Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction. (3DFACE)
Evaluation of the Effectiveness of Patient-Specific 3D-Printed Titanium Facial Implants in the Reconstruction and Aesthetic Correction of Facial Defects: A Clinical Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmad F Ahmad, Phd
- Número de teléfono: 00963992035690
- Correo electrónico: ahmad.fayez.ahmad@latakia-univ.edu.sy
Ubicaciones de estudio
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Latakia, Siria
- Reclutamiento
- Ahmad Fayez Ahmad
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Contacto:
- Ahmad F Ahmad, Phd
- Correo electrónico: ahmad.fayez.ahmad@latakia-univ.edu.sy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Patient-Specific 3D-Printed Titanium Implant Reconstruction Group
Participants in this study will undergo reconstruction of facial defects using patient-specific three-dimensional (3D)-printed titanium implants. Preoperative planning will be performed using clinical assessment and high-resolution radiographic imaging to design customized implants tailored to each patient's anatomical defect. The implants will be fabricated from medical-grade titanium using additive manufacturing technology. Surgical reconstruction will be performed under standard maxillofacial surgical protocols. The customized titanium implants will be positioned and fixed to restore both functional integrity and facial aesthetics. Postoperative follow-up will include clinical evaluation, radiographic assessment, and monitoring for complications, implant stability, and aesthetic outcomes over the defined study period. |
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 (SLM) additive manufacturing technology. Post-processing will include surface finishing and sterilization prior to surgical use. Surgical placement will be performed under general anesthesia following standard maxillofacial surgical protocols. The customized implants will be fixed to the native bone using titanium fixation screws when required to restore facial contour, structural support, and symmetry. Postoperative follow-up will include clinical and radiological assessment using CT imaging t |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative Complication Rate
Periodo de tiempo: From surgery up to 6 months postoperatively
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Assessment of postoperative complications following reconstruction with patient-specific 3D-printed titanium implants.
Complications include infection, implant exposure, implant failure, or the need for revision surgery.
Each patient will be assigned a binary score: 0 = no postoperative complication and 1 = presence of one or more postoperative complications.
The outcome will be evaluated and recorded by the treating surgeon during the follow-up period.
Higher values indicate a greater complication rate.
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From surgery up to 6 months postoperatively
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Outcome Measure Title: Implant Geometric Accuracy Assessed by 3D Deviation Analysis
Periodo de tiempo: Immediately after laser-based 3D printing of the implant and before surgical implantation.
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Assessment of the geometric accuracy of the patient-specific 3D-printed titanium implant by performing three-dimensional scanning of the manufactured implant and comparing it with the original digital design using 3D deviation analysis software.
Accuracy will be quantified as the root mean square (RMS) deviation between the scanned implant and the planned digital model.
Lower deviation values indicate higher manufacturing accuracy.
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Immediately after laser-based 3D printing of the implant and before surgical implantation.
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Aesthetic Improvement Score
Periodo de tiempo: 3 months after surgery
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Assessment of facial symmetry following reconstruction using a standardized 5-point facial symmetry scale evaluated by an independent plastic surgeon.
Scores range from 1 (severe asymmetry) to 5 (excellent symmetry).
Higher scores indicate better aesthetic outcomes.
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3 months after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Operative Time (Minutes)
Periodo de tiempo: During surgery
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Assessment of the total duration of the surgical procedure, measured from skin incision to wound closure and recorded in minutes.
Operative time will be compared with historical data from conventional reconstruction techniques.
Lower values indicate greater surgical efficiency.
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During surgery
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Patient Satisfaction Score Using a 10-Point Visual Analog Scale (VAS)
Periodo de tiempo: 3 months after surgery
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Assessment of patient satisfaction with the reconstructive outcome using a 10-point Visual Analog Scale (VAS).
The scale ranges from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction.
Higher scores indicate greater patient satisfaction.
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3 months after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Basim A Slim, Tishreen University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Neoplasias por sitio
- Neoplasias
- Condiciones Patológicas, Anatómicas
- Infecciones
- Neoplasias por tipo histológico
- Neoplasias de Cabeza y Cuello
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Anomalías craneofaciales
- Anomalías musculoesqueléticas
- Anomalías congénitas
- Infecciones bacterianas y micosis
- Carcinoma De Células Escamosas
- Osteocondrodisplasias
- Enfermedades óseas del desarrollo
- Disostosis
- Disostosis craneofacial
- Micosis
- Disostosis mandibulofacial
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Zigomicosis
- Carcinoma de células escamosas de cabeza y cuello
- Displasia fibrosa del hueso
- Mucormicosis
- Síndrome de Goldenhar
- Asimetría facial
Otros números de identificación del estudio
- latakia-univ-2100
- 1739 (Otro identificador: Scientific Research Council Decision No. 1739)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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