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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019712-20-NO
Enrollment
Unknown
Registered
2010-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Seromycin (Cycloserine Capsules, USP). Product Name: D-Cycloserine Pharmaceutical Form: Capsule*

Sponsors

University of Oslo, Institute of Clinical Dentistry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: • Hypersensitivity to cycloserine • Epilepsi • Renal insufficiency

Design outcomes

Primary

MeasureTime frame
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.

Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026