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A Stepped Care Approach to Treating Dental Fear

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 33 days later Mar 28, 2028 → Apr 30, 2028
Primary endpoint reworded 1 of 1 changed
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Primary completion pushed from Mar 28, 2028 to Apr 30, 2028
    v8
  2. Primary endpoint(s) modifiedv7
  3. Enrollment target: 1250 to 1000
    • Primary completion date: Apr 30, 2028 to Mar 28, 2028
    • Interventions: Dental FearLess (Behavioral) to A stepped-care approach to the treatment of dental fear; Dental Fearless (Behavioral)
    • Eligibility criteria expanded, about 23 words
    v6
  4. Primary completion date: Jun 4, 2028 to Apr 30, 2028v5
  5. Primary completion date: Jun 30, 2028 to Jun 4, 2028v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Aug 21, 2023 to Sep 11, 2023
    • Eligibility criteria revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06024395
Lead Sponsor New York University
Collaborators: University of Pennsylvania
Conditions
(from sponsor)		 Dental Fear
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov