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临床试验/NCT05506917
NCT05506917Unknown不适用

Impact of Periodontal Treatment on Brain Hemodynamics

University of Santiago de Compostela1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Cerebrovascular reactivity (CvR) (%)

研究概览

简要总结

Periodontitis has been linked to increased risk of cerebrovascular disease. Impaired brain hemodynamics has been suggested as early markers of cerebral macro and microangiopathy. Therefore, the aim of this clinical trial will be to assess the potential effect of periodontal treatment on cerebral hemodynamics in otherwise healthy patients with severe periodontitis over 6 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • Otherwise healthy subjects with severe periodontitis.

排除标准

  • <10 teeth
  • current smokers
  • undergo periodontal treatment within the last 6 months.
  • receive antibiotics or anti-inflammatory drugs within the last 3 months.

结局指标

主要结局

Cerebrovascular reactivity (CvR) (%)

时间窗: Baseline-6 months

CvR to hypercapnia was evaluated by means of the breath-holding index (BHI). Two dual 2-MHz transducers fitted on a headband and placed on the temporal bone windows were used to obtain a bilateral continuous measurement of mean flow velocity in the middle cerebral arteries. Depth of insonation ranged from 48 to 52 mm. The BHI is obtained by dividing the percentage increase in mean flow velocity occurring during breath holding by the length of time (seconds) subjects hold their breath af- ter a normal inspiration (\[mean flow velocity at the end of breath holding minus mean flow velocity at rest divided by mean flow velocity at rest\] multipled by 100 divided by seconds of breath holding).

次要结局

  • Pulsatility index(Baseline-6 months)
  • Resistivity index(Baseline-6 months)
  • Serum high sensitivity C-reactive protein (hs-CRP)(Baseline-6 months)
  • Brachial flow-mediated dilatation(Baseline-6 months)
  • Carotid intima-media thickness(Baseline-6 months)
  • Probing pocket depth(Baseline-3 months-6 months)
  • Clinical attachment level(Baseline-3 months-6 months)
  • Full-mouth bleeding score(Baseline-3 months-6 months)
  • Full-mouth plaque score(Baseline-3 months-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yago Leira Feijoo

Postoctoral resseacher and clinical supervisor

University of Santiago de Compostela

研究点 (1)

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