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Cognitive Behavioural Therapy and Dental Fear

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ClinicalTrials.gov Identifier: NCT03293342
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Tiril Willumsen, University of Oslo

Brief Summary:

The study is an RCT study comparing a 3-5 intervention treatment with dentist administered Cognitive Behavioural Therapy ( D-CBT) with a control treatment. The control treatment is a "treatment as usual" concept using premedication with benzodiazepines and a common sense approach.

The treatment will be performed in a regular dental office. The dentist is working as a regular dentist and is trained in the CBT Method.


Condition or disease Intervention/treatment Phase
Dental Fear Behavioral: D CBT Combination Product: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Single (Outcomes Assessor)
Masking Description:

Each patient receives a project number. A codebook between project number and journal number is stored at Tannhelsetjenestens kompetansesenter sør in Arendal. All data will be registered online using Nettskjema to collect data directly into Services for sensitive data (TSD). The research data from each patient will only be identified by the project number.

All data will be stored and analysed using the TSD platform. TSD complies with the directive of privacy and electronic communication in Norway. TSD is developed and operated by USIT, the UiO centre for IT.

Primary Purpose: Treatment
Official Title: The Effect of a Dentist Administered Cognitive Behavioural Therapy (D-CBT) in Adult Patients With Dental Fear
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: D CBT
Dentist administered cognitive behaviioral treatment
Behavioral: D CBT

Intervention:

a 3-5 session treatment of dental fear.

  • Psychoeducation about anxiety
  • Exploration of the individual anxiety
  • Exposure to the frightening stimuli (no hiding, but actively showing in detail all components of dental treatment, preferably utilizing a mirror while doing treatment).

Active Comparator: Control
Treatment as usual
Combination Product: Control

Intervention:

Traditional treatment of dental fear common sense/ benzodiazepine





Primary Outcome Measures :
  1. Level of Dental anxiety, Dental Anxiety Scale ( MDAS) [ Time Frame: At baseline, after 3-5 weeks of treatment, after 1 year and after 5 years ]
    MDAS is a 5 item scale measuring dental anxiety in a range from 5-25. Outcome measure: change in MDAS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Strong dental anxiety that affects the patients self-perceived ability to go through dental treatment
  • Age over 18
  • Agreement to all the practical arrangements of the study

Exclusion Criteria:

  • Substance abuse
  • Not being able to communicate fluently in Norwegian

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): NCT03293342


Contacts
Contact: Professor Ellingsen, phd +4722852141 j.e.e.@odont.uio.no

Locations
Norway
University of Oslo Recruiting
Oslo, Norway, 0317
Contact: Tiril Willumsen, phd    +4792299666    tiril.willumsen@odont.uio.no   
Contact: Professor Ellingsen    + 472285200    j.e.e@odnt.uio.no   
Sponsors and Collaborators
University of Oslo
Investigators
Principal Investigator: Professor Willumsen, PdD University of Oslo

Publications:

Responsible Party: Tiril Willumsen, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03293342     History of Changes
Other Study ID Numbers: REC-2017/97
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No