Actively Recruiting
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
Led by Global D · Updated on 2025-07-02
99
Participants Needed
3
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female patient
- Complete growth and development of the maxillary bone as judged by the investigator
- Partially or completely missing teeth (edentulous)
- Advanced maxillary bone loss (grades IV, V, or VI by Cawood and Howell classification, if used)
- Need for implant treatment with Global D zygomatic implants (two or four implants)
- Oral opening greater than 3 cm measured at the front
- Ability to read, understand, and answer quality-of-life questionnaires and provide consent
- Agreement to follow the study protocol and submit follow-up data
- Signed informed consent form
- In France, affiliation with a social security scheme
You will not qualify if you...
- General health conditions that contraindicate implant surgery
- Disease affecting the zygomatic bone
- Untreated periodontal (gum) disease
- Acute or chronic infection or inflammation in the implant area or systemic infection/inflammation, including maxillary sinusitis
- Uncontrolled diabetes with unstable blood sugar
- Immunodeficiency or use of immunosuppressive drugs
- Radiation therapy over 70 Gy to head and neck region
- Use of intravenous aminobisphosphonates within 5 years before surgery
- Smoking more than 10 cigarettes per day or alcohol/drug addiction
- Legal protection status such as guardianship or curatorship
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
CCOI Toulouse
Toulouse, France, France, 31000
Not Yet Recruiting
2
Cabinet dentaire Dr HADJ
Marseille, France, 13009
Actively Recruiting
3
Université de Bologne
Bologne, Italie, Italy
Not Yet Recruiting
Research Team
K
Karen LOUIS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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