Dental ImplantsNCT06960460
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
A study testing Dental implant surgery with ZygoFixU implants in people with Dental Implants, run by Global D at 3 sites in 2 countries.
Trial summary
Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments. These devices have a design similar to other zygomatic implants on the market and are therefore not innovative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Dental implant surgery with ZygoFixU implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Apr 2025to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patient,
- Patient whose growth and development of the maxillary bone is complete according to the investigator's judgement,
- Partially or completely edentulous patient,
- Patient with advanced maxillary atrophy (grades IV, V and VI according to the Cawood and Howell classification if used),
- Patient requiring implant treatment with Global D zygomatic implants (placement of two or four implants),
- Patient with acceptable oral opening (>3 cm measured anteriorly),
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- Patient able to read, understand and answer the quality-of-life questionnaire of the investigation and able to give consent,
- Patient agreeing to comply with the protocol design and to send his/her follow-up data, even in the event of a move,
- Patient having signed the consent form,
- In France, patient affiliated to a social security scheme.
Who cannot join
- Patient's state of health at enrolment:
- General contraindications to implant surgery
- Patient with zygomatic bone disease
- Patient with untreated periodontal disease
- Patient with acute or chronic infection in the implant placement area, or systemic infection, including acute or chronic maxillary sinusitis
- Patient with acute or chronic inflammation in the implant placement area, or systemic inflammation,
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- Patient with uncontrolled diabetes (unstable blood glucose)
- Patient with immunodeficiencies or using immunosuppressants
- Patient who received radiation of more than +70 Gy to the head and neck region
- Patient using intravenous aminobisphosphonates within 5 years prior to surgery
- Patient who are smokers (>10 cigarettes/day) or with alcohol or drug addiction
- Person placed under legal protection (this includes guardianship, curatorship and legal protection).
- Pregnant or breastfeeding women
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Cabinet dentaire Dr HADJ
Marseille, 13009
HADJ Medhi, dental surgeon
HADJ MEDHI
- Not yet recruiting
CCOI Toulouse
Toulouse, France, 31000
Bruno COURTOIS, 05 62 89 99 30, brunocourtois.co@gmail.com
Italy1 site, 1 recruiting
- Not yet recruiting
Université de Bologne
Bologne, Italie
Pietro FELICE, 390512088117, pietro.felice@unibo.it
About this study
Official title: Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System
Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments. These devices have a design similar to other zygomatic implants on the market and are therefore not innovative. These non-CE marked devices are assessed during investigation 2302-G-ZYGO-C for their performance and for their short- and medium-term safety. These implants will be placed using specific instruments, by oral or cranio-maxillofacial surgeons with significant experience in the placement of zygomatic implants and trained in clinical research.
Read the detailed description
Study design: Interventional pivotal study involving humans, prospective with continuous series, multicentre, European, open-label, non-comparative.
Clinical investigation classification: class 2 clinical investigation according to ANSM in France, aiming at establishing the conformity of a class IIb, non CE-marked medical device. Clinical investigation to demonstrate device compliance, in accordance with Article 62.1 of the MDR.
Investigators: Patient recruitment and follow-up will be carried out by dental surgeons or oral surgeons/stomatologists in France and Italy. 11 sites will participate in the CI in 2 countries (Italy and France).
Objective: To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
Population: Adult male or female patients, whose growth and development of the maxillary bone is complete, partially or completely edentulous with advanced atrophy of the maxillary bone (grades IV, V and VI according to the Cawood and Howell classification if used).
- Conditions
- Dental Implants
- Being tested
- Dental implant surgery with ZygoFixU implants
- Keywords
- dental implant, survival rate, zygomatic, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant surgery with ZygoFixU implantsOther
Adult patients who have had dental implant surgery.
| Study group | Role | What they receive |
|---|---|---|
| ZygoFixU system | Experimental | Adult male or female patient, requiring implant treatment with Global D zygomatic implants (placement of two or four implants), Receives: Other: Dental implant surgery with ZygoFixU implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
Measurement of the survival rate of Global D zygomatic implants 1 year after the surgical procedure by the rate of in situ implants.
Measured: 1 year
Secondary outcomes (6)
To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate
Measurement of performance by the survival rate of Global D zygomatic implants at 2, 3, 4 years and 5 years postoperatively
Measured: 2, 3, 4 years and 5 years
the success rate at 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively - the quality of life of patients preoperatively, at 6-8 months postoperatively, 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively.
The success rates at 12 months, 2, 3, 4 years and 5 years respectively defined by complication and failure indicators (implant mobility, continuous radiolucency around the implant, peri-implantitis with/without suppuration leading to implant failure, fracture of the implant or prosthetic components, pain, dysaesthesia, foreign body sensation, persistent oedema (periorbital region), persistent maxillary sinus infection leading to implant failure, postoperative hematoma, postoperative infection, postoperative suppuration)
Measured: 12 months, 2, 3, 4 years and 5 years
To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)
The survival rate at 2, 3, 4 years and 5 years postoperatively - The number and rate of serious and non-serious biological and technical complications reported as related to the use of Global D zygomatic implants and/or prosthetic parts throughout patient follow-up
Measured: 2, 3, 4 years and 5 years
To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system.
Measurement of surgeon satisfaction with all devices used by an investigation-specific questionnaire (without score scale), completed after surgery.
Measured: After surgery
To assess patient satisfaction with the ZygoFixU implant-prosthetic system
Measurement of patient satisfaction by an investigation-specific questionnaire completed 12 months postoperatively (without score scale).
Measured: 1 year
To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)
Manual stability at all patient follow-up visits: the practitioner exerts slight pressure to check that the implant-prosthetic system does not move. A stable implant is an immobile implant
Measured: 2, 3, 4 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start10 Apr 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960460
- Sponsor's protocol ID
- 2302-G-ZYGO-C
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2025
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System
- ClinicalTrials.gov ID
- NCT06960460
- Acronym / sponsor ID
- 2302-G-ZYGO-C
- Conditions
- Dental Implants
- Keywords
- dental implant, survival rate, zygomatic, performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Global DIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 7 May 2025 (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.
Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments. These devices have a design similar to other zygomatic implants on the market and are therefore not innovative. These non-CE marked devices are assessed during investigation 2302-G-ZYGO-C for their performance and for their short- and medium-term safety. These implants will be placed using specific instruments, by oral or cranio-maxillofacial surgeons with significant experience in the placement of zygomatic implants and trained in clinical research.
Detailed description
Study design: Interventional pivotal study involving humans, prospective with continuous series, multicentre, European, open-label, non-comparative.
Clinical investigation classification: class 2 clinical investigation according to ANSM in France, aiming at establishing the conformity of a class IIb, non CE-marked medical device. Clinical investigation to demonstrate device compliance, in accordance with Article 62.1 of the MDR.
Investigators: Patient recruitment and follow-up will be carried out by dental surgeons or oral surgeons/stomatologists in France and Italy. 11 sites will participate in the CI in 2 countries (Italy and France).
Objective: To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
Population: Adult male or female patients, whose growth and development of the maxillary bone is complete, partially or completely edentulous with advanced atrophy of the maxillary bone (grades IV, V and VI according to the Cawood and Howell classification if used).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZygoFixU system | Experimental | Other: Dental implant surgery with ZygoFixU implantsAdult male or female patient, requiring implant treatment with Global D zygomatic implants (placement of two or four implants), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult male or female patient,
- Patient whose growth and development of the maxillary bone is complete according to the investigator's judgement,
- Partially or completely edentulous patient,
- Patient with advanced maxillary atrophy (grades IV, V and VI according to the Cawood and Howell classification if used),
- Patient requiring implant treatment with Global D zygomatic implants (placement of two or four implants),
Key exclusion criteria (13 listed)
- Patient's state of health at enrolment:
- Patient who are smokers (>10 cigarettes/day) or with alcohol or drug addiction
- Person placed under legal protection (this includes guardianship, curatorship and 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 |
|---|---|---|
| Dental implant surgery with ZygoFixU implantsAdult patients who have had dental implant surgery. | Other | ZygoFixU system |
Primary outcome
To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
Time frame: 1 year
Measurement of the survival rate of Global D zygomatic implants 1 year after the surgical procedure by the rate of in situ implants.
6 secondary outcomes
To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate
Time frame: 2, 3, 4 years and 5 years
the success rate at 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively - the quality of life of patients preoperatively, at 6-8 months postoperatively, 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively.
Time frame: 12 months, 2, 3, 4 years and 5 years
To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)
Time frame: 2, 3, 4 years and 5 years
To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system.
Time frame: After surgery
To assess patient satisfaction with the ZygoFixU implant-prosthetic system
Time frame: 1 year
To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)
Time frame: 2, 3, 4 years and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant surgery with ZygoFixU implants in people with Dental Implants, run by Global D at 3 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen LOUIS (0615293325, clinical@globald.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively. (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 2 Jul 2025.