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临床试验/NCT01917292
NCT01917292已完成3 期

Periodontal Intervention Improves Vascular Function Among Chinese Prehypertensive Adults With Periodontitis

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
123
试验地点
1
主要终点
Change from Baseline in the Blood Pressure at 6 months

研究概览

简要总结

The purpose of this study is to determine the effect of periodontal intervention on vascular dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.

详细描述

Periodontitis is one of the low-grade chronic diseases, and it is the principal cause of tooth loss among middle-aged and elderly. Recently, epidemiological data indicate that patients with periodontitis are associated with increases in blood pressure levels and hypertension prevalence. Furthermore, studies from cross-sectional investigations demonstrate that hypertensive patients with periodontitis may enhance the risk and degree of vascular damage. Therefore, periodontal therapy is a novel therapeutic strategy to prevent the occurrence of BP elevation and retard the development vascular injury.

The term "prehypertension" indicates those with BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure. Accumulating evidence suggests that subjects with prehypertension is associated with higher incidence of atherosclerotic vascular disease. However, until now there are no available data to investigate the influence of periodontitis on prehypertension and whether periodontal intervention may reduce the BP rise in subjects with prehypertension and improve the vascular function. We hypothesized that periodontitis leads to elevation in BP and periodontal therapy improves vascular function in subjects with prehypertension. To address these assumptions, The present study is designed to study the effect of periodontal intervention on blood pressure and vascular function and inflammatory biomarkers among Chinese prehypertensive adults with moderate to severe periodontal disease, and determine whether intensive periodontal therapy improves these measures over a 6-month follow-up period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must be 18 years of age or older
  • Moderate to severe generalized periodontitis(probing pocket depths of >6 mm and Marginal alveolar bone loss of >30%) with 50% or more of their teeth affected
  • Have at least 16 natural teeth excluding third molars
  • BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure
  • 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
  • Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
  • Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension
  • Patients who received periodontal treatment within the last 6 months
  • Patients who require antibiotic prophylaxis before examination or treatment
  • Patients with mental retardation and dementia

结局指标

主要结局

Change from Baseline in the Blood Pressure at 6 months

时间窗: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

Change from Baseline in the Number of Endothelial Microparticle at 6 months

时间窗: Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

次要结局

  • Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)(Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy)
  • Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)(Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy)
  • Change in Periodontal Inflamed Surface Area(PISA)(Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy)
  • Change in Brachia-ankle Pulse Wave Velocity(baPWV)(Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy)
  • Change in Endothelium-dependent Brachial Artery Flow-mediated Dilation(FMD)(Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy)
  • Expression of the Long non-protein-coding RNA(lncRNA) and microRNA(baseline)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junying Yang

professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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