Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems

NCT06358833 | Completed

• 1 other identifier: 24-82-03
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain.

Conditions

Postoperative Pain; Irreversible Pulpitis

Keywords

root canal treatment; irrigation; ultrasonic activation; Endo1 Ultrasonic Endo Activate Device

Outcome Measures

Primary Outcomes (4)

• Postoperative pain

  Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)

  6 hours postoperatively

• Postoperative pain

  Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)

  12 hours postoperatively

• Postoperative pain

  Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)

  48 hours postoperatively

• Postoperative pain

  Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)

  1 week postoperatively

Secondary Outcomes (1)

• Irrigation time

  During root canal treatment

Other Outcomes (2)

• Adverse event

  During and immediately after root canal treatment

• Rescue medication

  Up-to 1 week postoperatively

Study Arms (2)

Endodontic needle (EN)

ACTIVE COMPARATOR

In this group, the irrigation of root canals will be done with 2.5 % sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.

Procedure: endodontic needle (EN)

Endodontic activation (EA)

EXPERIMENTAL

In this group, the irrigation of root canals will be done with 2.5% sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activator (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activator device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.

Procedure: Endodontic activation (EA)

Interventions

endodontic needle (EN) PROCEDURE

the irrigation of root canals will be done with 2.5 % sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.

Endodontic needle (EN)

Endodontic activation (EA) PROCEDURE

the irrigation of root canals will be done with 2.5% sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activator (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activator device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.

Endodontic activation (EA)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years of age) visiting the College of Dentistry and undergoing root canal treatment in posterior teeth (molars and premolars).
• Teeth having fully formed roots with mature apices.
• Patients willing to collaborate in the study must sign a written consent form.
• Diagnosis of irreversible pulpitis in posterior tooth/teeth requiring root canal treatment.
• No history of allergy to the anesthesia solution.
• Classified as class I, II in the American Society of Anesthesiologists Physical Status Classification System.

You may not qualify if:

• Patients diagnosed with pulp necrosis in the tooth require root canal treatment.
• Mentally or medically compromised patients.
• Pregnant women.
• Patients on any medications for the past two weeks
• Patients who refuse to participate in the study.
• Patients with a history of allergy from any of the contents of local anesthesia or rubber dam material.
• Non-restorable teeth

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Muhammad Zubair Ahmad

Ar Rass, Al-Qassim Region, 58883, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Zubair Ahmad, FCPS

  Qassim University, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be masked from the procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: April 15, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

SA (1)