Adherence to Computer-assisted Maxillofacial Reconstructions

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.

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Key information

Conditions

Maxillofacial Abnormalities Behavior Computer-assisted Surgery Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Health Behavior Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Treatment Adherence and Compliance Virtual Surgical Planning

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

computer-aided design

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Computer-assisted surgery

Device

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

Primary outcomes

The adherence of computer-assisted surgery

Time frame: The outcome were recorded preoperatively or intraoperatively

The original plans were classified as completely executed, partially executed or abandoned.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2021
First posted: May 20, 2021
Registry last updated: May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed