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