Natural Bioactive Gel for Peri-Implantitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Pavia

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators