Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Location status: Recruiting
Location contact
Buket Acar
CONTACT
Lütfiye Erdem
SUB_INVESTIGATOR
NCT Number: NCT06830200
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06100, Turkey (Türkiye)
Location status: Recruiting
Buket Acar
CONTACT
Lütfiye Erdem
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-surgical treatment of pre-implantitis with chitosan brush
Description: Non-surgical treatment of pre-implantitis with titanium curette
Time frame: 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]
Time frame: 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
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
According to the GI system; 0: Normal gingiva
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)
According to PI scores; 0: No plaque
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)
Time frame: 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
Time frame: 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
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
From PIOS
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
From PIOS
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
From PIOS
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
From-PIOS
Time frame: From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months)
From PIOS
Contact information is provided by the study sponsor or research team.
Hacettepe University
Other
Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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