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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Hacettepe University
RECRUITING
Ankara
Contact Information
Primary
Buket Acar, PHD
dtbuketacar@gmail.com
+90 312 305 2217
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 60
Treatments
Active_comparator: Chitosan Brush
The implants in the chitosan brush group will be debrided with a chitosan brush dipped in sterile physiological saline solution using a rotary instrument system for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological saline solution. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant in the same patient requiring peri-implantitis treatment, all of these implants will be included in the same treatment group.
Active_comparator: Titanium Curette
The implants in the titanium curette group will be treated with titanium curettes for 2 minutes. After mechanical treatment, the peri-implant pockets will be washed with sterile physiological serum. In cases with BOP+ and PD≥ 4 mm at 3 and 6 months after treatment, the treatment will be repeated in the same way as the previous one. Local infiltration anesthesia will be applied to the patients when deemed necessary. The prosthetic superstructures of the implants will not be removed for clinical examination or treatment. In cases where there is more than one implant requiring peri-implantitis treatment in the same patient, all of these implants will be included in the same treatment group.
Related Therapeutic Areas
Sponsors
Leads: Hacettepe University

This content was sourced from clinicaltrials.gov