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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07808684
Enrollment
30
Registered
2026-09-09
Start date
2026-06-01
Completion date
2026-12-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis, Postoperative Pain

Brief 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.

Detailed description

Root canal shaping represents a critical phase in endodontic treatment, as it facilitates effective cleaning and disinfection while preserving the original canal anatomy. The objective is to create a continuously tapered conical shape from coronal to apical regions without inducing procedural errors such as canal transportation, ledge formation, zipping, or perforation. With advancements in nickel-titanium (NiTi) technology, modern rotary systems have been developed to enhance shaping efficiency, improve debris removal, and reduce preparation time. Recently, single-file rotary systems have gained popularity due to their simplified protocols, reduced instrument fatigue, and improved clinical efficiency. A novel concept in instrument design involves flat-sided rotary files manufactured from proprietary heat-treated NiTi alloys, such as AF One Blue and Platinum V.EU. These instruments exhibit a modified S-shaped cross-section with an inactive tip and a distinctive flat surface. The flat-sided design reduces the metal mass of the instrument, potentially enhancing flexibility, cyclic fatigue resistance,and facilitating coronal transportation of debris during instrumentation. In contrast, One Curve is a single-file rotary system manufactured from heat treated C-wire alloy, which offers controlled memory properties, improved flexibility, and enhanced resistance to cyclic fatigue. It operates in continuous rotation and features a variable cross-sectional design that promotes efficient cutting while maintaining effective debris removal during canal preparation. Apical extrusion of debris is an inevitable consequence of root canal instrumentation. The extrusion of dentinal debris, microorganisms, and irrigants beyond the apical foramen may induce an inflammatory response in the periapical tissues, which is considered a major contributing factor to postoperative pain. The amount of apically extruded debris has been shown to vary according to the design and kinematics of the instrumentation system used. Despite the continuous evolution in instrument design, there is limited evidence regarding the influence of flat-sided rotary systems compared to non-flat cross-sectional systems on apical debris extrusion and postoperative pain,particularly in curved canals. Furthermore, the potential relationship between debris extrusion and the severity of postoperative pain remains insufficiently explored.

Interventions

PROCEDUREAF 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.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment of Postoperative Painfrom 0 hours to 1 week after the procedurePain 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.

Countries

Egypt

Contacts

CONTACTNahla Nasr El-Din Fouad Mohamed, MSC
nannanasr248@gmail.com+201009067349
CONTACTDalia Ali Mokarab, M.D
dalia.mokarab@mu.edu.eg+201068121523
STUDY_CHAIRMaged Mohamed Negm, Professor

Endodontics Department, Faculty of Dentistry, Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026