Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFi
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 2
| Condition(s) | Dental Implants |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Global D |
| Locations | Toulouse, France, France; Marseille, France; Bologne, Italie, Italy |
| Start date | 2025-04-10 |
| NCT ID | NCT06960460 |
| Official listing | https://clinicaltrials.gov/study/NCT06960460 |