Clinical trial NCT06960460: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Implants
Keywords: dental implant
survival rate
zygomatic
performance
Lead sponsor: Global D
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 outcomes:
measure: To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
timeFrame: 1 year
Secondary outcomes:
measure: To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate
timeFrame: 2, 3, 4 years and 5 years
measure: 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.
timeFrame: 12 months, 2, 3, 4 years and 5 years
measure: To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)
timeFrame: 2, 3, 4 years and 5 years
measure: To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system.
timeFrame: After surgery
measure: To assess patient satisfaction with the ZygoFixU implant-prosthetic system
timeFrame: 1 year
measure: To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects)
timeFrame: 2, 3, 4 years and 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CCOI Toulouse
city: Bologne
country: Italy
facility: Université de Bologne
state: Italie
Study officials:
References: