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

NCT ID: NCT06970730

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-01-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction.

Group Type: EXPERIMENTAL

virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 47 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Lecturer of Dental Public Health and biostatistical consultanat

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, Egypt

Countries

Egypt

Other Identifiers

644-08/2021

Identifier Type: -

Identifier Source: org_study_id