Program to Improve Dental Care: Children With ASD

NCT03546504 | Terminated

• 1 other identifier: IRB_0085018
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

child; dental; oral health; sensory desensitization; sensory processing; occupational therapy

Outcome Measures

Primary Outcomes (6)

• Child's behavior in typical oral hygiene activities

  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

  1 month post-intervention

• Decayed, Missing, Filled Surfaces (DMFS) Index

  record of caries and missing teeth from dental exam; higher number means poorer oral health

  6 months post-intervention

• Simplified Oral Hygiene Index

  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

  1 month post-intervention

• Modified Gingival index from the Community Periodontal Index

  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

  1 month post-intervention

• Assessment of saliva for bacteria content

  collection of drool and bacterial assay - greater the bacteria count, the worse the oral health status

  1 month post-intervention

• Number of dental procedures completed

  count of the number of dental procedures completed without sedation - greater the number of typical procedures, the better the functioning

  1 month post-intervention

Secondary Outcomes (15)

• Dental Subscale of the Childrens Fear Survey

  1 month post-intervention

• Frankl Behavioral Scale

  1 month post-intervention

• Child's behavior during dental visits

  1 month post-intervention

• Parent report of burden of oral hygiene activities

  1 month post-intervention

• Parent report of burden of oral hygiene activities

  6 months post-intervention

Study Arms (1)

dental procedures modification and OT

EXPERIMENTAL

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

Interventions

Procedure alteration and occupational therapy BEHAVIORAL

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

dental procedures modification and OT

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged 5-12
• able to follow 1-step verbal directions
• able to reliably answer simple yes/no questions
• have sensory processing difficulties as indicated by atypical scores on the Sensory Processing Measure \[ref\]
• has difficulty completing oral hygiene and dental visits
• has sufficient motor skills to brush own teeth
• family is fluent in English
• has a caregiver willing to adhere to home program
• \) caregiver is willing to bring child to clinic 8 weekly occupational therapy clinic sessions

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• Cermak SA, Stein Duker LI, Williams ME, Dawson ME, Lane CJ, Polido JC. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study. J Autism Dev Disord. 2015 Sep;45(9):2876-88. doi: 10.1007/s10803-015-2450-5.

  PMID: 25931290 RESULT

• Duker LIS, Henwood BF, Bluthenthal RN, Juhlin E, Polido JC, Cermak SA. Parents' perceptions of dental care challenges in male children with autism spectrum disorder: An initial qualitative exploration. Res Autism Spectr Disord. 2017 Jul;39:63-72. doi: 10.1016/j.rasd.2017.03.002. Epub 2017 May 20.

  PMID: 29098015 RESULT

MeSH Terms

Conditions

Autistic Disorder

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate Professor

Model Details: Single group pre-post-follow-up

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 6, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)