Идёт набор NCT07736222

Predication of Arterial Stiffness in Healthy Adults by Oral Health and Chewing Assessments

Без фазы С лечением Arterial Stiffness Oral Health Mastication Deglutition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Dentition and Occlusal Status Assessment, Oral Health Assessment Tool, Maximum Bite Force Measurement, Tongue Strength and Endurance Assessment.
Кому может быть актуально: Состояния в реестре: Arterial Stiffness, Oral Health, Mastication, Deglutition. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Oral Structural and Functional Profile as an Additive Biomarker for Explaining Central Arterial Stiffness in the INN.HEALTH Cohort

Обзор

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.

Подробное описание

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.

An additional methodological aim is to explore the feasibility of a semi-automated video-based workflow for analysis of the Test of Masticating and Swallowing Solids. This workflow will use two-dimensional facial landmark and trajectory features. Agreement between automatically derived parameters and manually annotated reference parameters will be quantified using appropriate agreement statistics.

The study will further evaluate the psychometric and criterion-related validity of a questionnaire on chewing-related food avoidance. Analyses will include internal consistency, item characteristics, factor structure, and associations with objective oral markers such as chewing efficiency, bite force, tongue pressure, selected Test of Masticating and Swallowing Solids parameters, and structural indicators.

An exploratory analysis will examine the association between sleep quality, assessed using the Pittsburgh Sleep Quality Index from the INN.HEALTH study, and lingual performance parameters, specifically maximum tongue strength and tongue endurance. This analysis is intended to explore potential links between sleep-related factors and oral functional performance.

The study population consists of adults participating in the INN.HEALTH cohort who meet the sub-study requirements for safe chewing and, where applicable, swallowing of the standardized test materials. Approximately 750 participants are expected to be included. The sample size is determined by the cohort-based implementation of the oral assessment at Visit 4 and is considered adequate for the planned model-based primary analysis.

As a non-interventional sub-study, INN.oral.HEALTH does not assign participants to treatment groups and does not test a therapeutic intervention. The study is intended to improve understanding of the relationship between oral health, oral function, vascular ageing, and preventive cardiovascular risk characterization in a general adult population.

Вмешательства

Диагностический тест Dentition and Occlusal Status Assessment
Dentition status, including dental reconstructions, is documented as part of the structural oral profile. The number of functional occlusal units and the Angle class are determined post hoc from standardized oral photographs.
Диагностический тест Oral Health Assessment Tool
Oral health is assessed once using the standardized Oral Health Assessment Tool (OHAT). The OHAT total score and individual item findings are documented as components of the oral core test battery.
Диагностический тест Maximum Bite Force Measurement
Maximum bite force is measured using a portable occlusal force measurement device (Innobyte by Kube). Three repeated measurements are performed on the left side and three on the right side. The highest value obtained from the six measurements is retained as the main analysis value.
Диагностический тест Tongue Strength and Endurance Assessment
Tongue function is assessed using instrument-based lingual performance testing (using JMS Tongue Pressure Measurement Device 2). Maximum tongue strength or pressure is measured in repeated trials, with the highest value retained for analysis. Tongue endurance is measured as the time, in seconds, for which the participant can maintain 50% of their individual maximum tongue pressure.
Диагностический тест Hue-Check Chewing Efficiency Test
Chewing efficiency is assessed using a two-colour chewing gum mixing test after 20 consecutive chewing cycles. The chewing gum (Hue Check Gum) is processed according to the study-specific standard operating procedure and analysed using ViewGum software to determine the Variance of Hue as a continuous mixing index. The result is additionally evaluated using the five-point subjective assessment scale.
Диагностический тест Test of Masticating and Swallowing Solids
Oral processing of solid food is assessed using the Test of Masticating and Swallowing Solids with two standardized TUC crackers. Participants consume the crackers according to the standardized study procedure. The assessment is video-recorded for determination of parameters including the number of bites, chewing cycles, swallows, and total completion time, and for exploratory semi-automated video analysis.
Диагностический тест Food Avoidance Texture-Based Questionnaire
Chewing-related food avoidance is assessed using the 12-item Food Avoidance Texture-Based Questionnaire (FAx-12). The questionnaire evaluates avoidance or modification of foods related to their texture and perceived chewing difficulty.
Диагностический тест Oral Health Impact Profile
Oral health-related quality of life is assessed using the standardized German 14-item Oral Health Impact Profile questionnaire (OHIP-G-14).
Диагностический тест Masseter Muscle Thickness Measurement
Right-sided masseter muscle thickness is measured using B-mode ultrasound with a Chison SonoAir 70 ultrasound system and a 7L linear probe operating at 4.5 to 10 MHz. The assessment is performed with the participant in the supine position. The probe is positioned perpendicular to the muscle fibres with minimal pressure. Muscle thickness is measured in millimetres at rest and during maximum voluntary contraction at the thickest visible site under standardized machine settings.

Первичные конечные точки

Baseline Carotid-Femoral Pulse Wave Velocity [Срок оценки: At the baseline vascular assessment of the INN.HEALTH parent study.]

Вторичные конечные точки (12)

Oral Health Assessment Tool Total Score [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]
Dentition Status [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]
Number of Functional Occlusal Units [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs]
Angle Classification [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs]
Maximum Bite Force [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]
Maximum Tongue Pressure [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]
Tongue Endurance [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]
Chewing Efficiency Assessed by Variance of Hue [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]
Right Masseter Muscle Thickness at Rest [Срок оценки: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)]

Критерии участия

Критерии включения

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