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Tests treatment safety and results for Dental Implants
Official title Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System
ClinicalTrials.gov ID: NCT06960460
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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),
You likely can't join if
- 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,
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France, France
- Marseille, France
- Bologne, Italie, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France, France; Marseille, France; Bologne, Italie, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.