Instrument motion and pain during and after root canal treatment in upper premolars with acute irreversible pulpitis
Official title: Effect of Instrumentation Kinematics on Intraoperative and Post-operative Pain in Maxillary Premolars With Acute Irreversible Pulpitis: A Randomized Clinical Trial
Run by Al-Azhar University · NCT07250399 · Data updated 2026-11-12
This test will compare two different ways of moving root canal instruments to see which causes less pain during and after treatment in adults (ages 20–50) with painful maxillary premolars.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 50 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | January 15, 2027 |
| Study ends | May 10, 2027 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07250399 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 20–50 years old with symptomatic acute irreversible pulpitis in a maxillary first or second premolar with Type I canals, closed apices, normal periapical appearance, and the ability to consent and record pain scores.
✕Probably not a fit
Patients with other tooth types, open apices, chronic periapical disease, major systemic conditions affecting pain, or those outside the 20–50 age range were not studied and may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, parallel-group trial will enroll about 50 adults aged 20–50 with symptomatic acute irreversible pulpitis in maxillary first or second premolars. Participants will be randomly assigned to root canal preparation with either the EdgeOne Fire reciprocating system or the JZ file system, with standardized instrumentation and irrigation protocols and pain measured using a visual analog scale at baseline, during treatment, and at multiple post-treatment time points. The protocol follows PRIRATE 2020 reporting guidelines and is conducted at the Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University. The main outcomes are intraoperative and postoperative pain intensity and the incidence of post-endodontic pain between the two kinematic approaches.
Why it matters
Potential benefit: If one instrument motion causes less tissue injury and debris extrusion, patients could have less pain during and after root canal treatment and a quicker, more comfortable recovery.
How similar studies have gone: Previous comparisons of reciprocating versus other kinematics have produced mixed results, with some studies reporting reduced debris extrusion and early postoperative pain but no clear consensus.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maxillary first and second bi-rooted premolar teeth having type I root canal. * have mature teeth with closed apex. * Teeth with prolonged response to the pulp tests. * Spontaneous pain (preoperative visual analog scale score )4-6). * Teeth with normal periapical appearance. * Restorable teeth. * Patients who will be able to understand the informed consent form and pain recording scales used in the study will be included. Exclusion Criteria: \-
Where it's running
-
from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Sabah M Sobhy, PHD — Al-Azhar University
- Study coordinator: Sabah M. Sobhy, PHD
- Email: sabamorad@yahoo.com
- Phone: +201096529143
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.