20
Participants
Start Date
July 30, 2025
Primary Completion Date
May 5, 2026
Study Completion Date
May 30, 2026
Sterify Gel (mucoadhesive bioactive gel)
Sterify Gel® is a sterile, ready-to-use mucoadhesive hydrogel formulated with polyvinyl polymers, hydroxytyrosol (a natural antioxidant), magnesium ascorbyl phosphate (a stable vitamin C derivative), and nisin (a naturally occurring antimicrobial peptide). In this study, it is applied into the peri-implant pocket using a 0.6 mm - 23GA sterile needle (Gerhò®) immediately after non-surgical debridement. Application is performed at baseline and at follow-up visits (1, 3, 6, and 9 months). Patients are instructed to avoid rinsing, eating, or using oral hygiene aids at the treated sites for at least 2 hours post-application, and to follow specific hygiene instructions for 48 hours.
Standard Non-Surgical Peri-Implantitis Therapy
Standard therapy consists of supra- and subgingival professional mechanical debridement of peri-implant sites using ultrasonic inserts and manual curettes covered with biocompatible materials (PEEK, teflon, or titanium) to avoid damage to the implant surface. This is followed by air-polishing using erythritol powder (Air-Flow Plus®, EMS; 14 µm) for supragingival biofilm removal and glycine powder (Air-Flow Perio®, EMS; 25 µm) for subgingival polishing. This procedure is repeated at baseline and at 1, 3, 6, and 9 months without the adjunctive use of any topical gel.
RECRUITING
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia
University of Pavia
OTHER