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Recruiting NCT07088679

Natural Bioactive Gel for Peri-Implantitis

No phase Interventional Peri-implantitis Dental Implants Non-surgical Periodontal Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sterify Gel (mucoadhesive bioactive gel), Standard Non-Surgical Peri-Implantitis Therapy.
Who it may be relevant to
Registry conditions: Peri-implantitis, Dental Implants, Non-surgical Periodontal Therapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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
  • Procedure 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

Primary outcome measures

  • Change in peri-implant Modified Plaque Index (mPI) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
Secondary outcome measures (9)
  • Change in percentage of peri-implant sites with Bleeding on Probing (BoP) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in peri-implant Bleeding Score (BS) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in mean peri-implant Probing Depth (PD) [Time frame: 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) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in peri-implant implant mobility score [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in percentage of peri-implant sites with Gingival Bleeding Index (GBI) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in percentage of peri-implant sites with Marginal Mucosal Conditions (MMC) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in percentage of peri-implant sites with Mucosal Margin Migration (MMM) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
  • Change in peri-implant Radiographic Bone Loss (RBL) [Time frame: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Identifiers

NCT: NCT07088679 · 2025-SMGEL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗