๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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:
โข Demonstrated inability to comply with trial protocol requirements
University of Michigan
Ann Arbor, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.