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Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety

NCT06912854 · University of Southern California
In plain English

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About this study
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
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
Study design
Enrollment target: 312 participants
Allocation: randomized
Masking: single
Age groups: child
Timeline
Starts: 2025-05-09
Estimated completion: 2029-03
Last updated: 2025-10-02
Interventions
Other: Sensory Adapted Dental EnvironmentOther: Video-based Modeling
Primary outcomes
  • Electrodermal Activity (EDA; Skin Conductance Level [SCL]) (Periprocedural)
  • Electrodermal Activity (EDA; Non-specific Skin Conductance Responses [NS-SCR]) (Periprocedural)
  • Frequency of Distress Behaviors (Periprocedural)
Sponsor
University of Southern California · other
With: Children's Hospital Los Angeles, National Institute of Dental and Craniofacial Research (NIDCR)
Contacts & investigators
ContactLeah Stein Duker, PhD, OTR/L · contact · lstein@chan.usc.edu · 323-442-0371
ContactRiley McGuire, OTD, OTR/L, MA · contact · riley.mcguire@chan.usc.edu · 323-442-0672
InvestigatorLeah Stein Duker, PhD, OTR/L · principal_investigator, University of Southern California
All locations (1)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States