Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
NCT07654647
Summary
This clinical study aims to evaluate the effectiveness of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects. The study will include patients presenting with congenital, traumatic, or post-surgical facial deformities requiring reconstructive intervention. Eligible participants will undergo preoperative clinical assessment and radiological imaging to design customized implants using computer-aided design (CAD) and 3D printing technology. The implants will be fabricated from medical-grade titanium and surgically placed according to standardized maxillofacial reconstructive protocols. Postoperative follow-up will assess functional outcomes, implant stability, complication rates, and aesthetic improvement over a defined observation period. Outcome evaluation will include clinical examination and patient-reported satisfaction measures. The objective of this study is to determine whether patient-specific 3D-printed titanium implants provide reliable functional restoration and improved aesthetic outcomes in facial reconstruction compared to conventional reconstructive techniques.
Eligibility
Inclusion Criteria: * Age 18 years or older. * Presence of facial bone defects resulting from cystic or tumoral osteolytic lesions. * Acquired or congenital facial deformities associated with bony defects or facial asymmetry. * Patients requiring patient-specific 3D-printed titanium implants for maxillofacial reconstruction. * Aesthetic indications requiring custom facial implant design, including microgenia (chin retrusion). * Ability to provide written informed consent. Exclusion Criteria: * Active pathological lesions at the time of enrollment. * Age below 18 years. * History of radiotherapy within 12 months prior to enrollment. * Chronic untreated vitamin D deficiency. * Uncontrolled diabetes mellitus. * Inability or unwillingness to comply with follow-up requirements.
Conditions7
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NCT07654647