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

Study acronym: 3DFACE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Changed Sponsor changed: Tishreen University to Latakia University
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07654647
Lead Sponsor Latakia University
Conditions
(from sponsor)		 Hemifacial Microsomia, Mucormycosis, Oral Squamous Cell Carcinoma, Microgenia, Facial Asymmetry, Fibrous Dysplasia
Related terms Facial Asymmetry, Fibrous Dysplasia of Bone, Goldenhar Syndrome, Mucormycosis, Squamous Cell Carcinoma of Head and Neck
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov