Performance and safety of the ZygoFixU zygomatic implant system over the medium and long term

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ZygoFixU range includes zygomatic implants, prosthetic components, and placement instruments that are similar in design to existing zygomatic systems but are not CE-marked. This is an open-label, non-comparative, prospective multicentre clinical investigation (class IIb) conducted at sites in France and Italy to document device performance and safety. Experienced oral and cranio-maxillofacial surgeons will place two or four implants per patient and patients will be followed with a primary endpoint of implant survival at one year postoperatively. The trial aims to demonstrate conformity with regulatory requirements under the MDR by collecting medium-term performance and safety data.

Why it matters

Who can join: the full rules

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

Where it's running

• Cabinet dentaire Dr HADJ
  Marseille, France Recruiting
• CCOI Toulouse
  Toulouse, France, France Not yet recruiting
• Université de Bologne
  Bologne, Italie, Italy Not yet recruiting

Study contacts

• Study coordinator: Karen LOUIS
• Email: clinical@globald.com
• Phone: 0615293325

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.