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Not yet recruitingNCT07365657Updated Jan 26, 2026

Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates

An observational study in Malocclusion, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
2
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Malocclusion

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 2 is below the median of 63 across 74 observational studies indexed under Malocclusion.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient operated on By Pr SAVOLDELLI.
  • Patient undergoing patient-specific orthognathic surgery.
  • Access to numerical (digital) planning.

Exclusion criteria

Exclusion Criteria:

  • Previous maxillo-facial trauma.
  • Facial cleft.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
2 participants (estimated)
Patient registry
No

Groups and cohorts

  • Type II maloclusion

    2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

    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

    Other: In silico orthognathic surgery with customized implants digital only on 3D scanners

Interventions

  • OtherIn silico orthognathic surgery with customized implants digital only on 3D scanners

    2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

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What researchers measure

Primary outcomes

  1. Plate stress levels

    assessed by FORGE software

    Time frame: At the inclusion

Secondary outcomes

  1. Stress on bone

    Mechanical stress in mecanics is measured in Pa (Pascal)

    Time frame: At the inclusion

  2. Maxillary displacement

    Displacement levels in mecanics is measured in millimeters or micrometers.

    Time frame: At the inclusion

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07365657
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
Jan 20, 2026 (estimated)
Primary completion
Jan 23, 2026 (estimated)
Completion
Jan 23, 2026 (estimated)
Last update
Jan 26, 2026

Study contacts

Olina Rios
Contact
rios.o@chu-nice.fr
0788454522 ext. + 33
Charles +33 SAVOLDELL
Contact
savoldelli.c@chu-nice.fr
33648275014 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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