Peri-implantitis Treatment With Chitosan Brush

Recruiting now · Not applicable

Conditions studied: Peri-implantitis

In brief

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.

Key facts

Study ID

NCT06830200

Run by

Hacettepe University

People needed

60

Starts

2025-04-10

Expected to finish

2027-06-01

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Hacettepe University — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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