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

Hams Hamed Abdelrahman

Status: Completed

Conditions: Craniofacial Surgery; Virtual Surgical Planning

Treatments: Procedure: virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT06970730

644-08/2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 10 to 47 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to:
• Trauma.
• Tumor resection (either by immediate or delayed reconstruction).
• Complex congenital and dentofacial deformities.

Exclusion criteria

• Patients with special needs.
• Medically compromised patients who are not fit for surgery.
• Irradiated patients.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction.

Experimental group

Treatment:

Procedure: virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction