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Clinical Trials in France / NCT07365657
Starting soon Observational

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

NCT07365657 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nice
Phase
Observational
Started
2026-01-20
Last updated
2026-01-26

Condition(s) studied

Malocclusion

Investigational drug(s) / intervention(s)

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

In 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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Plate stress levels — At the inclusion
    assessed by FORGE software

Trial sites (1)

FacilityCityRegionStatus
CHU Nice Nice Alpes Maritimes

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07365657 on ClinicalTrials.gov ↗ ← All trials in France