Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07088679

Natural Bioactive Gel for Peri-Implantitis

Led by University of Pavia · Updated on 2025-08-22

20

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Natural Bioactive Gel for Peri-Implantitis

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 and radiographic bone loss compared to previous examinations
  • If no prior clinical data: probing depth of 6 mm or more and bone loss of 3 mm or more from the implant coronal portion
  • Willingness and ability to comply with study protocol and follow-up visits
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • 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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Trial Site Locations

Total: 1 location

1

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy, 27100

Actively Recruiting

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Research Team

A

Andrea Scribante, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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