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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05899933
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria:
* Participants ≥ 18 years and ≤ 80 years of age
* Non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago
* Implants in function for more than 1 year after suprastructure connection
Inclusion Criteria for implants diagnosed with Peri-Implantitis:
* Presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling
* Absence of implant mobility
* in participants with more than one implant, the implant with the worst clinical condition will be studied.
Inclusion Criteria for implants diagnosed with Peri-Implant Health:
* Absence of peri-implant signs of inflammation (redness, swelling)
* Lack of bleeding on probing
* Absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm
Exclusion Criteria:
* Smokers
* Uncontrolled diabetes mellitus (HBA1c \>7)
* Treatment with bisphosphonates
* Needing antibiotic prophylaxis
* Currently pregnant or breast-feeding women
* History of systemic administration of antibiotic treatment during the preceding 3 months
* Systemic conditions that contraindicate treatment
* Use of medications known to induce gingival hyperplasia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05899933
Study Brief:
Protocol Section:
NCT05899933