MalocclusionNCT06235138
Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery
An observational study of Malocclusion, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Malocclusion
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 15 May 2017to 15 Aug 2023
- 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 to 43 years
- All sexes
- Adult
Study population: Patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France
- Inclusion Criteria: patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France
- Exclusion Criteria: None
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nice
Nice, Alpes Maritimes, 06000
CHU NICE
Nice, Alpes Maritimes, 06000
About this study
Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, **).
- Conditions
- Malocclusion
- Medical subject headings
- Malocclusion
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of interest was the postoperative aspect and position of the gonial angle
The primary outcome of interest was the postoperative aspect and position of the gonial angle, assessed by 3D-stereophotogrametry
Measured: postoperative week 4
Secondary outcome of interest is patients satisfaction
Scale title = échelle de Likert. Maximum score 5 (= not satisfied) / minimum score 1 (= total satisfaction)
Measured: From post operative week 1 to one year follow-up
Secondary outcome of interest is number and type of complications
Secondary outcome of interest is number and type of complications
Measured: From post operative week 1 to one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 May 2017
- Primary completion15 Aug 2022
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olina RIOS, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235138
- Sponsor's protocol ID
- 23IUFC01
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06235138
- Acronym / sponsor ID
- 23IUFC01
- Conditions
- Malocclusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 31 Jan 2024 (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.
Background: Jawline improvement is nowadays a strong patients' demand. Among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. A few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. The advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (CAD-CAM) techniques for patient-specific implant (PSI) fabrication has enabled new methods for managing the jawline in orthognathic surgery. The aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.Methods: A virtual simulation of a Le Fort I osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3D) model of each patient's skull using ProPlan CMF software (Materialise, Leuven, Belgium). Computer-assisted osteotomy saw-and-drill guides and patient-specific implants (PSIs, titanium plates and angle implants) were produced and used during the surgery. The investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3D-photographs using the VECTRA H2 3D imagine system (Canfield Scientific, **).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at Head and Neck Institute, Nice, France
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome of interest was the postoperative aspect and position of the gonial angle
Time frame: postoperative week 4
The primary outcome of interest was the postoperative aspect and position of the gonial angle, assessed by 3D-stereophotogrametry
Secondary outcome of interest is patients satisfaction
Time frame: From post operative week 1 to one year follow-up
Scale title = échelle de Likert. Maximum score 5 (= not satisfied) / minimum score 1 (= total satisfaction)
Secondary outcome of interest is number and type of complications
Time frame: From post operative week 1 to one year follow-up
Secondary outcome of interest is number and type of complications
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 31 Jan 2024.
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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.
Olina RIOS principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The primary outcome of interest was the postoperative aspect and position of the gonial angle (time frame: postoperative week 4). The study lists 3 primary outcomes in all. 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 31 Jan 2024.