Dental FearNCT02919241
Diagnostic Interview and One-session Cognitive Therapy in Treatment of Dental Fear
A study testing Diagnostic interview and Combined interview and treatment. in people with Dental Fear, run by University of Eastern Finland at 1 site in Finland.
Trial summary
Clinical trial of an application of cognitive behavioural one-session therapy method with patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and one-session treatment of dental care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Fear
- What is being tested?
- Diagnostic interview and Combined interview and treatment.
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2016to 31 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- MDAS 13 or over, dental care in normal circumstances doesn´t work, motivation to treat dental fear, minimum 18 year
Who cannot join
- Mental disorder, dementia, pregnancy, acute state of somatic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Application of Treatment Regarding a Diagnostic Interview and One-session Cognitive Behavioural Therapy - Effectiveness in Treatment of Dental Fear
Clinical trial of an application of cognitive behavioural one-session therapy method with patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst \& Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from three different places,primary care clinic, community dental care and dentist´s teaching clinic.
Read the detailed description
Purpose is to compare diagnostic interview (n=20) to diagnostic interview and one-session treatment of dental care (n=10). Partners come from three different places, 10 from each: public and private dental care and dental school. Participants from dental school take part to one-session treatment. All participants have normal dental care before final interview. Hypotheses is that dental fear/anxiety will decrease one category (5 points) when measured by Modified dental anxiety scale (MDAS) before the intervention and after normal dental care. Visual Analogue Scale is used to measure the strength of unpleasant feeling before and after intervention in both groups.
- Conditions
- Dental Fear
- Being tested
- Diagnostic interview, Combined interview and treatment.
- Keywords
- dental anxiety, cognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic interviewBehavioural
A profound interview to declare causes for negative thoughts, assumptions and beliefs towards dental care. Participants come from public and Private dental care.
Combined interview and treatment.Behavioural
Intervention for this group include both the diagnostic interview to declare causes for negative thoughts, assumptions and beliefs towards dental care and one session treatment. Participants come from the Institute of Dentistry.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic interview | Experimental | Intervention for this group include diagnostic interview. Oral health Impact Profile (OHIP 14) and Spielberg State and Trait Anxiety (STAI-1) questionnaires and behaviour analyses are used in diagnostic interview. Receives: Behavioral: Diagnostic interview |
| Combined interview and treatment | Experimental | Intervention for this group include both the diagnostic interview and one session treatment. Receives: Behavioral: Diagnostic interview; Behavioral: Combined interview and treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dental fear
Change in fear is measured by a questionnaire called Modified Dental Anxiety Scale (MDAS). Change in fear is indicated by change in mean value of the MDAS between baseline and follow-up measurement
Measured: 6 months
Secondary outcomes (1)
Compliance to care
Compliance to care is indicated if treatment defined before the baseline interview can be wholly executed. If patient interrupt treatment or cannot be executed at all after baseline interview, then compliance is not fulfilled.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental FearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liisa Suominen, Professor, Study director, University of easthern Finland, Kuopio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919241
- Sponsor's protocol ID
- UKuopio 001/2016
- Status last verified
- Nov 2021
- First submitted
- 23 Sep 2016
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: It has been planned to use same data later in a follow-up study
Publications
Kurki P, Korhonen M, Honkalampi K, Suominen AL. Patients' multifaceted views of dental fear in a diagnostic interview. Acta Odontol Scand. 2021 Apr;79(3):194-204. doi: 10.1080/00016357.2020.1817545. Epub 2020 Sep 12.
PubMed 32924725
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Application of Treatment Regarding a Diagnostic Interview and One-session Cognitive Behavioural Therapy - Effectiveness in Treatment of Dental Fear
- ClinicalTrials.gov ID
- NCT02919241
- Acronym / sponsor ID
- UKuopio 001/2016
- Conditions
- Dental Fear
- Keywords
- dental anxiety, cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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.
Clinical trial of an application of cognitive behavioural one-session therapy method with patients who have severe or average dental fear/anxiety measured by Modified Dental Anxiety Scale (MDAS). The intervention consists of two different parts: a diagnostic interview and one-session treatment of dental care. The method is based on One-Session Therapy manual (Öst \& Skaret, 2013). 30 minimum 18 years old adults takes part to the study. They comes from three different places,primary care clinic, community dental care and dentist´s teaching clinic.
Detailed description
Purpose is to compare diagnostic interview (n=20) to diagnostic interview and one-session treatment of dental care (n=10). Partners come from three different places, 10 from each: public and private dental care and dental school. Participants from dental school take part to one-session treatment. All participants have normal dental care before final interview. Hypotheses is that dental fear/anxiety will decrease one category (5 points) when measured by Modified dental anxiety scale (MDAS) before the intervention and after normal dental care. Visual Analogue Scale is used to measure the strength of unpleasant feeling before and after intervention in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic interview | Experimental | Behavioral: Diagnostic interviewIntervention for this group include diagnostic interview. Oral health Impact Profile (OHIP 14) and Spielberg State and Trait Anxiety (STAI-1) questionnaires and behaviour analyses are used in diagnostic interview. |
| Combined interview and treatment | Experimental | Behavioral: Diagnostic interview, Behavioral: Combined interview and treatment.Intervention for this group include both the diagnostic interview and one session treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MDAS 13 or over, dental care in normal circumstances doesn´t work, motivation to treat dental fear, minimum 18 year
Key exclusion criteria (1 listed)
- Mental disorder, dementia, pregnancy, acute state of somatic illness
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 |
|---|---|---|
| Diagnostic interviewA profound interview to declare causes for negative thoughts, assumptions and beliefs towards dental care. Participants come from public and Private dental care. | Behavioural | Combined interview and treatment, Diagnostic interview |
| Combined interview and treatment.Intervention for this group include both the diagnostic interview to declare causes for negative thoughts, assumptions and beliefs towards dental care and one session treatment. Participants come from the Institute of Dentistry. | Behavioural | Combined interview and treatment |
Primary outcome
Change in dental fear
Time frame: 6 months
Change in fear is measured by a questionnaire called Modified Dental Anxiety Scale (MDAS). Change in fear is indicated by change in mean value of the MDAS between baseline and follow-up measurement
1 secondary outcome
Compliance to care
Time frame: 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 15 Nov 2021.
- Derived from this study: PubMed 32924725Kurki P, Korhonen M, Honkalampi K, Suominen AL. Patients' multifaceted views of dental fear in a diagnostic interview. Acta Odontol Scand. 2021 Apr;79(3):194-204. doi: 10.1080/00016357.2020.1817545. Epub 2020 Sep 12.
- Individual participant dataSharing planned: No. It has been planned to use same data later in a follow-up study
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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.
Liisa Suominen, Professor study director
University of easthern Finland, Kuopio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic interview and Combined interview and treatment. in people with Dental Fear, run by University of Eastern Finland at 1 site in Finland.
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 Nov 2021. 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 Finland. 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?
Change in dental fear (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02919241, which also lists 1 linked publication.
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 Nov 2021.