Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System

Recruiting now · Not applicable

Conditions studied: Dental Implants

In brief

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.

Key facts

Study ID: NCT06960460
Run by: Global D
People needed: 99
Starts: 2025-04-10
Expected to finish: 2031-12-31
Last updated by the study team: 2025-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Cabinet dentaire Dr HADJ — Marseille, France (enrolling)
CCOI Toulouse — Toulouse, France, France
Université de Bologne — Bologne, Italie, Italy

Full record on ClinicalTrials.gov

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