Occlusal TraumaNCT05186376
Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates
An observational study of Occlusal Trauma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occlusal Trauma
- What is being tested?
- bimaxillair osteotomy with maxillar segmentation
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 21 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- bimaxillar osteotomy with maxillar segmentation and full imageries .
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Occlusal Trauma
- Being tested
- bimaxillair osteotomy with maxillar segmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimaxillair osteotomy with maxillar segmentationProcedure or surgery
Patients who underwent bimaxillair osteotomy with maxillar segmentation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 May 2021
- Primary completion1 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusal TraumaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186376
- Sponsor's protocol ID
- 21IUFC02
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05186376
- Acronym / sponsor ID
- 21IUFC02
- Conditions
- Occlusal Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- bimaxillar osteotomy with maxillar segmentation and full imageries .
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimaxillair osteotomy with maxillar segmentationPatients who underwent bimaxillair osteotomy with maxillar segmentation | Procedure or surgery | – |
Primary outcome
accuracy of patient-specific surgical guides and plates in maxillary repositioning with bi or tri-partite disjonction
Time frame: 2 months
Error (in millimeters) in repositionning the maxilla comaring 3D-plannification skulls and post-operative CBCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occlusal Trauma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of patient-specific surgical guides and plates in maxillary repositioning with bi or tri-partite disjonction (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.