NCT03072342已完成不适用
INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Common Carotid Intima-media Thickness (cIMT)
研究概览
简要总结
The investigators wish to assess whether intensive periodontal therapy will reduce the burden of chronic periodontal disease and will cause regression or prevent progression of atherosclerosis assessed by a surrogate end-point (carotid intima-media thickness) at 24 months compared to control periodontal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Participants must be ≥ 18 years-old.
- •Participants must have moderate to severe periodontitis (at least 30 periodontal pockets > 4mm with Bleeding on Probing) and radiographic signs of bone loss.
- •Participants must have voluntarily signed the informed consent.
排除标准
- •Female participant is pregnant or lactating or of childbearing and not using acceptable methods of birth control.
- •Participant is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit.
- •Participant knowingly has HIV or Hepatitis.
- •Participant has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
- •Participant on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures.
- •Participant had a course of periodontal therapy in the preceding 6 month
研究组 & 干预措施
Intensive Periodontal Treatment (IPT)
Active Comparator
干预措施: Intensive Periodontal Treatment (Procedure)
Control Periodontal Treatment (CPT)
Placebo Comparator
干预措施: Control Periodontal Treatment (Procedure)
结局指标
主要结局
Common Carotid Intima-media Thickness (cIMT)
时间窗: cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment
Assess whether intensive periodontal therapy will cause regression or prevent progression of atherosclerosis assessed by carotid intima-media thickness at 24 months compared to standard periodontal therapy.
次要结局
- Brachial artery Flow-mediated dilatation (FMD)(FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment)
- Pulse-wave velocity (PWV)(PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment)
- Blood inflammatory markers(Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment)
- Oxidative stress(Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment)
- Brachial artery Flow-mediated dilatation (FMD)(FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment)
研究者
研究点 (1)
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