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Completed

NCT Number: NCT01798355

Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.

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Key information

Conditions

Dental Anxiety Phobia, Specific

Age range

7 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet

Stockholm, Huddinge, 14104, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient and parents agree to participate in the research project
  • A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition.

Exclusion criteria

  • The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
  • The patient undergoing psychiatric examination and/or psychotherapy
  • The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.

Treatment as Usual

Behavioral

Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.

Primary outcomes

  1. Changes in dental anxiety

    Time frame: 3 months and 12 months from baseline

    Both child and parental versions of Children's Fear Survey Schedule - Dental Subscale will be administered.

Secondary outcomes

  1. Changes in Behavioral Avoidance

    Time frame: 3 months and 12 months from baseline

    Behavioral Avoidance Test consists of 18 dental situations. The patient is exposed to a situation at a time. Patients receive 1 point for every step he / she manage. The test is stopped when the patient does not want to go further.

Other outcomes

  1. General psychopathology

    Time frame: 3 months, 12 months from baseline

    Changes in general psychopathology is assessed by Developmental and Well-Being Assessment Questionnaire

  2. Changes in Self efficacy

    Time frame: 3 months and 12 months from baseline

    Self Efficacy is assessed by the Self Efficacy Questionnaire for Specific Phobias

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Eastmaninstitutet

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2013
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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