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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT02513602
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis: single or partial mandibular molar-premolar edentulism that requires up to 2 fixtures
* Good systemic compensation of the kidney transplant (≤ ASA American Society of Anesthesiologists score 3) with at least 1 year of previous hemodialysis or peritoneal dialysis and in actual immunosuppressive therapy
* Be older than 18 years
* The patient must be able to understand the meaning of the study and accept to undergo periodical follow-up controls.
* The patient must be able to understand and practice all the oral hygiene procedures demanded by the experimenter
* Signature of the informed consent form
and for control
* Diagnosis: single or partial mandibular molar-premolar edentulism that requires up to 2 fixtures
* Having a pre-operatory cone beam CT available
* Age older than 18 years
* Signature of the authorization to use and process personal details at the acceptance of every sort of treatment in the Company Hospital of Trieste.
Exclusion Criteria:
* Post extraction implant (before 3 months from the extraction)
* Be less than 18 years old
* Smoking more than 10 cigarettes/day
* Plaque index more than 25
* Bleeding on probe index more than 25
* Clear allergy or intolerance against the products used in the study
* Patients that require reconstructive bone surgery before the fixtures placement (gbr and bone grafting)
and for control group
* Patients that require reconstructive bone surgery before the fixtures placement (gbr and bone grafting)
* Pathologies and pharmacological therapies that interfere with bone (for instance osteoporosis, osteomalacia, malnutrition, Paget's disease, corticosteroid therapy, bisphosphonate therapy, head and neck radiotherapy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02513602
Study Brief:
Protocol Section:
NCT02513602