Oral Structural and Functional Profile as an Additive Biomarker for Explaining Central Arterial Stiffness in the INN.HEALTH Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- VASCage GmbH
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Baseline Carotid-Femoral Pulse Wave Velocity
研究概览
简要总结
INN.oral.HEALTH is an sub-study embedded in the Innsbruck Health Promotion Program (INN.HEALTH). The study investigates whether oral health, oral structure, and oral function provide additional information for understanding vascular health in adults from the general population.
Cardiovascular and cerebrovascular diseases, such as heart attack and stroke, remain major causes of death and disability. Many risk factors, including blood pressure, blood lipids, blood sugar, smoking, physical activity, sleep, and diet, are already known to influence vascular health. However, oral health may also be related to vascular risk. Conditions such as tooth loss, impaired chewing, reduced tongue strength, or oral disease burden may reflect or contribute to general health and vascular ageing, but their additional value in prevention programs is not yet well understood.
The main hypothesis of this study is that a standardized oral structure and function profile can improve the explanation of central arterial stiffness beyond established cardiovascular risk factors and lifestyle-related health metrics (INN.HEALTH study). Central arterial stiffness will be assessed using carotid-femoral pulse wave velocity, a marker of vascular ageing and cardiovascular risk.
Participants will undergo a single oral assessment during Visit 4 of the INN.HEALTH study. The assessment includes screening of oral health status, dentition, bite force, tongue pressure, chewing efficiency, chewing and swallowing performance, questionnaires on oral health-related quality of life and food avoidance, and measurement of masseter muscle thickness. The study does not involve any treatment.
The results may help clarify whether oral structural and functional markers can contribute to future vascular risk assessment and prevention strategies in the general adult population.
详细描述
INN.oral.HEALTH is a cross-sectional, monocentric, sub-study embedded within the Innsbruck Health Promotion Program (INN.HEALTH; NCT06813677). INN.HEALTH is a population-based prevention cohort designed to characterize vascular health and modifiable health determinants in adults from Innsbruck City and Innsbruck-Land. The INN.oral.HEALTH sub-study adds a standardized oral structure and function assessment to the existing INN.HEALTH study pathway.
The rationale for this sub-study is based on the growing recognition that oral health may be relevant to vascular health and prevention. Oral disease burden, tooth loss, impaired chewing function, and reduced oral muscular performance have been associated with adverse health outcomes and may reflect systemic vulnerability. However, oral parameters are not routinely integrated into cardiovascular prevention frameworks, and their incremental explanatory value beyond established cardiovascular risk factors and lifestyle-related metrics remains insufficiently defined.
The primary aim of INN.oral.HEALTH is to determine whether a multidimensional oral structure and function profile provides additional explanatory value for central arterial stiffness. Central arterial stiffness is operationalized as baseline carotid-femoral pulse wave velocity. The primary analysis will compare a predefined cardiovascular base model (INN.HEALTH study) with an extended model that additionally includes the oral core test battery. The incremental value of oral parameters will be assessed using changes in explained variance and nested model comparison.
The oral assessment is implemented as an add-on module at Visit 4 of the INN.HEALTH study. It consists of a single standardized test battery lasting up to approximately 20 minutes per participant. The assessment includes oral health screening, documentation of dentition and dental status, bite force measurement, tongue pressure assessment, chewing efficiency testing, the Test of Masticating and Swallowing Solids using two standardized crackers, questionnaires addressing texture-related food avoidance and oral health-related quality of life, and unilateral measurement of masseter muscle thickness. After completion of the assessment, results are reviewed with the participant and recommendations may be provided based on the findings.
Secondary aims include the description of prevalence, distribution, and reference ranges of oral structural and functional parameters and subjective oral impairments in the study sample. The study will also generate stratified normative data for the Test of Masticating and Swallowing Solids, including parameters such as number of bites, number of chewing cycles, number of swallows, and total completion time. These data will be described according to dental status, Angle class, and predefined age groups where applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults meeting the INN.HEALTH cohort eligibility criteria, including age ≥18 years, residence in Innsbruck City or Innsbruck-Land, and capacity to consent
- •additionally at Visit 4, participants must report being able to safely chew and, where required, swallow the standardized test materials
排除标准
- •temporalmandibular joint disorders
- •severe jaw joint complaints
- •active dental treatment at the time of assessment
- •inability to safely chew/swallow the standardized test materials.
结局指标
主要结局
Baseline Carotid-Femoral Pulse Wave Velocity
时间窗: At the baseline vascular assessment of the INN.HEALTH parent study.
Carotid-femoral pulse wave velocity (cfPWV) is measured in meters per second and analyzed as a continuous variable as an indicator of central arterial stiffness. The primary analysis evaluates whether addition of the predefined oral core test battery improves the explanatory value of the cardiovascular base model for baseline cfPWV. Incremental explanatory value will be assessed by the change in explained variance and nested model comparison.
次要结局
- Oral Health Assessment Tool Total Score(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Dentition Status(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Number of Functional Occlusal Units(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs)
- Angle Classification(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs)
- Maximum Bite Force(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Maximum Tongue Pressure(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Tongue Endurance(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Chewing Efficiency Assessed by Variance of Hue(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Chewing Efficiency Assessed Using the Five-Point Subjective Assessment Scale for Two-Colour Chewing Gum Mixing(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Chewing-Related Food Avoidance Assessed Using the 12-Item Food Avoidance Texture-Based Questionnaire (FAx-12)(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Oral Health-Related Quality of Life Assessed Using the German 14-Item Oral Health Impact Profile (OHIP-G-14)(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Right Masseter Muscle Thickness at Rest(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))
- Right Masseter Muscle Thickness During Maximum Voluntary Contraction(During the baseline oral assessment (at Visit 4 of the INN.HEALTH study))