Clinical trial NCT02430051: Sensory Adapted Dental Environments to Enhance Oral Care for Children
Official title: Sensory Adapted Dental Environments to Enhance Oral Care for Children (SADE-2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Keywords: sensory processing
oral care
electrodermal activity
cooperation
anxiety
distress
stress
behavior
occupational therapy
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2015-04-29
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Electrodermal Activity (EDA)
timeFrame: 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.
Secondary outcomes:
measure: Children's Dental Behavior Rating Scale (CDBRS)
timeFrame: Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.
measure: Anxiety and Cooperation Scale
timeFrame: Completed at the end of each dental cleaning (approximately 1 minute)
measure: Duration
timeFrame: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit
measure: Number of hands used to restrain child
timeFrame: Recorded throughout the dental cleaning (approximately 10-45 minutes)
measure: Faces Pain Scale - Revised
timeFrame: Completed at the end of each dental cleaning (approximately 1-2 minutes)
measure: Dental Sensory Sensitivity Scale
timeFrame: Completed at the end of each dental cleaning (approximately 3 minutes)
measure: Frankl Scale
timeFrame: Completed at the end of each dental cleaning (approximately 1 minute)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: University of Southern California
name: Sharon Cermak, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cermak SA, Stein Duker LI, Williams ME, Lane CJ, Dawson ME, Borreson AE, Polido JC. Feasibility of a sensory-adapted dental environment for children with autism. Am J Occup Ther. 2015 May-Jun;69(3):6903220020p1-10. doi: 10.5014/ajot.2015.013714.
citation: Stein LI, Lane CJ, Williams ME, Dawson ME, Polido JC, Cermak SA. Physiological and behavioral stress and anxiety in children with autism spectrum disorders during routine oral care. Biomed Res Int. 2014;2014:694876. doi: 10.1155/2014/694876. Epub 2014 Jul 10.
citation: Stein LI, Polido JC, Cermak SA. Oral care and sensory over-responsivity in children with autism spectrum disorders. Pediatr Dent. 2013 May-Jun;35(3):230-5.
citation: Stein LI, Polido JC, Cermak SA. Oral care and sensory concerns in autism. Am J Occup Ther. 2012 Sep-Oct;66(5):e73-6. doi: 10.5014/ajot.2012.004085.
citation: Stein LI, Polido JC, Najera SO, Cermak SA. Oral care experiences and challenges in children with autism spectrum disorders. Pediatr Dent. 2012 Sep-Oct;34(5):387-91.
citation: Stein LI, Polido JC, Mailloux Z, Coleman GG, Cermak SA. Oral care and sensory sensitivities in children with autism spectrum disorders. Spec Care Dentist. 2011 May-Jun;31(3):102-10. doi: 10.1111/j.1754-4505.2011.00187.x.