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

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2018

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.

Interventions

  • Behavioral: Sensory Adapted Dental Environment (SADE)
    • No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Sensory adapted dental environment (SADE) at first exam (visit 1)
  • Experimental: Group 2
    • Sensory adapted dental environment (SADE) at recall exam (visit 2)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Children with intellectual and/or developmental disabilities Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrice B Wunsch, DDS, MS, Principal Investigator, Virginia Commonwealth University

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