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Developmental DisabilityNCT03218462

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

A study testing Sensory Adapted Dental Environment (SADE) in people with Developmental Disability and Intellectual Disability, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 6 to 21 years
What is being tested?
Sensory Adapted Dental Environment (SADE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
10 Jul 2017to 30 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children with intellectual and/or developmental disabilities

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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).

Read the 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.

Being tested
Sensory Adapted Dental Environment (SADE)
Keywords
sensory adapted environment, pediatric dentistry, oral health, Developmental Disability, Intellectual Disability, dental anxiety, autism spectrum
Medical subject headings
Developmental Disabilities, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Adapted Dental Environment (SADE)Behavioural

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

Study groups in NCT03218462
Study groupRoleWhat they receive
Group 1ExperimentalSensory adapted dental environment (SADE) at first exam (visit 1)
Receives: Behavioral: Sensory Adapted Dental Environment (SADE)
Group 2ExperimentalSensory adapted dental environment (SADE) at recall exam (visit 2)
Receives: Behavioral: Sensory Adapted Dental Environment (SADE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Behavior during initial dental exam

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

    Measured: Day 1

  2. Behavior during recall exam

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

    Measured: 3 months

Secondary outcomes (6)

  1. Physiologic outcomes (oxygen saturation) during initial exam

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

    Measured: Day 1

  2. Physiologic outcomes (oxygen saturation) during recall exam

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

    Measured: 3 months

  3. Physiologic outcomes (hearts rate) during initial exam

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

    Measured: Day 1

  4. Physiologic outcomes (hearts rate) during initial exam

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

    Measured: 3 months

  5. Patient cooperation during initial exam

    Assessed by parent/caregiver with post treatment written survey

    Measured: Day 1

  6. Patient cooperation during recall exam

    Assessed by parent/caregiver with post treatment written survey

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2017
  2. Study start10 Jul 2017
  3. Primary completion30 Mar 2018
  4. Study completion30 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03218462
Sponsor's protocol ID
HM20009272
Status last verified
Apr 2018
First submitted
27 Jun 2017
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Adapted Dental Environment (SADE) in people with Developmental Disability and Intellectual Disability, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavior during initial dental exam (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03218462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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