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

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 Overview

• Status: Completed
• Conditions: Intellectual Disability; Dental Anxiety; Developmental Disability
• Intervention / Treatment: Behavioral: Sensory Adapted Dental Environment (SADE)

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with intellectual and/or developmental disabilities

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Sensory adapted dental environment (SADE) at first exam (visit 1)	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
EXPERIMENTAL: Group 2; Sensory adapted dental environment (SADE) at recall exam (visit 2)	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Patrice B Wunsch, DDS, MS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2017
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): March 30, 2018

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (ACTUAL): July 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: dental anxiety; Intellectual Disability; oral health; Developmental Disability; pediatric dentistry; autism spectrum; sensory adapted environment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Anxiety Disorders; Developmental Disabilities; Intellectual Disability
• Other Study ID Numbers: HM20009272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No