Oral Health and Risk Factors for Oral Disease

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081025
• Other study ID #: EpiWux
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Dalarna County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: January 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• None

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Dental Caries
• Periodontal Diseases
• Quality of Life

Intervention

Other:
• EpiWux
A cross-sectional and longitudinal study including a questionnaire and a clinical examination

Locations

Country	Name	City	State
Sweden	Kristina Edman	Falun	Dalarna

Sponsors (1)

Lead Sponsor	Collaborator
Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal disease	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.	10 years (2008-2018)
Primary	Periodontal disease	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.	At one occasion (2018)
Primary	Risk factors for periodontal disease	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	Ten years (2008-2018)
Primary	Dental caries	Number of teeth with dental caries	10 years (2008-2018)
Primary	Dental caries	Number of teeth with dental caries	At one occasion (2018)
Primary	Risk factors for dental caries	Number of teeth with dental caries	Ten years (2008-2018)
Primary	Oral Health Related Quality of Life	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	One occasion (2018)