Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System
Global D
99 participants
Apr 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria13
- 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
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Interventions
Adult patients who have had dental implant surgery.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06960460