Dental implant surgery with ZygoFixU implants: Adult patients who have had dental implant surgery.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively. — 1 year Measurement of the survival rate of Global D zygomatic implants 1 year after the surgical procedure by the rate of in situ implants.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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