Predication of Arterial Stiffness in Healthy Adults by Oral Health and Chewing Assessments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVASCage GmbH
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
temporalmandibular joint disorders
severe jaw joint complaints
active dental treatment at the time of assessment
inability to safely chew/swallow the standardized test materials.
Trial design
Design model
Single group
Treatments tested in this trial
Dentition and Occlusal Status Assessment
Diagnostic testDentition 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.
Oral Health Assessment Tool
Diagnostic testOral 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.
Maximum Bite Force Measurement
Diagnostic testMaximum 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.
Tongue Strength and Endurance Assessment
Diagnostic testTongue 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.
Hue-Check Chewing Efficiency Test
Diagnostic testChewing 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.
Test of Masticating and Swallowing Solids
Diagnostic testOral 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.
Food Avoidance Texture-Based Questionnaire
Diagnostic testChewing-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.
Oral Health Impact Profile
Diagnostic testOral health-related quality of life is assessed using the standardized German 14-item Oral Health Impact Profile questionnaire (OHIP-G-14).
Masseter Muscle Thickness Measurement
Diagnostic testRight-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.
Treatment groups
750 Participants
are divided into 1 treatment groupGroup A: INN.oral.HEALTH ParticipantsOther 9 interventions
Trial outcomes
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.
Time frame
At the baseline vascular assessment of the INN.HEALTH parent study.Secondary outcomes
1
Oral Health Assessment Tool Total Score
Oral health status is assessed using the Oral Health Assessment Tool (OHAT). The OHAT total score is calculated from the standardized item ratings. Higher scores indicate a greater burden of oral health problems.
Time frame
During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)2
Dentition Status
Dentition status, including the presence and type of dental reconstructions, is documented as a categorical structural oral variable. The prevalence and distribution of the predefined dentition categories will be reported.
Time frame
During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)3
Number of Functional Occlusal Units
The number of functional occlusal units is determined from standardized oral photographs and recorded as a count. Distribution and reference values will be described for the study sample and relevant subgroups.
Time frame
During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs4
Angle Classification
Occlusal relationship is classified from standardized oral photographs according to Angle classification. The prevalence and distribution of the predefined Angle classes will be reported.
Time frame
During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographsSponsors and contacts
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Source ClinicalTrials.gov