NCT07808684

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
3mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 9, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Postoperative PainIrreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Treatment of Postoperative Pain

    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.

    from 0 hours to 1 week after the procedure

Study Arms (2)

one curve file

ACTIVE COMPARATOR

About 15 cases will be subjected to one single file to the full working length. File will be operated at 300 rpm/2.5 Ncm torque in continuous rotation

Procedure: AF One single-file rotary system

AF Fanta flat sided file system

ACTIVE COMPARATOR

About 15 cases will be subjected to one single file to the full working length.File will be operated at 300 rpm/2.5 Ncm torque in continuous rotation

Procedure: AF One single-file rotary system

Interventions

AF One single-file rotary systemPROCEDURE

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.

Also known as: One Curve rotary system
AF Fanta flat sided file systemone curve file

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endodontics, Faculty of Dentistry, Minia University

Minya, Minya Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Maged Mohamed Negm, Professor

    Endodontics Department, Faculty of Dentistry, Cairo University

    STUDY CHAIR

Central Study Contacts

Nahla Nasr El-Din Fouad Mohamed, MSC

CONTACT

+201009067349nannanasr248@gmail.com

Dalia Ali Mokarab, M.D

CONTACT

+201068121523dalia.mokarab@mu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at Endodontics Department,Faculty of Dentistry

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 9, 2026

Record last verified: 2026-06

Locations

EG(1)