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OpenTrials
Completed

NCT Number: NCT06358833

Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad Zubair Ahmad

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

About this study

Background:

One of the primary objectives following root canal therapy is to alleviate pain. While postoperative pain is undesirable, it is often considered a common sensation following endodontic treatment.

Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task, even when using precise rotary, hand, or hybrid instruments. Therefore, irrigation plays a crucial role in the cleaning and shaping process.

Traditional root canal irrigation typically involves the use of an endodontic needle (EN) to disinfect the root canal. However, a newer approach called endodontic activation (EA) has been suggested to enhance root canal disinfection by activating irrigants within the canal.

Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment.

Rationale:

No study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) on postoperative pain using a pragmatic approach. Therefore, the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation.

Study objectives:

The study aims to assess and compare the levels of postoperative pain following endodontic activation (EA) of irrigants using the Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) versus conventional endodontic needle (EN) irrigation in root canal therapy.

Methods In this prospective single-blind, parallel-armed, randomized clinical trial, standard root canal preparation will be done; patients will be randomly assigned into one of the two groups. In the final irrigation protocol, group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

endodontic needle (EN)

Procedure

the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). 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 activation (EA)

Procedure

the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.

Primary outcomes

  1. Postoperative pain

    Time frame: 6 hours postoperatively

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

  2. Postoperative pain

    Time frame: 24 hours postoperatively

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

  3. Postoperative pain

    Time frame: 48 hours postoperatively

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

  4. Postoperative pain

    Time frame: 1 week postoperatively

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

Other outcomes

  1. Adverse event

    Time frame: During and immediately after root canal treatment

    If any adverse event will occur, it will be recorded

  2. Rescue medication

    Time frame: Up-to 1 week postoperatively

    In case of unbearable postoperative pain, the principal investigator will prescribe oral analgesic ibuprofen 400 mg (if Ibuprofen contraindicated, Paracetamol 500 mg), and the timepoint of medication intake will be recorded.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Registry information

Official study title

Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation: A Randomized Controlled Pragmatic Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
Jun 12, 2026

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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