Adherence to Computer-assisted Maxillofacial Reconstructions

Maxillofacial Abnormalities Clinical Trial

Official title:

Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895319
• Other study ID #: S63615-3
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

computer-aided design

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 1, 2021
• Est. primary completion date: June 1, 2020
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Computer-assisted Surgery
• Maxillofacial Abnormalities

Intervention

Device:
• Computer-assisted surgery
The reconstruction was performed with the help of virtual surgical plan and 3D printed models.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The adherence of computer-assisted surgery	The original plans were classified as completely executed, partially executed or abandoned.	The outcome were recorded preoperatively or intraoperatively