Clinical Trials Directory

Trials / Completed

CompletedNCT04895319

Adherence to Computer-assisted Maxillofacial Reconstructions

Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions

Status
Completed
Phase
Study type
Observational
Enrollment
136 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers

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

Conditions

Interventions

TypeNameDescription
DEVICEComputer-assisted surgeryThe reconstruction was performed with the help of virtual surgical plan and 3D printed models.

Timeline

Start date
2014-01-01
Primary completion
2020-06-01
Completion
2021-03-01
First posted
2021-05-20
Last updated
2021-05-21

Source: ClinicalTrials.gov record NCT04895319. Inclusion in this directory is not an endorsement.