Stannous Fluoride Regimen for Dental Plaque

Overseen By Dr. John Gallob, DMD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Colgate Palmolive

Must not be taking: Anticonvulsants, Sedatives, Antibiotics, others

Disqualifiers: Orthodontic appliances, Advanced periodontal disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special dental care routine can reduce dental plaque and gum inflammation (gingivitis). The routine includes a stannous fluoride toothpaste, a mouthwash with Cetylpyridinium Chloride, and a battery-powered toothbrush. Participants will follow this routine or a similar one with slight variations, such as the duration of mouthwash use or using a manual toothbrush. Ideal candidates for this trial have at least 20 natural teeth and noticeable gum inflammation and plaque buildup. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking dental care advancement.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. The trial excludes people who have used anticonvulsants, sedatives, tranquilizers, anti-inflammatory drugs, daily pain relievers, or antibiotics within one month before the study or plan to use them during the study. It also excludes those using medications that affect gum tissues or any prescription medicines that might interfere with the study.

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

Previous studies have shown that using stannous fluoride toothpaste, cetylpyridinium chloride mouthwash, and a battery-powered toothbrush is safe for people. Research indicates that users tolerate this combination well, with no significant negative effects reported. This suggests that these products are generally safe when used as directed.

Stannous fluoride toothpaste, commonly found in other dental products, helps protect against cavities and plaque. Cetylpyridinium chloride mouthwash is also safely used in dental care to reduce oral bacteria. Both products are considered safe when used according to instructions.

Overall, current evidence supports the safety of this regimen, which should not cause major side effects. Always follow the provided instructions to ensure safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Stannous Fluoride Regimen for Dental Plaque because it combines a unique trio of ingredients and tools. This regimen uses stannous fluoride toothpaste, which not only strengthens teeth but also has antibacterial properties to fight plaque. The addition of cetylpyridinium chloride mouthwash further boosts antibacterial action. Additionally, the option of a battery toothbrush in some treatment arms may offer more efficient cleaning compared to a manual toothbrush. Together, these features could potentially offer a more comprehensive approach to oral health than current options.

What evidence suggests that this trial's treatments could be effective for reducing dental plaque and gingivitis?

This trial will evaluate the effectiveness of different regimens involving stannous fluoride toothpaste, cetylpyridinium chloride mouthwash, and various toothbrush types. Research has shown that combining stannous fluoride toothpaste, cetylpyridinium chloride mouthwash, and a battery-powered toothbrush can significantly reduce dental plaque and gum inflammation. Studies have found that stannous fluoride strengthens teeth and reduces plaque. Cetylpyridinium chloride in mouthwash kills the bacteria responsible for plaque and gum disease. In past studies, participants using a battery-powered toothbrush with this routine achieved better plaque reduction than those using a manual toothbrush. Overall, this combination appears promising for improving oral health. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with good general health and at least 20 natural teeth, who have signs of gum inflammation and dental plaque. They must be able to commit to a twelve-week study period.

Inclusion Criteria

Signed Informed Consent Form

Availability for the twelve-week duration of the clinical research study

Good general health based on the opinion of the study investigator

Exclusion Criteria

I have had a dental check-up in the last 3 weeks.

I have a chronic disease or tumor in my mouth.

I have severe gum disease with symptoms like loose teeth and gum damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and either a battery or manual toothbrush regimen

12 weeks

Baseline, 6-week, and 12-week visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen

Trial Overview

The trial tests the effectiveness of a stannous fluoride toothpaste, Cetylpyridinium Chloride mouthwash, and battery toothbrush regimen in reducing dental plaque and gingivitis compared to other fluoride-based products.

How Is the Trial Designed?

Group I: Test 2 Experimental Treatment 2 Interventions

instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided

Group II: Test 1 Experimental Treatment 2 Interventions

instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and battery toothbrush provided instructed to 2x day / Swish 20mL for 30 secs with mouthwash provided

Group III: Test 3 Active Control 2 Interventions

instructed to brush w/ full ribbon, 2x day / 2mins with toothpaste and manual toothbrush provided instructed to 2x day / Swish 10mL for 1min with mouthwash provided

Who Is Running the Clinical Trial?

Colgate Palmolive

Lead Sponsor

Trials

106

Recruited

19,100+

Noel Wallace

Colgate Palmolive

Chief Executive Officer since 2019

MBA from Harvard Business School

Diana Haussling

Colgate Palmolive

Chief Marketing Officer since 2022

Bachelor's degree in Marketing

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07398846?term=John

Efficacy of a Stannous Fluoride Toothpaste, ...

A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1532338225000387

original article antiplaque and antigingivitis effects of a ...

This study assessed the overall health outcome of using multiple forms: a stabilized stannous fluoride toothpaste, an enhanced cetylpyridinium chloride ...

3.

ctv.veeva.com

ctv.veeva.com/study/efficacy-of-a-stannous-fluoride-toothpaste-cetylpyridinium-chloride-mouthwash-and-battery-toothbru

Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium ...

To evaluate the efficacy of a stannous fluoride toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40335199/

A RANDOMIZED CLINICAL TRIAL

This study assessed the overall health outcome of using multiple forms: a stabilized stannous fluoride toothpaste, an enhanced cetylpyridinium chloride ...

5.

withpower.com

withpower.com/trial/phase-3-plaque-amyloid-2026-85c5c

Stannous Fluoride Regimen for Dental Plaque

The trial tests the effectiveness of a stannous fluoride toothpaste, Cetylpyridinium Chloride mouthwash, and battery toothbrush regimen in ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07398846?term=NA

Efficacy of a Stannous Fluoride Toothpaste, ...

A 12-Week Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7559150/

Stannous Fluoride Effects on Enamel: A Systematic Review

Their human enamel samples showed a greater protection against dental erosion if SnF2 toothpaste was used instead of a sodium monofluorophosphate (SMFP)/ ...