NCT03218462

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

June 27, 2017

Last Update Submit

April 17, 2018

Conditions

Developmental DisabilityIntellectual DisabilityDental Anxiety

Keywords

sensory adapted environmentpediatric dentistryoral healthDevelopmental DisabilityIntellectual Disabilitydental anxietyautism spectrum

Outcome Measures

Primary Outcomes (2)

  • Behavior during initial dental exam

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

    Day 1

  • Behavior during recall exam

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

    3 months

Secondary Outcomes (6)

  • Physiologic outcomes (oxygen saturation) during initial exam

    Day 1

  • Physiologic outcomes (oxygen saturation) during recall exam

    3 months

  • Physiologic outcomes (hearts rate) during initial exam

    Day 1

  • Physiologic outcomes (hearts rate) during initial exam

    3 months

  • Patient cooperation during initial exam

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

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

Behavioral: Sensory Adapted Dental Environment (SADE)

Group 2

EXPERIMENTAL

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

Behavioral: Sensory Adapted Dental Environment (SADE)

Interventions

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

Group 1Group 2

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with intellectual and/or developmental disabilities

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Developmental DisabilitiesIntellectual Disability

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patrice B Wunsch, DDS, MS

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 14, 2017

Study Start

July 10, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)