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
| Type | Name | Description |
|---|---|---|
| DEVICE | Computer-assisted surgery | The 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.