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

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03218462
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 2.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Developmental Disability; Intellectual Disability; Dental Anxiety	Behavioral: Sensory Adapted Dental Environment (SADE)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities
• Actual Study Start Date: Jul 10, 2017
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Sensory adapted dental environment (SADE) at first exam (visit 1)	Behavioral: Sensory 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
Experimental: Group 2 Sensory adapted dental environment (SADE) at recall exam (visit 2)	Behavioral: Sensory 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

Outcome Measures

Primary Outcome Measures

1. Behavior during initial dental exam [Day 1]

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

2. Behavior during recall exam [3 months]

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

Secondary Outcome Measures

1. Physiologic outcomes (oxygen saturation) during initial exam [Day 1]

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

2. Physiologic outcomes (oxygen saturation) during recall exam [3 months]

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

3. Physiologic outcomes (hearts rate) during initial exam [Day 1]

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

4. Physiologic outcomes (hearts rate) during initial exam [3 months]

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

5. Patient cooperation during initial exam [Day 1]

   Assessed by parent/caregiver with post treatment written survey

6. Patient cooperation during recall exam [3 months]

   Assessed by parent/caregiver with post treatment written survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children with intellectual and/or developmental disabilities

Exclusion Criteria:

• No specific diagnosis

• Parents/guardians have limited English proficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: Patrice B Wunsch, DDS, MS, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03218462
• Other Study ID Numbers: HM20009272
• First Posted: Jul 14, 2017
• Last Update Posted: Apr 18, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Virginia Commonwealth University: sensory adapted environment; pediatric dentistry; oral health; Developmental Disability; Intellectual Disability; dental anxiety; autism spectrum
• Additional relevant MeSH terms: Intellectual Disability; Anxiety Disorders; Developmental Disabilities

Study Results

No Results Posted as of Apr 18, 2018