Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Program to Improve Dental Care: Children With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546504
Recruitment Status : Terminated (ran out of money)
First Posted : June 6, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Lorie Richards, University of Utah

Brief Summary:
Children, aged 5-12, with autism spectrum disorder (ASD) who have difficulty with dental visits and daily oral hygiene will complete 3 dental assessments at baseline, 3 months, and 6 months. The dental environment and dental procedures will be altered based on the work of Cermak. In between the baseline and 3 months appointments, they will receive 8 weeks of occupational therapy targeting desensitization around dental activities and oral hygiene training. Post testing will assess the number of caries and overall oral health, the number of dental activities able to be accomplished without sedation, and the change in burden of caregivers to achieve oral hygiene.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Procedure alteration and occupational therapy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group pre-post-follow-up
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Program to Improve Dental Care in Children With ASD: Reducing Sensory Stimulation and Building Oral Hygiene Habits
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: dental procedures modification and OT
Modifying dental environment and procedures to reduce sensory stimulation. Occupational therapy provides desensitization techniques around the dental visit and home oral hygiene and habit training for oral hygiene activities.
Behavioral: Procedure alteration and occupational therapy
Modification of the dental environment and procedures to decrease sensory stimulation. Occupational therapy (8 weeks; 2x/week): sensory desensitization, habit training, social stories around dental visits




Primary Outcome Measures :
  1. Child's behavior in typical oral hygiene activities [ Time Frame: 1 month post-intervention ]
    digital recordings of children during oral hygiene activities coded within 10 second intervals for on-task behavior, aggression, agitation, time to complete activity - more on-task behavior, less aggression, less agitation, duration of activity closer to 5-10 minutes represents better functioning

  2. Decayed, Missing, Filled Surfaces (DMFS) Index [ Time Frame: 6 months post-intervention ]
    record of caries and missing teeth from dental exam; higher number means poorer oral health

  3. Simplified Oral Hygiene Index [ Time Frame: 1 month post-intervention ]
    dental report of oral health - Scored on a 0-3 scale with 0 = no debris and 3 = soft debris over > 2/3 of tooth; lower scores represent better oral health

  4. Modified Gingival index from the Community Periodontal Index [ Time Frame: 1 month post-intervention ]
    report of level of gingivitis - scored on a 0-4 scale with 0 = normal, no inflammation and 4 = severe inflammation; lower scores represent better oral health

  5. Assessment of saliva for bacteria content [ Time Frame: 1 month post-intervention ]
    collection of drool and bacterial assay - greater the bacteria count, the worse the oral health status

  6. Number of dental procedures completed [ Time Frame: 1 month post-intervention ]
    count of the number of dental procedures completed without sedation - greater the number of typical procedures, the better the functioning


Secondary Outcome Measures :
  1. Dental Subscale of the Childrens Fear Survey [ Time Frame: 1 month post-intervention ]
    rating by parent of child's fear associated with dental visits; 15 items are scored by selecting the "not afraid at all", " a little afraid", "a fair amount afraid", "pretty much afraid", or "very afraid"; lower amounts of fear represent better functioning

  2. Frankl Behavioral Scale [ Time Frame: 1 month post-intervention ]
    measures dentist perception of child's behavior during the dental visit: scored by rating child's behavior at this visit on 1-4 scale with 1= definitely negative and 4 = definitely positive; higher score = better behavior

  3. Child's behavior during dental visits [ Time Frame: 1 month post-intervention ]
    recording and coding of child behavior during dental visits - refusals, aggression, agitation - fewer of these represents better functioning

  4. Parent report of burden of oral hygiene activities [ Time Frame: 1 month post-intervention ]
    interview with parent related to burden of assisting child complete oral hygiene activities - reports of less burden represent better functioning

  5. Parent report of burden of oral hygiene activities [ Time Frame: 6 months post-intervention ]
    interview with parent related to burden of assisting child complete oral hygiene activities - report of less burden represents better functioning

  6. Wong-Baker Faces Scale [ Time Frame: 1 month post-intervention ]
    ratings of pain - used to measure discomfort during dental visit - lower score means less pain and discomfort

  7. Wong-Baker Faces Scale [ Time Frame: 6 months post-intervention ]
    ratings of pain - used to measure discomfort during dental visit - lower score means less pain and discomfort

  8. Child's behavior in typical oral hygiene activities [ Time Frame: 6 months post-intervention ]
    digital recordings of children during oral hygiene activities coded within 10 second intervals for on-task behavior, aggression, agitation, time to complete activity - more on-task behavior, less aggression, less agitation, duration of activity closer to 5-10 minutes represents better functioning

  9. Simplified Oral Hygiene Index [ Time Frame: 6 months post-intervention ]
    dental report of oral health - Scored on a 0-3 scale with 0 = no debris and 3 = soft debris over > 2/3 of tooth; lower scores represent better oral health

  10. Modified Gingival index from the Community Periodontal Index [ Time Frame: 6 months post-intervention ]
    report of level of gingivitis - scored on a 0-4 scale with 0 = normal, no inflammation and 4 = severe inflammation; lower scores represent better oral health

  11. Assessment of saliva for bacteria content [ Time Frame: 6 months post-intervention ]
    collection of drool and bacterial assay - greater the bacteria count, the worse the oral health status

  12. Dental Subscale of the Childrens Fear Survey [ Time Frame: 6 months post-intervention ]
    rating by parent of child's fear associated with dental visits; 15 items are scored by selecting the "not afraid at all", " a little afraid", "a fair amount afraid", "pretty much afraid", or "very afraid"; lower amounts of fear represent better functioning

  13. Frankl Behavioral Scale [ Time Frame: 6 months post-intervention ]
    measures dentist perception of child's behavior during the dental visit: scored by rating child's behavior at this visit on 1-4 scale with 1= definitely negative and 4 = definitely positive; higher score = better behavior

  14. Child's behavior during dental visits [ Time Frame: 6 months post-intervention ]
    recording and coding of child behavior during dental visits - refusals, aggression, agitation - fewer of these represents better functioning

  15. Number of dental procedures completed [ Time Frame: 6 months post-intervention ]
    greater the number of typical procedures, the better the functioning



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 5-12
  2. able to follow 1-step verbal directions
  3. able to reliably answer simple yes/no questions
  4. have sensory processing difficulties as indicated by atypical scores on the Sensory Processing Measure [ref]
  5. has difficulty completing oral hygiene and dental visits
  6. has sufficient motor skills to brush own teeth
  7. family is fluent in English
  8. has a caregiver willing to adhere to home program

7) caregiver is willing to bring child to clinic 8 weekly occupational therapy clinic sessions

Exclusion Criteria:

  1. unable to communicate
  2. unable to physically handle toothbrush to brush teeth
  3. requires extensive restorative dental work or has had such work within the past 3 months
  4. has braces, temporary orthodontic prosthesis (e.g., retainers)
  5. Greater than mild uncorrected hearing or visual impairments
  6. uncontrolled seizures
  7. has additional other neurodevelopmental conditions other than ADHD and Anxiety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546504


Locations
Layout table for location information
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Publications of Results:
Layout table for additonal information
Responsible Party: Lorie Richards, Chair and Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03546504    
Other Study ID Numbers: IRB_0085018
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorie Richards, University of Utah:
child
dental
oral health
sensory desensitization
sensory processing
occupational therapy