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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Austria
VASCage Study Site
RECRUITING
Innsbruck
Contact Information
Primary
Simon Sollereder, MSc
simon.sollereder@vascage.at
+43 664 1004838
Backup
Petr Simurda, MD
petr.simurda@vascage.at
+43 512 554 43513
Time Frame
Start Date: 2026-07-08
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 750
Treatments
Other: INN.oral.HEALTH Participants
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.
Related Therapeutic Areas
Sponsors
Leads: VASCage GmbH

This content was sourced from clinicaltrials.gov