NCT07859553NARecruiting
Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents
University of Michigan
Start Date
10/28/2026
Completion Date
3/30/2028
Summary
This pilot study aims to evaluate dental caries experience in children ages 8-12 years old through comparing the use of a powered versus manual toothbrush, while using a standardized fluoride toothpaste as the control over the course of one year.
Eligibility Criteria
Age Range: 8 years to 12 years
Inclusion Criteria:
* Child:
* Male OR Female, between 8 - 12 years old at baseline
* In good health (i.e., free of any medical condition that would reasonably be anticipated to interfere with study participation)
* Must allow examination of the oral cavity at baseline
* Must have at least an ICDAS 2 or higher at baseline or radiographic signs of untreated caries lesions E2 or higher, or caries experience in the last 3 years (extraction due to caries, restoration due to caries, etc.)
* Able to tolerate radiographs
* Able to brush teeth by themselves with no assistance
Parent/Legal Guardian:
* Provide written informed consent for the child and her/himself prior to participation
* Must be at least 18 years old, or an emancipated minor who provides documentation of emancipation
* Must be willing and able to participate in study activities
Exclusion Criteria:
* Child:
* Hereditary generalized developmental dental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
* Presence of pain, pulpal exposure, or signs of pulpal infection (abscess, fistula, swelling) at baseline
* Participating in the foster care system
* Demonstrated inability to comply with study protocol requirements (including radiographs or abstaining from using other oral hygiene products such as mouth rinses during the study period)
* Has removable OR fixed orthodontic appliances
* Participation (within 30 days of Baseline Visit) in any other oral hygiene clinical study
Parent/Legal Guardian:
• Demonstrated inability to comply with trial protocol requirements
Interventions
DEVICE
Powered toothbrush
Conditions
Caries RiskCaries, Dental
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States