Adherence to Computer-assisted Maxillofacial Reconstructions

NCT04895319 | Completed

• 1 other identifier: S63615-3
• Study Type: observational
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maxillofacial Abnormalities; Computer-assisted Surgery; Virtual Surgical Planning

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Computer-assisted surgery DEVICE

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

136 patients who undergone computer-assisted maxillofacial reconstructive surgeries that conducted from June 2014 to June 2020.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead

MeSH Terms

Conditions

Maxillofacial Abnormalities; Treatment Adherence and Compliance

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: January 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: March 1, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05