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Recruiting NCT07859553

Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents

Conditions: Caries Risk, Caries, Dental

Sex: All
Ages: 8 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University of Michigan

Location: University of Michigan Ann Arbor Michigan

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07859553). StuddyBuddy aggregates publicly available trial information.