NCT05758467

Brief Summary

Non-communicable diseases (NCDs) are rising in prevalence because of aging, unhealthy diet and sedentary lifestyle, and common NCDs are caries and periodontitis (here oral diseases) and cardiovascular disease (CVD). Association between oral diseases and CVD has been observed in epidemiological studies, and suggested mechanisms include transfer of oral pathogen bacteria and pro-inflammatory mediators to other organs triggering immune response and systemic inflammation. Circulating mediators may initiate a response in the liver with production of C-reactive protein, serum amyloid A and increased tryptophan degradation, that contribute to CV inflammation and atherosclerosis. We have demonstrated that higher serum levels of these markers are associated with presence of hypertension and obesity and with higher risk of CVD. However, CVD and oral diseases also share many of the same risk factors, including hypertension, obesity, diabetes and smoking. Since the association of oral disease with CV risk factors mostly has been demonstrated in cross-sectional studies, the direction has not been ascertained. These CVD risk factors lead to changes in the heart and arteries (preclinical CVD); more harmful in women than men. If these conditions can impact development of oral diseases is not been investigated in large studies. Socio-economic inequalities have been reported for oral diseases and are linked to low socio-economic status (SES). It is unknown whether CV health and SES in midlife may impact prevalence of oral diseases later in life. It is also unknown if the oral microbiome differ by periodontitis severity and can be associated with inflammatory biomarkers, CV risk factors and preclinical CVD. The project will be performed in adults approaching the retirement age in Vestland county. We will combine their data from the ongoing Hordaland Oral Health Survey with their data from three surveys in the longitudinal Hordaland Health Study performed in the period 1992-2020.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

6.5 years

First QC Date

April 4, 2022

Last Update Submit

March 17, 2025

Conditions

Keywords

periodontitiscariesmicrobiomeblood pressurebiomarkers

Outcome Measures

Primary Outcomes (13)

  • Describe Oral health status

    describe the participants periodontal status, caries experience (DMFT given as a number) and number of missed teeth and their self-reported oral health based on a questionaire. The periodontal disease will be divided in mild, moderate and severe.Oral health will be described as the outcome measures: caries, periodontal health and tooth loss. Caries will be measured as number of teeth or surfaces with caries. We will also use DMFT measure defined as the sum of decayed, missed, filled teeth for each participant. The number of participants is 1325. Case definition of periodontal health in an intact periodontium PD ≤ 3 mm No interdental REC ≥1 mm BoP \< 10% (mean at patient level) Mild periodontitis * 2 interdental sites with CAL ≥ 3 mm and ≥ 2 interdental sites with PD ≥ 4 mm (not on the same tooth) or * 1 interdental site with PD ≥ 5 mm Moderate periodontitis * 2 interdental sites with CAL ≥4 mm (not on the same tooth) or * 2 interdental sites with PD ≥5 mm (not on

    3 years

  • Prospective study associations of CV risk factors with oral diseases.

    Hypertension is defined as SBP ≥140 mmHg and/or DBP ≥90 mmHg.

    3 years

  • Prospective study associations of CV risk factors with oral diseases.

    Diabetes is identified as HbA1c≥48mmol/mol or use of antidiabetic drug therapy.

    3 years

  • Prospective study associations of CV risk factors with oral diseases.

    The height will be measured in cm. .

    3 years

  • Prospective study associations of CV risk factors with oral diseases.

    weight will be measured in kilogram

    3 years

  • Prospective study associations of CV risk factors with oral diseases.

    BMI was calculated as weight (in kilograms) divided by height (in meters) squared

    3 years

  • Prospective study associations of systemic risk factors with oral diseases.

    Systemic inflammatory biomarkers While at the clinic, participants provided a non-fasting blood sample, kept on ice during transport, and then centrifuged and stored at -80 °C before analysis Neopterin, tryptophan, Kunurenine and kynurenine pathway metabolites (in nmol/L) were quantified by LC-tandem MS at Bevital, Bergen, Norway (www.bevital.no). Plasma hs-CRP (mg/L) was measured with an immuno-Matrix-Assisted Laser Desorption/Ionization-based assay.

    3 years

  • SES indicators

    Working arrangements will be measured as permanent , temporarly or non existing.

    3 years

  • SES indicators

    Social network will be evaluated : partner/married, living alone, live with other family-members

    3 years

  • SES indicators

    Education : measured as low, middle or high

    3 years

  • SES indicators

    Income measured in NOK and grouped in income ranges

    3 years

  • Cardiovascular health and oral health

    Arterial stiffness will be measured as carotid-femoral pulse wave velocity, and \>10 m/s will be set as arterial stiffness.

    3 years

  • Cardiovascular health and oral health

    Left ventricular hypertrophy is detected by echocardiography. Left ventricular mass \>47 g/height 2,7 for woman and \>50 g/height 2,7 for menn will be registrated aa left ventricular hypertrophy.

    3 years

Eligibility Criteria

Age71 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cohort of community dwelling adults approaching the retirement age (born in 1950-1951), in Hordaland County (now Vestland).

You may qualify if:

  • Participated in 3 Health surveys + one oral health survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral Health Centre of Expertice

Bergen, 5058, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and microbiological samples

MeSH Terms

Conditions

Mouth DiseasesCardiovascular DiseasesDiabetes MellitusPeriodontitis

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeriodontal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Department

Study Record Dates

First Submitted

April 4, 2022

First Posted

March 7, 2023

Study Start

July 1, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations