Orthognathic SurgeryCMF-ORTHONCT05271383
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
An observational study of Orthognathic Surgery and Maxillofacial Abnormalities, run by Global D at 1 site in France.
Trial summary
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for orthognathic surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- What is being tested?
- Orthognathic surgery using Global D's implants.
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2022to 2 Aug 2024
- How long will I take part?
- 1 Year
- 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: The study population is composed of male and female, major or minor, who will be treated by orthognatic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.
Who may be able to join
- Male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator,
- Patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty)
- Patient who received orthodontic treatment prior to orthognathic surgery.
- Patient with abilities to read, understand and answer to the study quality of life questionnaire.
- Patient (and his legal representative if minor) who signed the study consent form.
- Patient affiliated to a social security system.
Who cannot join
- Patient allergic to one of the components of the implants
- Patient with physical or mental inabilities that will compromise the follow-up during the study
- Patient with acute or chronic infection (local or systemic)
- Person on legal protection
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study to Evaluate the Performance (by the Assessment of Patient's Quality of Life) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for orthognathic surgery.
Read the detailed description
Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.
Investigators : 7 sites in France.
A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.
- Being tested
- Orthognathic surgery using Global D's implants.
- Keywords
- Orthognathic surgery, Performance, Security, Plates, Screw, Medical device, Cranio-maxillofacial
- Medical subject headings
- Maxillofacial Abnormalities, Maxillary Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic surgery using Global D's implants.Device
Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Male and female, major or minor, who will be treated by orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment. Receives: Device: Orthognathic surgery using Global D's implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the Global D's implants used for orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery.
The evolution of patient's quality of life will be assessed by comparing the score of the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery. The OQLQ can vary from 0 (better quality of life) to 88 (worst quality of life).
Measured: 1 year
Secondary outcomes (4)
Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a
Bone consolidation after the surgery, assessed by a correct dental occlusion on the postoperative image. This information is assessed 6 weeks after the surgery: correct occlusion (Yes/No).
Measured: 6 weeks after the surgery
Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b
Bone consolidation after the surgery, assessed by the alimentation of the patient. This information is assessed 6 weeks after the surgery: solid alimentation of the patient (Yes/No).
Measured: 6 weeks after the surgery
Security of the Global D implants used for orthognathic surgery - Outcome Measure 2
Adverse events identification, assessment and follow-up.
Measured: 18 months
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start4 Feb 2022
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic 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
- 198 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Global D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre CORRE, MD, Principal investigator, Cranio-maxillofacial surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271383
- Sponsor's protocol ID
- 2101-G-CMF-ORTHO-R
- Acronym
- CMF-ORTHO
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Performance (by the Assessment of Patient's Quality of Life) and the Safety of Global D's Implants of Cranio-maxillofacial Surgery Indicated for Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT05271383
- Acronym / sponsor ID
- CMF-ORTHO / 2101-G-CMF-ORTHO-R
- Keywords
- Orthognathic surgery, Performance, Security, Plates, Screw, Medical device, Cranio-maxillofacial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Global DIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 9 Mar 2022 (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.
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for orthognathic surgery.
Detailed description
Study design : Non-interventional, prospective, multicentric, national, open-label, non-comparative study.
Investigators : 7 sites in France.
A statistical evaluation will be performed on those data in order to determine the performance and the security of those devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Orthognathic surgery using Global D's implants.Male and female, major or minor, who will be treated by orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is composed of male and female, major or minor, who will be treated by orthognatic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.
Key inclusion criteria (6 listed)
- Male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator,
- Patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty)
- Patient who received orthodontic treatment prior to orthognathic surgery.
- Patient with abilities to read, understand and answer to the study quality of life questionnaire.
- Patient (and his legal representative if minor) who signed the study consent form.
Key exclusion criteria (5 listed)
- Patient allergic to one of the components of the implants
- Patient with physical or mental inabilities that will compromise the follow-up during the study
- Patient with acute or chronic infection (local or systemic)
- Person on legal protection
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Orthognathic surgery using Global D's implants.Major or minor participants who will be treated by an orthognathic surgery with ORTRAUTEK® or MINITEK® implant(s). | Device | Study group |
Primary outcome
Performance of the Global D's implants used for orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery.
Time frame: 1 year
The evolution of patient's quality of life will be assessed by comparing the score of the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery. The OQLQ can vary from 0 (better quality of life) to 88 (worst quality of life).
4 secondary outcomes
Security of the Global D implants used for orthognathic surgery - Outcome Measure 1a
Time frame: 6 weeks after the surgery
Security of the Global D implants used for orthognathic surgery - Outcome Measure 1b
Time frame: 6 weeks after the surgery
Security of the Global D implants used for orthognathic surgery - Outcome Measure 2
Time frame: 18 months
Surgeon satisfaction on the implant's utilisation
Time frame: Immediately following surgery
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 7 Oct 2026.
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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.
Pierre CORRE, MD principal investigator
Cranio-maxillofacial surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery and Maxillofacial Abnormalities, run by Global D at 1 site in France.
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 5 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 7 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 1 site in France. 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?
Performance of the Global D's implants used for orthognathic surgery, assessed by the Orthognathic Quality of Life Questionnaire (OQLQ) before and after the surgery. (time frame: 1 year). 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 7 Oct 2026.