Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities

Study Overview
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Brief Summary
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Children with intellectual/developmental disabilities (ID/DD) will experience less dental anxiety and cooperate better in a Sensory Adapted Dental Environment (modified visual, sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental environment (RDE).

Detailed Description
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The aim of this pilot study is to determine the effect of sensory adapted dental environment (SADE) on reducing dental anxiety of children with intellectual and/or developmental disabilities (ID/DD). With the growing number of children diagnosed with ID/DD and their inclusion in the community, there are more opportunities for dentists to encounter this population for their routine oral health care. If improvement in dental anxiety and behavior is evident from the study, as other pilot studies have suggested, it can be applied as one of clinical tools for treating children with ID/DDs. Furthermore, utilization of a SADE in clinical training of pediatric dentists or general dentists can improve clinicians' comfort level in managing behavior of individuals with ID/DD. This will encourage more clinicians to provide care and address the unmet oral health needs of this vulnerable population.

Official Title
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Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities

Conditions
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Developmental Disability, Intellectual Disability, Dental Anxiety

Intervention / Treatment
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* Behavioral: Sensory Adapted Dental Environment (SADE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with intellectual and/or developmental disabilities Exclusion Criteria: No specific diagnosis Parents/guardians have limited English proficiency

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Sensory adapted dental environment (SADE) at first exam (visit 1) | Behavioral: Sensory Adapted Dental Environment (SADE)<br>* No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background<br>|
| Experimental: Group 2<br>Sensory adapted dental environment (SADE) at recall exam (visit 2) | Behavioral: Sensory Adapted Dental Environment (SADE)<br>* No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior during initial dental exam | Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive | Day 1 | 
| Behavior during recall exam | Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic outcomes (oxygen saturation) during initial exam | Measured every 5 minutes during the exam (up to one hour) | Day 1 | 
| Physiologic outcomes (oxygen saturation) during recall exam | Measured every 5 minutes during the exam (up to one hour) | 3 months | 
| Physiologic outcomes (hearts rate) during initial exam | Measured every 5 minutes during the exam (up to one hour) | Day 1 | 
| Physiologic outcomes (hearts rate) during initial exam | Measured every 5 minutes during the exam (up to one hour) | 3 months | 
| Patient cooperation during initial exam | Assessed by parent/caregiver with post treatment written survey | Day 1 | 
| Patient cooperation during recall exam | Assessed by parent/caregiver with post treatment written survey | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensory adapted environment, pediatric dentistry, oral health, Developmental Disability, Intellectual Disability, dental anxiety, autism spectrum