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
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Developmental Disabilities
• Developmental Disability
• Intellectual Disability

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