Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System

NCT ID: NCT06960460

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2031-12-31

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZygoFixU system

Adult male or female patient, requiring implant treatment with Global D zygomatic implants (placement of two or four implants),

Group Type: EXPERIMENTAL

Dental implant surgery with ZygoFixU implants

Intervention Type: OTHER

Adult patients who have had dental implant surgery.

Interventions

Dental implant surgery with ZygoFixU implants

Adult patients who have had dental implant surgery.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CCOI Toulouse

Toulouse, France, France

Site Status: NOT_YET_RECRUITING

Cabinet dentaire Dr HADJ

Marseille, , France

Site Status: RECRUITING

Université de Bologne

Bologne, Italie, Italy

Site Status: NOT_YET_RECRUITING

Countries

France; Italy

Central Contacts

Karen LOUIS

Role: CONTACT

clinical@globald.com

0615293325

Facility Contacts

Bruno COURTOIS

Role: primary

brunocourtois.co@gmail.com

05 62 89 99 30

HADJ Medhi, dental surgeon

Role: primary

Pietro FELICE

Role: primary

pietro.felice@unibo.it

390512088117

Other Identifiers

2302-G-ZYGO-C

Identifier Type: -

Identifier Source: org_study_id