Periodontal DiseasesNCT04081025
Oral Health and Risk Factors for Oral Disease
An observational study of Periodontal Diseases and Dental Caries, run by Dalarna County Council, Sweden at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Periodontal Diseases, Dental Caries, Quality of Life
- What is being tested?
- EpiWux
- Type of treatment
- Pill or oral medicine
- How many people
- 2,500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals in age Groups 35, 50, 65, 75 and 85 years
Who may be able to join
- None
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 10 Year Longitudinal Study of 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.
Read the 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.
- Conditions
- Periodontal Diseases, Dental Caries, Quality of Life
- Being tested
- EpiWux
- Medical subject headings
- Periodontal Diseases, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiWuxOther
Also called Oral Health
A cross-sectional and longitudinal study including a questionnaire and a clinical examination
| Study group | Role | What they receive |
|---|---|---|
| Adults | Age Groups 35, 50, 65, 75 and 85 Receives: Other: EpiWux |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years (2008-2018)
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.
Measured: At one occasion (2018)
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
Measured: Ten years (2008-2018)
Dental caries
Number of teeth with dental caries
Measured: 10 years (2008-2018)
Dental caries
Number of teeth with dental caries
Measured: At one occasion (2018)
Risk factors for dental caries
Number of teeth with dental caries
Measured: Ten years (2008-2018)
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
Measured: One occasion (2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2018
- Primary completion30 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Edman, Dalarna County Council, Sweden
- Investigators
- Karin Gunnars Hellgren, Study chair, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081025
- Sponsor's protocol ID
- EpiWux
- Status last verified
- Feb 2023
- First submitted
- 31 Aug 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10 Year Longitudinal Study of Oral Health and Risk Factors for Oral Disease
- ClinicalTrials.gov ID
- NCT04081025
- Acronym / sponsor ID
- EpiWux
- Conditions
- Periodontal Diseases, Dental Caries, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Other: EpiWuxAge Groups 35, 50, 65, 75 and 85 |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals in age Groups 35, 50, 65, 75 and 85 years
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiWuxAlso: Oral HealthA cross-sectional and longitudinal study including a questionnaire and a clinical examination | Other | Adults |
Primary outcome
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.
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.
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
Dental caries
Time frame: 10 years (2008-2018)
Number of teeth with dental caries
Dental caries
Time frame: At one occasion (2018)
Number of teeth with dental caries
Risk factors for dental caries
Time frame: Ten years (2008-2018)
Number of teeth with dental caries
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Gunnars Hellgren study chair
Dalarna County Council, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Dental Caries, run by Dalarna County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal disease (time frame: 10 years (2008-2018)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.