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

Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07365657
Enrollment
2
Registered
2026-01-26
Start date
2026-01-20
Completion date
2026-01-23
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

Brief 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.

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Previous maxillo-facial trauma. * Facial cleft.

Design outcomes

Primary

MeasureTime frameDescription
Plate stress levelsAt the inclusionassessed by FORGE software

Secondary

MeasureTime frameDescription
Stress on boneAt the inclusionMechanical stress in mecanics is measured in Pa (Pascal)
Maxillary displacementAt the inclusionDisplacement levels in mecanics is measured in millimeters or micrometers.

Countries

France

Contacts

CONTACTOlina Rios
rios.o@chu-nice.fr0788454522
CONTACTCharles +33 SAVOLDELL
savoldelli.c@chu-nice.fr33648275014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026