Using a chitosan brush to treat peri-implantitis
Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment
This will test whether cleaning infected dental implants with a chitosan brush works better than a titanium curette for adults with peri-implantitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ankara) |
| Trial ID | NCT06830200 on ClinicalTrials.gov |
What this trial studies
This interventional study compares non-surgical implant debridement using a chitosan brush versus a titanium curette in adults with peri-implantitis. Eligible participants have implants in function for more than 12 months and have completed prior periodontal treatment before enrollment. Treatments are non-surgical and outcomes will include clinical signs of inflammation and measurements of inflammatory cytokines such as IL-1β, IL-6, and TNF-α. The aim is to see if the chitosan brush reduces biofilm and inflammatory markers more effectively than conventional instrumentation.
Who should consider this trial
Good fit: Adults aged 18–64 with peri-implantitis on implants placed more than 12 months earlier who can undergo non-surgical debridement and have completed periodontal treatment are ideal candidates.
Not a fit: Patients needing implant removal, with prosthetic access restrictions, recent systemic antibiotics, current chemo/radiotherapy or long-term steroids, pregnancy/lactation, or ASA score ≥ 3 are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could offer a less invasive way to reduce implant inflammation and bacterial biofilm, helping preserve implant health and slow bone loss.
How similar studies have performed: Laboratory and small clinical studies show chitosan has antibacterial and anti-inflammatory effects, but strong clinical evidence for non-surgical peri-implantitis treatment is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of peri-implantitis in an implant that has been in function for more than 12 months * Age ≥ 18 and \< 65 * Agreeing to participate in the study after reading the informed consent form * Completion of periodontal treatment of patients diagnosed with periodontitis before inclusion in the study Exclusion Criteria: * Patients under 18 years of age * Patients who have received or are currently receiving radiotherapy, chemotherapy and long-term systemic corticosteroid treatment * Patients who received systemic antibiotics within 6 months from baseline * Pregnant or lactating patients * Patients with anatomical abnormalities around the implant (e.g., apically positioned implants adjacent to a tooth) * Patients with prostheses that prevent access for implant debridement with chitosan brushes or titanium curettes * Implants with an overdenture superstructure * Implants to be explanted * Patients with ASA score ≥ 3 * Patients reporting reactions or adverse events to chitosan, stainless steel, adhesives, or polypropylene * Clinically mobile implants * Recently placed and non-osseointegrated implants * Around major nerves and blood vessels, if there is a risk of structural damage
Where this trial is running
Ankara
- Hacettepe University — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Buket Acar, PHD
- Email: dtbuketacar@gmail.com
- Phone: +90 312 305 2217
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.