Intensive Treatment on Periodontitis in Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 920
- 试验地点
- 1
- 主要终点
- Composite Major Cardiovascular Events (MACE) Endpoint
研究概览
简要总结
The goal of this clinical trial is to determine if standardized periodontal therapy can effectively slow the progression of aortic valve stenosis in adult patients diagnosed with moderate aortic valve stenosis and coexisting gingivitis or mild-to-moderate periodontitis.
The main questions it aims to answer are: Can periodontal therapy slow the progression of aortic valve stenosis? Is chronic periodontitis an independent risk factor for the accelerated progression of aortic valve stenosis? Researchers will compare a group of patients receiving standardized periodontal therapy to a control group receiving only oral hygiene education to see if periodontal treatment results in a slower progression of aortic valve stenosis.
Participants will undergo initial screening to confirm eligibility based on aortic valve peak velocity and periodontal status. They will then be randomly assigned to either the treatment group, which will receive comprehensive periodontal therapy, or the control group, which will receive only oral hygiene education. Participants will be followed up regularly over a 36-month period, with assessments including echocardiograms to monitor the progression of aortic valve stenosis, periodontal examinations to assess oral health status, and blood tests to measure relevant serum biomarkers. The study will also track any cardiovascular events and adverse events related to the interventions.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Aortic valve peak velocity (Vmax) between 3.0 and 3.9 m/s.
- •Diagnosis of aortic valve stenosis identified as degenerative aortic valve stenosis.
- •Presence of gingivitis or mild-to-moderate periodontitis confirmed by periodontal probing or panoramic dental radiography.
- •Willingness to participate in the study and signing of informed consent.
排除标准
- •End-stage renal disease with eGFR < 15 ml/min/1.73m² (according to the Cockcroft & Gault formula).
- •Pregnant, breastfeeding, and women of childbearing age (except those with effective contraception).
- •Factors that may affect study follow-up or adherence to periodontal therapy.
- •Patients unwilling or unable to undergo comprehensive periodontal treatment.
- •Patients who do not consent to participate in the study.
结局指标
主要结局
Composite Major Cardiovascular Events (MACE) Endpoint
时间窗: From enrollment to the follow-up periods at 12, 24, and 36 months.
Composite Major Cardiovascular Events (MACE), including: 1. Hospitalization or emergency/outpatient visits due to heart failure. 2. Hospitalization or emergency/outpatient visits due to angina. 3. Hospitalization or emergency/outpatient visits due to syncope. 4. Cardiovascular death. 5. Undergoing interventional or surgical valve replacement. 6. Non-fatal myocardial infarction. 7. Undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 8. Ischemic stroke.
次要结局
- Aortic Valve Peak Velocity Change Endpoint(From enrollment to the follow-up periods at 12, 24, and 36 months.)
- Serum Biomarker Endpoint(From enrollment to the follow-up periods at 12, 24, and 36 months.)
- Periodontal Bacterial Biomarker Endpoint(From enrollment to the follow-up periods at 12, 24, and 36 months.)