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Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
RECRUITINGN/ASponsored by University of Southern California
Actively Recruiting
PhaseN/A
SponsorUniversity of Southern California
Started2025-05-09
Est. completion2029-03
Eligibility
Age6 Years – 12 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06912854
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
Age: 6 Years – 12 YearsHealthy volunteers accepted
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 braces in the upcoming 6 months
Conditions2
AnxietyDental Fear and Anxiety
Locations1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
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Actively Recruiting
PhaseN/A
SponsorUniversity of Southern California
Started2025-05-09
Est. completion2029-03
Eligibility
Age6 Years – 12 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06912854