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Clinical Trials/NCT03218462
NCT03218462
Completed
Not Applicable

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

Virginia Commonwealth University1 site in 1 country22 target enrollmentJuly 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Developmental Disability
Sponsor
Virginia Commonwealth University
Enrollment
22
Locations
1
Primary Endpoint
Behavior during initial dental exam
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2017
End Date
March 30, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children with intellectual and/or developmental disabilities

Exclusion Criteria

  • No specific diagnosis
  • Parents/guardians have limited English proficiency

Outcomes

Primary Outcomes

Behavior during initial dental exam

Time Frame: Day 1

Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive

Behavior during recall exam

Time Frame: 3 months

Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive

Secondary Outcomes

  • Patient cooperation during recall exam(3 months)
  • Physiologic outcomes (hearts rate) during initial exam(3 months)
  • Physiologic outcomes (oxygen saturation) during initial exam(Day 1)
  • Physiologic outcomes (oxygen saturation) during recall exam(3 months)
  • Patient cooperation during initial exam(Day 1)

Study Sites (1)

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