Clinical Trial

A Stepped Care Approach to Treating Dental Fear

Recruiting
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-04
notable Primary completion pushed: 2028-03-28 -> 2028-04-30 2026-08-04
critical Primary endpoint(s) modified 2026-05-16
Trial Details
NCT Number NCT06024395
Lead Sponsor New York University
Collaborators: University of Pennsylvania
Conditions Dental Fear
Enrollment 1,000 participants
Start Date 2023-09-11
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-03