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OpenTrials
Completed

NCT Number: NCT03218462

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

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).

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Key information

Conditions

Developmental Disability Dental Anxiety Developmental Disabilities Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with intellectual and/or developmental disabilities

Exclusion criteria

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

Treatment and study plan

Sensory Adapted Dental Environment (SADE)

Behavioral

No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background

Primary outcomes

  1. Behavior during initial dental exam

    Time frame: Day 1

    Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive

  2. Behavior during recall exam

    Time frame: 3 months

    Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive

Secondary outcomes

  1. Physiologic outcomes (oxygen saturation) during initial exam

    Time frame: Day 1

    Measured every 5 minutes during the exam (up to one hour)

  2. Physiologic outcomes (oxygen saturation) during recall exam

    Time frame: 3 months

    Measured every 5 minutes during the exam (up to one hour)

  3. Physiologic outcomes (hearts rate) during initial exam

    Time frame: Day 1

    Measured every 5 minutes during the exam (up to one hour)

  4. Physiologic outcomes (hearts rate) during initial exam

    Time frame: 3 months

    Measured every 5 minutes during the exam (up to one hour)

  5. Patient cooperation during initial exam

    Time frame: Day 1

    Assessed by parent/caregiver with post treatment written survey

  6. Patient cooperation during recall exam

    Time frame: 3 months

    Assessed by parent/caregiver with post treatment written survey

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2017
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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