Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures

March 26, 2025 updated by: Mazen Tharwat Abou Elkhier, Mansoura University

Evaluation of Accuracy of Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures: A Prospective Clinical Study

The primary objective of this study was to evaluate the accuracy of virtual reduction and the prebending of the 3D miniplates on printed models for fixation of anterior mandibular fractures. The secondary objective is to evaluate the bone healing of anterior mandibular reduction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The mandible is the largest and most prominent bone in the maxillofacial region. Facial fractures frequently involve the mandible. Rigid internal fixation combined with maxillomandibular fixation is the standard surgical procedure for treating mandibular fractures. Maxillofacial surgery currently makes extensive use of digital technology in areas like surgical navigation, titanium plate preforming technology, and 3D digital guide plate technology.

Monocortical miniplates that are easily adaptable are used in Champy's semi-rigid fixation technique, along with an "ideal osteosynthesis line" to counteract the developing masticatory forces. The location of the bone plate fixation must provide the fixation method that is most stable in relation to the line of tension at the base of the alveolar process. One plate is often used for fractures that are posterior to the foramen, and two plates are typically used for fractures anterior to the foramen.

Due to muscles working against each other, the anterior mandible fractures are subject to strong torsional forces. Some researchers have suggested using the three-dimensional (3D) miniplates as a viable option for fixation.

To ensure successful osteosynthesis with a minimally invasive approach, three-dimensional (3D) miniplate systems can be used. The system comprises two miniplates joined by interconnecting crossbars and fixed to the bone with monocortical screws. When placed in the fracture line, the 3D miniplate system ensures fracture stabilization, regardless of plate thickness and geometry. The placement of screws in a square pattern on either side of the fracture creates a solid platform that increases resistance to twisting and rotation of the longitudinal axis of the plate.

The stability of occlusion after using 3D miniplates may be due to the box-like configuration, providing rigid fixation of fractures that prevent Buccolingual splaying and gap formation at the fracture site and subsequent occlusal discrepancy; this is the advantage of 3D miniplates over 2D miniplates.

The surgeon is now able to use 3D segmentation and mirroring methods, which are highly effective in simulating the pre-traumatized anatomy at a minimal cost, using advanced open-source software programs.

The idea behind 3D printing in the medical industry is to take anatomical scans utilizing imaging methods like computed tomography (CT) and magnetic resonance imaging (MRI). The images from these methods will be saved in a common format, such as the Digital Imaging and Communications in Medicine (DICOM) format, and then with the aid of computer-aided design (CAD) software, a virtual 3D prototype with Standard Tessellation Language (STL) format will be created to enable 3D printing and the deposition of the material layer by layer to achieve the final structure.

Thus, in the present study, the goal was to assess the accuracy of virtual planning and pre-bent 3D miniplates in anterior mandibular fixation by comparing postoperative outcomes with preoperative virtual reduction and to evaluate the clinical outcomes and bone density after fixation with 3D miniplates.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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, 21526
        • oral and maxillofacial department , faculty of dentistry, Alexandria university
      • Alexandria, Egypt, 21526
        • oral and maxillofacial department, faculty of dentistry,Alexandria
      • Alexandria, Egypt, 21526
        • Oral and Maxillofacial Department

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recent anterior mandibular fractures (within one week).
  • Adult patients of both genders (18-50 years old).
  • Systematic healthy patients.
  • Radiographic evidence of anterior mandibular fracture.

Exclusion Criteria:

  • Medically compromised patients contraindicated for general anaesthesia and bone surgery.
  • Comminuted fractures.
  • Bilateral anterior mandibular fractures.
  • Previously treated fractures.
  • Pathological fractures and 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: virual plan before and after mandibular fracture fixation
virual plan before and after mandibular fracture fixation and 3D miniplate fixation
Device: 3d miniplate
3d miniplate was used for mandibular fracture fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone density was measured by Hounsfield units (HU) measured on CT images
Time Frame: 3 months
The length and width of the mandible were measured using 3D CT scan with digital callipers in millimetres.
3 months
mandible dimensions
Time Frame: 3 months
Mandibular length and width were measured using 3D CT scan with digital callipers in millimetres.
3 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Collaborators

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 10, 2021

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

March 10, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D printing and virtual plan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to [privacy/ethical/confidentiality] reasons, the research data are not publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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