold (1.5-2.5°C) 0.9% saline will be delivered 1 mm short of the working length over 5 minutes as intracanal cryotherapy. The canals will then be obturated and permanently restored in the same visit.
Procedure: Ultrasonic Activated Irrigation
Ultrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement.
Procedure: Intracanal cryotherapy
Intracanal cryotherapy was performed by delivering 10 mL of cold 0.9% saline (1.5-2.5°C) passively 1 mm short of the working length over 5 minutes as the final irrigation step during single-visit root canal treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: 12,24,48 and 72 hours after the completion of single-visit root canal treatment
Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded through telephone follow-up at 12, 24, 48, and 72 hours after completion of single-visit root canal treatment.
12,24,48 and 72 hours after the completion of single-visit root canal treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr Arsalan Ali Khan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shakeel Ur Rehman Khattak, BDS,BSc,MHR,FCPS, Sardar Begum Dental College,Gandhara University,Peshawar,Pakitstan

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GU/Ethical Committee/2025/248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared because this is an investigator-initiated academic study, and no formal data-sharing plan has been established. Participant confidentiality and privacy will be maintained in accordance with institutional ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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