NCT06741592 - Postoperative Pain in Endodontic Therapy | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

57

Conditions

Endodontic Disease Postoperative Pain

Interventions

EDDY GroupDEVICE

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.

PUI GroupDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ordu University

Ordu, Karadeniz, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.