Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk in People at Risk of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.
研究概览
简要总结
This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.
详细描述
Previous studies showed that the treatment of periodontitis can partially improve the control of risk factors of cardiovascular disease (e.g. blood pressure, interleukin 6), whereas the evidence is still limited. Moreover, there is currently no study reporting the impact of periodontal treatment on the overall risk of cardiovascular disease. The prevalence of periodontitis in China was 62.4%. In clinical practice, a large number of patients with moderate/severe periodontitis and at risk of cardiovascular disease seek medical advice. However, the existing guidelines lack relevant recommendations. Therefore, this study intends to evaluate whether non-surgical periodontal therapy can help to control cardiovascular risk.
376 patients with moderate/severe periodontitis and at risk of cardiovascular disease will be randomized. Those randomized to the intervention arm will receive non-surgical periodontal therapy which includes full-mouth subgingival scaling and root planing. Those randomized to the control arm will receive supragingival ultrasonic scaling. All patients were given instructions on basic oral hygiene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the characteristics of the intervention in this trial, it would be impossible to blind the enrolled participants. However, the investigators and outcomes assessors will be blinded. Allocation to arms will be concealed in an envelope and revealed to the stomatologist and patient before delivering the first treatment. Other investigators like outcomes assessors and staff involved in the data collection and analyses will be masked.
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
- •Age ≥ 18 years;
- •At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
- •Moderate//severe periodontitis;
排除标准
- •Cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease);
- •Received periodontal treatment within the past 6 months;
- •Pregnant or lactating females;
- •Non residents of Guangzhou and its surrounding cities or expected to leave Guangzhou or its surrounding cities within 1 year;
- •Malignant tumors or other end-stage diseases with life expectancy less than 1 year;
- •End-stage renal disease;
- •Patients with high bleeding risk, high blood pressures or other situations that make them unable to receive interventions;
- •Refuse to provide informed consent;
结局指标
主要结局
Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.
时间窗: Baseline; 1 year
Cardiovascular risk is assessed by "Framingham risk score (FRS)". (Circulation, 2008,117(6): 743-753.) Generally, the "Framingham risk score (FRS)" ranges from -4 to 33 for men and -5 to 33 for women. A higher "Framingham risk score (FRS)" means a higher risk of developing cardiovascular disease.
次要结局
- Change from baseline fasting blood glucose at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline triglyceride at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline diastolic blood pressure at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline low-density lipoprotein cholesterol at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline high sensitivity C-reactive protein at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline interleukin-6 at 1 year after enrollment.(Baseline; 1 year)
- Major adverse cardiovascular event(Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;)
- All-cause mortality(Baseline; 3 months; 6 months; 9 months; 1 year; 2 years; 3 years;)
- Change from baseline glycosylated hemoglobin at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline pain at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline systolic blood pressure at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline high-density lipoprotein cholesterol at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline community periodontal index at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline anxiety at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline total cholesterol at 1 year after enrollment.(Baseline; 1 year)
- Change from baseline cardiovascular risk (CHINA-PAR) at 1 year after enrollment.(Baseline; 1 year)