Cognitive Behavioural Therapy and Dental Fear
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03293342|
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2017
Last Update Posted : May 1, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Clinical Trial|
|Masking:||Single (Outcomes Assessor)|
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.
|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|
Experimental: D CBT
Dentist administered cognitive behaviioral treatment
Behavioral: D CBT
a 3-5 session treatment of dental fear.
Active Comparator: Control
Treatment as usual
Combination Product: Control
Traditional treatment of dental fear common sense/ benzodiazepine
- 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
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
|University of Oslo|
|Oslo, Norway, 0317|
|Principal Investigator:||Professor Willumsen, PdD||University of Oslo|