Evaluation of the Association Between the Effects of Generalized Stage 3 and 4 Periodontitis on Arterial Stiffness and Cardiovascular Risk: the PAROCAR Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Difference in mean pulse wave velocity between exposed and non-exposed groups.
研究概览
简要总结
Periodontal diseases are chronic inflammatory conditions affecting nearly half of the adult population and are associated with systemic inflammatory responses. Recent evidence suggests a possible link between severe periodontitis and cardiovascular diseases through shared inflammatory pathways.
The PAROCAR study aims to evaluate the association between generalized periodontitis (stages 3 and 4, 2017 Chicago Classification) and arterial stiffness measured by pulse wave velocity (PWV), compared to matched controls without periodontitis, adjusted for conventional cardiovascular risk factors.
详细描述
Periodontal disease is the sixth most prevalent human disease, affecting 45-50% of the adult population, with 11.2% exhibiting severe forms (stages 3 and 4). This chronic inflammation of the gingiva, caused by dysbiosis of the subgingival microbiota, leads to progressive destruction of the supporting tissues of the teeth (alveolar bone and periodontal ligament) and induces local and systemic inflammatory responses.
The translocation of periodontal bacteria and their metabolites into the bloodstream, as well as the systemic release of inflammatory mediators such as C-reactive protein (CRP), interleukins (IL-1β, IL-6), and tumor necrosis factor-alpha (TNF-α), contributes to endothelial dysfunction and oxidative stress. These mechanisms are thought to play a role in the initiation and progression of atherosclerotic lesions, thus linking periodontitis to cardiovascular disease development.
The PAROCAR study aims to provide a proof of concept of the contributory role of severe periodontitis in cardiovascular risk by comparing arterial stiffness between subjects with generalized periodontitis (stage 3-4) and healthy controls.
This is a monocentric, prospective, cross-sectional, observational, exposed/non-exposed study conducted at the Dental Care Center of Nantes University Hospital.
A total of 206 participants will be included:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-69 years
- •Minimum of 12 teeth (3 per quadrant)
- •Written informed consent Exposed group: generalized periodontitis stage 3 or 4 (Chicago 2017 Classification) Non-exposed group: healthy periodontium
排除标准
- •Patients diagnosed with diabetes,
- •Patients diagnosed with hypertension or with a history of severe cardiovascular disease,
- •Patients diagnosed with familial hypercholesterolaemia,
- •Patients with a medical history or current condition that, in the investigator's opinion, is likely to interfere with the study results,
- •Patients with a BMI ≥ 30 kg/m²,
- •Patients who have previously undergone periodontal treatment,
- •Patients who consume more than 2 units of alcohol per day,
- •Patients who refuse to participate in the study,
- •Minors and patients under the age of 40,
- •Adult patients under legal protection (guardianship, curatorship),
- •Patients deprived of their liberty,
- •Pregnant or breastfeeding women,
- •Patients not affiliated with a health insurance scheme (AME)
- •Patients already included in another interventional study
研究组 & 干预措施
Exposed group (periodontitis)
Patients diagnosed with generalized stage 3 or 4 periodontitis (Chicago 2017 Classification).
干预措施: Periodontal examination and pulse wave velocity (Other)
Non-exposed group (healthy control)
Patients with a healthy periodontium and no history of periodontal disease.
干预措施: Periodontal examination and pulse wave velocity (Other)
结局指标
主要结局
Difference in mean pulse wave velocity between exposed and non-exposed groups.
时间窗: Day 1 At the single study visit
Comparison of the mean pulse wave velocity (PWV) values between patients with generalized periodontitis and healthy controls, using a Class IIa medical device (pOpmètre®) based on photoplethysmography technology.
Difference in mean pulse wave velocity between exposed and non-exposed groups.
时间窗: Day 1 At the single study visit
Comparison of the mean pulse wave velocity (PWV) values between patients with generalized periodontitis and healthy controls, using a Class IIa medical device (pOpmètre®) based on photoplethysmography technology.
次要结局
- Correlation between periodontitis severity (stage 3 or stage 4) and pulse wave velocity.(Day 1 At the single study visit)