Status:
RECRUITING
Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Children's Hospital Los Angeles
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Dental Fear and Anxiety
Eligibility:
All Genders
6-12 years
Phase:
NA
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), comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06912854
Start Date
May 9 2025
End Date
March 1 2029
Last Update
October 2 2025
Active Locations (1)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027