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NCT03218462 Clinical Trial

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

Intellectual Disability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03218462
Other study ID # HM20009272
Secondary ID
Status Completed
Phase N/A
First received June 27, 2017
Last updated April 17, 2018
Start date July 10, 2017
Est. completion date March 30, 2018

Study information
Verified date April 2018
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 21 Years
Eligibility Inclusion Criteria:

- Children with intellectual and/or developmental disabilities

Exclusion Criteria:

- No specific diagnosis

- Parents/guardians have limited English proficiency

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)
Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Behavior during initial dental exam Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive Day 1
Primary Behavior during recall exam Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive 3 months
Secondary Physiologic outcomes (oxygen saturation) during initial exam Measured every 5 minutes during the exam (up to one hour) Day 1
Secondary Physiologic outcomes (oxygen saturation) during recall exam Measured every 5 minutes during the exam (up to one hour) 3 months
Secondary Physiologic outcomes (hearts rate) during initial exam Measured every 5 minutes during the exam (up to one hour) Day 1
Secondary Physiologic outcomes (hearts rate) during initial exam Measured every 5 minutes during the exam (up to one hour) 3 months
Secondary Patient cooperation during initial exam Assessed by parent/caregiver with post treatment written survey Day 1
Secondary Patient cooperation during recall exam Assessed by parent/caregiver with post treatment written survey 3 months
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