Natural Bioactive Gel for Peri-Implantitis

NCT07088679 | Recruiting

• 1 other identifier: 2025-SMGEL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Peri-implantitis; Dental implants; Bioactive gel; Sterify Gel; Non-surgical therapy; Split-mouth design; Oral biofilm; Mechanical debridement; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant Modified Plaque Index (mPI)

  The Modified Plaque Index (mPI) is a semi-quantitative index used to assess the presence and accumulation of bacterial plaque around dental implants. Scores are recorded at six peri-implant sites per implant using a 3-point scale, where 0 indicates no plaque, 1 indicates plaque detectable only with a probe, and 2 indicates plaque visible to the naked eye. For each implant, the mean score is calculated. At the patient level, the percentage of sites with a score greater than or equal to 1 is also calculated. The primary outcome is the change in mPI between baseline and the final follow-up, comparing treated and control sites.

  At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)

Secondary Outcomes (9)

• Change in percentage of peri-implant sites with Bleeding on Probing (BoP)

  At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)

• Change in peri-implant Bleeding Score (BS)

  At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)

• Change in mean peri-implant Probing Depth (PD)

  At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)

• Change in percentage of peri-implant sites with Suppuration (Suppuration Index, SI)

  At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)

• Change in peri-implant implant mobility score

  At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)

Study Arms (2)

Sterify Gel + Non-Surgical Therapy

EXPERIMENTAL

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.

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

Non-Surgical Therapy Only

ACTIVE COMPARATOR

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.

Procedure: Standard Non-Surgical Peri-Implantitis Therapy

Interventions

Sterify Gel (mucoadhesive bioactive gel) 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.

Sterify Gel + Non-Surgical Therapy

Standard Non-Surgical Peri-Implantitis Therapy 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; Sterify Gel + Non-Surgical Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, Associate Professor

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 28, 2025
• Study Start: July 30, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)