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NCT Number: NCT07365657

Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI 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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Plate stress levels

    Time frame: At the inclusion

    assessed by FORGE software

Secondary outcomes

  1. Stress on bone

    Time frame: At the inclusion

    Mechanical stress in mecanics is measured in Pa (Pascal)

  2. Maxillary displacement

    Time frame: At the inclusion

    Displacement levels in mecanics is measured in millimeters or micrometers.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles +33 SAVOLDELL

CONTACT

[email protected]

33648275014 ext. +33

Olina Rios

CONTACT

[email protected]

0788454522 ext. + 33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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