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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609648
Other study ID # 30641-B
Secondary ID U54DE014254U01DE
Status Completed
Phase N/A
First received January 24, 2008
Last updated February 15, 2013
Start date January 2008
Est. completion date July 2010

Study information

Verified date February 2013
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections.


Description:

This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections. All patients (96 people with high fear of dental injections) will be tested to assess pre-existing dental fear levels prior to being assigned to study condition. Subsequently, patients in the active treatment group will complete computerized psychological therapy in 1 to 9 weekly 45-minute sessions. Subjects in the control condition will meet with a dental assistant once for approximately 15 minutes to go over a pamphlet. The pamphlet is based on written information developed by a commercial dental web site development company. Following the intervention or control procedures, patients will be reassessed for dental fear using computerized questionnaires. They will also be scheduled to receive a dental injection. Subjects' willingness to complete the dental injection and fear levels during the dental injection will be assessed.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- High dental injection fear

- Age 18 and over

- Healthy with no untreated systemic conditions

- Able to read and write English

Exclusion Criteria:

- Heart murmur

- Known allergies to lidocaine or benzocaine

- Under 18 year old

- Untreated systemic conditions

- Currently receiving medication for anxiety

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Computer Assisted Relaxation Learning
A self-paced computer program for reducing dental injection fear.
Pamphlet
A pamphlet reassuring patients about dental injections.

Locations

Country Name City State
United States Northwest Dental Fears Research Bremerton Washington
United States Valley View Health Center Chehalis Washington
United States Dr. Gary Templeman, DDS Corvallis Oregon
United States Dental Fears Research Clinic Seattle Washington
United States Michael C Hazel, DMD, PC West Linn Oregon

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Coldwell SE, Getz T, Milgrom P, Prall CW, Spadafora A, Ramsay DS. CARL: a LabVIEW 3 computer program for conducting exposure therapy for the treatment of dental injection fear. Behav Res Ther. 1998 Apr;36(4):429-41. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Interval Scale of Anxiety Response at dental injection appointment One to two-weeks post-intervention/control No
Secondary Completion of the behavioral avoidance test One to two-weeks post-intervention/control No
Secondary Needle Survey Immediately post-intervention/control No
Secondary Modified Dental Anxiety Scale Immediately post-intervention/control No
Secondary Dental Fear Survey Immediately post-intervention/control No
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