Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
Recruiting · NCT06912854 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Southern California
View the official record on ClinicalTrials.gov →Interventions studied
Sensory Adapted Dental EnvironmentVideo-based Modeling
What this trial is about
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 take part
Age range
6 Years to 12 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Children's Hospital Los Angeles - Los Angeles, California, United States