Clinical trial NCT06358833: Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Irreversible Pulpitis
Keywords: root canal treatment
irrigation
ultrasonic activation
Endo1 Ultrasonic Endo Activate Device
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain
timeFrame: 6 hours postoperatively
measure: Postoperative pain
timeFrame: 12 hours postoperatively
measure: Postoperative pain
timeFrame: 48 hours postoperatively
measure: Postoperative pain
timeFrame: 1 week postoperatively
Secondary outcomes:
measure: Irrigation time
timeFrame: During root canal treatment
Other outcomes:
measure: Adverse event
timeFrame: During and immediately after root canal treatment
measure: Rescue medication
timeFrame: Up-to 1 week postoperatively
Locations:
city: Ar Rass
country: Saudi Arabia
facility: Muhammad Zubair Ahmad
state: Qassim
Study officials:
affiliation: Qassim University, Saudi Arabia
name: Muhammad Zubair Ahmad, FCPS
role: PRINCIPAL_INVESTIGATOR
References: