- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081025
Oral Health and Risk Factors for Oral Disease
A 10 Year Longitudinal Study of Oral Health and Risk Factors for Oral Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dalarna
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Falun, Dalarna, Sweden, 79129
- Kristina Edman
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- None
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults
Age Groups 35, 50, 65, 75 and 85
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A cross-sectional and longitudinal study including a questionnaire and a clinical examination
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periodontal disease
Time Frame: 10 years (2008-2018)
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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.
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10 years (2008-2018)
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Periodontal disease
Time Frame: At one occasion (2018)
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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.
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At one occasion (2018)
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Risk factors for periodontal disease
Time Frame: Ten years (2008-2018)
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A questionnaire is used to assess risk factors for periodontal disease.The outcome variables is: Education:
Economy for dental care:
Marital status:
Tobacco use:
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Ten years (2008-2018)
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Dental caries
Time Frame: 10 years (2008-2018)
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Number of teeth with dental caries
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10 years (2008-2018)
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Dental caries
Time Frame: At one occasion (2018)
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Number of teeth with dental caries
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At one occasion (2018)
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Risk factors for dental caries
Time Frame: Ten years (2008-2018)
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Number of teeth with dental caries
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Ten years (2008-2018)
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Oral Health Related Quality of Life
Time Frame: One occasion (2018)
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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:
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One occasion (2018)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EpiWux
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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