Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Endothelial function
研究概览
简要总结
Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.
详细描述
At V2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. The add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (V3) in comparison with V2 by taking into account with the effect of 10 weeks of CPAP in the control group with severe OSA but not periodontitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe OSA defined by an apnea hypopnea index > or = 30 per hour
- •with or without chronic parodontitis
排除标准
- •non equilibrated diabetes
- •obesity (BMI > or = 40)
- •active smoker (> 1 pack per day (20 cigarettes))
- •pregnancy
- •antibiotics within the preceding three months
- •prophylactic antibiotherapy required for the parodontitis treatment
- •acute parodontitis or all parontal pathology requiring immediate therapy
- •less than 10 teeth
研究组 & 干预措施
Obstructive sleep apnea with chronic parodontis
patients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment
干预措施: scaling and root planing (Procedure)
Obstructive sleep apnea without chronic parodontis
patients with severe OSA treated by CPAP
结局指标
主要结局
Endothelial function
时间窗: 20 weeks
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
次要结局
- Endothelial function(10 weeks)
- blood biomarkers(0, 10 and 20 weeks)
- Epworth Sleepiness Scale(0, 10 and 20 weeks)