Impact of Periodontal Therapy on Endothelial Function
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Brachial Artery Flow-mediated Dilation
研究概览
简要总结
The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease
详细描述
Periodontitis is one of the most prevalent chronic diseases and a frequent cause of tooth loss. Accumulation of subgingival dental biofilm in susceptible individuals is associated with an inflammatory host response characterized by the production of Matrix Metalloproteinases, reduction in collagen synthesis, increase in cytokine gene expression, and apoptosis of gingival fibroblasts. Finally, inflammation leads to destruction of periodontal ligament, alveolar bone resorption, and chronic periodontitis.
Periodontitis is associated with increased serum levels of inflammatory cytokines and acute phase reactants. Multiple case-control and cohort studies have suggested that periodontitis is an independent risk factor for cardiovascular events, diabetic end-organ damage, pregnancy complications and respiratory diseases. Recent interventional studies have found that periodontal therapy could increase endothelium-dependent brachial artery flow-mediated dilation.
The purpose of this controlled clinical trial is to determine the effect of periodontal therapy on endothelial function in subjects with moderate to severe chronic periodontitis. Furthermore, the relationship between putative periodontal pathogens and endothelial function will be also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 25 years of age or older
- •Three or more periodontal pockets with a probing depth (PD) > 5mm
- •Have at least 20 natural teeth
- •Provide informed consent and willingness to cooperate with the study protocol
排除标准
- •History of antibiotic use in the previous three months
- •Pregnant or lactating females
- •Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
- •Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
- •Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident
- •Patients who received periodontal treatment within the last 3 months
- •Patients who require antibiotic prophylaxis before examination or treatment
- •Patients with mental retardation and dementia
结局指标
主要结局
Brachial Artery Flow-mediated Dilation
时间窗: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).
次要结局
- High-sensitivity C-Reactive Protein(Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)
- Total Cholesterol(Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)
- White Blood Cell Count(Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)
- Subgingival Microbiota(12 weeks post-periodontal therapy)
- LDL Cholesterol(Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)
- Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)(12 weeks post periodontal therapy)
- Intercellular Adhesion Molecule 1 (ICAM-1)(12 weeks post periodontal therapy)
- Vascular Cell Adhesion Molecule 1 (VCAM-1)(12 weeks post periodontal therapy)
- Myeloperoxidase (MPO)(12 weeks post periodontal therapy)
- Matrix Metalloproteinase-9 (MMP-9)(12 weeks post periodontal therapy)
- Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)(12 weeks post periodontal therapy)
研究者
Jorge Hernán Ramírez
principal investigator
Universidad del Valle, Colombia