Natural Bioactive Gel for Peri-Implantitis (PERISTER)

University of Pavia

Status: Enrolling

Conditions: Dental Implants; Peri-implantitis; Non-surgical Periodontal Therapy

Treatments: Procedure: Standard Non-Surgical Peri-Implantitis Therapy; Drug: Sterify Gel (mucoadhesive bioactive gel)

Study type: Interventional

Funder types: Other

Identifiers

NCT07088679

2025-SMGEL

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sterify Gel + Non-Surgical Therapy

Experimental group

Description:

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.

Treatment:

Drug: Sterify Gel (mucoadhesive bioactive gel)

Procedure: Standard Non-Surgical Peri-Implantitis Therapy

Non-Surgical Therapy Only

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Non-Surgical Peri-Implantitis Therapy