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

NCT06960460 | Recruiting

• 1 other identifier: 2302-G-ZYGO-C
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 3

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.

Conditions

Dental Implants

Keywords

dental implant; survival rate; zygomatic; performance

Outcome Measures

Primary Outcomes (1)

• To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.

  Measurement of the survival rate of Global D zygomatic implants 1 year after the surgical procedure by the rate of in situ implants.

  1 year

Secondary Outcomes (6)

• To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate

  2, 3, 4 years and 5 years

• the success rate at 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively - the quality of life of patients preoperatively, at 6-8 months postoperatively, 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively.

  12 months, 2, 3, 4 years and 5 years

• To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)

  2, 3, 4 years and 5 years

• To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system.

  After surgery

• To assess patient satisfaction with the ZygoFixU implant-prosthetic system

  1 year

Study Arms (1)

ZygoFixU system

EXPERIMENTAL

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

Other: Dental implant surgery with ZygoFixU implants

Interventions

Dental implant surgery with ZygoFixU implants OTHER

Adult patients who have had dental implant surgery.

ZygoFixU system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Global D: lead

Study Sites (3)

CCOI Toulouse

Toulouse, France, 31000, France

NOT YET RECRUITING

Cabinet dentaire Dr HADJ

Marseille, 13009, France

RECRUITING

Université de Bologne

Bologne, Italie, Italy

NOT YET RECRUITING

Central Study Contacts

Karen LOUIS

CONTACT

0615293325; clinical@globald.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 7, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); IT (1)