Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07088679

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

Led by University of Pavia · Updated on 2025-08-22

20

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a natural bioactive gel called Sterify Gel® as an additional treatment to standard non-surgical therapy for peri-implantitis. Peri-implantitis is an inflammatory condition affecting tissues around dental implants that can cause bone loss and implant failure. This randomized controlled clinical trial uses a split-mouth design to compare outcomes in patients with at least two affected implants in different mouth quadrants. Participants will receive two types of treatment: one implant site will get the standard non-surgical therapy plus the Sterify Gel®, while the other implant site will be treated with standard therapy alone. The standard therapy includes mechanical cleaning using ultrasonic and manual instruments, followed by air-polishing with erythritol and glycine powders. The gel is applied into the peri-implant pocket using a sterile needle at baseline and during follow-up visits at 1, 3, 6, and 9 months. During the 9-month study period, researchers will assess clinical outcomes such as plaque levels, bleeding on probing, probing depth, suppuration, implant mobility, gingival bleeding, mucosal conditions, mucosal margin changes, and bone loss through regular examinations. Participants will attend follow-up visits at these intervals for treatment application and detailed assessments to monitor changes. The study aims to determine if adding the Sterify Gel® improves results compared to standard treatment alone.

CONDITIONS

Brief Title

Natural Bioactive Gel for Peri-Implantitis

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 and radiographic bone loss compared to previous examinations
  • In absence of previous clinical data: probing depth ≥ 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 9 months

Participants receive standard non-surgical peri-implantitis therapy with mechanical debridement and air-polishing. In one treatment phase, the natural bioactive Sterify Gel is applied into the peri-implant pockets as an adjunct to the standard therapy. Applications occur at baseline and follow-up visits.

5 visits (baseline, 1, 3, 6, and 9 months)

Trial Site Locations

Total: 1 location

1

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

Pavia, Lombardy, Italy, 27100

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Research Team

A

Andrea Scribante, Associate Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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