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临床试验/NCT05758467
NCT05758467Enrolling By Invitation不适用

Oral Health in Adults: Predictors, Social Gradients and Correlation With Cardiovascular Health in Women and Men

Oral Health Centre of Expertise in Western Norway1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,200
试验地点
1
主要终点
Describe Oral health status

研究概览

简要总结

Non-communicable diseases (NCDs) are rising in prevalence because of aging, unhealthy diet and sedentary lifestyle, and common NCDs are caries and periodontitis (here oral diseases) and cardiovascular disease (CVD). Association between oral diseases and CVD has been observed in epidemiological studies, and suggested mechanisms include transfer of oral pathogen bacteria and pro-inflammatory mediators to other organs triggering immune response and systemic inflammation. Circulating mediators may initiate a response in the liver with production of C-reactive protein, serum amyloid A and increased tryptophan degradation, that contribute to CV inflammation and atherosclerosis. We have demonstrated that higher serum levels of these markers are associated with presence of hypertension and obesity and with higher risk of CVD. However, CVD and oral diseases also share many of the same risk factors, including hypertension, obesity, diabetes and smoking. Since the association of oral disease with CV risk factors mostly has been demonstrated in cross-sectional studies, the direction has not been ascertained. These CVD risk factors lead to changes in the heart and arteries (preclinical CVD); more harmful in women than men. If these conditions can impact development of oral diseases is not been investigated in large studies.

Socio-economic inequalities have been reported for oral diseases and are linked to low socio-economic status (SES).

It is unknown whether CV health and SES in midlife may impact prevalence of oral diseases later in life. It is also unknown if the oral microbiome differ by periodontitis severity and can be associated with inflammatory biomarkers, CV risk factors and preclinical CVD. The project will be performed in adults approaching the retirement age in Vestland county. We will combine their data from the ongoing Hordaland Oral Health Survey with their data from three surveys in the longitudinal Hordaland Health Study performed in the period 1992-2020.

详细描述

Title:

Oral health in adults: predictors, social gradients and correlation with cardiovascular health in women and men. Date: 24.02.2023

  1. Excellence 1.1 State of the art, knowledge needs and project objectives Non-communicable diseases (NCD) are rising in prevalence globally because of aging, refined diets and sedentary lifestyle. Two of the most common NCDs in humans, caries and periodontitis (here named oral diseases), contribute substantially to years lived with disability in age-standardized prevalence rates worldwide. Cardiovascular (CV) disease (CVD) is the leading cause of death and years lived with disability globally. Co-presence of CVD and oral diseases is therefore common, and an association between oral diseases and CVD has been observed in epidemiological studies.

Mechanisms linking oral diseases to CVD include transfer of oral pathogen bacteria and pro-inflammatory mediators to other organs triggering immune response and systemic and vascular inflammation. Circulating inflammatory cytokines may initiate an acute-phase response in the liver with production of C-reactive protein and serum amyloid A and increased tryptophan degradation, that contribute to CV inflammation and atherosclerosis. We have demonstrated that higher serum levels of these inflammatory markers are associated with presence of hypertension and obesity in midlife in the Hordaland Health Study, and with higher risk of subsequent CVD independent of clinical risk factors. However, CVD and oral diseases also share many of the same risk factors, including hypertension, obesity, diabetes, and smoking. Since the association of oral disease with CV risk factors so far mostly has been demonstrated in cross-sectional studies, the direction of these associations has not been ascertained. These CVD risk factors lead to chronic CV inflammation which promotes atherosclerosis as well as structural and functional changes in the heart and arteries (preclinical CVD) and are all more harmful in women than men. Whether these conditions can impact development of oral diseases is not fully explored.

Socio-economic inequalities have been reported for many oral diseases. In a study in subjects older than 65 yrs from Northern Norway, severe periodontitis was more prevalent in men, smokers and subjects with low socio-economic status (SES). Thus, sex and SES may modify the association between oral diseases and CVD. It is presently unknown whether CV health in midlife, measured by CV risk factor burden, circulating inflammatory markers and SES, may impact presence and severity of oral disease in women and men later in life. It is also unknown if the structural and functional oral microbiome differ by periodontitis severity and can be associated with inflammatory biomarkers, CV risk factors and presence or absence of preclinical CVD. Finally, the association between oral diseases and preclinical CVD has to date not been explored in large studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
71 Years 至 72 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participated in 3 Health surveys + one oral health survey

排除标准

  • 未提供

结局指标

主要结局

Describe Oral health status

时间窗: 3 years

describe the participants periodontal status, caries experience (DMFT given as a number) and number of missed teeth and their self-reported oral health based on a questionaire. The periodontal disease will be divided in mild, moderate and severe.Oral health will be described as the outcome measures: caries, periodontal health and tooth loss. Caries will be measured as number of teeth or surfaces with caries. We will also use DMFT measure defined as the sum of decayed, missed, filled teeth for each participant. The number of participants is 1325. Case definition of periodontal health in an intact periodontium PD ≤ 3 mm No interdental REC ≥1 mm BoP \< 10% (mean at patient level) Mild periodontitis * 2 interdental sites with CAL ≥ 3 mm and ≥ 2 interdental sites with PD ≥ 4 mm (not on the same tooth) or * 1 interdental site with PD ≥ 5 mm Moderate periodontitis * 2 interdental sites with CAL ≥4 mm (not on the same tooth) or * 2 interdental sites with PD ≥5 mm (not on

Prospective study associations of CV risk factors with oral diseases.

时间窗: 3 years

BMI was calculated as weight (in kilograms) divided by height (in meters) squared

Prospective study associations of systemic risk factors with oral diseases.

时间窗: 3 years

Systemic inflammatory biomarkers While at the clinic, participants provided a non-fasting blood sample, kept on ice during transport, and then centrifuged and stored at -80 °C before analysis Neopterin, tryptophan, Kunurenine and kynurenine pathway metabolites (in nmol/L) were quantified by LC-tandem MS at Bevital, Bergen, Norway (www.bevital.no). Plasma hs-CRP (mg/L) was measured with an immuno-Matrix-Assisted Laser Desorption/Ionization-based assay.

SES indicators

时间窗: 3 years

Income measured in NOK and grouped in income ranges

Cardiovascular health and oral health

时间窗: 3 years

Left ventricular hypertrophy is detected by echocardiography. Left ventricular mass \>47 g/height 2,7 for woman and \>50 g/height 2,7 for menn will be registrated aa left ventricular hypertrophy.

次要结局

未报告次要终点

研究者

发起方
Oral Health Centre of Expertise in Western Norway
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Berggreen

Head of Research Department

Oral Health Centre of Expertise in Western Norway

研究点 (1)

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