Electronic Toothbrushes for Dental Health

Overseen By Danna R Paulson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Phenytoin, Calcium antagonists, Cyclosporin, others

Disqualifiers: Uncontrolled diabetes, HIV, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new full-mouth electronic toothbrush (FMET) in maintaining dental health. It compares three groups: one using the FMET with regular toothpaste, another using a conventional electronic toothbrush with regular toothpaste, and a third using the FMET with a special foam. The goal is to determine which method best reduces gum inflammation (gingivitis), plaque, and improves overall dental comfort. Suitable candidates for this trial are patients at the University of Minnesota School of Dentistry who have mild to moderate gum disease, at least five natural teeth in each part of their mouth, and are willing to avoid other dental cleaning tools during the study. As an unphased trial, this study allows participants to contribute to innovative dental research and potentially improve their own dental health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medications that affect periodontal conditions, like phenytoin or steroids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that powered toothbrushes, including full-mouth electronic toothbrushes (FMET), are generally safe and effective for dental care. Studies have found that electric toothbrushes remove more plaque and reduce gum inflammation better than manual ones. Safety checks confirm that the bristles are not sharp, ensuring safe use.

Although specific data on FMET is limited, electric toothbrushes overall have a strong record of safety and ease of use. For those considering joining a trial for the FMET, existing evidence suggests it is likely safe based on the performance of similar devices. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores new ways to enhance dental health using electronic toothbrushes. The trial compares different combinations, including a full-mouth electronic toothbrush (FMET) used with ADA-approved toothpaste or foam, to conventional electronic toothbrushes. This approach may offer more effective plaque removal and gingivitis reduction by targeting multiple areas of the mouth simultaneously. If successful, these combinations could improve oral hygiene routines and enhance patient perceptions of using electronic toothbrushes for better dental care.

What evidence suggests that this trial's treatments could be effective for dental health?

Studies have shown that powered toothbrushes, such as the full-mouth electronic toothbrush (FMET), generally reduce dental plaque and gum disease more effectively than manual ones. Research indicates that the circular motion of the FMET brush improves gum health and removes plaque better than manual and some other electric toothbrushes. In this trial, participants will use either the FMET with ADA dentifrice, the FMET with foam, or a conventional electronic toothbrush with ADA dentifrice. Previous studies suggest that FMET might promote oral health more effectively than traditional manual or even some other electric toothbrushes. ^{5 6 7 8 9}

Who Is on the Research Team?

Michelle C Arnett, MS

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are patients at the University of Minnesota School of Dentistry, have a certain amount of dental plaque and gingivitis, and enough natural teeth. Participants must not receive other oral hygiene care or use additional cleaning aids during the study.

Inclusion Criteria

I have at least 5 natural teeth in each quadrant, not counting wisdom teeth, implants, or heavily restored teeth.

Access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team

A minimum of 25% plaque measured O'Leary plaque score

Exclusion Criteria

I have a severe or uncontrolled gum disease.

I need help with daily oral hygiene due to physical limitations.

Unable to comply with the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measures are collected to evaluate clinical indicators of gingivitis, plaque, and patient perceptions

1 day

1 visit (in-person)

Treatment

Participants use assigned toothbrush and dentifrice for 30 days

4 weeks

Daily use at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Full-mouth Electronic Toothbrush

Trial Overview

The study compares three methods: a full-mouth electronic toothbrush (FMET) with standard toothpaste, a conventional electronic toothbrush (ETB) with the same toothpaste, and FMET with a foam system to see which is better for oral health.

How Is the Trial Designed?

Group I: FMET + Foam Experimental Treatment 1 Intervention

Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + foam on clinical indicators of gingivitis, plaque, and patient perceptions.

Group II: FMET + ADA dentifrice Experimental Treatment 1 Intervention

Baseline and 30-day outcome measures will be collected to evaluate the impact of FMET + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.

Group III: Conventional electronic toothbrush + ADA dentifrice Active Control 1 Intervention

Baseline and 30-day outcome measures will be collected to evaluate the impact of conventional electronic toothbrush + ADA dentifrice on clinical indicators of gingivitis, plaque, and patient perceptions.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

FENO.Co

Collaborator

Trials

1

Recruited

110+

Published Research Related to This Trial

In a 12-week study involving 100 adults with gingivitis and plaque, the oscillating-rotating (O-R) electric toothbrush significantly improved gingival health, with 86% of users achieving a 'healthy' status compared to only 20% of manual toothbrush users.

The O-R toothbrush also led to a greater reduction in bleeding sites and plaque across all regions, demonstrating its superior efficacy in improving oral health compared to a manual toothbrush.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gingival health effects with an oscillating-rotating electric toothbrush with micro-vibrations and a novel brush head designed for stain control: Results from a 12-week randomized controlled trial. Grender, J., Goyal, CR., Qaqish, J., et al.[2022]

In a study of 110 adults with gingivitis, the novel oscillating-rotating electric toothbrush (Oral-B iO) significantly reduced gingivitis and plaque compared to a manual toothbrush, with benefits observed as early as one week and continuing through the eight-week trial.

After eight weeks, 82% of participants using the O-R toothbrush were classified as 'healthy' (less than 10% bleeding sites), compared to only 24% of those using the manual brush, highlighting the O-R toothbrush's superior efficacy in improving gum health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An 8-week randomized controlled trial comparing the effect of a novel oscillating-rotating toothbrush versus a manual toothbrush on plaque and gingivitis. Grender, J., Ram Goyal, C., Qaqish, J., et al.[2022]

The use of the Oral-B PC 5000 electric toothbrush with oscillating-rotating technology significantly improved oral hygiene in 93.5% of patients over a 12-week period, as assessed by 21,088 participants.

Regular use of this electric toothbrush also led to a 92.5% reduction in plaque and improved gingival health in 87.1% of participants, demonstrating its efficacy in enhancing dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of the efficacy and safety of electric toothbrushes Oral-B with oscillating-rotating technology in «Healthy smile» program]. Nikolaev, AI., Ginali, NV., Tsepov, LM., et al.[2019]

In a 3-month study involving 110 healthy participants, the Braun Oral-B D17 power toothbrush demonstrated greater efficacy in reducing plaque and gingivitis compared to a manual toothbrush, with significant improvements observed at both 1 and 3 months.

The D17 toothbrush was found to be safe, with no product-related adverse effects reported and no clinically significant tissue abrasion noted, indicating it is a reliable option for oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy and acceptability of a new power toothbrush: a 3-month comparative clinical investigation. Warren, PR., Cugini, M., Marks, P., et al.[2006]

In a study involving 140 participants over four weeks, the Crest SpinBrush Pro powered toothbrush was found to be at least as safe as two leading manual toothbrushes, with no significant differences in adverse events reported among the groups.

The most common adverse event was mild localized irritation of the gums, with only one severe case of tooth sensitivity, indicating that while some irritation occurred, it was generally mild and manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study to assess the safety and tolerability of three toothbrushes. Papas, AS., Martuscelli, G., Singh, ML., et al.[2006]

In a study involving 150 participants over five weeks, the oscillating-rotating (O-R) electric toothbrush significantly reduced plaque and gingivitis more effectively than a manual toothbrush, with a 52.2% reduction in bleeding sites compared to 23.6% for the manual brush.

Both toothbrushes improved oral health, but the O-R brush showed statistically significant greater reductions in plaque and gingivitis measures, indicating its superior efficacy in maintaining dental hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 5-week randomized clinical evaluation of a novel electric toothbrush head with regular and tapered bristles versus a manual toothbrush for reduction of gingivitis and plaque. Ccahuana-Vasquez, RA., Adam, R., Conde, E., et al.[2020]

In a study involving 35 healthy participants, the Braun Oral-B 3D Plaque Remover electric toothbrush significantly reduced gingivitis and bleeding on probing compared to a manual toothbrush after 4 weeks of use.

The electric toothbrush also demonstrated superior plaque removal effectiveness, and participants preferred it over the manual toothbrush, indicating it may encourage longer brushing sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the efficacy of a novel electric toothbrush and a manual toothbrush in the treatment of gingivitis. van der Weijden, FA., Timmerman, MF., Piscaer, M., et al.[2006]

In a 3-month study involving 114 participants, the Braun Oral-B 3D electric toothbrush significantly outperformed a standard manual toothbrush in reducing plaque and gingivitis, with reductions of 15% and 16% respectively, compared to 8% and 12% for the manual toothbrush.

Both toothbrushes were safe to use, showing no clinically significant tissue abrasion, but the 3D electric toothbrush demonstrated greater efficacy in plaque reduction across all evaluated time points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 3-month clinical investigation comparing the safety and efficacy of a novel electric toothbrush (Braun Oral-B 3D Plaque Remover) with a manual toothbrush. Cronin, M., Dembling, W., Warren, PR., et al.[2006]

In a study of 104 participants over 4 weeks, all three toothbrushes (Crest Spin Brush, Colgate ActiBrush, and Oral B 40) were found to be generally safe, with only mild adverse events reported, primarily localized gingivitis.

The Crest Spin Brush and Colgate ActiBrush were better tolerated than the Oral B 40, suggesting that electric toothbrushes can be as safe as manual ones for daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of three toothbrushes. He, T., Carpinello, L., Baker, R., et al.[2007]

A study involving 104 young adults (ages 19 to 25) found that the novel isosceles-configured SUN Teeth™ toothbrush effectively reduced plaque levels, similar to a standard ADA-approved toothbrush over a 28-day period.

Both toothbrushes showed significant plaque reduction after brushing, but there were no significant differences in effectiveness between the SUN Teeth™ toothbrush and the standard toothbrush at any time point.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the isosceles-configured SUN TeethTMtoothbrush in dental plaque removal and gingival health. Hari, P., Dutta, S., Hanapi, NSBM., et al.[2022]

The new sonic powered toothbrush demonstrated significant reductions in supragingival plaque and gingivitis severity after just one use and continued effectiveness over 12 weeks, outperforming a manual toothbrush.

After four and 12 weeks, the sonic toothbrush showed up to 90 times greater reductions in plaque and significant improvements in gingival health compared to the manual toothbrush, indicating its superior efficacy in maintaining oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush. Nathoo, S., Mankodi, S., Mateo, LR., et al.[2013]

In a study comparing an oscillating/rotating power toothbrush (Oral-B Precision Clean) to a manual toothbrush, the power toothbrush demonstrated significantly greater plaque removal, achieving 28.8% reduction for the whole mouth, 44.3% along the gingival margin, and 20.7% on approximal surfaces.

Both toothbrushes were effective in reducing plaque, but the power toothbrush outperformed the manual toothbrush with statistically significant results (p < 0.001), indicating its superior efficacy in maintaining oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The plaque removal efficacy of a novel power brush head. Sharma, NC., Qaqish, J., Klukowska, M., et al.[2015]

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