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:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT06138392
Eligibility Criteria:
Inclusion Criteria:
* Individuals between the ages of 18 and 75 years (inclusive)
* Partially edentulous patients with missing teeth in the posterior mandible (positions 34-37 and 44-47) and a healed site at least four weeks after tooth extraction
* Patients requiring a single dental implant
* Patients with physical status 1 or 2 according to the American Society of Anesthesiologists Classification System
* Inadequate native bone quality and quantity to place implants with a diameter of ≥4.0 mm
* Removable prosthesis or complete dentures in the antagonizing dentition
* Written informed consent
Exclusion Criteria:
* Patients with compromised general health contraindicating surgical intervention
* Presence of conditions requiring chronic routine prophylactic or prolonged use of antibiotics
* Heavy smokers (exceeding ten cigarettes/day or equivalent) and chewing tobacco users
* Pregnancy or childbearing potential with a positive urine pregnancy test
* Insufficient oral hygiene, untreated periodontitis (any residual pockets \>4 mm), or persistent intra-oral infection
* Mucosal diseases such as erosive lichen planus
* Patients with severe bruxism or clenching habits
* Unwillingness to participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06138392
Study Brief:
Protocol Section:
NCT06138392