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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02919241
Other study ID # UKuopio 001/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date December 31, 2020

Study information

Verified date November 2021
Source University of Eastern Finland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Diagnostic interview
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.
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.

Locations

Country Name City State
Finland University of Eastern Finland Kuopio

Sponsors (1)

Lead Sponsor Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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. 6 months
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