NCT06970730

Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction

Evaluation of Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction (Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hams Hamed Abdelrahman · Academic / Other
• Sex: All
• Age: 10 Years – 47 Years
• Healthy volunteers: Not accepted

Summary

The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan

Detailed description

The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome. The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.

Conditions

• Craniofacial Surgery
• Virtual Surgical Planning

Interventions

Type	Name	Description
PROCEDURE	virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction	Image acquisition by computed tomography (CT slice thickness 1 mm or less) + laser scanning of patient models. Virtual surgical planning and design of patient specific implants. Patient specific implants manufacturing (milling technique) and 3D printing of surgical guides and fit models.

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: Egypt