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Natural Bioactive Gel for Peri-Implantitis

RecruitingNAAges 18 Years - 70 YearsAllUniversity of Pavia
NCT07088679 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Sterify Gel (mucoadhesive bioactive gel)
  • Standard Non-Surgical Peri-Implantitis Therapy
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Where

1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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