NCT06960460 Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
| NCT ID | NCT06960460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Global D |
| Condition | Dental Implants |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2030-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 99 participants in total. It began in 2025-04-10 with a primary completion date of 2030-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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), * 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. Exclusion Criteria: * 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, * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06960460 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dental Implants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960460 currently recruiting?
Yes, NCT06960460 is actively recruiting participants. Contact the research team at clinical@globald.com for enrollment information.
Where is the NCT06960460 trial being conducted?
This trial is being conducted at Toulouse, France, Marseille, France, Bologne, Italy.
Who is sponsoring the NCT06960460 clinical trial?
NCT06960460 is sponsored by Global D. The trial plans to enroll 99 participants.