NCT00609648

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

2.5 years

First QC Date

January 24, 2008

Last Update Submit

February 15, 2013

Conditions

Keywords

Dental AnxietyDental PhobiaOdontophobia

Outcome Measures

Primary Outcomes (1)

  • Modified Interval Scale of Anxiety Response at dental injection appointment

    One to two-weeks post-intervention/control

Secondary Outcomes (4)

  • Completion of the behavioral avoidance test

    One to two-weeks post-intervention/control

  • Needle Survey

    Immediately post-intervention/control

  • Modified Dental Anxiety Scale

    Immediately post-intervention/control

  • Dental Fear Survey

    Immediately post-intervention/control

Study Arms (2)

CARL

EXPERIMENTAL

CARL computer program

Behavioral: Computer Assisted Relaxation Learning

Pamphlet

ACTIVE COMPARATOR

Reassuring pamphlet about dental injections

Behavioral: Pamphlet

Interventions

A self-paced computer program for reducing dental injection fear.

CARL
PamphletBEHAVIORAL

A pamphlet reassuring patients about dental injections.

Pamphlet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High dental injection fear
  • Age 18 and over
  • Healthy with no untreated systemic conditions
  • Able to read and write English

You may not qualify if:

  • Heart murmur
  • Known allergies to lidocaine or benzocaine
  • Under 18 year old
  • Untreated systemic conditions
  • Currently receiving medication for anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dr. Gary Templeman, DDS

Corvallis, Oregon, 97330, United States

Location

Michael C Hazel, DMD, PC

West Linn, Oregon, 97068, United States

Location

Northwest Dental Fears Research

Bremerton, Washington, 98310, United States

Location

Valley View Health Center

Chehalis, Washington, 98632, United States

Location

Dental Fears Research Clinic

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • 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. doi: 10.1016/s0005-7967(97)10038-9.

    PMID: 9670603BACKGROUND
  • Heaton LJ, Leroux BG, Ruff PA, Coldwell SE. Computerized dental injection fear treatment: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):37S-42S. doi: 10.1177/0022034513484330. Epub 2013 May 20.

Study Officials

  • Susan E Coldwell, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations