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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03218462
Enrollment
22
Registered
2017-07-14
Start date
2017-07-10
Completion date
2018-03-30
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety, Developmental Disability, Intellectual Disability

Keywords

sensory adapted environment, pediatric dentistry, oral health, Developmental Disability, Intellectual Disability, dental anxiety, autism spectrum

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.

Interventions

BEHAVIORALSensory 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

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

* Children with intellectual and/or developmental disabilities

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Behavior during initial dental examDay 1Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive
Behavior during recall exam3 monthsMeasured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive

Secondary

MeasureTime frameDescription
Physiologic outcomes (hearts rate) during initial examDay 1Measured every 5 minutes during the exam (up to one hour)
Physiologic outcomes (oxygen saturation) during initial examDay 1Measured every 5 minutes during the exam (up to one hour)
Patient cooperation during recall exam3 monthsAssessed by parent/caregiver with post treatment written survey
Patient cooperation during initial examDay 1Assessed by parent/caregiver with post treatment written survey
Physiologic outcomes (oxygen saturation) during recall exam3 monthsMeasured every 5 minutes during the exam (up to one hour)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026