Effect of Different Root Canal Disinfection Procedures on Postoperative Pain (EDRCD-PP)

January 13, 2026 updated by: İbrahim AKDENİZ, Cumhuriyet University

Effect of Different Root Canal Disinfection Procedures on Postoperative Pain: A One-Week Follow-Up Clinical Study

This clinical study evaluated the effects of different root canal disinfection procedures on postoperative pain. Patients requiring root canal treatment received one of several disinfection methods. Postoperative pain was assessed at 6,24, 48, 72 hours and on the 7th day using a standard pain scale. The aim of the study was to identify which method resulted in the least discomfort. Participation involved a single treatment session and short-term follow-up for pain measurement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
80

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

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

  • Turkey (Türkiye)
      • Sivas, Turkey (Türkiye), 58000
        • Faculty of Dentistry, Cumhuriyet University, Sivas

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Systemically healthy individuals between the ages of 18 and 65,
  • Adequate mouth opening,
  • Asymptomatic devitaled mandibular premolar with a single root and single canal,
  • Negative response to cold and electric pulp tests and no bleeding at the pulp chamber opening,
  • Able to provide rubber dam isolation,
  • Presence of opposing teeth.

Exclusion criteria

  • Presence of mental or psychiatric disorders,
  • Allergic diseases,
  • Use of painkillers within 12 hours or antibiotics within 1 week before the procedure,
  • Swelling, palpation/percussion pain, or sinus tract before treatment,
  • Presence of a periodontal pocket greater than 3 mm in diameter on the involved tooth,
  • Presence of a periapical radiolucency greater than 5 mm in diameter associated with the involved tooth,
  • Initiation of root canal treatment,
  • Irreparable material loss, root fracture, or crack,
  • Severe mobility,
  • Open apex,
  • Severe root canal calcification,
  • Internal or external resorption,
  • Bruxism,
  • Complaints of pain elsewhere in the mouth or in a tooth,
  • Being pregnant or breastfeeding.

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: Prevention
  • 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.
Experimental: conventional needle irrigation
Conventional needle irrigation(CNI) Group: A total of 6 mL of 2.5% NaOCl was delivered in three cycles using a 31-gauge irrigation needle positioned 2 mm short of the working length. Each cycle lasted 20 seconds, followed by a 20-second waiting period. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic acid(EDTA) (Imicryl Dental, Konya, Türkiye) was applied for 1 minute, followed by another 1-minute waiting period, and finally 2 mL of distilled water was used as the final rinse.
Procedure: Conventional Needle Irrigation
Root canals will be irrigated using a conventional syringe and needle technique with standard irrigant solutions. This method relies solely on manual delivery without activation devices.
Experimental: Passive Ultrasonic Irrigation Group
Passive ultrasonic irrigation(PUI) Group: Passive ultrasonic activation was performed with an ultrasonic device (Ultra X, Eighteeth, Changzhou, China) using a 20/.02 tip during the waiting periods used in the CNI group. The ultrasonic tip was positioned 2 mm short of the working length and activated vertically with 2-3 mm strokes without contacting the canal walls.
Procedure: Passive Ultrasonic Irrigation
Root canals will be irrigated using passive ultrasonic activation, which uses ultrasonic energy to improve irrigant effectiveness and reduce microbial load beyond manual techniques.
Experimental: Sonic Irrigation Group
Sonic irrigation(SI) Group: Sonic activation was performed using a polymer tip (Dentsply Tulsa Dental Specialties) loosely fitted into the canal and placed 2 mm short of the working length during the waiting periods used in the CNI group. The tip was activated by vertical in-and-out motion to induce sonic agitation.
Procedure: Sonic Irrigation
Root canals will be irrigated using a sonic activation device (e.g., EndoActivator) to enhance irrigant penetration and bacterial elimination compared to conventional irrigation.
Experimental: KTP Laser Disinfection Group
Potassium titanyl phosphate(KTP) Laser Group: In this group, after shaping was completed, the final irrigation procedure was carried out as in the CNI group. Following irrigation, the root canals were dried with sterile paper points at the working length. Then, KTP laser irradiation (SMARLITE D, DEKA laser system, Calenzano FI, Italy) was applied in a pulsed mode at 1.5 W power (Ton: 20 ms, Toff: 50 ms). A 200 µm fiber tip attached to the handpiece was inserted 1 mm short of the working length and moved coronally in a spiral motion for 5 seconds. After each 5-second irradiation, a 20-second interval was allowed, and the process was repeated five times. Laser safety protocols were strictly followed, and protective goggles were used by the operator, assistant, and patient.
Procedure: KTP Laser Disinfection
Root canals will be disinfected using a KTP laser following standard irrigation protocols. Laser application aims to provide enhanced antimicrobial effects not achievable with conventional or activated irrigation methods.

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: 6, 12, 24, 48, and 72 hours after root canal treatment
Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 100, where 0 indicates no pain and 100 indicates the worst pain imaginable; higher scores indicate greater pain severity
6, 12, 24, 48, and 72 hours after 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.
Cumhuriyet University

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)

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.
June 13, 2023

Primary Completion (Actual)

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.
November 11, 2024

Study Completion (Actual)

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.
November 11, 2024

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).
November 19, 2025

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.
January 13, 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.
January 21, 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.
January 21, 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.
January 13, 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.
January 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.
  • 2022-11/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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