Effects of Nonsurgical Periodontal Therapy on Biomarkers in Serum and Gingival Crevicular Fluid in Severe Periodontitis (Stage III/IV) and Hyperlipidemia:A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- oxidized low-density lipoprotein cholesterol, oxLDL
研究概览
简要总结
This study was a single-center, non-randomized, parallel-group design clinical trial, and each group was assigned a 1:1 ratio with or without hyperlipidemia. Both groups underwent periodontal non-surgical treatment, and blood and gingival crevicular fluid were collected before surgery, 1 month and 3 months after surgery for the detection of MCP-1, IL-8, oxLDL, TNF-α, TG, LDL-C, HDL-C.
详细描述
This study was a single-center, non-randomized, parallel-group design clinical trial, and each group was assigned a 1:1 ratio with or without hyperlipidemia. Both groups underwent periodontal non-surgical treatment, and blood and gingival crevicular fluid were collected before surgery, 1 month and 3 months after surgery for the detection of MCP-1, IL-8, oxLDL, TNF-α, TG, LDL-C, HDL-C.MCP-1, IL-8, oxLDL, TNF-α will be tested for concentration using ELISA.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects had to meet at least one of the following criteria for the diagnosis of hyperlipidemia: triglyceride (TRG) levels >2.26 mmol/L; high density lipoprotein cholesterol (HDL-C) levels <1.04 mmol/L; or low density lipoprotein cholesterol (LDL-C) levels >4.14 mmol/L
- •Patients with severe periodontitis (stage III/IV) with probing depth (PD) ≥ 6 mm at at least six sites, at least two multi-rooted or two single-rooted teeth in at least one quadrant, and extended bone loss on imaging to the middle or top third of the root. Periodontitis results in the loss of less than or equal to four teeth.
排除标准
- •systemic illnesses
- •pregnancy or lactation
- •systemic antibiotics taken within the previous 6 months
- •use of cholesterol reduction medication during the past 6 months
- •subgingival scaling and root planing or surgical periodontal therapy in the last year
- •chewing smokeless tobacco, smoking pipes or cigars 1 or more times per week, or smoking more than 20 cigarettes per week (1 pack per week) in the past 6 months
结局指标
主要结局
oxidized low-density lipoprotein cholesterol, oxLDL
时间窗: 3 months after surgery
Concentration of oxLDL in gingival crevicular fluids and serum
monocyte chemotactic protein-1，MCP-1
时间窗: 3 months after surgery
Concentration of MCP-1 in gingival crevicular fluids
次要结局
- interleukin-8，IL-8(3 months after surgery)
- high-density lipoprotein cholesterol，HDL-C(3 months after surgery)
- low-density lipoprotein cholesterol，LDL-C(3 months after surgery)
- triglycerides，TG(3 months after surgery)
- probing depth，PD(3 months after surgery)
- clinical attachment level，CAL(3 months after surgery)
- percentage of bleeding on probing，BOP%(3 months after surgery)