NCT05186376

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 27, 2021

Last Update Submit

January 12, 2022

Conditions

Occlusal Trauma

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

bimaxillair osteotomy with maxillar segmentationPROCEDURE

Patients who underwent bimaxillair osteotomy with maxillar segmentation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \- bimaxillar osteotomy with maxillar segmentation and full imageries .

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital - IUFC

Nice, 06000, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 11, 2022

Study Start

May 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 21, 2021

Last Updated

January 13, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)