Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06830200

Peri-implantitis Treatment With Chitosan Brush

Led by Hacettepe University · Updated on 2025-09-15

60

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Peri-implantitis Treatment With Chitosan Brush

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of peri-implantitis in an implant that has been in function for more than 12 months
  • Age 18 years or older and under 65 years
  • Agreeing to participate after reading the informed consent form
  • Completion of periodontal treatment for diagnosed periodontitis before joining the study
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Receiving or have received radiotherapy, chemotherapy, or long-term corticosteroid treatment
  • Received systemic antibiotics within 6 months before baseline
  • Pregnant or lactating
  • Anatomical abnormalities around the implant (e.g., apically positioned implants next to a tooth)
  • Prostheses preventing access for cleaning with chitosan brushes or titanium curettes
  • Implants with overdenture superstructure
  • Implants planned for removal
  • ASA score of 3 or higher
  • Allergic reactions or adverse events to chitosan, stainless steel, adhesives, or polypropylene
  • Clinically mobile implants
  • Recently placed or non-osseointegrated implants
  • Implants near major nerves or blood vessels with risk of damage

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hacettepe University

Ankara, Turkey (Türkiye), 06100

Actively Recruiting

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Research Team

B

Buket Acar, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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