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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT02375750
Eligibility Criteria:
Inclusion Criteria:
* age 18 years or older
* Presence of peri-implantitis
* A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
* Clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site.
* During surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present.
* The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included.
* Implants included in the study must have been in function for more than 12 months.
* Ability to fully understand the nature of the proposed surgery and ability to sign an Ethics Committee-approved informed consent form
Exclusion Criteria:
* Subjects with diabetes mellitus (HbA1c \> 7.0)
* Subjects taking prednisone or other anti-inflammatory prescription drug
* Subjects taking medications known to have effects on gingival growth
* If the same patient has more than one defect meeting the inclusion criteria, only one such defect will be included in the study
* General contraindications for dental and/or surgical treatments
* Smokers (\> 10 cigarettes per day).
* Pregnant or lactating women
* Allergy to collagen
* Inability to consent for participation in the study and/or to accept the proposed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02375750
Study Brief:
Protocol Section:
NCT02375750