Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.

Официальное название

Evaluation of the Effectiveness of Patient-Specific 3D-Printed Titanium Facial Implants in the Reconstruction and Aesthetic Correction of Facial Defects: A Clinical Study

Обзор

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.

Подробное описание

Background:

Facial bone defects and contour deformities may result from congenital anomalies, trauma, tumor resection, cystic lesions, or developmental deficiencies. Conventional reconstructive techniques often rely on standard implants or intraoperative modification of grafts, which may not provide optimal anatomical adaptation or aesthetic outcomes.

Recent advances in three-dimensional (3D) imaging, computer-aided design (CAD), and additive manufacturing technologies have enabled the production of patient-specific titanium implants tailored to the unique anatomy of individual patients. These implants may improve surgical precision, reduce operative time, enhance facial symmetry, and provide more predictable functional and aesthetic outcomes.

Objective:

This clinical study aims to evaluate the effectiveness, safety, and clinical performance of patient-specific 3D-printed titanium facial implants in the reconstruction and aesthetic correction of facial defects.

Methods:

Eligible adult patients presenting with facial bone defects, facial asymmetry, congenital deformities, post-traumatic defects, or aesthetic indications requiring customized facial augmentation will undergo preoperative imaging using computed tomography (CT). Patient-specific titanium implants will be designed using computer-aided design software and manufactured using 3D-printing technology.

Clinical evaluation will include assessment of implant fit accuracy, facial symmetry, aesthetic outcomes, postoperative complications, patient satisfaction, and overall treatment success. Follow-up assessments will be performed at regular intervals for up to 12 months after surgery.

Expected Outcomes:

The study is expected to demonstrate that patient-specific 3D-printed titanium implants provide accurate anatomical reconstruction, improved facial aesthetics, high patient satisfaction, and acceptable safety profiles when used for facial reconstruction and contour correction.

Вмешательства

• Процедура Patient-specific titanium implants for facial reconstruction
  Patient-specific 3D-printed titanium implants will be used for reconstruction of facial bone defects and correction of facial deformities. Each implant will be individually designed based on high-resolution computed tomography (CT) imaging and three-dimensional virtual surgical planning (VSP) using computer-aided design (CAD) software to accurately match the patient's anatomical defect. The implants will be manufactured from medical-grade titanium alloy (Ti6Al4V) using selective laser melting (

Первичные конечные точки

• Postoperative Complication Rate [Срок оценки: From surgery up to 6 months postoperatively]
• Outcome Measure Title: Implant Geometric Accuracy Assessed by 3D Deviation Analysis [Срок оценки: Immediately after laser-based 3D printing of the implant and before surgical implantation.]
• Aesthetic Improvement Score [Срок оценки: 3 months after surgery]

Вторичные конечные точки (2)

• Total Operative Time (Minutes) [Срок оценки: During surgery]
• Patient Satisfaction Score Using a 10-Point Visual Analog Scale (VAS) [Срок оценки: 3 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Syria · 1 центр

• Ahmad Fayez Ahmad — Latakia

Публикации

• Mayo W, Mohamad AH, Zazo H, Zazo A, Alhashemi M, Meslmany A, Haddad B. Facial defects reconstruction by titanium mesh bending using 3D printing technology: A report of two cases. Ann Med Surg (Lond). 2022 May 20;78:103837. doi: 10.1016/j.amsu.2022.103837. eCollection 2022 Jun. PMID 35734651
• Almudarris BA, Rajput T, Singh V, Feroz SMA, Qurishi AA, Kumar J, Homeida HE. Outcomes of Using 3D-Printed Titanium Implants in Mandibular Reconstruction. J Pharm Bioallied Sci. 2025 Jun;17(Suppl 2):S1529-S1531. doi: 10.4103/jpbs.jpbs_1816_24. Epub 2025 Jun 18. PMID 40655799
• Lim HK, Choi YJ, Choi WC, Song IS, Lee UL. Reconstruction of maxillofacial bone defects using patient-specific long-lasting titanium implants. Sci Rep. 2022 May 9;12(1):7538. doi: 10.1038/s41598-022-11200-0. PMID 35534499
• Zhang WB, Yu Y, Mao C, Wang Y, Guo CB, Yu GY, Peng X. Outcomes of Zygomatic Complex Reconstruction With Patient-Specific Titanium Mesh Using Computer-Assisted Techniques. J Oral Maxillofac Surg. 2019 Sep;77(9):1915-1927. doi: 10.1016/j.joms.2019.03.014. Epub 2019 Mar 23. PMID 31002789

Идентификаторы

NCT: NCT07654647 · latakia-univ-2100 · 1739

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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