MalocclusionNCT07365657
Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates
An observational study of Malocclusion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion
- What is being tested?
- In silico orthognathic surgery with customized implants digital only on 3D scanners
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2026to 23 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery
Who may be able to join
- Patient operated on By Pr SAVOLDELLI.
- Patient undergoing patient-specific orthognathic surgery.
- Access to numerical (digital) planning.
Who cannot join
- Previous maxillo-facial trauma.
- Facial cleft.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates
This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Two distinct clinical scenarios-a minor advancement without impaction and a moderate advancement with posterior impaction-were analyzed to determine how surgical movements influence implant stress, bone stress, and maxillary micromotion. By combining surgical planning with validated computational modeling, this work provides clinically relevant insight to optimize PSI design and guide fixation strategy selection in orthognathic surgery.
- Conditions
- Malocclusion
- Being tested
- In silico orthognathic surgery with customized implants digital only on 3D scanners
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In silico orthognathic surgery with customized implants digital only on 3D scannersOther
2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery
| Study group | Role | What they receive |
|---|---|---|
| Type II maloclusion | 2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery Receives: Other: In silico orthognathic surgery with customized implants digital only on 3D scanners | |
| Type III maloclusion | 2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery Receives: Other: In silico orthognathic surgery with customized implants digital only on 3D scanners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plate stress levels
assessed by FORGE software
Measured: At the inclusion
Secondary outcomes (2)
Stress on bone
Mechanical stress in mecanics is measured in Pa (Pascal)
Measured: At the inclusion
Maxillary displacement
Displacement levels in mecanics is measured in millimeters or micrometers.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion23 Jan 2026 (estimated)
- Study completion23 Jan 2026 (estimated)
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2 participants (estimated)
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
- NCT07365657
- Sponsor's protocol ID
- 26IUFC01
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates
- ClinicalTrials.gov ID
- NCT07365657
- Acronym / sponsor ID
- 26IUFC01
- Conditions
- Malocclusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 23 Jan 2026 (estimated)
- Study completion
- 23 Jan 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Two distinct clinical scenarios-a minor advancement without impaction and a moderate advancement with posterior impaction-were analyzed to determine how surgical movements influence implant stress, bone stress, and maxillary micromotion. By combining surgical planning with validated computational modeling, this work provides clinically relevant insight to optimize PSI design and guide fixation strategy selection in orthognathic surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type II maloclusion | – | Other: In silico orthognathic surgery with customized implants digital only on 3D scanners2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery |
| Type III maloclusion | – | Other: In silico orthognathic surgery with customized implants digital only on 3D scanners2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery
Key inclusion criteria (3 listed)
- Patient operated on By Pr SAVOLDELLI.
- Patient undergoing patient-specific orthognathic surgery.
- Access to numerical (digital) planning.
Key exclusion criteria (2 listed)
- Previous maxillo-facial trauma.
- Facial cleft.
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 |
|---|---|---|
| In silico orthognathic surgery with customized implants digital only on 3D scanners2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery | Other | Type II maloclusion, Type III maloclusion |
Primary outcome
Plate stress levels
Time frame: At the inclusion
assessed by FORGE software
2 secondary outcomes
Stress on bone
Time frame: At the inclusion
Maxillary displacement
Time frame: At the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
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 Malocclusion, 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olina Rios (0788454522 ext. + 33, rios.o@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plate stress levels (time frame: At the inclusion). 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 26 Jan 2026.