Caries Risk, Caries, Dental
Conditions
Keywords
toothbrush, child, children, cavities
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.
Interventions
DEVICEPowered toothbrush
Powered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch
Sponsors
University of Michigan
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician will remain blinded during analyses.
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of new caries surfaces and number of progressed caries surfaces | 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of new caries surfaces | 12 Months | 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. |
| Number of new caries surfaces and number of progressed caries surfaces | 6 Months | 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. |
Countries
United States
Contacts
CONTACTTaylor Cezon, RDH
Outcome results
None listed