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

NCT07654647 | Recruiting DMC

• 2 other identifiers: latakia-univ-21001739
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemifacial Microsomia; Mucormycosis; Oral Squamous Cell Carcinoma; Microgenia; Facial Asymmetry; Fibrous Dysplasia

Keywords

3D-Printed Titanium Implant * Facial Reconstruction

Outcome Measures

Primary Outcomes (3)

• Postoperative Complication Rate

  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.

  From surgery up to 6 months postoperatively

• Outcome Measure Title: Implant Geometric Accuracy Assessed by 3D Deviation Analysis

  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.

  Immediately after laser-based 3D printing of the implant and before surgical implantation.

• Aesthetic Improvement Score

  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.

  3 months after surgery

Secondary Outcomes (2)

• Total Operative Time (Minutes)

  During surgery

• Patient Satisfaction Score Using a 10-Point Visual Analog Scale (VAS)

  3 months after surgery

Study Arms (1)

Patient-Specific 3D-Printed Titanium Implant Reconstruction Group

EXPERIMENTAL

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.

Procedure: Patient-specific titanium implants for facial reconstruction

Interventions

Patient-specific titanium implants for facial reconstruction PROCEDURE

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

Patient-Specific 3D-Printed Titanium Implant Reconstruction Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Ahmad Fayez Ahmad

Latakia, Syria

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Goldenhar Syndrome; Mucormycosis; Squamous Cell Carcinoma of Head and Neck; Facial Asymmetry; Fibrous Dysplasia of Bone

Condition Hierarchy (Ancestors)

Mandibulofacial Dysostosis; Craniofacial Dysostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Osteochondrodysplasias

Study Officials

• Basim A Slim

  Tishreen University

  STUDY CHAIR

Central Study Contacts

Ahmad F Ahmad, Phd

CONTACT

00963992035690; ahmad.fayez.ahmad@latakia-univ.edu.sy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 17, 2026
• Study Start: April 26, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)