Trial Parameters
Brief Summary
This study is a randomized controlled clinical trial using a split-mouth design to evaluate the effectiveness of a natural bioactive gel (Sterify Gel®) as an adjunct to standard non-surgical therapy for peri-implantitis. Peri-implantitis is an inflammatory disease that affects the tissues around dental implants and can lead to bone loss and implant failure. The goal of the study is to determine whether the application of Sterify Gel®, which contains polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, can improve clinical outcomes when used in addition to conventional mechanical debridement and air-polishing. The trial will include 20 patients, each with at least two implants in different quadrants affected by peri-implantitis. One implant will be treated with standard therapy plus the gel (test site), while the other will receive standard therapy alone (control site). Clinical outcomes will be measured over a 9-month period, including plaque levels, bleeding on probing, probing depth, suppuration, and bone loss. The results will help assess whether this gel enhances the effectiveness of routine non-surgical peri-implantitis treatment.
Eligibility Criteria
Inclusion Criteria: * Patients aged between 18 and 70 years * Presence of peri-implantitis involving at least two dental implants located in different quadrants * Presence of bleeding and/or suppuration on probing * Increased probing depth (PD) and radiographic bone loss compared to previous examinations * In the absence of previous clinical data: PD ≥ 6 mm and bone loss ≥ 3 mm apically from the coronal portion of the intraosseous implant area (radiographically assessed) * Willingness and ability to comply with study protocol and follow-up visits * Written informed consent provided Exclusion Criteria: * Patients with cardiac pacemakers or other implanted electronic devices * Neurological or psychiatric disorders that may interfere with study participation * Systemic diseases, metabolic disorders, or autoimmune conditions * Pregnancy or lactation Current participation in other clinical trials