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Diagnostic Interview and One-session Cognitive Therapy in Treatment of Dental Fear

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ClinicalTrials.gov Identifier: NCT02919241
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Eastern Finland

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Fear Behavioral: Diagnostic interview Behavioral: Combined interview and treatment. Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Application of Treatment Regarding a Diagnostic Interview and One-session Cognitive Behavioural Therapy - Effectiveness in Treatment of Dental Fear
Study Start Date : August 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
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.

Experimental: Combined interview and treatment
Intervention for this group include both the diagnostic interview and one session treatment.
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.

Behavioral: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919241


Contacts
Contact: Anna L Suominen, Professor +358403552442 liisa.suominen@uef.fi
Contact: Pirjo Kurki, DDS +358400711904 pirjokurki65@gmail.com

Locations
Finland
University of Eastern Finland Recruiting
Kuopio, Finland, 70211
Contact: Anna L Suominen, PHD    +358403552442    liisa.suominen@uef.fi   
Contact: Pirjo A Kurki, DDS    +358400711904    pirjokurki65@gmail.com   
Sponsors and Collaborators
University of Eastern Finland
Investigators
Study Director: Liisa Suominen, Professor University of easthern Finland, Kuopio

Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02919241     History of Changes
Other Study ID Numbers: UKuopio 001/2016
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It has been planned to use same data later in a follow-up study

Keywords provided by University of Eastern Finland:
dental anxiety
cognitive therapy