Recruiting

Powered & Manual Toothbrush

Sponsor:

University of Michigan

Code:

NCT07859553

Conditions

Caries Risk

Caries, Dental

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Powered toothbrush

Study Details

Brief 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.

Conditions

Caries Risk

Caries, Dental

Study ID

NCT07859553

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Manual Toothbrush

experimental: Powered Toothbrush

Interventions

Powered toothbrush

Powered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch

Primary outcome measure

  • Number of new caries surfaces and number of progressed caries surfaces [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Taylor Cezon, RDH

734-730-8533kidscavities@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Margherita Fontana, DDS, PhD

More Information

Sponsor

University of Michigan

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • toothbrush
  • child
  • children
  • cavities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.