NCT07375030

Brief Summary

This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 17, 2026

Last Update Submit

January 24, 2026

Conditions

Mandibular Angle Fracture

Keywords

Mandibular angle fractureguided reduction and fixation

Outcome Measures

Primary Outcomes (1)

  • Evaluation of accuracy of surgical reduction and fixation

    Evaluation of accuracy of surgical guide will be done using slicer and blender, and mimics software with the aid of the preoperative and postoperative CT. Preoperative planning will be merged with the new CT data to identify the accuracy of reduction.

    Day 1

Secondary Outcomes (1)

  • Clinical evaluation for Intra-opreative time

    Intra-opreative

Study Arms (1)

patients with recent mandibular angle fractures managed with patient specific stents and plates

EXPERIMENTAL
Device: Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

Interventions

Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixationDEVICE

Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

patients with recent mandibular angle fractures managed with patient specific stents and plates

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medically fit patients free from relevant conditions contraindicating surgery.
  • Patients with mandibular angle fracture indicated for open reduction and internal fixation.
  • Presented within 2 weeks from trauma.

You may not qualify if:

  • Infected fracture site.
  • Patients with systemic bone diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

Location

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 29, 2026

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

EG(1)