Peri-implantitis Treatment With Chitosan Brush

Not Applicable

Not yet recruiting

• Conditions: Peri-implantitis

• Registration Number: NCT06830200
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Study Start: 2025-04-10
• Primary Completion: 2026-12-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probing Pocket Depth	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	The distance between the mucosal margin and the bottom of the peri-implant pocket \[six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant\]
Radiographic Bone Level (RBL)	From the baseline to the 12th month (Baseline, 6th, 12th months)	RBL is determined in millimeters by metrically measuring the distance from the implant shoulder to the first bone-implant contact on the radiograph. Increasing RBL indicates worse outcome

Secondary Outcome Measures

Name	Time	Method
Gingival index (GI)	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	According to the GI system; 0: Normal gingiva; 1. Mild inflammation with no edema, color change or bleeding on probing in the gingiva; 2. Moderate inflammation with redness, edema and brightness in the gingiva and bleeding on probing; 3. Severe inflammation with significant redness, edema, ulceration and spontaneous bleeding.; Six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant. The gingival index of an implant is calculated by dividing the total score of that implant by 4. Increased GI indicates worse outcome.
Keratinized Mukoza Width	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	The distance between the keratinized mucosa margin and the mucogingival junction in the mid-buccal region of the implant
Plaque Index (PI)	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	According to PI scores; 0: No plaque; 1. Invisible film-like plaque attached to the free gingival margin and adjacent implant surface, detectable with a probe; 2. Visible, moderate soft attachment within the gingival pocket or on the gingival margin and adjacent implant surface; 3. Indicates the presence of dense soft attachment within the gingival pocket or on the gingival margin and adjacent implant surface.; Six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) were measured on each implant.The arithmetic average of 4 measurement values obtained from an implant is recorded as the PI score for that implant. Increased PI indicates worse outcome
Bleeding on Probing	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
IL-1β	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	From PIOS
TNF-α	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	From PIOS
IL-8	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	From PIOS
IL-10	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	From-PIOS
IL-17	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	From PIOS
Recession Depth	From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)	The distance between the margin of the prosthetic restoration and the keratinized mucosal marjin

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey