Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Den
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 dis
| Condition(s) | Dental Fear and Anxiety |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 incr |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Southern California |
| Locations | Los Angeles, California, United States |
| Start date | 2025-05-09 |
| NCT ID | NCT06912854 |
| Official listing | https://clinicaltrials.gov/study/NCT06912854 |