drugset / Trial / NCT07088679

Natural Bioactive Gel for Peri-Implantitis

NCT07088679 ↗

Recruiting 20 enrolled University of Pavia
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2025-07-30
Primary completion
2026-12-01
Completion
2026-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Sterify Gel Other / unclassified — Other

Indications