Postoperative Pain in Endodontic Therapy

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: Completed
• Conditions: Postoperative Pain; Endodontic Disease
• Intervention / Treatment: Device: EDDY Group; Device: PUI Group

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	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	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	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	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	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

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Investigators: Principal Investigator: Seca MUTLU, Ordu University, Faculty of Dentistry, Department of Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: EDDY; Irrigation Activation; Passive Ultrasonic Irrigation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Tooth Diseases; Pain, Postoperative; Dental Pulp Diseases
• Other Study ID 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