Whole vs Segmented 3D Models for Mandibular Reconstruction

January 27, 2026 updated by: Kristaninta Bangun, Indonesia University

Whole Versus Segmented In-House 3D Mandibular Guides for Mandibular Reconstruction Using Free Fibular Flaps: A Randomized Clinical Trial

Three-dimensional (3D) printing is increasingly used in surgery to help doctors plan and perform complex operations with greater accuracy. In this study, the investigators used 3D-printed jaw models to assist in rebuilding the lower jaw (mandible) after tumor removal, using bone taken from the lower leg in a procedure called a free fibular flap.

The investigators compared two types of 3D-printed mandibular guides. One used a complete model of the patient's healthy mandible to guide reconstruction, while the other rebuilt the jaw by dividing the leg bone into planned segments and fitting them precisely into the jaw defect. All 3D design and printing were performed in-house by the surgical team using free computer software.

After surgery, the investigators evaluated facial symmetry using standardized photographs taken before surgery and three months afterward. Both techniques helped surgeons achieve good reconstruction results. However, the segmented model produced more consistent facial symmetry, while results from the whole-mandible model varied more between patients.

Overall, this study shows that in-house 3D printing is a practical and affordable tool for jaw reconstruction surgery. Although both approaches were effective, segmented models may offer more reliable results. Larger studies are needed to confirm these findings and improve future patient care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • Indonesia
    • Central Jakarta
      • Jakarta, Central Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients undergoing segmental mandibular reconstruction with a free fibular flap.
  2. Mandibular defects resulting from benign tumors, malignant tumors, trauma, or osteonecrosis requiring reconstruction.
  3. Availability of preoperative high-resolution CT imaging suitable for virtual surgical planning and 3D modeling.
  4. Agreed and signed the consent forms

Exclusion Criteria:

  1. Contraindications to free fibular flap harvest (e.g., significant peripheral vascular disease, prior fibular surgery).
  2. History of previous mandibular reconstruction or major maxillofacial surgery altering baseline anatomy.
  3. Preexisting severe facial asymmetry unrelated to the mandibular defect.
  4. Inadequate imaging data or incomplete medical records.
  5. Incomplete or poor-quality postoperative photographs preventing accurate asymmetry measurement.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEGMENTED MODEL
Segmented 3D Mandibular Model.
Device: 3D-printed surgical guide - segmented model
In this technique, a 3D scan of the patient's mandible was isolated, the defect excised, mimicking post-surgical resection mandible. Then, the 3D scan of the patient's fibula was isolated and arranged into segments to match the post-resection defect of the mandible. The final result would resemble the patient's mandible after reconstruction with free fibular flap.
Active Comparator: WHOLE MANDIBLE MODEL
Whole 3D Mandibular Model.
Device: 3D-printed surgical guide - whole mandible model
In this technique, the patient's mandibular anatomy was segmented from the preoperative 3D scan, and the diseased portion of the mandible was digitally removed. The unaffected hemimandible was then mirrored across the sagittal plane to generate a symmetrical, anatomically normal mandibular contour. When the defect extended beyond the midline, a standardized normal mandibular model was digitally trimmed and adapted to the patient's anatomy by adjusting the intercondylar distance and mandibular curvature. The finalized model was positioned within the patient's mandibular fossa to ensure accurate anatomical alignment and optimal fit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACIAL SYMMETRY
Time Frame: From enrollment to 1 month postoperatively

Postoperative assessment of facial symmetry was performed using clinical photographs and plain radiograph of the head (AP) taken 1 month after surgery. The facial asymmetry index (AI) was calculated using the formula:

AI (%) = (R - L)/(R + L) × 100%, based on cephalometric landmarks including sella-nasion (Sn), angle of the mouth (Am), and soft tissue pogonion (Po) (Figure 3), in accordance with the method described by Nakamura et al.⁴. This index represents the proportional difference between the right and left sides of each landmark relative to total facial width, expressed as a percentage. Higher AI values indicate greater facial asymmetry.
From enrollment to 1 month postoperatively

Collaborators and Investigators

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

Sponsor

Indonesia 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)

June 1, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3DFFF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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