Postoperative Pain in Endodontic Therapy

NCT06741592 | Completed

• 1 other identifier: ODU-MUTLU-001
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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."

Conditions

Endodontic Disease; Postoperative Pain

Keywords

EDDY; Irrigation Activation; Passive Ultrasonic Irrigation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

EDDY Group

EXPERIMENTAL

The effect of the EDDY device, preferred for root canal irrigation activation, on postoperative pain formation

Device: EDDY Group

PUI Group

EXPERIMENTAL

The effect of the passive ultrasonic activation method, preferred for root canal irrigation activation, on postoperative pain formation

Device: PUI Group

Control Group

NO INTERVENTION

Root canal treatment performed with conventional irrigation without the use of any activation method

Interventions

EDDY Group DEVICE

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.

EDDY Group

PUI Group DEVICE

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.

PUI Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, Karadeniz, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Seca MUTLU

  Ordu University, Faculty of Dentistry, Department of Endodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 19, 2024
• Study Start: February 12, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 5, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)