Documenting Toothbrushing Experiences of Caregivers Who Care for Children With Autism Spectrum Disorders (humBrush)

Exploring Caregivers' Experiences Related to the Use of a Smart Toothbrush by Children With Autism Spectrum Disorder

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).

Study Overview

• Status: Completed
• Conditions: ASD I; ASD2
• Intervention / Treatment: Device: Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Dental School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User experiences of hum connected toothbrush as observed by the caregiver with interviews & questionnaires.	The hum Smart Kids Toothbrush aims to capture the reactions of the caregivers of the children with ASD on the ease and usefulness of the toothbrush and the app. The goal is to gauge if the experience of using the connected toothbrush is ultimately enjoyable for the caregivers of the children with ASD. Insights from the caregivers will assist in exploring the value of utilizing "smart" toothbrush technologies for oral hygiene in children with ASD.	4 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Katherine France, DMD, MBE, Penn Dental School of Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• Oral Health and Autism Spectrum Disorders: A Unique Collaboration between Dentistry and Occupational Therapy

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: autism spectrum disorder; ASD; Smart toothbrush; Caregiver experience
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Sodium Fluoride
• Other Study ID Numbers: 850364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All information may be stored or shared for future research purposes. All the information will be de-identified. All audio recordings will be transcribed and de-identified. De-identified means that all identifiers have been removed. The information could be stored and shared for future research in this de-identified fashion. The information may be shared with other researchers within Penn, or other research institutions, as well as pharmaceutical, device, or biotechnology companies. It would not be possible for future researchers to identify the subjects as we would not share any identifiable information about the subjects with future researchers. This can be done without again seeking their consent in the future, as permitted by law. The future use of the information only applies to the information collected on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No