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

Not Applicable

Completed

• Conditions: Intellectual Disability; Developmental Disability; Dental Anxiety
• Interventions: Behavioral: Sensory Adapted Dental Environment (SADE)

• Registration Number: NCT03218462
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-27
• Study Start: 2017-07-10
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Children with intellectual and/or developmental disabilities

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Sensory Adapted Dental Environment (SADE)	Sensory adapted dental environment (SADE) at first exam (visit 1)
Group 2	Sensory Adapted Dental Environment (SADE)	Sensory adapted dental environment (SADE) at recall exam (visit 2)

Primary Outcome Measures

Name	Time	Method
Behavior during initial dental exam	Day 1	Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive
Behavior during recall exam	3 months	Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States