Prospective Study to Evaluate the Performance and Safety of Custom-made Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery

Last updated: July 28, 2025
Sponsor: Global D
Overall Status: Completed

Phase

N/A

Condition

Surgery

Treatment

Personalized guides and plates

Custom-made guides and plates

Clinical Study ID

NCT05073757
2001-S-CMF-SUR MESURE-R
  • All Genders

Study Summary

With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.

Our project aims to study the performance and safety of custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patient, adult or minor having reached bone maturity according to thejudgment of the investigator,

  • Patient having first orthognathic surgery with SLS France custom-made guides andplates,

  • Patient who received orthodontic treatment prior to orthognathic surgery,

  • Patient able to read, understand and answer the study quality of life questionnaire,

  • Patient (and legal representative if a minor) who is not opposed to hisparticipation in the study or to the processing of his data.

  • Patient affiliated to a social insurance

Exclusion

Exclusion Criteria:

  • Patient allergic to one of the compounds of the plates and / or guides,

  • Patient with physical or mental disability making it impossible to follow up in thestudy,

  • Patient with significant expansion

  • Patient with a congenital craniofacial malformation

  • Patient with acute or chronic local or systemic infection,

  • Person placed under legal protection,

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Personalized guides and plates
Phase:
Study Start date:
September 17, 2021
Estimated Completion Date:
February 25, 2025

Connect with a study center

  • Cabinet chirurgie Maxillo-faciale

    Tournai, 7500
    Belgium

    Site Not Available

  • Cabinet Orhognatic

    Lyon, 69005
    France

    Site Not Available

  • Hôpital de la Loire

    Saint-Etienne, 42100
    France

    Site Not Available

  • Hôpital Villefranche sur Sâone

    Villefranche sur Saône, 69655
    France

    Site Not Available

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