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

NCT07736222 | Recruiting

• 1 other identifier: nC_FIN_0103_019
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carotid-femoral pulse wave velocity; Pulse wave velocity; Central arterial stiffness; Oral health; Bite force; Tongue pressure; Chewing efficiency; Mastication; Swallowing; Test of Masticating and Swallowing Solids; ToMASS; Food avoidance; Oral health-related quality of life; Masseter muscle thickness; Life's Essential 8; Vascular prevention

Outcome Measures

Primary Outcomes (1)

• Baseline Carotid-Femoral Pulse Wave Velocity

  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.

  At the baseline vascular assessment of the INN.HEALTH parent study.

Secondary Outcomes (13)

• 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)

Study Arms (1)

INN.oral.HEALTH Participants

OTHER

Adults participating in the INN.HEALTH cohort who complete the standardized INN.oral.HEALTH oral structure and function assessment at Visit 4. Participants are not assigned to a therapeutic or preventive intervention. All study-specific procedures are performed for observational and research purposes.

Diagnostic Test: Dentition and Occlusal Status Assessment; Diagnostic Test: Oral Health Assessment Tool; Diagnostic Test: Maximum Bite Force Measurement; Diagnostic Test: Tongue Strength and Endurance Assessment; Diagnostic Test: Hue-Check Chewing Efficiency Test; Diagnostic Test: Test of Masticating and Swallowing Solids; Diagnostic Test: Food Avoidance Texture-Based Questionnaire; Diagnostic Test: Oral Health Impact Profile; Diagnostic Test: Masseter Muscle Thickness Measurement

Interventions

Dentition and Occlusal Status Assessment DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Oral Health Assessment Tool DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Maximum Bite Force Measurement DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Tongue Strength and Endurance Assessment DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Hue-Check Chewing Efficiency Test DIAGNOSTIC_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.

INN.oral.HEALTH Participants

Test of Masticating and Swallowing Solids DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Food Avoidance Texture-Based Questionnaire DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Oral Health Impact Profile DIAGNOSTIC_TEST

Oral health-related quality of life is assessed using the standardized German 14-item Oral Health Impact Profile questionnaire (OHIP-G-14).

INN.oral.HEALTH Participants

Masseter Muscle Thickness Measurement DIAGNOSTIC_TEST

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.

INN.oral.HEALTH Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• temporalmandibular joint disorders
• severe jaw joint complaints
• active dental treatment at the time of assessment
• inability to safely chew/swallow the standardized test materials.

Sponsors & Collaborators

• VASCage GmbH: lead

Study Sites (1)

VASCage Study Site

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Study Officials

• Petr Simurda, MD

  VASCage GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Sollereder, MSc

CONTACT

+43 664 1004838; simon.sollereder@vascage.at

Petr Simurda, MD

CONTACT

+43 512 554 43513; petr.simurda@vascage.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 30, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)