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

Global D99 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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

Measurement of performance by the survival rate of Global D zygomatic implants at 2, 3, 4 years and 5 years postoperatively

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.

The success rates at 12 months, 2, 3, 4 years and 5 years respectively defined by complication and failure indicators (implant mobility, continuous radiolucency around the implant, peri-implantitis with/without suppuration leading to implant failure, fracture of the implant or prosthetic components, pain, dysaesthesia, foreign body sensation, persistent oedema (periorbital region), persistent maxillary sinus infection leading to implant failure, postoperative hematoma, postoperative infection, postoperative suppuration)

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)

The survival rate at 2, 3, 4 years and 5 years postoperatively - The number and rate of serious and non-serious biological and technical complications reported as related to the use of Global D zygomatic implants and/or prosthetic parts throughout patient follow-up

Time frame: 2, 3, 4 years and 5 years

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

Measurement of surgeon satisfaction with all devices used by an investigation-specific questionnaire (without score scale), completed after surgery.

Time frame: After surgery

To assess patient satisfaction with the ZygoFixU implant-prosthetic system

Measurement of patient satisfaction by an investigation-specific questionnaire completed 12 months postoperatively (without score scale).

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)

Manual stability at all patient follow-up visits: the practitioner exerts slight pressure to check that the implant-prosthetic system does not move. A stable implant is an immobile implant

Time frame: 2, 3, 4 years and 5 years

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts