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Efficacy of a Natural Bioactive Gel as an Adjunct to Standard Therapy in the Treatment of Peri-Implantitis: A Randomized Controlled Split-Mouth Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
RECRUITING
Pavia
Contact Information
Primary
Andrea Scribante, Associate Professor
andrea.scribante@unipv.it
+39 0382516223
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 20
Treatments
Experimental: Sterify Gel + Non-Surgical Therapy
This arm receives standard non-surgical peri-implantitis treatment (mechanical debridement, air-polishing with erythritol and glycine) plus the application of Sterify Gel®, a mucoadhesive hydrogel containing polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, applied in the peri-implant pocket using a sterile needle.
Active_comparator: Non-Surgical Therapy Only
This arm receives standard non-surgical peri-implantitis treatment only, including mechanical debridement with ultrasonic and manual instruments, and air-polishing with erythritol and glycine powders. No adjunctive gel is applied.
Related Therapeutic Areas
Sponsors
Leads: University of Pavia

This content was sourced from clinicaltrials.gov