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Clinical Trials in Turkey / NCT06830200
Recruiting Not applicable

Peri-implantitis Treatment With Chitosan Brush

NCT06830200 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-04-10
Last updated
2025-09-15

Condition(s) studied

Peri-implantitis

Investigational drug(s) / intervention(s)

Non-surgical periodontal treatment with chitosan brushNon-surgical treatment of pre-implantitis with titanium curette

Non-surgical periodontal treatment with chitosan brush: Non-surgical treatment of pre-implantitis with chitosan brush

Non-surgical treatment of pre-implantitis with titanium curette: Description: Non-surgical treatment of pre-implantitis with titanium curette

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hacettepe University Ankara Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830200 on ClinicalTrials.gov ↗ ← All trials in Turkey