Recruiting

Observational Study

Sponsor:

New York University

Code:

NCT06024395

Conditions

Dental Fear

Eligibility Criteria

Sex: All

Age: 13 - 70+

Healthy Volunteers: Accepted

Interventions

A stepped-care approach to the treatment of dental fear; Dental Fearless

Study Details

Brief summary:

The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever participants' dentist typically does to help participants manage their fear). The dental fear intervention has 2 separate steps. Step 1 (the less intensive or 'light touch' intervention step) involves using a mobile application (app). Step 2 consists of a one-hour telehealth session with a mental health provider tailored to individualized dental fear.

This is a randomized study. The time spent participating in the study will depend on which study condition(s) participants are randomly assigned to. Because this study compares the dental fear intervention to the standard approach, 25% of participants will not get the intervention during the study period. These participants (called controls) will be offered the opportunity to provide feedback about their experiences with dentists. Participants will be offered the intervention free of charge at the conclusion of the study.

For each step of the intervention (Dental FearLess app or one-on-one session) relative to treatment as usual, the investigators hypothesize that participants will show greater declines in self-reported dental fear and improved oral health-related quality of life at post-treatment and follow-up period. De-identified attendance records will be collected from dental practices.

Conditions

Dental Fear

Study ID

NCT06024395

Start date

Sep 11, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Access to a smartphone or tablet
  • Willing to comply with all study procedures and be available for the duration of the study
  • 13 years or older, and if under 18 years, a parent or legal guardian can consent to their participation in the study
  • Proficient in English
  • Score 4 or above on the Gatchel single-item dental fear rating scale
  • Willingness to allow access to dental attendance records
  • Located in the USA

Exclusion Criteria:

Given the scope and nature of the study, there is no exclusion criteria.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dental FearLess Intervention

Dental FearLess app is an e-health intervention that includes psychoeducation about anxiety; affective, cognitive, and behavioral strategies for coping at the dentist.

no intervention: Treatment as Usual

Interventions

A stepped-care approach to the treatment of dental fear; Dental Fearless

Step 1. Dental FearLess is a self-administered CBT-based mobile app that takes approximately 1 hour to complete.

Step 2. A one-hour, one-on-one telehealth session with a mental health provider tailored to the participant's individualized dental fear for those who still report moderate to severe dental fear following completion of the Dental Fearless app.

Primary outcome measure

  • Change in dental fear in intervention group [ Time Frame: Up to 15-21-month period following enrollment and baseline measures. ]

Central Contacts and Locations

Central contacts

Locations

New York University

Recruiting

New York, New York, United States, 10010

More Information

Sponsor

New York University

Last update posted

Aug 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by New York University on 2026-08-03.