NCT07365657

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

3 days

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (1)

  • Plate stress levels

    assessed by FORGE software

    At the inclusion

Secondary Outcomes (2)

  • Stress on bone

    At the inclusion

  • Maxillary displacement

    At the inclusion

Study Arms (2)

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

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

Type II maloclusionType III maloclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Previous maxillo-facial trauma.
  • Facial cleft.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nice

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Olina Rios

CONTACT

0788454522rios.o@chu-nice.fr

Charles +33 SAVOLDELL

CONTACT

33648275014savoldelli.c@chu-nice.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

January 20, 2026

Primary Completion

January 23, 2026

Study Completion

January 23, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

FR(1)