Cipto Mangunkusumo Hospital
Jakarta, Central Jakarta, 10430, Indonesia
NCT Number: NCT07365085
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Jakarta, Central Jakarta, 10430, Indonesia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From enrollment to 1 month postoperatively
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.
Indonesia University
Other
Whole Versus Segmented In-House 3D Mandibular Guides for Mandibular Reconstruction Using Free Fibular Flaps: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07483008
3D Printing, Arrhythmias, Cardiac
Hong Kong, New Territories
View Trial DetailsNCT07389382
3D Printing, Agnosia
Zonguldak, Zonguldak Province, Turkey (Türkiye)
View Trial DetailsNCT06622538
3D Printing, Anesthesia
Mexico City, Cuauhtemoc, Mexico
View Trial DetailsNCT07676929
3D Printing, Composite Restoration
Tanta, Egypt
View Trial Details