Evaluation of the Accuracy of 3d Printed Reduction Guide in Treatment of Mandibular Fractures Using Two Different Methods of Virtual Planning

January 27, 2026 updated by: Alexandria University

Evaluation of Accuracy of the Use of 3d Printed Reduction Guide in Treatment of Mandibular Fractures Using Two Different Methods of Virtual Planning

This study will evaluate the accuracy of the use of 3-D printed reduction guide in treatment of mandibular fractures using two different methods of virtual planning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted clinically on 24 patients with mandibular fracture divided into 2 groups, (group A) virtual planning will be done using the manual virtual reduction method and (group B) virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.

Study Type

Interventional

Enrollment (Actual)

24

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.
  • Unilateral mandibular fractures indicated for open reduction and internal fixation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual planning will be done using the manual virtual reduction method
virtual planning will be done using the manual virtual reduction method and . Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
Device: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.
Experimental: virtual planning will be done using the mirror image technique.
virtual planning will be done using the mirror image technique. Design of the reduction guide will be done in accordance with the virtual plan. The surgical reduction will be done with the aid of the guide.
Device: Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.
Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of accuracy of mandibular reduction of each surgical guide.
Time Frame: Immediately after the surgery

Evaluation of accuracy of surgical guide will be done using slicer and blender 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.

Landmark-Based Positional Analysis was used to quantify positional accuracy of the reduced mandibular segment. Bilateral mandibular landmarks were selected to represent the spatial position of the fractured and adjacent segments. The selected landmarks included condylion (Co), gonion (Go), and mental foramen (MF), which are distributed across the mandibular ramus, angle, and body regions. linear distances to the three reference planes were recorded in millimeters. To provide a comprehensive three-dimensional representation of positional discrepancy, an asymmetry index (AI) was calculated for each bilateral landmark.
Immediately after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of postoperative occlusion
Time Frame: 3 months

Assessment of occlusion will be done By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization.

The percentage of patients suffering from occlusal disturbances will be recorded.
3 months

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)

February 1, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00010825-12/2023

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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