D-CYCLOSERINE ENHANCEMENT OF EXPOSURE TREATMENT OF DENTALLY FEARFUL AND AVOIDANT CHILDREN. A PILOT STUDY

Phase 1

• Conditions: Avoidance of dental care because of dental anxiety often result in reduced dental health and need for sedation or treatment in general anesthesia. Treatment of dental anxiety is time consuming and not given priority. D-cycloserine has shown to increase the effectiveness of the anxiety/ phobia treatment among adults, but needs to be tested among younger age groups. A medication that will enhance the effect of the anxiety treatment would be of great advantage for the fearful young patient.

• Registration Number: EUCTR2010-019712-20-NO
• Lead Sponsor: niversity of Oslo, Institute of Clinical Dentistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-15
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Persons of both sexes (ASA type I).
•Persons under no other medicational treatment
•Age 12 to 18 years
•Not able to receive ordinary dental treatment because of dental anxiety and/ or intra-oral injection phobia

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Hypersensitivity to cycloserine
•Epilepsi
•Renal insufficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The research is a pilot study where the major aim is to get more experience with the combination of brief CBT and low-dose of DCS used in children and adolescents ;Secondary Objective: To develop and pilot test a protocol (procedure and instruments) for planning of a future randomized clinical trial in children and adolescents to test the effectiveness of a combination of cognitive behavior therapy and D-cycloserine among younger age groups.;Primary end point(s): Changes in self-reports of dental anxiety and positive and negative thoughts during dental treatment.