Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Presence of Carotid Plaque
研究概览
简要总结
The aim of the study is to evaluate the association between apical periodontitis (AP) and atherosclerotic cardiovascular disease (ASCVD) by assessing the multiplicative effect of AP on secondary outcomes of ASCVD. Sixty-two subjects will be enrolled from the Unit of Endodontics and Restorative dentistry and allocated into 2 distinct groups depending on the presence or absence of periapical lesions. Group 1 will be composed of 31 patients with radiographic signs of AP. On the contrary, another 31 healthy individual (free from clinical and radiographic evidence of AP) meeting the inclusion and exclusion criteria were included as controls (group 2) A complete dental examination will performed on each patient in both groups. All the patients will be subjected to a cardiovascular examination to assess carotid intima-media thickness (cIMT), presence of abdominal aortic aneurysm, presence of peripheral pulses through echo-color-doppler.
详细描述
The aim of the present case-control study is to evaluate the multiplicative effect of AP on secondary outcomes of ASCVD. Sixty-two subjects will be enrolled from the Unit of Endodontics and Restorative dentistry of the university of Siena.
The inclusion criteria of the study are healthy patients older than 40 years old, the presence of at least 24 teeth and the ability and willingness to give informed consent.Participants affected by any systemic disease or being administered either antibiotics in the last 6 months or antiaggregant, antiplatelet and antihypertensive medications will be excluded from this study.
The atherosclerosis risk factors excluded in our study are prior or existing signs of CVD, smoking habits, diabetes, obesity, arterial hypertension, dyslipidemia, and echocardiographically detectable left ventricular hypertrophy. Patients with periodontal disease and lesions other than endodontic etiology in maxilla/mandible are also excluded from this study. Participants that were pregnant or lactating females, non-Italian, or only English-speaking are also excluded from the study, as well as those who were unable or unwilling to give informed consent.
Sixty-two subjects fulfilling the previously described criteria will be enrolled from the outpatient department and allocated into two distinct groups depending on the presence or absence of periapical lesions. Group 1 will be composed of 31 patients with radiographic signs of AP. On the contrary, another 31 healthy individuals (free from clinical and radiographic evidence of AP) meeting the inclusion and exclusion criteria will be included as controls (group 2) and matched on age, BMI, sex, and physical characteristics. AP cases will be designated those patients with at least one tooth exhibiting radiographic evidence of apical radiolucency exceedingly twice the width of the periodontal ligament space. A complete dental examination will be performed on each patient in both groups.
To perform the initial screening, patients will undergo panoramic radiography and clinical examination followed by periapical radiographs of the teeth suspected of AP using the long cone paralleling technique with a film holder. The following parameters will be recorded:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 40 years old
- •the presence of at least 24 teeth
- •the ability and willingness to give informed consent
排除标准
- •any systemic diseases
- •antibiotic administration in the last 6 months
- •antiaggregant, antiplatelet and antihypertensive medications
- •existing signs of CVD
- •smoking habits, diabetes
- •arterial hypertension
- •dyslipidemia
- •periodontal disease
- •lesions other than endodontic etiology in maxilla/mandible were also excluded from this study
- •pregnant or lactating females non-Italian or only English speaking
- •inability or unwillingness to give informed consent.
结局指标
主要结局
Presence of Carotid Plaque
时间窗: The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
the presence of atherosclerotic plaques is considered as a surrogate endpoint point variable to diagnose early alterations of carotid atherosclerotic cardiovascular disease. Plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness \>1.5 mm as measured from the media-adventitia interface to the intima-lumen interface.
Carotid Intima medial Thickness (c-IMT)
时间窗: The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
C-IMT measurements are done in mm, and they are taken from the right and left common carotid artery (CCA) and they are used as surrogate endpoints to diagnose early signs of carotid atherosclerotic cardiovascular diseases.
次要结局
- Abdominal aorta maximum diameter(The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point)
- North American Symptomatic Carotid Endarterectomy Trial (NASCET)(The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point)
- Right and Left Common Iliac Arteries (CIA) diameter(The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point)
- Ankle Brachial Index (ABI)(The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point)
研究者
Simone Grandini
Professor
University of Siena