Whole vs Segmented 3D Models for Mandibular Reconstruction

University of Indonesia (UI)

Status: Completed

Conditions: Facial Symmetry; Mandibular Reconstruction; 3d Model; 3d Printing; Free Fibular Flap

Treatments: Device: 3D-printed surgical guide - segmented model; Device: 3D-printed surgical guide - whole mandible model

Study type: Interventional

Funder types: Other

Identifiers

NCT07365085

3DFFF

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

SEGMENTED MODEL

Experimental group

Description:

Segmented 3D Mandibular Model.

Treatment:

Device: 3D-printed surgical guide - segmented model

WHOLE MANDIBLE MODEL

Active Comparator group

Description:

Whole 3D Mandibular Model.

Treatment:

Device: 3D-printed surgical guide - whole mandible model