Clinical trial NCT06830200: Peri-implantitis Treatment With Chitosan Brush
Official title: Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peri-implantitis
Keywords: Chitosan Brush
Non-Surgical Peri-implantitis Treatment
Peri-implantitis
Cytokine
Titanium Curette
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Probing Pocket Depth
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: Radiographic Bone Level (RBL)
timeFrame: From the baseline to the 12th month (Baseline, 6th, 12th months)
Secondary outcomes:
measure: Gingival index (GI)
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: Plaque Index (PI)
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: Bleeding on Probing
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: Keratinized Mukoza Width
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: Recession Depth
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: IL-1β
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: TNF-α
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: IL-8
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: IL-10
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
measure: IL-17
timeFrame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: