NCT05552144

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: —

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.

Conditions

• ASD I
• ASD2

Interventions

Type	Name	Description
DEVICE	Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871	The first 15 caregivers and their children who meet the inclusion/exclusion characteristics and sign an Informed Consent Form/provide assent will be entered into the study. The caregivers will be asked to supervise the tooth brushing experience of the children with hum Kids toothbrush twice a day for 4 weeks using the associated app. The caregivers will also be asked to fill out questionnaires and participate in interviews regarding the children's brushing habits and experiences.

Timeline

• Start date: 2022-08-23
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2022-09-23
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States