An interventional study of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction in Craniofacial Surgery and Virtual Surgical Planning, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 10 Years to 47 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment
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
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.
Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
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
Time frame: 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
Time frame: Immediate post operative
Change in post operative aesthetic results of surgery
aesthetic scale from zero to 5 * 5 points - changes are not visually noticeable. * 4 points - changes in appearance are barely noticeable and do not affect the patient's quality of life. * 3 points - aesthetic deficit that does not require surgical correction. * 2 points - aesthetic defects require minor surgical corrections in the postoperative period. * 1 point - significant aesthetic defects require serious (often multi-stage surgical correction). * 0 points - the presence of severe aesthetic defects that cannot be eliminated.
Time frame: 1 week, 4 weeks, 8 weeks, and 6 months
change in Quality of Life (QOL)
Scores as follow 0 = much better. 1. = better. 2. = the same. 3. = worse. 4. = much worse
Time frame: 1 week, 4 weeks, 8 weeks, and 6 months
Ran from Feb 2021 to primary completion in Jan 2025, 47 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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