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Study of Anxiety Free Experiences at the Dentist

One Session Treatment for Dental Phobia in an Underserved Population

Who can join

Ages 7 to 16 · All sexes

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

* Subject and one parent/LAR must be willing and able to give informed assent/consent for participation in the study.
* Subject and one parent/LAR must be willing and able to comply with all study procedures for the duration of the study, including randomization to treatment condition and interventionist.
* Subject must be between 7 and 16 years of age.
* Subject must meet DSM 5 criteria for a specific phobia, blood- injection -injury type with dental stimuli as the focus of the phobia.
* Subject and parent/LAR must be able to read, write, and converse in English or Spanish.

Exclusion Criteria:

An individual who meets any of the following criteria at baseline will be excluded from participating in this study:

If the parent-reports:

* Subject or first degree relative participated in the pilot study (UG3DE031247).
* Subject has active suicidal ideation, psychotic disorder, intellectual disability (as indicated by school placement), or severe autism spectrum disorder.
* Subject's dental fears are limited to fear of injections or sight of blood.
* Subject resides in the same household as another individual already participating in current study.
* Subject is a first degree relative of another individual already participating in current study.
* Subject has received a trial of exposure therapy or relaxation treatment for dental phobia in the past year.
* Subject is currently taking anxiolytic medication, and the dose or medication is likely to change between Baseline Assessment and Six-Month Post Treatment Assessment.
* Any other significant disease or disorder that would place the subject at risk because of participation in the study or preclude the subject's full compliance with or completion of the study.

About the study

The goal of this clinical trial is to compare two treatments for dental phobia in children and adolescents: One-Session Treatment for Dental Phobia (OSTD) and psychoeducation plus relaxation training (RELAX).

The main questions this study aims to answer are:

* Is one intervention more effective in reducing the severity of dental phobia 6 months after treatment? * Are improvements in dental fear and anxiety maintained 12 months after treatment? * How do changes in fear-related learning and beliefs contribute to treatment outcomes? * How acceptable and practical are these treatments for youth, their parents, and the professionals delivering the treatments?

Researchers will enroll approximately 160 youth with dental phobia and randomly assign them to one of two treatment groups. Participants will receive either OSTD or RELAX.

Participants will:

* Complete an initial assessment of their dental fear and anxiety. * Participate in their assigned treatment. * Complete assessments 1 week, 6 months, and 12 months after treatment to evaluate changes in dental fear, anxiety, and related beliefs and behaviors.

Researchers will compare the two groups to determine which treatment is more effective in reducing dental phobia, whether improvements last over time, and how changes in fear-related learning may contribute to treatment outcomes.

What is being tested

• One-Session Treatment for Dental Phobia (OSTD) (behavioral)
• Psychoeducation and Relaxation Training (RELAX) (behavioral)

Sponsor: University of Texas Rio Grande Valley · Participants: 160 · Started: 2026-11

Contact the study team

• SAFE-D Research Team Member · Phone: 956-665-3500

Official record on ClinicalTrials.gov — NCT07931131

Locations in the U.S.

Conditions

• Anxiety

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.