Status:
RECRUITING
Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
Lead Sponsor:
Global D
Conditions:
Dental Implants
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Study design: Interventional pivotal study involving humans, prospective with continuous series, multicentre, European, open-label, non-comparative. Clinical investigation classification: class 2 cli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06960460
Start Date
April 10 2025
End Date
December 31 2031
Last Update
July 2 2025
Active Locations (3)
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1
CCOI Toulouse
Toulouse, France, France, 31000
2
Cabinet dentaire Dr HADJ
Marseille, France, 13009
3
Université de Bologne
Bologne, Italie, Italy