Los Angeles, California 90027


Purpose:

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.


Study summary:

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 184 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.


Criteria:

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.


NCT ID:

NCT02430051


Primary Contact:

Principal Investigator
Sharon Cermak, EdD
University of Southern California

Sharon Cermak, EdD
Phone: (323)442-2879
Email: cermak@usc.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90027
United States

Jose Polido, DDS
Phone: 213-209-5054
Email: jpolido@chla.usc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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