Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT06960460
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06960460
Study Brief:
Protocol Section:
NCT06960460