Evaluation of Patient-specific Surgical Stents and Plates for Guided Reduction And Fixation of Mandibular Angle Fractures

January 24, 2026 updated by: Alexandria University
This study will evaluate the patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

seven patients with recent mandibular angle fractures indicated for open reduction and internal fixation were treated by patient specific surgical stent and plate for guided reduction and fixation of mandibular angle fractures. Follow-up extended to 12 weeks. Clinical parameters included pain, operative time, postoperative occlusion, wound healing and mouth opening. Radiographic evaluation was conducted using computed tomography scans acquired preoperatively and postoperatively ,superimposition of the pre and postoperative models will be done to create error map and measure the accuracy

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21523
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with recent mandibular angle fractures managed with patient specific stents and plates
Device: Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation
Patient specific surgical stents and plates for guided reduction and fixation of mandibular angle fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of accuracy of surgical reduction and fixation
Time Frame: Day 1
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 Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation for Intra-opreative time
Time Frame: Intra-opreative
Intra-opreative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00010824-12/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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