Sensory Adapted Dental Environments to Enhance Oral Care for Children

NCT02430051 | Completed Results DMC

• 1 other identifier: DE024978-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

sensory processing; oral care; electrodermal activity; cooperation; anxiety; distress; stress; behavior; occupational therapy

Outcome Measures

Primary Outcomes (2)

• Electrodermal Activity (EDA) - Skin Conductance Level (SCL)

  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.

  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.

• Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)

  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. Each unique increase \>0.05uS in the EDA waveform is counted as an NS-SCR, indicating a increase in sympathetic nervous system activation; NS-SCRs are measured as a frequency per minute (calculated as the number of NS-SCRs/time).

  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 (11)

• Children's Dental Behavior Rating Scale (CDBRS)

  Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.

• Whimper, Cry, Scream Duration

  Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.

• Whimper, Cry, Scream Frequency

  Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.

• Mouth Movement Frequency

  Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.

• Head Movement Frequency

  Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.

Study Arms (2)

Regular Dental Environment

NO INTERVENTION

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.

Sensory Adapted Dental Environment

EXPERIMENTAL

In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, and tactile adaptations).

Behavioral: Sensory Adapted Dental Environment

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.

Also known as: SADE Intervention

Sensory Adapted Dental Environment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (7)

• 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.

  PMID: 25871593 BACKGROUND

• 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.

  PMID: 25114916 BACKGROUND

• 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.

  PMID: 23756306 BACKGROUND

• 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.

  PMID: 22917131 BACKGROUND

• 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.

  PMID: 23211914 BACKGROUND

• 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.

  PMID: 21592164 BACKGROUND

• Stein Duker LI, Como DH, Jolette C, Vigen C, Gong CL, Williams ME, Polido JC, Florindez-Cox LI, Cermak SA. Sensory Adaptations to Improve Physiological and Behavioral Distress During Dental Visits in Autistic Children: A Randomized Crossover Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316346. doi: 10.1001/jamanetworkopen.2023.16346.

  PMID: 37266941 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Leah Stein Duker
• Organization: University of Southern California

lstein@chan.usc.edu

(323)442-0371

Study Officials

• Sharon Cermak, EdD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2015
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Locations

US (1)