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Recruiting NCT06912854

Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety

Trial Parameters

Condition Dental Fear and Anxiety
Sponsor University of Southern California
Study Type INTERVENTIONAL
Phase N/A
Enrollment 312
Sex ALL
Min Age 6 Years
Max Age 12 Years
Start Date 2025-05-09
Completion 2029-03
Interventions
Sensory Adapted Dental EnvironmentVideo-based Modeling

Brief Summary

This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.

Eligibility Criteria

Inclusion Criteria: * Male or female, aged 6 through 12 years, of any race/ethnicity; * English- or Spanish-speaking child and parent; * Have experienced at least one prior dental cleaning; * If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited). Exclusion Criteria: * Dental cleaning within the previous 4 months (i.e., not in need of cleaning); * Plan to move out of the area within 6 months; * Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties); * Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures); * Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings); * Presence of orthodontia (braces) or with a plan to get brac

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