Impact of Periodontal Treatment on Brain Hemodynamics
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
- 是
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.
研究组 & 干预措施
Periodontal treatment group
Patients will receive an intensive (non surgical) regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one session or two sessions within 2 days). Any tooth that from the baseline examination is defined as hopeless or irrational to treat will be extracted at the oral hygiene visit. After the 2 months re-assessment individuals if presenting with at least one periodontal pocket of 6 mm in depth will undergo additional corrective periodontal therapy consisting of periodontal surgery and re-instrumentation under local analgesia. If surgical periodontal therapy is not indicated, appropriate re-instrumentation of the sites will be performed.
干预措施: periodontal treatment (Procedure)
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
Yago Leira Feijoo
Postoctoral resseacher and clinical supervisor
University of Santiago de Compostela