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

Summary

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.

Conditions

• Arterial Stiffness
• Oral Health
• Mastication
• Deglutition
• Vascular Aging
• Cardiovascular Risk

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• VASCage GmbH

  lead OTHER

Principal Investigators

• Petr Simurda, MD · VASCage GmbH

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-08

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• Austria

Study Locations