NCT06830200 Peri-implantitis Treatment With Chitosan Brush
| NCT ID | NCT06830200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hacettepe University |
| Condition | Peri-implantitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-10 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In dentistry, dental implant applications for tooth loss/deficiency are prominent and provide successful long-term results in terms of functionality and aesthetics. However, peri-implant diseases such as peri-implant mucositis and peri-implantitis may develop due to biofilm accumulation around the implant. In peri-implantitis, in addition to the clinical inflammation findings seen in peri-implant mucositis, there is also progressive bone loss. This condition is to be treated with non-surgical or surgical methods. Titanium curettes, ultrasonic instruments, laser systems, and chitosan brushes are used for biofilm removal in non-surgical treatment. Chitosan is a natural polysaccharide obtained from chitin. It is biocompatible, biodegradable, and has antibacterial activity. In addition, chitosan reduces the levels of IL-1β, IL-6, and TNF-α, which also play a role in the pathogenesis of peri-implantitis, and exhibits anti-inflammatory effects on macrophages activated by lipopolysaccharide. Although many methods are used to treat peri-implantitis, successful and predictable results cannot be obtained. This study aims to examine the clinical and immunological findings and observe the changes in the non-surgical treatment of peri-implantitis using chitosan brush or titanium curette over 12 months. Sixty dental implants diagnosed with peri-implantitis clinically and radiographically at the Department of Periodontics, Faculty of Dentistry, Hacettepe University will be included in the study. Non-surgical peri-implantitis treatment of these patients will be performed using a chitosan brush (N=30, case group) or titanium curette (N=30, control group). Pre-operative and post-operative 3rd, 6th, and 12th months, clinical periodontal indices will be recorded, peri-implant crevicular fluid (PIF) will be collected, and maintenance treatment will be applied to the patients. IL-1β, TNF-α, IL-8, IL-10, and IL-17 levels in the collected PIF will be determined by the ELISA method. The effectiveness of chitosan brush and titanium curette in treating peri-implantitis will be evaluated and compared clinically and immunologically.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06830200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Peri-implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06830200 currently recruiting?
Yes, NCT06830200 is actively recruiting participants. Contact the research team at dtbuketacar@gmail.com for enrollment information.
Where is the NCT06830200 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT06830200 clinical trial?
NCT06830200 is sponsored by Hacettepe University. The trial plans to enroll 60 participants.