Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Clinical parameter probing depth
研究概览
简要总结
Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. When evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. In the Peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. Many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. Mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. In this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. In our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, Interleukin-10, Interleukin-17, RANKL, osteoprotegerin, TWEAK and sclerostin biomarkers in Peri-implant crevicular fluid and clinically.
详细描述
Primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. The change between these parameters is observed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of 5mm or more peri-implant pockets
- •Not having periodontal treatment in the last 3 months,
- •The informed consent form must be approved,
- •At least 18 years old.
排除标准
- •Presence of systemic disease,
- •Regular use of non-steroidal anti inflammatory drugs,
- •Having been treated with antibiotics in the last 3 months,
- •Individuals in need of pre-treatment antibiotic prophylaxis,
- •Pregnancy and lactation,
- •Not approving the informed consent form,
- •Patients with known allergies.
研究组 & 干预措施
Diode Laser
At baseline, diode laser is applied to one group.
干预措施: Diode laser (Device)
Diode Laser
At baseline, diode laser is applied to one group.
干预措施: Titanium curettes (Device)
Titanium curettes
At baseline, titanium curettes are used to both of the groups
干预措施: Titanium curettes (Device)
结局指标
主要结局
Clinical parameter probing depth
时间窗: Baseline, 3 months and 6 months
The primary outcome of the study was the control examination performed 3 months after the first examination. Probing depth was measured with a periodontal probe by the distance between gingival margin and the base of the pocket. The change between these time frames are recorded.
次要结局
- Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.(Baseline, 3 months and 6 months)
- Gingival bleeding time index(Baseline, 3 months and 6 months)
- Gingival index(Baseline, 3 months and 6 months)
- Plaque index(Baseline, 3 months and 6 months)
- Clinical attachment level(Baseline, 3 months and 6 months)
研究者
Nazan Ece Erduran
Research Assistant
Hacettepe University