Stannous Fluoride Toothpaste for Gum Disease

Not currently recruiting at 1 trial location

Overseen By Clinical Scientist

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Procter and Gamble

Must not be taking: Antibiotics, Anti-inflammatories, Anti-coagulants

Disqualifiers: Advanced periodontal disease, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of two kinds of toothpaste with stannous fluoride against gum disease compared to regular toothpaste. The goal is to determine if these special toothpastes can reduce gingivitis symptoms (gum inflammation) after 12 weeks of use. Individuals with mild to moderate gum disease and noticeable bleeding when brushing might be suitable for this study. Participants must use only the study's toothpaste and avoid other dental products during the trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain medications like antibiotics, anti-inflammatories, or anti-coagulants within 4 weeks before starting the study.

What is the safety track record for the stannous fluoride dentifrices?

Studies have shown that stannous fluoride toothpaste is safe for use. This toothpaste helps prevent gum disease and cavities. Research indicates it can reduce gum swelling and combat bacteria that cause plaque. Stannous fluoride works by killing bacteria and inhibiting their growth.

The toothpaste in this trial contains 0.454% stannous fluoride. This concentration has been studied and found effective in controlling gum disease and bleeding. No major safety issues have emerged in these studies, so it is considered safe for daily use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the stannous fluoride toothpaste for gum disease because it uses 0.454% stannous fluoride, which is known for its antimicrobial properties. Unlike standard toothpastes that often use sodium monofluorophosphate as the active ingredient, stannous fluoride not only helps prevent cavities but also targets bacteria that cause gum disease. This dual action could offer a more comprehensive approach to oral health, potentially reducing gum inflammation and improving overall gum health more effectively than current options.

What is the effectiveness track record for stannous fluoride toothpaste in treating gum disease?

This trial will compare different toothpaste formulations for their effectiveness in reducing gum disease. Research has shown that stannous fluoride toothpaste, which participants in this trial may receive, helps reduce gum disease. Specifically, studies have found that using toothpaste with 0.454% stannous fluoride can decrease plaque and gum inflammation after just two weeks. Over six months, participants have demonstrated noticeable improvements in gum health and a reduction in harmful substances in the mouth. This toothpaste can also help reverse gum inflammation and reduce bleeding gums. Overall, stannous fluoride toothpaste is a strong tool for fighting gingivitis and improving oral health. ^{4 6 7 8 9}

Who Is on the Research Team?

Nachnani

Principal Investigator

University Health Resources Group, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with gum disease or dental conditions who want to test the effectiveness of different toothpastes. Participants should be willing to use one of the study toothpastes regularly and attend follow-up visits.

Inclusion Criteria

Agree to return for scheduled visits and follow the study procedures

Agree to refrain from any oral hygiene for 12 hours prior to their next visit

I am 18 years old or older.

Exclusion Criteria

Have a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics

Have fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers, removable partial dentures

I had oral or gum surgery in the last two months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the assigned dentifrice for 12 weeks to evaluate anti-gingivitis efficacy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Test Stannous Fluoride Dentifrice

Trial Overview

The trial is testing two types of stannous fluoride dentifrices against a regular sodium monofluorophosphate toothpaste (Colgate® Cavity Protection) to see which is better at reducing gingivitis after 12 weeks.

How Is the Trial Designed?

Group I: Negative Control Active Control 1 Intervention

0.76% Sodium Monofluorophosphate

Group II: Test Product Active Control 1 Intervention

0.454% stannous fluoride

Group III: Positive Control Active Control 1 Intervention

0.454% stannous fluoride

Who Is Running the Clinical Trial?

Procter and Gamble

Lead Sponsor

Trials

150

Recruited

77,000+

Marc Pritchard

Procter and Gamble

Chief Marketing Officer since 2008

B.S. in Finance from Indiana University, Bloomington

Jon R. Moeller

Procter and Gamble

Chief Executive Officer since 2021

MBA from Cornell University, B.S. in Biology from Cornell University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02750943

Potential of Stannous Fluoride Toothpaste to Reduce Gum ...

This study will evaluate the efficacy of a dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to control gingivitis and gingival bleeding ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34511098/

A randomised clinical study investigating efficacy of a ...

These results indicate that plaque and gingivitis-reducing benefits of 0.454% w/w stannous fluoride may be seen from 2 weeks' use.

3.

compendiumlive.com

compendiumlive.com/2024/active-prevention/a-6-month-randomized-controlled-trial-to-measure-the-efficacy-of-a-stannous-fluoride-toothpaste-stabilized-with-nitrate-and-phosphates-snap-on-dental-plaque-and-gingivitis/

A 6-Month Randomized Controlled Trial to Measure the ...

The test SnF2 dentifrice showed statistically significant reductions in all plaque and gingivitis indices compared to baseline and to the ...

4.

bmcoralhealth.biomedcentral.com

bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-024-04785-7

Effects of stannous fluoride dentifrice on gingival health and ...

SnF 2 dentifrice use reversed gingival inflammation, suppressed endotoxins and reduced some harmful oxidant products in saliva and gingiva.

5.

perio.org

perio.org/press-release/new-clinical-study-suggests-effectiveness-of-new-toothpaste-in-combating-gingivitis-and-plaque-two-precursors-of-periodontitis/

Two Precursors of Periodontitis

The results of this clinical study demonstrate that “use of the innovative gel dentifrice with 0.454% stannous fluoride resulted in clinically ...

6.

go.drugbank.com

go.drugbank.com/drugs/DB11092

Stannous fluoride: Uses, Interactions, Mechanism of Action

Stannous fluoride is a medication used to treat dental hypersensitivity, produce enamel, prevent gingivitis and cavities, and prevent periodontal infections.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11942899/

Stannous Fluoride in Toothpastes: A Review of Its Clinical ...

The results show that the stannous fluoride toothpaste led to a clinical reduction in gingival inflammation, a reduction in microbiome ...

8.

colgate.com

colgate.com/en-us/oral-health/fluoride/what-is-stannous-fluoride-toothpaste

What Is Stannous Fluoride Toothpaste?

Does stannous fluoride prevent gum disease? Yes, stannous fluoride helps fight harmful bacteria and reduce plaque buildup which are the major causes of ...

9.

dentalcare.com

dentalcare.com/en-us/stannous-fluoride

Crest Stannous Fluoride Toothpaste Formula Overview

Stannous fluoride has both bactericidal and bacteriostatic properties, which fight plaque and treat/prevent gingivitis. 5,6 The stannous fluoride also deposits ...