Evaluating the Influence of Obesity on Peri-Implant Health Through Clinical and Biochemical Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Levels of TNF-alfa in PICF
研究概览
简要总结
This clinical study aims to evaluate the influence of obesity on peri-implant health. Both clinical parameters and biochemical markers in peri-implant crevicular fluid(PICF) will be assessed. The study will include patients with dental implants who are classified as obese as well as a control group of non-obese participants. Clinical outcomes such as probing depth, plaque index, bleeding on probing, and peri-implant bone levels will be recorded. In addition, PICF samples will be analyzed for inflammatory biomarkers including interleukin-1 beta(IL-1beta), tumor necrosis factor-alpha(TNF-alfa), and matrix metalloproteinase-8(MMP-8). The results of this study may help to clarify the relationship between obesity and inflammatory responses in peri-implant tissues.
详细描述
This prospective clinical study investigates the role of obesity in peri-implant health by assessing both clinical and biochemical parameters. The study population will consist of systemically healthy individuals aged 18 years or older who have undergone dental implant treatment. Participants will be categorized into obese and non-obese groups according to body mass index (BMI) and waist circumference measurements. Clinical evaluations will include plaque index, bleeding on probing, probing depth, and radiographic assessment of peri-implant marginal bone loss. PICF will be collected from implant sites using standardized paper strips. The collected fluid will be analyzed for inflammatory biomarkers, including IL-1 beta, TNF-alfa, and MMP-8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to determine whether obesity is associated with altered peri-implant clinical parameters and increased levels of inflammatory biomarkers. By correlating clinical and biochemical findings with obesity-related measures (BMI and waist circumference), this study aims to provide valuable insights into the potential impact of obesity on peri-implant tissue health and the risk of peri-implant diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 是
入选标准
- •Adults ≥18 years with dental implants in function for at least 1 year.
- •Patients diagnosed with peri-implantitis according to clinical and radiographic criteria.
- •For control group: systemically healthy individuals with peri-implant health.
- •Written informed consent obtained.
排除标准
- •Patients with systemic diseases affecting periodontal/implant health (e.g., uncontrolled diabetes, HIV, cardiovascular disease, kidney disorders).
- •Pregnant or lactating women.
- •Current smokers or individuals using smokeless tobacco.
- •Alcohol abuse.
- •Use of antibiotics or anti-inflammatory drugs within the last 3 months.
- •Patients who had received peri-implant treatment within the last 6 months.
结局指标
主要结局
Levels of TNF-alfa in PICF
时间窗: Baseline
TNF-alfa concentration in PICF will be quantified using ELISA. Samples will be collected from four sites per implant (mesial, distal, buccal, lingual). Higher levels indicate increased inflammation.
Levels of IL-1 beta in PICF
时间窗: Baseline
IL-1beta concentration in PICF will be quantified using ELISA. Samples will be collected from four sites per implant (mesial, distal, buccal, lingual). Higher levels indicate increased inflammation.
Levels of MMP-8 in PICF
时间窗: Baseline
MMP-8 concentration in PICF will be quantified using ELISA. Samples will be collected from four sites per implant (mesial, distal, buccal, lingual). Higher levels indicate increased inflammation.
次要结局
- Probing depth around dental implants(Baseline)
研究者
Mine Keskin
Principal Investigator, Specialist in Periodontology, Recep Tayyip Erdogan University Faculty of Dentistry
Recep Tayyip Erdogan University