Sensory Adapted Dental Environments to Enhance Oral Care for Children

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT02430051
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Sensory Adapted Dental Environment — BEHAVIORAL
    The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.

Study Details

The goal of this project is to examine the efficacy of a sensory adapted dental environment (SADE) for children who have difficulty tolerating oral care in the dental clinic. The investigators hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights,and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders (ASD). This has the potential to contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.

Key Dates

Start date
May 31, 2015
Status verified
Aug 2025
Primary completion
Apr 29, 2021
Completion
Apr 29, 2021

Study Design

Enrollment
220 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Regular Dental Environment
    There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.
  • Experimental: Sensory Adapted Dental Environment
    In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, and tactile adaptations).

Primary Outcome Measure

Electrodermal Activity (EDA) - Skin Conductance Level (SCL) [ Time Frame: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-

Find similar trials in Los Angeles, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Children's Hospital Los Angeles· Los Angeles, CA

Related Studies