NCT06960460

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Global D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study design: Interventional pivotal study involving humans, prospective with continuous series, multicentre, European, open-label, non-comparative. Clinical investigation classification: class 2 clinical investigation according to ANSM in France, aiming at establishing the conformity of a class IIb, non CE-marked medical device. Clinical investigation to demonstrate device compliance, in accordance with Article 62.1 of the MDR. Investigators: Patient recruitment and follow-up will be carried out by dental surgeons or oral surgeons/stomatologists in France and Italy. 11 sites will participate in the CI in 2 countries (Italy and France). Objective: To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively. Population: Adult male or female patients, whose growth and development of the maxillary bone is complete, partially or completely edentulous with advanced atrophy of the maxillary bone (grades IV, V and VI according to the Cawood and Howell classification if used).

Conditions

• Dental Implants

Interventions

Type	Name	Description
OTHER	Dental implant surgery with ZygoFixU implants	Adult patients who have had dental implant surgery.

Timeline

• Start date: 2025-04-10
• Primary completion: 2030-09-01
• Completion: 2031-12-31
• First posted: 2025-05-07
• Last updated: 2025-07-02

Locations

3 sites across 2 countries: France, Italy