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

NCT07654647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-17

No results posted yet for this study

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

Interventions

PROCEDURE

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 (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

Sponsors & Collaborators

  • Latakia University

    lead OTHER

Principal Investigators

  • Basim A Slim · Latakia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-26
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654647 on ClinicalTrials.gov