Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems

Postoperative Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358833
• Other study ID #: 24-82-03
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Qassim University
• Contact: Muhammad Zubair Ahmad, FCPS
• Phone: +966 (0)163011111
• Email: m.muhammad[@]qu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pain, Postoperative
• Postoperative Pain
• Pulpitis

Intervention

Procedure:
• endodontic needle (EN)
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 activation (EA)
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.

Locations

Country	Name	City	State
Saudi Arabia	Muhammad Zubair Ahmad	Ar Rass	Qassim

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event	If any adverse event will occur, it will be recorded	During and immediately after root canal treatment
Other	Rescue medication	In case of unbearable postoperative pain, the principal investigator will prescribe oral analgesic (ibuprofen 200 mg as the over-the-counter drug), and the timepoint of medication intake will be recorded.	Up-to 1 week postoperatively
Primary	Postoperative pain	Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)	6 hours postoperatively
Primary	Postoperative pain	Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)	12 hours postoperatively
Primary	Postoperative pain	Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)	48 hours postoperatively
Primary	Postoperative pain	Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)	1 week postoperatively
Secondary	Irrigation time	Time spent in irrigation procedures	During root canal treatment