Peri-implantitis Treatment With Chitosan Brush

Official title

Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment

Overview

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.

Interventions

• Procedure Non-surgical periodontal treatment with chitosan brush
  Non-surgical treatment of pre-implantitis with chitosan brush
• Device Non-surgical treatment of pre-implantitis with titanium curette
  Description: Non-surgical treatment of pre-implantitis with titanium curette

Primary outcome measures

• Probing Pocket Depth [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• Radiographic Bone Level (RBL) [Time frame: From the baseline to the 12th month (Baseline, 6th, 12th months)]

Secondary outcome measures (10)

• Gingival index (GI) [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• Plaque Index (PI) [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• Bleeding on Probing [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• Keratinized Mukoza Width [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• Recession Depth [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• IL-1β [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• TNF-α [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• IL-8 [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• IL-10 [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]
• IL-17 [Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Hacettepe University — Ankara

Identifiers

NCT: NCT06830200 · KA-23071

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗