Natural Bioactive Gel for Peri-Implantitis

NCT ID: NCT07088679

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2026-05-30

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sterify Gel (mucoadhesive bioactive gel)

Intervention Type: DRUG

Sterify Gel® is a sterile, ready-to-use mucoadhesive hydrogel formulated with polyvinyl polymers, hydroxytyrosol (a natural antioxidant), magnesium ascorbyl phosphate (a stable vitamin C derivative), and nisin (a naturally occurring antimicrobial peptide). In this study, it is applied into the peri-implant pocket using a 0.6 mm - 23GA sterile needle (Gerhò®) immediately after non-surgical debridement. Application is performed at baseline and at follow-up visits (1, 3, 6, and 9 months). Patients are instructed to avoid rinsing, eating, or using oral hygiene aids at the treated sites for at least 2 hours post-application, and to follow specific hygiene instructions for 48 hours.

Standard Non-Surgical Peri-Implantitis Therapy

Intervention Type: PROCEDURE

Standard therapy consists of supra- and subgingival professional mechanical debridement of peri-implant sites using ultrasonic inserts and manual curettes covered with biocompatible materials (PEEK, teflon, or titanium) to avoid damage to the implant surface. This is followed by air-polishing using erythritol powder (Air-Flow Plus®, EMS; 14 µm) for supragingival biofilm removal and glycine powder (Air-Flow Perio®, EMS; 25 µm) for subgingival polishing. This procedure is repeated at baseline and at 1, 3, 6, and 9 months without the adjunctive use of any topical gel.

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.

Group Type: ACTIVE_COMPARATOR

Standard Non-Surgical Peri-Implantitis Therapy

Intervention Type: PROCEDURE

Standard therapy consists of supra- and subgingival professional mechanical debridement of peri-implant sites using ultrasonic inserts and manual curettes covered with biocompatible materials (PEEK, teflon, or titanium) to avoid damage to the implant surface. This is followed by air-polishing using erythritol powder (Air-Flow Plus®, EMS; 14 µm) for supragingival biofilm removal and glycine powder (Air-Flow Perio®, EMS; 25 µm) for subgingival polishing. This procedure is repeated at baseline and at 1, 3, 6, and 9 months without the adjunctive use of any topical gel.

Interventions

Sterify Gel (mucoadhesive bioactive gel)

Sterify Gel® is a sterile, ready-to-use mucoadhesive hydrogel formulated with polyvinyl polymers, hydroxytyrosol (a natural antioxidant), magnesium ascorbyl phosphate (a stable vitamin C derivative), and nisin (a naturally occurring antimicrobial peptide). In this study, it is applied into the peri-implant pocket using a 0.6 mm - 23GA sterile needle (Gerhò®) immediately after non-surgical debridement. Application is performed at baseline and at follow-up visits (1, 3, 6, and 9 months). Patients are instructed to avoid rinsing, eating, or using oral hygiene aids at the treated sites for at least 2 hours post-application, and to follow specific hygiene instructions for 48 hours.

Intervention Type: DRUG

Standard Non-Surgical Peri-Implantitis Therapy

Standard therapy consists of supra- and subgingival professional mechanical debridement of peri-implant sites using ultrasonic inserts and manual curettes covered with biocompatible materials (PEEK, teflon, or titanium) to avoid damage to the implant surface. This is followed by air-polishing using erythritol powder (Air-Flow Plus®, EMS; 14 µm) for supragingival biofilm removal and glycine powder (Air-Flow Perio®, EMS; 25 µm) for subgingival polishing. This procedure is repeated at baseline and at 1, 3, 6, and 9 months without the adjunctive use of any topical gel.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Scribante, Associate Professor

Role: CONTACT

andrea.scribante@unipv.it

+39 0382516223

Facility Contacts

Andrea Scribante, Associate Professor

Role: primary

andrea.scribante@unipv.it

+39 0382516223

Other Identifiers

2025-SMGEL

Identifier Type: -

Identifier Source: org_study_id