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

Official title

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

Overview

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).

Interventions

• Other Dental implant surgery with ZygoFixU implants
  Adult patients who have had dental implant surgery.

Primary outcome measures

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

Secondary outcome measures (6)

• To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate [Time frame: 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. [Time frame: 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) [Time frame: 2, 3, 4 years and 5 years]
• To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system. [Time frame: After surgery]
• To assess patient satisfaction with the ZygoFixU implant-prosthetic system [Time frame: 1 year]
• To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects) [Time frame: 2, 3, 4 years and 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 2 centers

• CCOI Toulouse — Toulouse
• Cabinet dentaire Dr HADJ — Marseille

Italy · 1 center

• Université de Bologne — Bologne

Identifiers

NCT: NCT06960460 · 2302-G-ZYGO-C

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗