Oral Health and Risk Factors for Oral Disease

Sponsor
Dalarna County Council, Sweden (Other)
Overall Status
Unknown status
CT.gov ID
NCT04081025
Collaborator
(none)
2,500
1
36
69.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EpiWux

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
A 10 Year Longitudinal Study of Oral Health and Risk Factors for Oral Disease
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Adults

Age Groups 35, 50, 65, 75 and 85

Other: EpiWux
A cross-sectional and longitudinal study including a questionnaire and a clinical examination
Other Names:
  • Oral Health
  • Outcome Measures

    Primary Outcome Measures

    1. Periodontal disease [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 [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 [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 [10 years (2008-2018)]

      Number of teeth with dental caries

    5. Dental caries [At one occasion (2018)]

      Number of teeth with dental caries

    6. Risk factors for dental caries [Ten years (2008-2018)]

      Number of teeth with dental caries

    7. Oral Health Related Quality of Life [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • None
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kristina Edman Falun Dalarna Sweden 79129

    Sponsors and Collaborators

    • Dalarna County Council, Sweden

    Investigators

    • Study Chair: Karin Gunnars Hellgren, Region Dalarna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristina Edman, Principal Investigator, Dalarna County Council, Sweden
    ClinicalTrials.gov Identifier:
    NCT04081025
    Other Study ID Numbers:
    • EpiWux
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    May 20, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 20, 2020