Oral Health Related Quality of LifeNCT05923762
Oral Health Related Quality of Life
An observational study of Oral Health Related Quality of Life and Oral Disease, run by Dalarna County Council, Sweden.
Trial summary
As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oral Health Related Quality of Life, Oral Disease
- What is being tested?
- OHRQoL
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 3,700 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 15 Jul 2025
- 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: The target population is adults aged 18-85 years that resides in Region Dalarna, Sweden.
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Oral Health Related Quality of Life and Its Implications for Dental Health Care - a Swedish National Survey
As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to circumstances. FDI World Dental federations definition of oral health is; "Oral health is multifaceted and includes the ability to speak, smile, smell, taste, touch, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex.
- Conditions
- Oral Health Related Quality of Life, Oral Disease
- Being tested
- OHRQoL
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHRQoLBehavioural
Oral health-related quality of life will be measured by the "Oral Impact on Daily Performance" (OIDP)
| Study group | Role | What they receive |
|---|---|---|
| 18-85 years of age | Not described Receives: Behavioral: OHRQoL |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHRQoL
Questionnaire, Oral health problems in the last six months with eating, cleaning teeth, socializing. The questionnaire used will be OIDP
Measured: 2024-01-15 - 2024-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Related Quality of LifeStudies 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
- 3,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Gävleborg
- Responsible party
- Principal investigator, Kristina Edman, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923762
- Sponsor's protocol ID
- OHRQoL
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Related Quality of Life and Its Implications for Dental Health Care - a Swedish National Survey
- ClinicalTrials.gov ID
- NCT05923762
- Acronym / sponsor ID
- OHRQoL
- Conditions
- Oral Health Related Quality of Life, Oral Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,700 participants (estimated)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Collaborators
- Region Gävleborg
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 28 Jun 2023 (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.
As oral health has a major impact on general health and quality of life, good oral health are essential. The aspects of oral health that are most important for each individual vary, and quality of life is subjective, and influenced by the person´s experiences, perceptions, expectations and ability to adapt to circumstances. FDI World Dental federations definition of oral health is; "Oral health is multifaceted and includes the ability to speak, smile, smell, taste, touch, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-85 years of age | – | Behavioral: OHRQoL |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The target population is adults aged 18-85 years that resides in Region Dalarna, Sweden.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| OHRQoLOral health-related quality of life will be measured by the "Oral Impact on Daily Performance" (OIDP) | Behavioural | 18-85 years of age |
Primary outcome
OHRQoL
Time frame: 2024-01-15 - 2024-12-31
Questionnaire, Oral health problems in the last six months with eating, cleaning teeth, socializing. The questionnaire used will be OIDP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Health Related Quality of Life and Oral Disease, run by Dalarna County Council, 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 0 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
OHRQoL (time frame: 2024-01-15 - 2024-12-31). 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 28 Jun 2023.