Effects Of PeriodontitisTtreatment On The Worsening Of Heart Failure: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- NT-proBNP in blood samples
研究概览
简要总结
Heart failure (HF) is a rapidly growing public health issue affecting more than 40 million individuals globally; while gum disease with bone loss affects 50% of people in general. The objective of this study is to evaluate the effect of dental treatment on blood levels of a HF parameter at 3 and at 6 months. In addition to verify the relation between blood and salivary exam results and severity of HF. Imune response against one important oral bacterial will be also monitored at 3 and 6 months. Approximately 80 adult individuals will be included and divided into 3 groups. The first two groups will receive dental scaling and root planing (periodontitis individuals with heart failure [n = 25]; periodontitis individuals without heart failure [n = 25]). The third group named negative control will receive dental treatment only after 6 months of dental follow-up (periodontitis individuals with heart failure [n = 25]). HF treatment by oral medication will be continuous. Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up.
详细描述
Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of > 40 million individuals globally; while periodontitis affects 50% of people in general, and its most severe form affects approximately 11% of the population. The primary objective of this study is to evaluate the effect of periodontal therapy on blood levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) at 3 and at 6 months. Secondary aims are the relation between biomarker blood levels and a) functional classes and b) its salivary levels. Antibodies against P. gingivalis besides species' levels will be also determined initially and at 3 and 6 months. As 66 participants must complete the study, 75 to 85 individuals over 35 years of age will be included and randomly assigned to dental scaling and root planing (periodontitis individuals with heart failure [n = 25]; periodontitis individuals without heart failure [n = 25]) or negative control (periodontitis individuals with heart failure [n = 25]). Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up. NT-proBNP and antibodies against P. gingivalis will be evaluated by enzyme immunoassay using commercially available kits while P. gingivalis levels will be determined by quantitative polymerase chain reaction (qPCR).
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
statistics and laboratorial exams personnel
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •minimum of 35 years of age;
- •possibility and availability for medical and dental examinations;
- •specifically for HF groups: HF having as primary causes ischemic problems, myocardial infarction, hypertension and valvulopathies will be selected
- •HF with intermediate or reduced ejection fraction under one of the three following pharmacological therapeutic regimens: a) Angiotensin Converting Enzyme Inhibitors, as the first option, or b) Angiotensin II Receptor Blockers and b) Angiotensin II Receptor Blockers and c) Angiotensin/neprilysin receptor inhibitors.
排除标准
- •pregnant or lactating women;
- •individuals with stage D of HF using vasoactive drugs or circulatory devices;
- •HF individuals with preserved ejection fraction;
- •participants who do not meet the criteria for periodontal disease;
- •participants who are unable to comply with the study protocol;
- •diabetes, obesity, chronic kidney disease and other non-ischemic causes of HF;
- •familial and congenital heart alterations and myocarditis
- •rheumatological and autoimmune diseases;
- •drugs and cardiotoxic substances such as cocaine and oncological chemotherapy;
- •Specifically for the negative control group a progression of periodontitis revealed by 0.3mm additional clinical attachment loss within 6 months of follow-up.
研究组 & 干预措施
periodontitis heart failure mechanical treatment
scaling and root planing plus oral hygiene instructions
干预措施: Mechanical Treatment (Procedure)
periodontitis mechanical treatment
scaling and root planing plus oral hygiene instructions
干预措施: Mechanical Treatment (Procedure)
periodontitis heart failure control
oral hygiene instructions
结局指标
主要结局
NT-proBNP in blood samples
时间窗: baseline versus 6 months
Changes in NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels in blood samples. Higher levels indicate worse heart failure status.
次要结局
- Salivary NT-proBNP(baseline, 3 and 6 months)
- clinical pocket depth response(baseline, 3 and 6 months)
- clinical attachment level response(baseline, 3 and 6 months)
- clinical bleeding response(baseline, 3 and 6 months)
- P. gingivalis bacterium salivary levels(baseline and 3 months)
- P. gingivalis antibody salivary levels(baseline and 3 months)
研究者
Jose Roberto Cortelli
dentist, specialist, master and doctorate
University of Taubate