About this trial
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
Qualifiers
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).
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Sensory Adapted Dental Environment
- Video-based Modeling
Treatment groups
Sponsors and collaborators
University of Southern California
Lead sponsor
Children's Hospital Los Angeles
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator