Occlusal Trauma Clinical Trial
Official title:
Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates : a Case Series
| NCT number | NCT05186376 |
| Other study ID # | 21IUFC02 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 1, 2021 |
| Est. completion date | July 21, 2021 |
| Verified date | December 2021 |
| Source | Centre Hospitalier Universitaire de Nice |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | July 21, 2021 |
| Est. primary completion date | July 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - bimaxillar osteotomy with maxillar segmentation and full imageries . Exclusion Criteria: None |
| Country | Name | City | State |
|---|---|---|---|
| France | Nice University Hospital - IUFC | Nice |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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|---|---|---|---|
| Completed |
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