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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04741594
Eligibility Criteria:
4\. Inclusion / Exclusion Criteria
The inclusion criteria include:
1. Adult patients ≥18 years old
2. Able to understand and sign a written informed consent form and willing to fulfil all study requirements
3. Healed edentulous ridge that is planned for an implant restoration.
4. Experimental site has not been previously augmented with xenograft
5. Experimental site has at least 2 mm of cancellous bone
The exclusion criteria include:
1. Uncontrolled systemic disease
2. Currently smoking \>10 cigarettes/day
3. History of head/neck radiotherapy within the past five years
4. Current use of oral bisphosphonates or history of IV bisphosphonate use
5. Pregnant, expecting to become pregnant, or lactating women
6. Presence of active periodontal disease
7. Poor oral hygiene
8. Previous history of implant failure at the site
The early termination criteria include:
1. The researcher believes that it is not in the patient's best interest to stay in the study
2. Based on the exclusion criteria, the patient becomes ineligible to participate
3. Patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
4. Patient does not follow study related instructions
5. The study is suspended or canceled
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04741594
Study Brief:
Protocol Section:
NCT04741594