Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion

NCT07808684 · tracked via the Priya Life Science Egypt tracker

Sponsor

Minia University

Phase

Not applicable

Started

2026-06-01

Last updated

2026-09-09

Condition(s) studied

Postoperative PainIrreversible Pulpitis

Investigational drug(s) / intervention(s)

AF One single-file rotary system

AF One single-file rotary system: to evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars. Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.

Study summary

Endodontic treatment aims to achieve optimal biological outcomes while minimizing patient's discomfort during and after the procedure. Postoperative pain remains a common complication and is considered a multifactorial phenomenon influenced by several factors, including preoperative pain, age, gender, systemic health, presence of apical periodontitis, instrumentation technique, type and design of endodontic instruments, and the use of intracanal medications.

Eligibility

Sex

ALL

Min age

20 Years

Max age

40 Years

Healthy volunteers

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.

Primary outcome measure(s)

Treatment of Postoperative Pain — from 0 hours to 1 week after the procedure
Pain scores will be recorded on Visual Analog Scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain. Recording will be done everyday for 7 days period.

Trial sites (1)

Facility	City	Region	Status
Endodontics, Faculty of Dentistry, Minia University	Minya	Minya Governorate	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07808684 on ClinicalTrials.gov ↗ ← All trials in Egypt