Natural bioactive gel to treat peri-implantitis around dental implants.
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
NA · University of Pavia · NCT07088679
This study will try adding a natural bioactive gel (Sterify Gel®) to standard non-surgical cleaning to see if adults with peri-implantitis have less inflammation and bone loss around their implants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pavia (other) |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07088679 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled, split-mouth clinical trial in which each participant serves as their own control: one affected implant will receive standard non-surgical therapy plus a mucoadhesive bioactive gel (Sterify Gel®) and a second implant will receive standard therapy alone. The gel contains polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and the antimicrobial peptide nisin and is applied as an adjunct to mechanical debridement and air-polishing. Twenty patients with at least two implants in different quadrants affected by peri-implantitis will be enrolled and followed for nine months. Clinical outcomes will include plaque levels, bleeding on probing, probing depth, and radiographic measures of bone loss.
Who should consider this trial
Good fit: Adults aged 18–70 with peri-implantitis involving at least two dental implants in different quadrants, clinical signs of bleeding and/or suppuration on probing, and increased probing depth and radiographic bone loss who can attend follow-up visits are ideal candidates.
Not a fit: Patients with only one affected implant, those with excluded conditions (such as implanted electronic devices, uncontrolled systemic or autoimmune diseases, pregnancy or lactation), or those unable to comply with follow-up visits may not be eligible or likely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding Sterify Gel® could reduce inflammation and pocket depth around implants and help limit further bone loss, potentially lowering the need for more invasive treatments.
How similar studies have performed: Local antimicrobial and bioactive adjuncts for peri-implant and periodontal disease have shown mixed but sometimes promising results in prior studies, while clinical data specific to Sterify Gel® are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Lombardy
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia — Pavia, Lombardy, Italy (RECRUITING)
Study contacts
- Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
- Study coordinator: Andrea Scribante, Associate Professor
- Email: andrea.scribante@unipv.it
- Phone: +39 0382516223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peri-implantitis, Dental Implants, Non-surgical Periodontal Therapy, Dental implants, Bioactive gel, Sterify Gel, Non-surgical therapy, Split-mouth design