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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

  • 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

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
Intervention / Treatment
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

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

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)

June 13, 2023

Primary Completion (Actual)

November 11, 2024

Study Completion (Actual)

November 11, 2024

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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