Postoperative Pain in Endodontic Therapy

December 17, 2024 updated by: Seca MUTLU, T.C. ORDU ÜNİVERSİTESİ

The Effect of Different Irrigation Activation Methods Preferred During Root Canal Treatment On Postoperative Pain: A Randomized Clinical Trial

The goal of this clinical trial is to evaluate the change in postoperative pain in mandibular premolar and first molar teeth with asymptomatic apical periodontitis when using EDDY and passive ultrasonic irrigation activation methods.

The null hypothesis is: "There is no difference in postoperative pain after root canal treatment between the irrigation activation systems in mandibular first molars and premolar teeth."

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.
57

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
    • Karadeniz
      • Ordu, Karadeniz, Turkey, 52200
        • Ordu University

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

Yes

Description

Inclusion Criteria:

  • Patients aged between 18 and 55 years, medically healthy, and free from systemic diseases.
  • Patients without pregnancy or breastfeeding status.
  • Patients diagnosed with asymptomatic apical periodontitis confirmed through radiographic and clinical examination.
  • Patients not having a regular intake of analgesic or anti-inflammatory drugs within the last 12 hours.
  • Patients lacking a history of drug allergies.
  • Teeth free from calcifications, resorptions, periodontal problems, incomplete root development, a history of endodontic treatment, traumatic occlusion, or severe coronal destruction.
  • Teeth with a root canal curvature of 5° or less.
  • Mandibular premolars and first molars.

Exclusion Criteria:

  • Teeth where the apical area could not be reached with a #8K file.
  • Teeth with an apical diameter larger than #20K file.
  • Patients with a Periapical Index (PAI) score of 1 or 2.
  • Teeth having extra canals.
  • Teeth requiring a second local anesthesia during treatment.
  • Teeth where a file fractured within the canal during preparation.
  • Vital teeth.
  • Patients reporting preoperative pain.
  • Teeth showing clinical symptoms such as percussion or palpation sensitivity.
  • Teeth with persistent purulent discharge.

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: Double

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: EDDY Group
The effect of the EDDY device, preferred for root canal irrigation activation, on postoperative pain formation
Device: EDDY Group
The EDDY activation of the irrigation solutions used is performed to achieve root canal disinfection and enhance antibacterial effectiveness once the root canal preparation is completed.
Experimental: PUI Group
The effect of the passive ultrasonic activation method, preferred for root canal irrigation activation, on postoperative pain formation
Device: PUI Group
The passive ultrasonic activation of the irrigation solutions used is performed to achieve root canal disinfection and enhance antibacterial effectiveness once the root canal preparation is completed.
No Intervention: Control Group
Root canal treatment performed with conventional irrigation without the use of any activation method

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
Time Frame: 8th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
8th hour
Postoperative Pain
Time Frame: 12th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
12th hour
Postoperative Pain
Time Frame: 24th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
24th hour
Postoperative Pain
Time Frame: 48th hour
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
48th hour
Postoperative Pain
Time Frame: 7th day
Prior to treatment, patients were instructed in detail on how to complete the VAS (Visual Analog Scale). Patients were asked to mark their pain levels on a 10 cm line based on the severity of pain experienced after the procedure. Pain intensity was numerically documented on a scale of 0 to 10. 0 is described as no pain number, 10 is described as the highest pain number.
7th day

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.
T.C. ORDU ÜNİVERSİTESİ

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.
  • Principal Investigator: Seca MUTLU, Ordu University, Faculty of Dentistry, Department of Endodontics

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.
February 12, 2024

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.
December 4, 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.
December 5, 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).
December 12, 2024

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.
December 17, 2024

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.
March 25, 2025

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.
March 25, 2025

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.
December 17, 2024

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.
November 1, 2024

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.
  • ODU-MUTLU-001

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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