Skip to main content
OpenTrials
Completed

NCT Number: NCT07385924

Evaluation of the Accuracy 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the manual reduction technique.

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 mirror image reduction technique.

Device

Mandibular fracture treatment by 3d printed guide where virtual planning will be done using the mirror image reduction technique.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.