Adherence to Computer-assisted Maxillofacial Reconstructions

Completed

• Conditions: Maxillofacial Abnormalities; Computer-assisted Surgery; Virtual Surgical Planning

• Registration Number: NCT04895319
• Lead Sponsor: KU Leuven

Brief 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.

Detailed Description

computer-aided design

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2020-06-01
• Study Completion: 2021-03-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models.
2. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis.

Exclusion Criteria

1. Patients undergoing computer-assisted implant surgery were excluded.
2. Patients undergoing computer-assisted orthognathic surgery were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The adherence of computer-assisted surgery	The outcome were recorded preoperatively or intraoperatively	The original plans were classified as completely executed, partially executed or abandoned.