Sensory Adapted Dental Environments to Enhance Oral Care for Children

Autism Clinical Trial

— SADE-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02430051
• Other study ID #: DE024978-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism

Intervention

Behavioral:
• Sensory Adapted Dental Environment
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.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrodermal Activity (EDA)	Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. EDA will be analyzed in two ways in this study to investigate physiological stress/anxiety: (1) tonic skin conductance level (SCL) and (2) frequency of non-specific skin conductance responses (NS-SCR).	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	Children's Dental Behavior Rating Scale (CDBRS)	The Children's Dental Behavioral Rating Scale (CDBRS) evaluates overt distress behaviors exhibited by children in the dental office. The child's behavior is videotaped during the dental cleaning; the first five minutes of prophylaxis are coded from the video data at a later date. Coding included marking the presence or absence of three distress behaviors (mouth movement, head movement, forehead movement) and the presence or absence and the severity of two distress behaviors (whimper/cry/scream, verbal stall or delay) during each one-minute interval of the five minute video. Significant inter-rater reliability by two trained raters on a sample of children with and without ASD was obtained. The raw score (0-45) was converted, via Rasch analysis, to a scale score of 1-100.	Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.
Secondary	Anxiety and Cooperation Scale	The Anxiety and Cooperation Scale (A & C Scale) has been shown to assess children's anxiety, fear, and cooperation as rated by dentists, and has good established reliability and validity. Following a routine dental cleaning, the dentist rated overall patient behavior during treatment using a one-item Likert scale ranging from 0 (relaxed, smiling, demonstrates desired behavior, complies with demands) to 5 (out of control, loud crying, reverts to primitive flight responses, physical restraint required).	Completed at the end of each dental cleaning (approximately 1 minute)
Secondary	Duration	The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.	Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit
Secondary	Number of hands used to restrain child	The maximum number of hands (at any one time) required to restrain the child during the dental cleaning experience was utilized as a measure of cost and also a measure of uncooperative behavior. This variable was recorded on researcher notes during the dental cleaning and was verified using the videotape of the dental cleaning. Scoring included presence/absence as well as the number of hands used for restraint purposes during the cleaning.	Recorded throughout the dental cleaning (approximately 10-45 minutes)
Secondary	Faces Pain Scale - Revised	Faces Pain Scale is a valid tool comprised of six faces to assess perception and intensity of pain.	Completed at the end of each dental cleaning (approximately 1-2 minutes)
Secondary	Dental Sensory Sensitivity Scale	Dental Sensory Sensitivity Scale describes the presence and magnitude of discomfort with different sensory stimuli in the dental environment.	Completed at the end of each dental cleaning (approximately 3 minutes)
Secondary	Frankl Scale	The Frankl Scale was completed by the dentist following the dental cleaning. This one-item Likert Scale ranges from 1 (definitely negative) to 2 (negative) to 3 (positive) to 4 (definitely positive). This assessment has high inter-rater reliability and moderate validity and has been used to measure the behavior of children with ASD.	Completed at the end of each dental cleaning (approximately 1 minute)