NCT07365085

Whole vs Segmented 3D Models for Mandibular Reconstruction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• 3d Printing
• Facial Symmetry
• Free Fibular Flap
• 3d Model
• Mandibular Reconstruction

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2026-01-26
• Last updated: 2026-01-29

Locations

1 site across 1 country: Indonesia