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

NCT07385924 | Completed Phase 4

• 1 other identifier: 00010825-12/2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Fracture; Virtual Plan of Mandibular Fracture

Keywords

mandibular fracture; virtual surgical planning

Outcome Measures

Primary Outcomes (1)

• Evaluation of accuracy of mandibular reduction of each surgical guide.

  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 Outcomes (1)

• Clinical evaluation of postoperative occlusion

  3 months

Study Arms (2)

virtual planning will be done using the manual virtual reduction method

EXPERIMENTAL

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.

virtual planning will be done using the mirror image technique.

EXPERIMENTAL

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.

Interventions

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.

virtual planning will be done using the manual virtual reduction method

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.

virtual planning will be done using the mirror image technique.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Medically fit patients free from relevant conditions contraindicating surgery.
• Unilateral mandibular fractures indicated for open reduction and internal fixation

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). (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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)