Sensory Adapted Dental Environments to Enhance Oral Care for Children



Status:Recruiting
Conditions:Neurology, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:6 - 12
Updated:8/11/2018
Start Date:May 2015
End Date:April 2020
Contact:Sharon Cermak, EdD
Email:cermak@usc.edu
Phone:(323)442-2879

Use our guide to learn which trials are right for you!

Sensory Adapted Dental Environments to Enhance Oral Care for Children (SADE-2)

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.

This project, which builds upon the investigator's previous R34 National Institute of Dental
and Craniofacial Research (NIDCR) Planning and Feasibility study, is designed to examine the
efficacy of a sensory adapted dental environment (SADE) to enhance oral care for children
with autism spectrum disorders (ASD). Children with ASD often exhibit sensory
over-responsivity when confronted with experiential aspects of dental visits such as exposure
to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of
various oral care products. This often results in increased anxiety and negative behavioral
responses which hinder the dentist's ability to perform treatment. In the proposed project,
the investigators test a SADE intervention designed to reduce children's anxiety and negative
responses during oral care.

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.

The specific aims are to conduct a randomized clinical trial in order to:

1. Determine if SADE, relative to a regular dental environment (RDE), reduces physiological
anxiety and negative responses (behavioral distress, perception of pain, sensory
discomfort) during dental cleaning for children with ASD.

2. Identify whether physiological anxiety mediates the beneficial effects of the
intervention and whether severity of ASD and communication ability, or dental anxiety,
sensory over-responsivity, and age act as moderating variables.

3. Assess the quality of care and cost effectiveness/savings of the dental cleaning
associated with SADE.

Research participants will be 220 ethnically diverse children aged 6-12 years. Using a
randomized counterbalanced study design, each child will undergo two dental cleanings four
months apart: one dental cleaning in RDE and one dental cleaning in SADE.

This project is significant because it is the first full-scale trial of an intervention
designed to reduce oral care problems in children with ASD. It is theoretically important
because it will elucidate the mechanisms that underlie the effects of the SADE intervention.
Based on the study findings, the investigators will develop a model to transform the standard
of pediatric dental care by modifying the sensory qualities of the dental environment. This
model will have the potential to be utilized in dental clinics worldwide. As such, the
project promises to have a major public health impact insofar as the potential gains in oral
health, child comfort, and cost-savings will be dramatic, potentially applying to more than
one-fourth of all children.

Inclusion Criteria:

- Diagnosis of autism using ADOS;

- Parents speak English or Spanish;

- Have experienced at least one prior dental cleaning;

- In need of an oral cleaning (no previous cleaning within past four months).

Exclusion Criteria:

- Cleft palate or other oral condition which makes dental care more difficult than usual
practice;

- Prescription of anti-cholinergic drugs (which may alter EDA);

- Presence of orthodontia (braces);

- Significant motor impairment, such as cerebral palsy;

- Any known genetic, endocrine, or metabolic dysfunctions;

- Participation in the R34 SADE pilot study;

- Any medical condition such as significant cardiac problems that would place the
individual at increased risk in the study.
We found this trial at
1
site
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 213-209-5054
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials