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Adherence to Computer-assisted Maxillofacial Reconstructions

Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04895319
Enrollment
136
Registered
2021-05-20
Start date
2014-01-01
Completion date
2021-03-01
Last updated
2021-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computer-assisted Surgery, Maxillofacial Abnormalities, Virtual Surgical Planning

Keywords

Computer-Assisted Surgery, Treatment Adherence and Compliance, Patient-Specific Modelling

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

Interventions

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

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
The adherence of computer-assisted surgeryThe outcome were recorded preoperatively or intraoperativelyThe original plans were classified as completely executed, partially executed or abandoned.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026