Program to Improve Dental Care: Children With ASD

Autism Clinical Trial

Official title:

Program to Improve Dental Care in Children With ASD: Reducing Sensory Stimulation and Building Oral Hygiene Habits

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03546504
• Other study ID #: IRB_0085018
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After providing consent and assent from applicable children, the researchers will administer the Sensory Processing Measure to test for sensory processing difficulties. Those that meet criteria on this assessment will then complete baseline testing. If the child does not score as having sensory processing problems on the Sensory Processing Measure, the family will be thanked for their time and withdrawn from the study. Their data will be destroyed and only that they were an interested family that failed screening due to lack of sensory processing problems recorded (no identifying information recorded). For those families that pass this screen, the caregivers will complete the following study measures Vineland Adaptive Behavior Scales, Dental Subscale of the Childrens Fear Survey, the Sensory Profile, the Screen for Child Anxiety Related Disorders, and study occupational therapists will complete an occupational performance evaluation (observing actual oral hygiene activities to assess skill level and determine barriers and supports for performance, interviewing parents for oral hygiene and dental visit history how they handle child's behavior that interferes with oral hygiene and dental visit activities, and gathering information about what rewards motivate the child using the Reinforcer Assessment for Individuals with Severe Disabilities. The oral hygiene activities observations serve as baseline data and information for clinical treatment planning, as well as research data. Information about parent reactions to child behaviors is clinical data that is necessary for individualizing occupational therapy treatment. The caregivers will be asked to videotape a typical oral hygiene session at home to be scored for the child's behavior by the researchers. The children will then complete a standard of care preventative dental visit (cleaning, X-rays, periodontal health check). The dental researcher will record the Decayed, Missing, Filled Surfaces (DMFS) Index, the Simplified Oral Hygiene Index, the Modified Gingival index from the Community Periodontal Index, and the child will be administered the Wong-Baker Faces Scale to measure discomfort. The dentist will obtain a saliva sample to test for bacteria associated with caries risk. The sample will be collected by having the child spit or drool into a cup. The saliva is analyzed on-site using a kit. That session will be videotaped for later scoring of behaviors. The dental research staff will fill out the Frankl Behavioral Scale describing the dental visit. The children will be scheduled for 8 sensory-based occupational therapy sessions, once per week, over 10 weeks. These sessions will be geared towards developing skills to discriminate, modulate, and integrate input from their multiple sensory systems, adapting their home environment and oral hygiene tasks to provide greater structure and reducing noxious sensory stimulation, and practicing of oral hygiene tasks using behavior learning techniques. By increasing their ability to properly interpret sensory input, we are increasing their ability to adapt to and respond to stimuli (self-regulation). Examples of activities that may be used include: increased input to muscles and joints through yoga or other weight bearing activities; oral desensitization for those that may have adverse responses (often specific textures); teaching coping techniques to decrease anxiety when presented with perceived adverse stimuli. The caregiver will be given a home program consisting of a sensory activity schedule everyday at home. These activities are specifically chosen and placed into a program to provide input to the sensory system that will help self-regulation. Activities can include: wall push-ups to provide increased input to the muscles and joints; utilizing a vibrating toothbrush to decrease oral sensitivity; warm baths; smelling specific scents. A visual schedule will be given to parents to use during tooth brushing at home to aid the participant in completing the task. These are typical occupational therapy services for children with life skill difficulties due to sensory processing problems. At the last session, occupational therapy research staff will complete study questionnaires. The occupational therapy sessions will primarily take place at the Division of Occupational Therapy's Life Skills Clinic, but up to 2 sessions may occur at the child's home if the occupational therapist deems that providing the therapy in the home would offer greater benefit to the child than all the session taking place at the clinic. After the 8 sessions of occupational therapy, the caregiver will be asked to videotape another typical oral hygiene session at home within 2 weeks of final occupational therapy session.

Then, the child will return to the dentist office for a 2nd preventative dental visit within 1 month at which the level of plaque, gingivitis, caries, fear, and cooperativeness with the dental procedures will be assessed. Two weeks before the follow-up dental appointment, parents will be sent a social story, about what to expect from the dental visit, to read with their child twice per day. At the 2nd dental visit, the teeth will be cleaned as well as assessed, but no X-rays will be taken. At this visit the dental environment and procedures will be modified to provide a better amount and type of sensory stimulation to the child. Examples may include the use of a weighted apron for deep proprioceptive input, which can be calming, using a head lamp rather than the typical dental light, providing headphones with soothing sounds playing, etc. This visit will be videotaped and dental research staff and caregivers will fill out study questionnaires as they did at baseline. The occupational therapist will also re-evaluate the child on the study outcome measures, observe the child tooth brushing and flossing, and interview the parent with the formal questionnaires and semi-structured interview.

Six months later, the child will have a 3rd preventative dental visit (with modifications as described above), which will be videotaped and with dental staff and caregivers filling out study questionnaires. The teeth will be assessed and cleaned, but no x-rays taken consistent with standard care procedures of x-rays only 1x/year. All dental visits will occur at the pediatric dental clinic at the Noorda Oral Health Sciences building. At the 6 month dental visit, parents will again be interviewed for changes in the ease of completing and quality of daily hygiene routines and perceived changes in tolerance for preventative dental visits and OT will again perform study outcome measures and observations with the child and caregiver.

If any dental caries are found during this period, they will be taken care of per standard of care dental procedures. If a child is found to need major restorative dental procedures during this study, he or she will be withdrawn from the study (although still offered standard clinical care) as the noxious sensation associated with a lot of dental procedures would confound the results of this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Dental Subscale of the Childrens Fear Survey	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	1 month post-intervention
Secondary	Frankl Behavioral Scale	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	1 month post-intervention
Secondary	Child's behavior during dental visits	recording and coding of child behavior during dental visits - refusals, aggression, agitation - fewer of these represents better functioning	1 month post-intervention
Secondary	Parent report of burden of oral hygiene activities	interview with parent related to burden of assisting child complete oral hygiene activities - reports of less burden represent better functioning	1 month post-intervention
Secondary	Parent report of burden of oral hygiene activities	interview with parent related to burden of assisting child complete oral hygiene activities - report of less burden represents better functioning	6 months post-intervention
Secondary	Wong-Baker Faces Scale	ratings of pain - used to measure discomfort during dental visit - lower score means less pain and discomfort	1 month post-intervention
Secondary	Wong-Baker Faces Scale	ratings of pain - used to measure discomfort during dental visit - lower score means less pain and discomfort	6 months post-intervention
Secondary	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	6 months post-intervention
Secondary	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	6 months post-intervention
Secondary	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	6 months post-intervention
Secondary	Assessment of saliva for bacteria content	collection of drool and bacterial assay - greater the bacteria count, the worse the oral health status	6 months post-intervention
Secondary	Dental Subscale of the Childrens Fear Survey	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	6 months post-intervention
Secondary	Frankl Behavioral Scale	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	6 months post-intervention
Secondary	Child's behavior during dental visits	recording and coding of child behavior during dental visits - refusals, aggression, agitation - fewer of these represents better functioning	6 months post-intervention
Secondary	Number of dental procedures completed	greater the number of typical procedures, the better the functioning	6 months post-intervention