Caries RiskNCT07859553
Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents
A study testing Powered toothbrush in people with Caries Risk and Caries, Dental, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Caries Risk, Caries, Dental
- What is being tested?
- Powered toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Margherita Fontana, DDS, PhD
About this study
Official title: Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents, A Pilot Study
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
- Being tested
- Powered toothbrush
- Keywords
- toothbrush, child, children, cavities
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered toothbrushDevice
Powered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush | No intervention | Not described |
| Powered Toothbrush | Experimental | Not described Receives: Device: Powered toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (3)
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.
Measured: 12 Months
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.
Measured: 6 Months
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries RiskStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, Margherita Fontana, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859553
- Sponsor's protocol ID
- HUM00295963
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Interested parties and contact the PI for potential collaboration
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents, A Pilot Study
- ClinicalTrials.gov ID
- NCT07859553
- Acronym / sponsor ID
- HUM00295963
- Conditions
- Caries Risk, Caries, Dental
- Keywords
- toothbrush, child, children, cavities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush | No intervention | – |
| Powered Toothbrush | Experimental | Device: Powered toothbrush |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Child:
- 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
Key exclusion criteria (9 listed)
- Child:
- Demonstrated inability to comply with trial protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered toothbrushPowered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch | Device | Powered Toothbrush |
Primary outcome
Number of new caries surfaces and number of progressed caries surfaces
Time frame: 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.
3 secondary outcomes
Number of new caries surfaces
Time frame: 12 Months
Number of new caries surfaces and number of progressed caries surfaces
Time frame: 6 Months
Number of new caries surfaces
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. Interested parties and contact the PI for potential collaboration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered toothbrush in people with Caries Risk and Caries, Dental, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Cezon, RDH (734-730-8533, kidscavities@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new caries surfaces and number of progressed caries surfaces (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.