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

NCT06970730 | Completed

• 1 other identifier: 644-08/2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Craniofacial Surgery; Virtual Surgical Planning

Outcome Measures

Primary Outcomes (2)

• Distance deviation

  the accuracy of reconstruction, defined as linear deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans

  Immediate post operative

• Angular deviation

  the accuracy of reconstruction, defined as angulation deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans

  Immediate post operative

Secondary Outcomes (2)

• Change in post operative aesthetic results of surgery

  1 week, 4 weeks, 8 weeks, and 6 months

• change in Quality of Life (QOL)

  1 week, 4 weeks, 8 weeks, and 6 months

Study Arms (1)

virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction.

EXPERIMENTAL

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

Interventions

virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction 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.

virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction.

Eligibility Criteria

• Age: 10 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Azarita, 00203, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: February 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

EG (1)