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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02430051
Recruitment Status : Active, not recruiting
First Posted : April 29, 2015
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Sharon Cermak, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Sensory Adapted Dental Environment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sensory Adapted Dental Environments to Enhance Oral Care for Children (SADE-2)
Study Start Date : May 2015
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
No Intervention: Regular Dental Environment
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.
Experimental: Sensory Adapted Dental Environment
In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).
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.
Other Name: SADE Intervention




Primary Outcome Measures :
  1. Electrodermal Activity (EDA) [ Time Frame: 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) 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).


Secondary Outcome Measures :
  1. Children's Dental Behavior Rating Scale (CDBRS) [ Time Frame: Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis. ]
    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.

  2. Anxiety and Cooperation Scale [ Time Frame: Completed at the end of each dental cleaning (approximately 1 minute) ]
    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).

  3. Duration [ Time Frame: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit ]
    The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.

  4. Number of hands used to restrain child [ Time Frame: Recorded throughout the dental cleaning (approximately 10-45 minutes) ]
    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.

  5. Faces Pain Scale - Revised [ Time Frame: Completed at the end of each dental cleaning (approximately 1-2 minutes) ]
    Faces Pain Scale is a valid tool comprised of six faces to assess perception and intensity of pain.

  6. Dental Sensory Sensitivity Scale [ Time Frame: Completed at the end of each dental cleaning (approximately 3 minutes) ]
    Dental Sensory Sensitivity Scale describes the presence and magnitude of discomfort with different sensory stimuli in the dental environment.

  7. Frankl Scale [ Time Frame: Completed at the end of each dental cleaning (approximately 1 minute) ]
    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.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430051


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
University of Southern California
Children's Hospital Los Angeles
Investigators
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Principal Investigator: Sharon Cermak, EdD University of Southern California
Publications:
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Responsible Party: Sharon Cermak, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02430051    
Other Study ID Numbers: DE024978-01
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by Sharon Cermak, University of Southern California:
sensory processing
oral care
electrodermal activity
cooperation
anxiety
distress
stress
behavior
occupational therapy