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Completed

NCT Number: NCT04081025

Oral Health and Risk Factors for Oral Disease

Oral health has improved considerably in recent decades in Sweden, as well as in other countries. However, despite great improvements with regard to periodontal disease and dental caries in recent decades, global problems still persist, and as a consequence of retaining natural teeth high up in age, the risk for oral disease increases.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kristina Edman

Falun, Dalarna County, 79129, Sweden

About this study

Traditionally, the number of teeth has been a measure of good oral health, and the World Health Organization (WHO) stipulated goals of a minimum of 20 functional teeth at the age of 80 years have been reached in some industrialized countries. Oral Health means more than good teeth and is integral to general health. The relationship between oral and general health has been recognized. For example, periodontal disease is associated with diabetes and rheumatoid arthritis. The severity of periodontal disease and number of teeth have been associated with an increased burden of cardiovascular disease.

There is a lack of longitudinal studies of oral Health and risk factors for oral disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • None

Exclusion criteria

  • None

Treatment and study plan

EpiWux

Other

A cross-sectional and longitudinal study including a questionnaire and a clinical examination

Other names: Oral Health

Primary outcomes

  1. Periodontal disease

    Time frame: 10 years (2008-2018)

    The severity of alveolar bone loss are based on bone levels at interproximal sites as seen on radiographs in the premolar and molar regions in both jaws. The diagnostic categories are (1)'no bone loss', defined as normal alveolar bone height in the molar and premolar regions (i.e., a distance ≤2 mm between the cemento-enamel junction and the alveolar bone crest (2) moderate bone loss, defined as alveolar bone loss >2 mm but not exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on two to three teeth in the molar-premolar region; and (3)'severe bone loss', defined as alveolar bone loss exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on more than three teeth in the molar and premolar regions.

  2. Periodontal disease

    Time frame: At one occasion (2018)

    The severity of alveolar bone loss are based on bone levels at interproximal sites as seen on radiographs in the premolar and molar regions in both jaws. The diagnostic categories are (1)'no bone loss', defined as normal alveolar bone height in the molar and premolar regions (i.e., a distance ≤2 mm between the cemento-enamel junction and the alveolar bone crest (2) moderate bone loss, defined as alveolar bone loss >2 mm but not exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on two to three teeth in the molar-premolar region; and (3)'severe bone loss', defined as alveolar bone loss exceeding one-third of the length of the roots, or if angular bony defects/furcation defects degree II and III are present on more than three teeth in the molar and premolar regions.

  3. Risk factors for periodontal disease

    Time frame: Ten years (2008-2018)

    A questionnaire is used to assess risk factors for periodontal disease.The outcome variables is: Education:

    • Up to secondary school
    • University or college of higher learning

    Economy for dental care:

    • No limited financial resources for dental care
    • Limited financial resources for dental care

    Marital status:

    • Married/cohabitant
    • Single living

    Tobacco use:

    • Current smoker
    • Former smoker
  4. Dental caries

    Time frame: 10 years (2008-2018)

    Number of teeth with dental caries

  5. Dental caries

    Time frame: At one occasion (2018)

    Number of teeth with dental caries

  6. Risk factors for dental caries

    Time frame: Ten years (2008-2018)

    Number of teeth with dental caries

  7. Oral Health Related Quality of Life

    Time frame: One occasion (2018)

    A 9-item survey instrument (Oral Impact on Daily Performance), using a five-point Likert scale, ranging from "never" (1), "less than once a month (2), 1-2 times a month (3), 1-2 times a week (4), and "every, or nearly every day" (5) was used.

    The questions are as follows: "during the past 6 months, how often have problems with your mouth or teeth caused any difficulty with:

    • Eating and enjoying food
    • Speaking
    • Pronouncing clearly
    • Doing light physical activities
    • Cleaning teeth
    • Sleeping and relaxing
    • Smiling, laughing and showing teeth without embarrassment
    • Maintaining usual emotional state without being irritable
    • Carrying out major work or social role and enjoying contact with people

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Registry information

Official study title

A 10 Year Longitudinal Study of Oral Health and Risk Factors for Oral Disease

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 6, 2019
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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