Whole vs Segmented 3D Models for Mandibular Reconstruction

NCT07365085 | Completed

• 1 other identifier: 3DFFF
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

3d printing; facial symmetry; free fibular flap; 3d model; mandibular reconstruction

Outcome Measures

Primary Outcomes (1)

• FACIAL SYMMETRY

  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

Study Arms (2)

SEGMENTED MODEL

EXPERIMENTAL

Segmented 3D Mandibular Model.

Device: 3D-printed surgical guide - segmented model

WHOLE MANDIBLE MODEL

ACTIVE COMPARATOR

Whole 3D Mandibular Model.

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

Interventions

3D-printed surgical guide - segmented model DEVICE

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.

SEGMENTED MODEL

3D-printed surgical guide - whole mandible model DEVICE

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.

WHOLE MANDIBLE MODEL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Central Jakarta, 10430, Indonesia

Location

Related Publications (7)

• Probst FA, Liokatis P, Mast G, Ehrenfeld M. Virtual planning for mandible resection and reconstruction. Innov Surg Sci. 2023 Dec 6;8(3):137-148. doi: 10.1515/iss-2021-0045. eCollection 2023 Sep.

  PMID: 38077486 RESULT

• Barr ML, Haveles CS, Rezzadeh KS, Nolan IT, Castro R, Lee JC, Steinbacher D, Pfaff MJ. Virtual Surgical Planning for Mandibular Reconstruction With the Fibula Free Flap: A Systematic Review and Meta-analysis. Ann Plast Surg. 2020 Jan;84(1):117-122. doi: 10.1097/SAP.0000000000002006.

  PMID: 31633539 RESULT

• Davies JC, Chan HHL, Jozaghi Y, Goldstein DP, Irish JC. Analysis of simulated mandibular reconstruction using a segmental mirroring technique. J Craniomaxillofac Surg. 2019 Mar;47(3):468-472. doi: 10.1016/j.jcms.2018.12.016. Epub 2018 Dec 30.

  PMID: 30661926 RESULT

• Nakamura T, Okamoto K, Maruyama T. Facial asymmetry in patients with cervicobrachial pain and headache. J Oral Rehabil. 2001 Nov;28(11):1009-14. doi: 10.1046/j.1365-2842.2001.00766.x.

  PMID: 11722716 RESULT

• Kargilis DC, Xu W, Reddy S, Ramesh SSK, Wang S, Le AD, Rajapakse CS. Deep learning segmentation of mandible with lower dentition from cone beam CT. Oral Radiol. 2025 Jan;41(1):1-9. doi: 10.1007/s11282-024-00770-6. Epub 2024 Aug 14.

  PMID: 39141154 RESULT

• Bosc R, Hersant B, Carloni R, Niddam J, Bouhassira J, De Kermadec H, Bequignon E, Wojcik T, Julieron M, Meningaud JP. Mandibular reconstruction after cancer: an in-house approach to manufacturing cutting guides. Int J Oral Maxillofac Surg. 2017 Jan;46(1):24-31. doi: 10.1016/j.ijom.2016.10.004. Epub 2016 Nov 2.

  PMID: 27815013 RESULT

• Chiu YT, Liao YF. Is cleft severity related to maxillary growth in patients with unilateral cleft lip and palate? Cleft Palate Craniofac J. 2012 Sep;49(5):535-40. doi: 10.1597/10-044. Epub 2010 Dec 23.

  PMID: 21214323 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristaninta Bangun

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 26, 2026
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)