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Completed

NCT Number: NCT06741592

Postoperative Pain in Endodontic Therapy

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."

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, Karadeniz, 52200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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