Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates

Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates : a Case Series

The aim of this study was to assess the accuracy of computer-aided orthognathic surgery and patient specific titanium plates for maxillar osteotomy with bi or tripartite disjonction in 22 patients who underwent bimaxillar osteotomy for occlusal trouble.

Study Overview

• Status: Completed
• Conditions: Occlusal Trauma
• Intervention / Treatment: Procedure: bimaxillair osteotomy with maxillar segmentation

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital - IUFC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

22 patients, who underwent bimaxillar osteotomy with maxillar segmentation, in Nice from September 2017 to July 2021, operated by Charles SAVOLDELLI, using patient-specific implants

Description

Inclusion Criteria:

- bimaxillar osteotomy with maxillar segmentation and full imageries .

Exclusion Criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of patient-specific surgical guides and plates in maxillary repositioning with bi or tri-partite disjonction	Error (in millimeters) in repositionning the maxilla comaring 3D-plannification skulls and post-operative CBCT	2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 21IUFC02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No