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CompletedNCT04895319Updated May 21, 2021

Adherence to Computer-assisted Maxillofacial Reconstructions

An observational study in Maxillofacial Abnormalities, Computer-assisted Surgery and Virtual Surgical Planning, sponsored by KU Leuven. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
136
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

computer-aided design

02

Conditions studied

  • Maxillofacial Abnormalities
  • Computer-assisted Surgery
  • Virtual Surgical Planning

Keywords

  • Computer-Assisted Surgery
  • Treatment Adherence and Compliance
  • Patient-Specific Modelling
03

In context

Maxillofacial Abnormalities

21 studies on the registry are indexed under Maxillofacial Abnormalities; 2 are open to participants now.

Browse Maxillofacial Abnormalities studies →

Lead sponsor

KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patients undergoing computer-assisted implant surgery were excluded.
  2. Patients undergoing computer-assisted orthognathic surgery were excluded.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
136 participants (actual)
Patient registry
No

Interventions

  • DeviceComputer-assisted surgery

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

06

What researchers measure

Primary outcomes

  1. The adherence of computer-assisted surgery

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

    Time frame: The outcome were recorded preoperatively or intraoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04895319
Lead sponsor
KU Leuven
Responsible party
Hongyang Ma (Principle investigator, KU Leuven) — Principal investigator
First posted
May 20, 2021
Start date
Jan 1, 2014
Primary completion
Jun 1, 2020
Completion
Mar 1, 2021
Last update
May 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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