Impact of a 1-file rotary system on debris extrusion during root canal treatment
Official title: Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion and Postoperative Pain Following Single-Visit Root Canal Treatment: An In Vitro and Randomized Clinical Study
Run by Minia University · NCT07808684 · Data updated 2026-11-12
This study tests whether using a single-file AF One system during root canal shaping reduces postoperative discomfort in teeth with irreversible pulpitis and mature roots.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | December 20, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07808684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults requiring endodontic treatment of teeth with mature apices, straight to mildly curved canals (Schneider 5–10 degrees), intact crowns, and confirmed canal patency.
✕Probably not a fit
Patients with more complex canal anatomies, prior root canal treatment, or unfavorable canal features may not experience benefit from this single-file approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines the effect of a single-file AF One rotary system on apical debris extrusion during root canal preparation. The trial compares a flat-sided NiTi AF One file with conventional multi-step techniques to determine its impact on postoperative pain and cleaning efficacy. Eligible participants have mature teeth with either straight or mildly curved canals, intact crowns, and confirmed patency up to the apical foramen. Exclusion criteria include prior root canal treatment, resorption, immature apices, significant caries or fractures, and more than mild canal curvature. The study is conducted at Minia University Endodontics, focusing on standardized instrumentation, debris management, and clinical outcomes related to postoperative pain.
Why it matters
Potential benefit: If successful, patients may experience less postoperative pain and more efficient root canal shaping with a simplified single-file approach.
How similar studies have gone: Other single-file and heat-treated NiTi systems have shown promise in simplifying procedures and improving efficiency, though results vary by design and technique.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Teeth with mature apex * Straight root canal or mild curvature not exceeding(5-10) Schneider. * Has intact crown ( coronal structure) * Presence of one orifices and one apices, patency achieved by a #10-15 K-file to the apical foramen Exclusion Criteria: * Previous root canal treatment. * Internal/external resorption. * Immature root apices. * Caries/cracks/fractures on the root surface. * Root canal curvature more than 10 degrees. * Teeth in which the apical minor constriction was gauged larger than a size 20 hand file.
Where it's running
-
Endodontics, Faculty of Dentistry, Minia University
Minya, Minya Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Nahla Nasr El-Din Fouad Mohamed, MSC
- Email: nannanasr248@gmail.com
- Phone: +201009067349
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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.