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

October 8, 2021 updated by: SLS France

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Tournai, Belgium, 7500
        • Active, not recruiting
        • Cabinet chirurgie Maxillo-faciale
  • France
      • Lyon, France, 69005
        • Recruiting
        • Cabinet Orhognatic
        • Contact:
          • Paul Cresseaux
      • Villefranche sur Saône, France, 69655
        • Recruiting
        • Hôpital Villefranche sur Sâone
        • Contact:
          • Grégory Murcier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Orthognatic surgery Male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Orthognatic surgery
Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthognatic quality of life questionnaire
Time Frame: 12 months post-operatively
To evaluate the performance of personalized implants indicated for orthognathic surgery by measuring the quality of life of patients
12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SLS France

Collaborators

Global D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

October 8, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-S-CMF-SUR MESURE-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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