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

Overview

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.

Full Title of Study: “Children and Adolescents With Dental Anxiety – Randomized Controlled Study of Cognitive Behavioral Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2015

Interventions

  • Behavioral: Cognitive Behavioral Therapy
    • 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.
  • Behavioral: Treatment As Usual
    • 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.

Arms, Groups and Cohorts

  • Experimental: Cognitive Behavioral Therapy
  • Active Comparator: Treatment as usual

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Collaborator
    • Public Dental Health Services, Eastmaninstitutet, Pediatric Dentistry, Sweden
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shervin Shahnavaz, PhD – Karolinska Institutet
  • Overall Official(s)
    • Göran Dahllöf, PhD, Study Director, Department of Dental Medicine, Karolinska Institutet
    • Shervin Shahnaavz, PhD, Principal Investigator, Department of Dental Medicine, Karolinska Institutet

References

Shahnavaz S, Hedman E, Grindefjord M, Reuterskiöld L, Dahllöf G. Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Oct;1(3):234-243. doi: 10.1177/2380084416661473. Epub 2016 Aug 15.

Shahnavaz S, Hedman-Lagerlöf E, Hasselblad T, Reuterskiöld L, Kaldo V, Dahllöf G. Internet-Based Cognitive Behavioral Therapy for Children and Adolescents With Dental Anxiety: Open Trial. J Med Internet Res. 2018 Jan 22;20(1):e12. doi: 10.2196/jmir.7803.

Shahnavaz S, Rutley S, Larsson K, Dahllöf G. Children and parents' experiences of cognitive behavioral therapy for dental anxiety–a qualitative study. Int J Paediatr Dent. 2015 Sep;25(5):317-26. doi: 10.1111/ipd.12181. Epub 2015 Jul 4.

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