Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
ConditionDental Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlobal D
About this trial
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 criteria
Qualifiers
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),
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dental implant surgery with ZygoFixU implants
Treatment groups
99 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov