NCT06912854NARecruitingAccepts Healthy Volunteers
Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
University of Southern California
Start Date
5/9/2025
Completion Date
3/1/2029
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
Age Range: 6 years to 12 years
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
Interventions
OTHER
Sensory Adapted Dental Environment
OTHER
Video-based Modeling
Conditions
Dental Fear and Anxiety
Locations
Children's Hospital Los Angeles
Los Angeles, California 90027
United States