Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorUniversity of Michigan
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Powered toothbrush
DevicePowered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Manual ToothbrushNo intervention 0 interventions
Group B: Powered ToothbrushExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of new caries surfaces and number of progressed caries surfaces
Composite Endpoint. New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. Caries progression defined if baseline was enamel decay and follow-up was dentin decay, filling, or extracted due to caries.
Time frame
12 MonthsSecondary outcomes
1
Number of new caries surfaces
New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries.
Time frame
12 Months2
Number of new caries surfaces and number of progressed caries surfaces
Composite Endpoint. New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. Caries progression defined if baseline was enamel decay and follow-up was dentin decay, filling, or extracted due to caries.
Time frame
6 Months3
Number of new caries surfaces
New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries.
Time frame
6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Procter and Gamble
Collaborator
Source ClinicalTrials.gov