Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
ConditionDental Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlobal D
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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),
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Dental implant surgery with ZygoFixU implants
Other interventionAdult patients who have had dental implant surgery.
Treatment groups
99 Participants
are divided into 1 treatment groupGroup A: ZygoFixU systemExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
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 years2
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 years3
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 years4
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 Source ClinicalTrials.gov