Peri-implantitis Treatment With Chitosan Brush
ConditionPeri-implantitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Non-surgical periodontal treatment with chitosan brush
Procedure/SurgeryNon-surgical treatment of pre-implantitis with chitosan brush
Non-surgical treatment of pre-implantitis with titanium curette
DeviceDescription: Non-surgical treatment of pre-implantitis with titanium curette
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Chitosan BrushActive comparator 1 intervention
Group B: Titanium CuretteActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Probing Pocket Depth
The distance between the mucosal margin and the bottom of the peri-implant pocket \[six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual) on each implant\]
Time frame
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)2
Radiographic Bone Level (RBL)
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
Time frame
From the baseline to the 12th month (Baseline, 6th, 12th months)Secondary outcomes
1
Gingival index (GI)
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.
Time frame
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)2
Plaque Index (PI)
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
Time frame
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)3
Bleeding on Probing
Time frame
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)4
Keratinized Mukoza Width
The distance between the keratinized mucosa margin and the mucogingival junction in the mid-buccal region of the implant
Time frame
From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)Sponsors and contacts
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Source ClinicalTrials.gov