Predication of Arterial Stiffness in Healthy Adults by Oral Health and Chewing Assessments (INNoralHEALTH)
Oral Structural and Functional Profile as an Additive Biomarker for Explaining Central Arterial Stiffness in the INN.HEALTH Cohort
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.
연구 개요
상태
개입 / 치료
- 진단 검사: Dentition and Occlusal Status Assessment
- 진단 검사: Oral Health Assessment Tool
- 진단 검사: Maximum Bite Force Measurement
- 진단 검사: Tongue Strength and Endurance Assessment
- 진단 검사: Hue-Check Chewing Efficiency Test
- 진단 검사: Test of Masticating and Swallowing Solids
- 진단 검사: Food Avoidance Texture-Based Questionnaire
- 진단 검사: Oral Health Impact Profile
- 진단 검사: Masseter Muscle Thickness Measurement
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Simon Sollereder, MSc
- 전화번호: +43 664 1004838
- 이메일: simon.sollereder@vascage.at
연구 연락처 백업
- 이름: Petr Simurda, MD
- 전화번호: +43 512 554 43513
- 이메일: petr.simurda@vascage.at
연구 장소
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Tyrol
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Innsbruck, Tyrol, 오스트리아, 6020
- 모병
- VASCage Study Site
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연락하다:
- Simon Sollereder, MSc
- 전화번호: +43 664 1004838
- 이메일: simon.sollereder@vascage.at
-
연락하다:
- Petr Simurda, MD
- 전화번호: +43 512 554 43513
- 이메일: petr.simurda@vascage.at
-
수석 연구원:
- Petr Simurda, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- temporalmandibular joint disorders
- severe jaw joint complaints
- active dental treatment at the time of assessment
- inability to safely chew/swallow the standardized test materials.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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.
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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.
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.
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.
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.
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.
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.
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.
Oral health-related quality of life is assessed using the standardized German 14-item Oral Health Impact Profile questionnaire (OHIP-G-14).
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Baseline Carotid-Femoral Pulse Wave Velocity
기간: At the baseline vascular assessment of the INN.HEALTH parent study.
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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.
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At the baseline vascular assessment of the INN.HEALTH parent study.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Oral Health Assessment Tool Total Score
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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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.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Dentition Status
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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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.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Number of Functional Occlusal Units
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs
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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.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs
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Angle Classification
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs
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Occlusal relationship is classified from standardized oral photographs according to Angle classification.
The prevalence and distribution of the predefined Angle classes will be reported.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study), based on standardized photographs
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Maximum Bite Force
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Maximum bite force is measured in newtons using a portable occlusal force measurement device.
Three trials are performed on each side.
The highest value among the six measurements is used for analysis.
Higher values indicate greater maximum bite force.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Maximum Tongue Pressure
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Maximum tongue pressure is measured in kilopascals using instrument-based lingual performance testing.
Repeated trials are performed, and the highest recorded value is used for analysis.
Higher values indicate greater maximum tongue strength.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Tongue Endurance
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Tongue endurance is measured as the duration, in seconds, for which the participant maintains 50% of their individual maximum tongue pressure.
Longer holding times indicate greater lingual endurance.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Chewing Efficiency Assessed by Variance of Hue
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Chewing efficiency is assessed using the Hue-Check two-color chewing gum mixing test after 20 consecutive chewing cycles.
The processed chewing gum is analyzed using ViewGum software.
Chewing efficiency is expressed as the continuous Variance of Hue mixing index.
Lower Variance of Hue values indicate more homogeneous color mixing and therefore better chewing efficiency.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Chewing Efficiency Assessed Using the Five-Point Subjective Assessment Scale for Two-Colour Chewing Gum Mixing
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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After 20 chewing cycles, the processed two-colour chewing gum specimen is visually evaluated using the Five-Point Subjective Assessment Scale for Two-Colour Chewing Gum Mixing.
The scale ranges from 1 to 5, with a score of 1 indicating no or minimal colour mixing and a score of 5 indicating complete or nearly complete colour mixing.
Higher scores indicate better chewing efficiency.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Chewing-Related Food Avoidance Assessed Using the 12-Item Food Avoidance Texture-Based Questionnaire (FAx-12)
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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The questionnaire evaluates whether foods with different textures are eaten without modification, eaten only with an adapted texture or consistency, or avoided because of their texture or perceived chewing difficulty. Each item is scored from 0 to 3, with higher scores indicating fewer texture-related restrictions: 0 indicates complete avoidance, whereas 3 indicates that the food is eaten without texture-related modification or avoidance. Responses indicating that a food is not eaten for reasons unrelated to texture or consistency are treated as missing and are not included in the score calculation. Item scores are summed when at least 10 of the 12 items have valid responses. For participants with all 12 items completed, the total score ranges from 0 to 36. Higher scores indicate less texture-related food avoidance and fewer subjective chewing-related limitations. |
During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Oral Health-Related Quality of Life Assessed Using the German 14-Item Oral Health Impact Profile (OHIP-G-14)
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Oral health-related quality of life is assessed using the German 14-item Oral Health Impact Profile.
Each item is scored from 0 to 4, and the item scores are summed to obtain a total score ranging from 0 to 56.
Higher scores indicate a greater negative impact of oral health problems on quality of life and therefore poorer oral health-related quality of life.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Right Masseter Muscle Thickness at Rest
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Right masseter muscle thickness is measured in millimetres using B-mode ultrasound, with the participant in the supine position.
The measurement is obtained at rest at the thickest visible site using standardized machine settings.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Right Masseter Muscle Thickness During Maximum Voluntary Contraction
기간: During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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Right masseter muscle thickness is measured in millimeteres using B-mode ultrasound during maximum voluntary contraction.
The measurement is obtained at the thickest visible site using standardized machine settings.
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During the baseline oral assessment (at Visit 4 of the INN.HEALTH study)
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Petr Simurda, MD, VASCage GmbH
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- nC_FIN_0103_019
개별 참가자 데이터(IPD) 계획
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