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3d PrintingNCT07365085

Whole vs Segmented 3D Models for Mandibular Reconstruction

A study testing 3D-printed surgical guide - segmented model and 3D-printed surgical guide - whole mandible model in people with 3d Printing and Facial Symmetry, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
3d Printing, Facial Symmetry, Free Fibular Flap
What is being tested?
3D-printed surgical guide - segmented model and 3D-printed surgical guide - whole mandible model
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndonesia
Study dates
1 Jun 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta, Central Jakarta, 10430

Other trials in Indonesia

About this study

Official title: 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.

Read more

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.

Being tested
3D-printed surgical guide - segmented model, 3D-printed surgical guide - whole mandible model
Keywords
3d printing, facial symmetry, free fibular flap, 3d model, mandibular reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D-printed surgical guide - segmented modelDevice

    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.

  • 3D-printed surgical guide - whole mandible modelDevice

    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.

Study groups in NCT07365085
Study groupRoleWhat they receive
SEGMENTED MODELExperimentalSegmented 3D Mandibular Model.
Receives: Device: 3D-printed surgical guide - segmented model
WHOLE MANDIBLE MODELActive comparatorWhole 3D Mandibular Model.
Receives: Device: 3D-printed surgical guide - whole mandible model

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to 1 month postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start1 Jun 2023
  3. Primary completion30 Jun 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07365085
Sponsor's protocol ID
3DFFF
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38077486

  • 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.

    PubMed 31633539

  • 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.

    PubMed 30661926

  • 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.

    PubMed 11722716

  • 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.

    PubMed 39141154

  • 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.

    PubMed 27815013

  • 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.

    PubMed 21214323

Questions about this trial

What is this clinical trial studying?

A study testing 3D-printed surgical guide - segmented model and 3D-printed surgical guide - whole mandible model in people with 3d Printing and Facial Symmetry, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACIAL SYMMETRY (time frame: From enrollment to 1 month postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365085, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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