Clinical and Immunological Evaluation of the Efficacy of Chitosan Brush in Non-Surgical Peri-implantitis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Non-surgical periodontal treatment with chitosan brush (Procedure)
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.
干预措施: Non-surgical treatment of pre-implantitis with titanium curette (Device)
结局指标
主要结局
Probing Pocket Depth
时间窗: 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)
时间窗: 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
次要结局
- Gingival index (GI)(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- Keratinized Mukoza Width(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- Plaque Index (PI)(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- 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))
- TNF-α(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- IL-8(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- IL-10(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- IL-17(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
- Recession Depth(From the baseline to the 12th month (Baseline, 3rd, 6th, 12th months))
研究者
Buket Acar
Assistant Professor
Hacettepe University