Dental AnxietyNCT03596255
Clinical Estimation of Dental Anxiety
An observational study of Dental Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Introduction: Dental anxiety (DA) is treatable and preventable when dental personnel correctly estimate the patient's level of DA. Objective: To evaluate dental personnel's ability to estimate DA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Estimated level of DA and MDAS
- How many people
- 1,230 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 1 Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden
Who may be able to join
- Adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden during a two week period.
Who cannot join
- inability to fill in the questionnaire
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centrum för Orofacial Medicin, Torkelbergsgatan 11.
Linköping, Östergötland County, 58212
About this study
Introduction: Dental anxiety (DA) is treatable and preventable when dental personnel correctly estimate the patient's level of DA. Objective: To evaluate dental personnel's ability to estimate DA.
Read the detailed description
Method: All public dental clinics in the region of Östergötland, Sweden, were asked to consecutively recruit adult patients returning for their annual examination. The patient rated DA using the Modified Dental Anxiety Scale (MDAS) and a Visual Analogue Scale of dental anxiety (DA-VAS). The patient also recorded gender, age, level of education and confidence in handling DA. After the examination, the dental personnel estimated the patient's level of DA (eDA) on a VAS. The examiner also recorded gender, age, profession, years of experience, country of education, interest in DA, special education concerning DA and confidence in ability to handle DA.
- Conditions
- Dental Anxiety
- Being tested
- Estimated level of DA, MDAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimated level of DADiagnostic test
the dental personnel estimated the patient's level of DA (eDA) on a 100mm VAS
MDASDiagnostic test
The patient rated their DA using the Modified Dental Anxiety Scale (MDAS)
| Study group | Role | What they receive |
|---|---|---|
| Patients | All public dental clinics in the region of Östergötland, Sweden, were asked to consecutively recruit adult patients returning for their annual examination Receives: Diagnostic Test: MDAS | |
| Dental personnel | All public dental clinics in the region of Östergötland, Sweden were contacted and asked to participate in the study Receives: Diagnostic Test: Estimated level of DA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Dental anxiety on a 100mm VAS vs MDAS
The dental personnel's Clinical estimation of how dentally anxious their patient are (where 0mm represent minimal and 100mm maximal.) compared to the patients one rating of dental anxiety(Measured whit the Modified Dental Anxiety Scale(MDAS) where 5 is minimal and 25 maximal) .
Measured: through study completion, 2 weeks/clinic and a total of aproximatly 6 months
Secondary outcomes (1)
The patients Dental Anxiety, measured whit the "Modified Dental Anxiety Scale"(MDAS)
The Patients own ration of how dentally anxious they are. Measured whit the Modified Dental Anxiety Scale(MDAS) where 5 is minimal and 25 maximal
Measured: through study completion, 2 weeks/clinic and a total of approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Sep 2017
- Primary completion20 Dec 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Ostergotland County Council, Sweden
- Responsible party
- Principal investigator, Markus Höglund, Karolinska Institutet
- Investigators
- Mats Bågesund, Lecturer, Study director, Linköpings University, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596255
- Sponsor's protocol ID
- 0001
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be presented at group level.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Estimation of Dental Anxiety
- ClinicalTrials.gov ID
- NCT03596255
- Acronym / sponsor ID
- 0001
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Ostergotland County Council, Sweden
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 23 Jul 2018 (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.
Introduction: Dental anxiety (DA) is treatable and preventable when dental personnel correctly estimate the patient's level of DA. Objective: To evaluate dental personnel's ability to estimate DA.
Detailed description
Method: All public dental clinics in the region of Östergötland, Sweden, were asked to consecutively recruit adult patients returning for their annual examination. The patient rated DA using the Modified Dental Anxiety Scale (MDAS) and a Visual Analogue Scale of dental anxiety (DA-VAS). The patient also recorded gender, age, level of education and confidence in handling DA. After the examination, the dental personnel estimated the patient's level of DA (eDA) on a VAS. The examiner also recorded gender, age, profession, years of experience, country of education, interest in DA, special education concerning DA and confidence in ability to handle DA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: MDASAll public dental clinics in the region of Östergötland, Sweden, were asked to consecutively recruit adult patients returning for their annual examination |
| Dental personnel | – | Diagnostic Test: Estimated level of DAAll public dental clinics in the region of Östergötland, Sweden were contacted and asked to participate in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden
Key inclusion criteria (1 listed)
- Adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden during a two week period.
Key exclusion criteria (1 listed)
- inability to fill in the questionnaire
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 |
|---|---|---|
| Estimated level of DAthe dental personnel estimated the patient's level of DA (eDA) on a 100mm VAS | Diagnostic test | Dental personnel |
| MDASThe patient rated their DA using the Modified Dental Anxiety Scale (MDAS) | Diagnostic test | Patients |
Primary outcome
Estimated Dental anxiety on a 100mm VAS vs MDAS
Time frame: through study completion, 2 weeks/clinic and a total of aproximatly 6 months
The dental personnel's Clinical estimation of how dentally anxious their patient are (where 0mm represent minimal and 100mm maximal.) compared to the patients one rating of dental anxiety(Measured whit the Modified Dental Anxiety Scale(MDAS) where 5 is minimal and 25 maximal) .
1 secondary outcome
The patients Dental Anxiety, measured whit the "Modified Dental Anxiety Scale"(MDAS)
Time frame: through study completion, 2 weeks/clinic and a total of approximately 6 months
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 23 Jul 2018.
- Individual participant dataSharing planned: No. Data will only be presented at group level.
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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.
Mats Bågesund, Lecturer study director
Linköpings University, 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 Dental Anxiety, run by Karolinska Institutet 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 23 Jul 2018. 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?
Estimated Dental anxiety on a 100mm VAS vs MDAS (time frame: through study completion, 2 weeks/clinic and a total of aproximatly 6 months). 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 23 Jul 2018.