To Evaluate the Performance and Safety of Personalized Implants in CMF Surgery Indicated for Orthognathic Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073757
• Other study ID #: 2001-S-CMF-SUR MESURE-R
• Status: Recruiting
• Start date: September 17, 2021
• Est. completion date: September 2023

Study information

• Verified date: October 2021
• Source: SLS France
• Contact: Marie Groussaud
• Phone: 0624173902
• Email: m.groussaud[@]globald.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 personalized implants (personalized guides and plates) in orthognathic surgery in order to obtain specific clinical data on SLS France devices.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 personalized 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.

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
Belgium	Cabinet chirurgie Maxillo-faciale	Tournai
France	Cabinet Orhognatic	Lyon
France	Hôpital Villefranche sur Sâone	Villefranche sur Saône

Sponsors (2)

Lead Sponsor	Collaborator
SLS France	Global D

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orthognatic quality of life questionnaire	To evaluate the performance of personalized implants indicated for orthognathic surgery by measuring the quality of life of patients	12 months post-operatively