SurgeryNCT05073757
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
An observational study of Surgery and Orthognathic Surgery, run by Global D at 4 sites in 2 countries.
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 custom-made implants (custom-made guides and plates) in orthognathic surgery in order to obtain specific clinical data on… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures
- What is being tested?
- Custom-made guides and plates
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 17 Sep 2021to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthognatic surgery male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Cabinet Orhognatic
Lyon, 69005
Hôpital de la Loire
Saint-Etienne, 42100
Hôpital Villefranche sur Sâone
Villefranche-sur-Saône, 69655
About this study
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.
- Being tested
- Custom-made guides and plates
- Keywords
- orthognatic surgery, guided surgery, 3D printing, plate, screw, custom-made
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made guides and platesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Orthognatic surgery | Orthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator. Receives: Device: Custom-made guides and plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthognatic quality of life questionnaire
To evaluate the performance of custom-made implants indicated for orthognathic surgery by measuring the quality of life of patients
Measured: 12 months post-operatively
Secondary outcomes (2)
Surgeon satisfaction on the implant's utilisation
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).
Measured: Immediately following surgery
Security of the implants used for orthognathic surgery
Adverse events identification, assessment and follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start17 Sep 2021
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073757
- Sponsor's protocol ID
- 2001-S-CMF-SUR MESURE-R
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT05073757
- Acronym / sponsor ID
- 2001-S-CMF-SUR MESURE-R
- Keywords
- orthognatic surgery, guided surgery, 3D printing, plate, screw, custom-made
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Global DIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthognatic surgery | – | Device: Custom-made guides and platesOrthognathic surgery patients, adults or minors whose bone maturity is sufficient according to the investigator. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthognatic surgery male or female patients, adults or minors whose bone maturity is sufficient according to the judgment of the investigator.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-made guides and platesPatients 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. | Device | Orthognatic surgery |
Primary outcome
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
2 secondary outcomes
Surgeon satisfaction on the implant's utilisation
Time frame: Immediately following surgery
Security of the implants used for orthognathic surgery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Orthognathic Surgery, run by Global D at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthognatic quality of life questionnaire (time frame: 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.