Recruiting

OSTD vs. RELAX

Sponsor:

University of Texas Rio Grande Valley

Code:

NCT07931131

Conditions

Dental Phobia

Dental Anxiety in Children

Dental Fear

Dental Fear and Anxiety

Eligibility Criteria

Sex: All

Age: 7 - 16

Healthy Volunteers: Not accepted

Interventions

One-Session Treatment for Dental Phobia (OSTD)

Psychoeducation and Relaxation Training (RELAX)

Study Details

Brief summary:

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.

Conditions

Dental Phobia

Dental Anxiety in Children

Dental Fear

Dental Fear and Anxiety

Study ID

NCT07931131

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 16

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OSTD

OSTD is a cognitive behavioral treatment with the main component of the treatment being massed exposure exercises guided by an inhibitory learning framework.

active comparator: RELAX

RELAX is a psychoeducational intervention paired with progressive muscle relaxation.

Interventions

One-Session Treatment for Dental Phobia (OSTD)

OSTD is a single-session behavioral intervention designed to reduce dental phobia in children and adolescents. The intervention uses individualized, graduated exposure to feared dental situations and procedures. Exposure activities are guided by a participant-specific fear hierarchy and cognitive-behavioral assessment developed before treatment. During the treatment session, participants engage in exposure exercises intended to help them confront feared dental situations and develop new learning about anticipated negative outcomes.

Psychoeducation and Relaxation Training (RELAX)

RELAX is a single-session behavioral comparison intervention consisting of psychoeducation and relaxation training for children and adolescents with dental phobia. The intervention includes information about dental-related fear and anxiety and instruction in relaxation strategies, including progressive muscle relaxation. Participants receive guided relaxation training intended to support the management of anxiety associated with dental situations.

Primary outcome measure

  • Change in Dental Phobia Severity From Baseline to 6 Months Post-Treatment [ Time Frame: 6 months post-treatment ]
  • Change in Dental Phobia Severity From Baseline to 12 Months Post-Treatment [ Time Frame: 12 months post-treatment ]
  • Change in Dental Anxiety Symptoms From Baseline to 12 Months Post-Treatment [ Time Frame: 1 week, 6 months, and 12 months post-treatment ]
  • Attainment of Personalized Treatment Goal at 6 Months and 12 Months Post Treatment [ Time Frame: 6 months and 12 months post-treatment ]
  • Attendance at Recommended Dental Cleaning Appointment [ Time Frame: 6 months and 12 months post-treatment ]

Central Contacts and Locations

Central contacts

SAFE-D Research Team Member

956-665-3500safe-d@utrgv.edu

Locations

University of Texas Rio Grande Valley

Recruiting

Edinburg, Texas, United States, 78539

Contacts

SAFE-D Study Team Member

956-665-3500safe-d@utrgv.edu

More Information

Sponsor

University of Texas Rio Grande Valley

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • dental fear
  • dental phobia
  • dental anxiety
  • child anxiety
  • adolescent anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by University of Texas Rio Grande Valley on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.