Sensory Adapted Dental Environments to Enhance Oral Care for Children

Not Applicable

Completed

Conditions: Autism

Registration Number: NCT02430051

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 220

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Electrodermal Activity (EDA) - Skin Conductance Level (SCL)	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.
Electrodermal Activity (EDA) - 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.	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).

Secondary Outcome Measures

Name	Time	Method
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.	The CDBRS is a video-coded measure of overt distress behaviors exhibited by children during a routine dental visit. A research team member marks 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 a five-minute recording of a child receiving prophylaxis during their dental cleaning. Coding is conducted by a trained research team member who achieves strong inter-rater reliability with a second trained rater on a representative sample of children with and without ASD. Raw scores (range=0-45) are converted to a scale score ranging from 1 to 100, with higher scores indicating greater distress.
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.	Duration of whimpers, cries, or screams, as scored by video coding.
Faces Pain Scale - Revised	Completed at the end of each dental cleaning (approximately 1-2 minutes)	The Faces Pain Scale - Revised is single-item self-report measure used to assess the perception and intensity of pain in children. The scale is comprised of six faces depicting increasing levels of pain ranging from a neutral expression (no pain) to a face showing severe pain. Each face corresponds to a numerical value on a 0-10 scale (0, 2, 4, 6, 8, 10). Higher scores indicate greater perception and intensity of pain.
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.	Frequency of whimpers, cries, or screams, as scored by video coding.
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.	Frequency of mouth movement impeding treatment, as scored by video coding.
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.	Frequency of head movement away from the dentist and/or equipment impeding treatment, as scored by video coding.
Dental Sensory Sensitivity Scale	Completed at the end of each dental cleaning (approximately 3 minutes)	The Dental Sensory Sensitivity Scale is a child-report measure assessing the presence and magnitude of discomfort with different sensory stimuli in the dental environment (i.e., tactile, auditory, proprioceptive). The scale is comprised of 6 items rated on a 3-point Likert scale ranging from 0 (not at all) to 2 (a lot). Scores range from 0 - 12 with higher scores indicating greater sensory discomfort during routine dental treatment.
Frankl Scale	Completed at the end of each dental cleaning (approximately 1 minute)	The Frankl Scale is dentist-report measure of a child's overall behavior during a dental visit. It is an observational, single-item measure that includes four behavioral categories, each assigned a numerical value (1=definitely negative, 2=negative, 3=positive, 4=definitely positive). Higher scores indicate greater cooperation and less distress.
Anxiety and Cooperation Scale	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).
Duration	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.
Number of Hands Used to Restrain Child	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.

Trial Locations

Locations (1): Children's Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States