Performance and safety of the ZygoFixU zygomatic implant system over the medium and long term
Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System
This study will test ZygoFixU zygomatic implants to see if they last at least one year and are safe for adults with severe upper-jaw bone loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Global D Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Toulouse, France and 2 other locations) |
| Trial ID | NCT06960460 on ClinicalTrials.gov |
What this trial studies
The ZygoFixU range includes zygomatic implants, prosthetic components, and placement instruments that are similar in design to existing zygomatic systems but are not CE-marked. This is an open-label, non-comparative, prospective multicentre clinical investigation (class IIb) conducted at sites in France and Italy to document device performance and safety. Experienced oral and cranio-maxillofacial surgeons will place two or four implants per patient and patients will be followed with a primary endpoint of implant survival at one year postoperatively. The trial aims to demonstrate conformity with regulatory requirements under the MDR by collecting medium-term performance and safety data.
Who should consider this trial
Good fit: Adults with completed maxillary growth who are partially or completely edentulous and have advanced maxillary atrophy (Cawood & Howell grades IV–VI) and who require placement of two or four zygomatic implants are ideal candidates.
Not a fit: Patients with adequate maxillary bone for standard implants, general contraindications to implant surgery, or serious medical comorbidities are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the ZygoFixU system could provide a reliable option to restore function with fixed prostheses for patients who have severe maxillary bone loss.
How similar studies have performed: Zygomatic implants have an extensive published track record with generally high short- and medium-term survival rates, although this specific ZygoFixU device is unapproved and is being tested for conformity and safety.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse, France and 2 other locations
- CCOI Toulouse — Toulouse, France, France (Not_yet_recruiting)
- Cabinet dentaire Dr HADJ — Marseille, France (Recruiting)
- Université de Bologne — Bologne, Italie, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Karen LOUIS
- Email: clinical@globald.com
- Phone: 0615293325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.