Clinical trial NCT03218462: Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities
Official title: Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Disability
Intellectual Disability
Dental Anxiety
Keywords: sensory adapted environment
pediatric dentistry
oral health
Developmental Disability
Intellectual Disability
dental anxiety
autism spectrum
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Children with intellectual and/or developmental disabilities

Exclusion Criteria:

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

Primary outcomes:
measure: Behavior during initial dental exam
timeFrame: Day 1
measure: Behavior during recall exam
timeFrame: 3 months
Secondary outcomes:
measure: Physiologic outcomes (oxygen saturation) during initial exam
timeFrame: Day 1
measure: Physiologic outcomes (oxygen saturation) during recall exam
timeFrame: 3 months
measure: Physiologic outcomes (hearts rate) during initial exam
timeFrame: Day 1
measure: Physiologic outcomes (hearts rate) during initial exam
timeFrame: 3 months
measure: Patient cooperation during initial exam
timeFrame: Day 1
measure: Patient cooperation during recall exam
timeFrame: 3 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Patrice B Wunsch, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: