Peri-implantitisPERISTERNCT07088679
Natural Bioactive Gel for Peri-Implantitis
A study testing Sterify Gel (mucoadhesive bioactive gel) and Standard Non-Surgical Peri-Implantitis Therapy in people with Peri-implantitis and Dental Implants, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peri-implantitis, Dental Implants, Non-surgical Periodontal Therapy
- What is being tested?
- Sterify Gel (mucoadhesive bioactive gel) and Standard Non-Surgical Peri-Implantitis Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
Andrea Scribante, Associate Professor, +39 0382516223, andrea.scribante@unipv.it
About this study
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
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.
- Being tested
- Sterify Gel (mucoadhesive bioactive gel), Standard Non-Surgical Peri-Implantitis Therapy
- Keywords
- Peri-implantitis, Dental implants, Bioactive gel, Sterify Gel, Non-surgical therapy, Split-mouth design, Oral biofilm, Mechanical debridement, Randomized controlled trial
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard Non-Surgical Peri-Implantitis TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Non-Surgical Peri-Implantitis Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)
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.
Measured: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)
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.
Measured: 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)
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.
Measured: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)
Change in peri-implant implant mobility score
Implant mobility is assessed manually using two rigid instruments. The score is assigned as follows: 0 = no mobility, 1 = perceptible horizontal mobility on manual testing, 2 = clinically visible horizontal mobility, 3 = horizontal and vertical mobility (indication for implant removal). The outcome is the change in implant mobility score over time, evaluated per implant.
Measured: 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)
The Gingival Bleeding Index (GBI) assesses marginal gingival inflammation. Four sites per implant (mesial, distal, buccal, lingual/palatal) are gently probed. A score of 1 indicates bleeding within 10-15 seconds; 0 indicates absence of bleeding. The outcome is the change in the percentage of sites with GBI = 1 at the patient level over time.
Measured: 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)
Marginal Mucosal Conditions (MMC) assess visible signs of inflammation (redness, edema, altered contour) at four peri-implant sites. Each site is scored as 0 (healthy mucosa) or 1 (clinical signs of inflammation). The outcome is the change in the percentage of sites with MMC = 1 at the patient level over time.
Measured: 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)
Mucosal Margin Migration (MMM) assesses the presence of apical migration of the mucosal margin compared to baseline. Four sites per implant are examined visually. A score of 0 indicates no migration; 1 indicates visible apical shift. The outcome is the change in the percentage of sites with MMM = 1 at the patient level over time.
Measured: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)
Change in peri-implant Radiographic Bone Loss (RBL)
Radiographic Bone Loss (RBL) is a quantitative parameter used to assess marginal bone loss around dental implants. Standardized intraoral radiographs are obtained using a Rinn-type centering device. For each implant, the distance in millimeters from the implant shoulder to the first visible bone-to-implant contact is measured both mesially and distally. Bone loss is recorded in absolute millimeters and expressed as a percentage of the total implant length. The outcome is the change in mesial and distal RBL values between timepoints, comparing test and control sites.
Measured: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088679
- Sponsor's protocol ID
- 2025-SMGEL
- Acronym
- PERISTER
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07088679
- Acronym / sponsor ID
- PERISTER / 2025-SMGEL
- Keywords
- Peri-implantitis, Dental implants, Bioactive gel, Sterify Gel, Non-surgical therapy, Split-mouth design, Oral biofilm, Mechanical debridement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterify Gel + Non-Surgical Therapy | Experimental | Drug: Sterify Gel (mucoadhesive bioactive gel), Procedure: Standard Non-Surgical Peri-Implantitis TherapyThis 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. |
| Non-Surgical Therapy Only | Active comparator | Procedure: Standard Non-Surgical Peri-Implantitis TherapyThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Sterify Gel + Non-Surgical Therapy |
| Standard Non-Surgical Peri-Implantitis TherapyStandard 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. | Procedure or surgery | Non-Surgical Therapy Only, Sterify Gel + Non-Surgical Therapy |
Primary outcome
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)
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
Related trials for Peri-implantitis
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis
Recruiting
Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants
Periimplant Diseases, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Scribante, Associate Professor principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterify Gel (mucoadhesive bioactive gel) and Standard Non-Surgical Peri-Implantitis Therapy in people with Peri-implantitis and Dental Implants, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Scribante, Associate Professor (+39 0382516223, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.