Natural Bioactive Gel for Peri-Implantitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Pavia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
Sterify Gel (mucoadhesive bioactive gel)
DrugSterify 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
Procedure/SurgeryStandard 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Sterify Gel + Non-Surgical TherapyExperimental treatment 2 interventions
Group B: Non-Surgical Therapy OnlyActive comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)Secondary outcomes
1
Change in percentage of peri-implant sites with Bleeding on Probing (BoP)
Bleeding on Probing (BoP) is a binary clinical index used to assess inflammation of peri-implant soft tissues. Six peri-implant sites are evaluated per implant. Each site is scored as 0 if no bleeding occurs within 15 seconds of gentle probing, or 1 if bleeding is present. The percentage of bleeding sites is calculated for each patient. The outcome is the change in the percentage of peri-implant sites with BoP ≥1 over time, comparing test and control sites.
Time frame
At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)2
Change in peri-implant Bleeding Score (BS)
The Bleeding Score (BS) assesses bleeding severity upon probing at six sites per implant. Each site is scored on a 4-point scale: 0 = no bleeding, 1 = isolated bleeding points, 2 = continuous bleeding line along the margin, 3 = profuse bleeding. The outcome is the change in the mean BS and the percentage of sites with BS ≥1 over time, calculated at the patient level.
Time frame
At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)3
Change in mean peri-implant Probing Depth (PD)
Probing Depth (PD) is measured at six sites per implant using a calibrated periodontal probe with light force (≤ 0.25 N). It represents the distance in millimeters from the mucosal margin to the base of the pocket. The outcome is the change in mean PD per implant and the percentage of sites with PD ≥4 mm, calculated at the patient level over time.
Time frame
At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)4
Change in percentage of peri-implant sites with Suppuration (Suppuration Index, SI)
Suppuration Index (SI) evaluates the presence of purulent exudate at four peri-implant sites per implant (mesial, distal, buccal, lingual/palatal). Each site is scored as 0 (no suppuration) or 1 (visible suppuration upon probing). The outcome is the change over time in the percentage of sites with suppuration, calculated at the patient level.
Time frame
At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)Sponsors and contacts
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Source ClinicalTrials.gov