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Adherence to Computer-assisted Maxillofacial Reconstructions

NCT04895319 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 136

Last updated 2021-05-21

No results posted yet for this study

Summary

The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.

Conditions

  • Maxillofacial Abnormalities
  • Computer-assisted Surgery
  • Virtual Surgical Planning

Interventions

DEVICE

Computer-assisted surgery

The reconstruction was performed with the help of virtual surgical plan and 3D printed models.

Sponsors & Collaborators

  • KU Leuven

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2020-06-01
Completion
2021-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895319 on ClinicalTrials.gov