- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02919241
Diagnostic Interview and One-session Cognitive Therapy in Treatment of Dental Fear
November 10, 2021 updated by: University of Eastern Finland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kuopio, Finland, 70211
- University of Eastern Finland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- MDAS 13 or over, dental care in normal circumstances doesn´t work, motivation to treat dental fear, minimum 18 year
Exclusion Criteria:
- Mental disorder, dementia, pregnancy, acute state of somatic illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic interview
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.
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A profound interview to declare causes for negative thoughts, assumptions and beliefs towards dental care.
Participants come from public and Private dental care.
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Experimental: Combined interview and treatment
Intervention for this group include both the diagnostic interview and one session treatment.
|
A profound interview to declare causes for negative thoughts, assumptions and beliefs towards dental care.
Participants come from public and Private dental care.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dental fear
Time Frame: 6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance to care
Time Frame: 6 months
|
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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Liisa Suominen, Professor, University of easthern Finland, Kuopio
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
September 23, 2016
First Submitted That Met QC Criteria
September 28, 2016
First Posted (Estimate)
September 29, 2016
Study Record Updates
Last Update Posted (Actual)
November 15, 2021
Last Update Submitted That Met QC Criteria
November 10, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UKuopio 001/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It has been planned to use same data later in a follow-up study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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