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Completed

NCT Number: NCT06970730

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

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

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Key information

Conditions

Craniofacial Surgery Virtual Surgical Planning

Age range

10 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Distance deviation

    Time frame: Immediate post operative

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

  2. Angular deviation

    Time frame: Immediate post operative

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

Secondary outcomes

  1. Change in post operative aesthetic results of surgery

    Time frame: 1 week, 4 weeks, 8 weeks, and 6 months

    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.

  2. change in Quality of Life (QOL)

    Time frame: 1 week, 4 weeks, 8 weeks, and 6 months

    Scores as follow 0 = much better.

    • = better.
    • = the same.
    • = worse.
    • = much worse

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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