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

ClinicalTrials.gov ID

NCT06960460

Lead Sponsor

Global DINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

99Estimated

Last Update Posted

Jul 2, 2025Actual

Start Date

Apr 10, 2025Actual

Primary Completion Date

Sep 1, 2030Estimated

Completion Date

Dec 31, 2031Estimated

Official Title

Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System

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).

• Dental Implants

• Dental implant surgery with ZygoFixU implants

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Global DINDUSTRY

pietro.felice@unibo.it390512088117

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