CompletedNot Applicable

Whole vs Segmented 3D Models for Mandibular Reconstruction

Indonesia36 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FACIAL SYMMETRY

Timeframe: From enrollment to 1 month postoperatively

Trial details

NCT IDNCT07365085

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

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