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

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.

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Key information

Conditions

Surgery Orthognathic Surgery Orthognathic Surgical Procedures

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet chirurgie Maxillo-faciale, Tournai, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Male or female patient, adult or minor having reached bone maturity according to the judgment of the investigator,
Patient having first orthognathic surgery with SLS France custom-made guides and plates,
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 his participation in the study or to the processing of his data.
Patient affiliated to a social insurance

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 the study,
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.

Treatment and study plan

Custom-made guides and plates

Device

Patients will be included in the study and then followed clinically according to the routine care of orthognathic surgery with custom-made guides and plates. The only specific act of this study is the completion of an OQLQ quality of life questionnaire by patients preoperatively and between 8 to 12 months postoperatively.

Primary outcomes

Orthognatic quality of life questionnaire

Time frame: 12 months post-operatively

To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients

Secondary outcomes

Surgeon satisfaction on the implant's utilisation

Time frame: Immediately following surgery

Assessment by a satisfaction questionnaire, specially developed for the study, completed by the surgeon after the surgery. The surgeon evaluates each item using a likert scale (Highly Satisfied/ Satisfied/ Not very satisfied / Unsatisfied).
Security of the implants used for orthognathic surgery

Time frame: 12 months

Adverse events identification, assessment and follow-up.

Sponsors and collaborators

Lead sponsor

Global D

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Oct 11, 2021
Registry last updated: Jan 21, 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.

Published trials that share one or more normalized conditions with this study.

Completed