Clinical trial NCT05552144: Documenting Toothbrushing Experiences of Caregivers Who Care for Children With Autism Spectrum Disorders
Official title: Exploring Caregivers' Experiences Related to the Use of a Smart Toothbrush by Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ASD I
ASD2
Keywords: autism spectrum disorder
ASD
Smart toothbrush
Caregiver experience
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 17
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 15 children, aged 5-12 years old, male and female with ASD Level I or ASD Level II.

   1. ASD Level I requires support
   2. ASD Level II requires substantial support
2. Primary caregivers of the children.

Brief summary: The objective of this study is to examine caregiver reactions to the use of the hum by Colgate Smart Kids Toothbrush and associated app by children with autism spectrum disorder (ASD).

Detailed description: This is a single-center, pretest-posttest, non-randomized, clinical study involving interviews with caregivers prior to utilization of the research toothbrush and after 4 weeks of product use by the child. All participants enrolled will be children ages 5-12 years and their primary caregivers. Participants will be asked to utilize a Hum by Colgate Smart Kids Toothbrush (manual or battery-powered) for four weeks.

To assure that subjects are comfortable with the oral care regime proposed, toothbrushes will be distributed based on the subject's previous oral hygiene habits. Children who are currently using manual brushes will receive the Hum by Colgate Smart Manual Kids Toothbrush, likewise, children who are used to battery-powered toothbrushes will receive the Hum by Colgate Smart Kids battery-powered toothbrush.

All the participants will be offered the electric toothbrush and will have a chance to try it during the first visit.

Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form by the child's legal guardian on behalf of the child and from the primary (responsible for child's oral healthcare) caregiver.
2. Caregiver must be able to observe the child using the Hum by Colgate Smart Manual Kids Toothbrush and app twice a day.
3. Caregivers must have a child between the ages of 5-12 years old, who is willing to participate.
4. Child must be reported in good general health and good oral health based on the opinion of the study investigator.
5. Caregiver and child must be available for the duration of the study.
6. Caregiver must have access to Apple iPhone (newer than 8) or iPad (newer than 5th generation) or Android users (running Android 6.0 and up) with access to an Internet Connection.
7. Caregiver must be willing to comply with the study protocol.
8. Caregiver must be willing to download and use app associated with the connected brush.
9. Caregiver must be willing to be audiotaped during key informant interview sessions.
10. English fluency for the child's legal guardian/caregiver.
11. Caregiver must be willing to have a shared brushing experience between themselves and the child.
12. Caregiver's child must be diagnosed with ASD Level I or ASD Level II .

    1. ASD Level I: Requiring support
    2. ASD Level II: Requiring substantial support

Exclusion Criteria:

1. Child undergoing active orthodontic treatment with fixed appliances.
2. Child has obvious signs of oral disease, severe dental caries, or pain as determined by the investigator's judgment.
3. Concurrent participation by child in another clinical study.
4. Child's behavior precludes participation in the study at the investigator's discretion.
5. Current or previous use of the Hum by Colgate Smart Kids Toothbrush by the child.

Primary outcomes:
measure: User experiences of hum connected toothbrush as observed by the caregiver with interviews & questionnaires.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Dental School of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn Dental School of Medicine
name: Katherine France, DMD, MBE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Como DH, Stein Duker LI, Polido JC, Cermak SA. Oral Health and Autism Spectrum Disorders: A Unique Collaboration between Dentistry and Occupational Therapy. Int J Environ Res Public Health. 2020 Dec 27;18(1):135. doi: 10.3390/ijerph18010135.