search
Back to results

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

Primary Purpose

Developmental Disability, Intellectual Disability, Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory Adapted Dental Environment (SADE)
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Developmental Disability focused on measuring sensory adapted environment, pediatric dentistry, oral health, Developmental Disability, Intellectual Disability, dental anxiety, autism spectrum

Eligibility Criteria

6 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with intellectual and/or developmental disabilities

Exclusion Criteria:

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Sensory adapted dental environment (SADE) at first exam (visit 1)

Sensory adapted dental environment (SADE) at recall exam (visit 2)

Outcomes

Primary Outcome Measures

Behavior during initial dental exam
Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive
Behavior during recall exam
Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2017
Last Updated
April 17, 2018
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT03218462
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disability, Intellectual Disability, Dental Anxiety
Keywords
sensory adapted environment, pediatric dentistry, oral health, Developmental Disability, Intellectual Disability, dental anxiety, autism spectrum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Sensory adapted dental environment (SADE) at first exam (visit 1)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Sensory adapted dental environment (SADE) at recall exam (visit 2)
Intervention Type
Behavioral
Intervention Name(s)
Sensory Adapted Dental Environment (SADE)
Intervention Description
No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background
Primary Outcome Measure Information:
Title
Behavior during initial dental exam
Description
Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive
Time Frame
Day 1
Title
Behavior during recall exam
Description
Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Physiologic outcomes (oxygen saturation) during initial exam
Description
Measured every 5 minutes during the exam (up to one hour)
Time Frame
Day 1
Title
Physiologic outcomes (oxygen saturation) during recall exam
Description
Measured every 5 minutes during the exam (up to one hour)
Time Frame
3 months
Title
Physiologic outcomes (hearts rate) during initial exam
Description
Measured every 5 minutes during the exam (up to one hour)
Time Frame
Day 1
Title
Physiologic outcomes (hearts rate) during initial exam
Description
Measured every 5 minutes during the exam (up to one hour)
Time Frame
3 months
Title
Patient cooperation during initial exam
Description
Assessed by parent/caregiver with post treatment written survey
Time Frame
Day 1
Title
Patient cooperation during recall exam
Description
Assessed by parent/caregiver with post treatment written survey
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with intellectual and/or developmental disabilities Exclusion Criteria: No specific diagnosis Parents/guardians have limited English proficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice B Wunsch, DDS, MS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs