Stannous Fluoride Toothpaste for Gum Disease

(ILIMSIR Trial)

RA
Overseen ByRoger Arce, DDS, MS, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special toothpaste with stannous fluoride affects gum health and oral bacteria. Researchers aim to compare it to regular fluoride toothpaste, focusing on reducing gum inflammation and altering the oral microbiome. Ideal participants have at least 20 natural teeth and have not undergone a deep dental cleaning in the past three months. Those with serious gum issues or using certain medications are not eligible. The study seeks to enhance understanding of oral hygiene and may lead to improved toothpaste options for gum health. As a Phase 4 trial, this research involves an FDA-approved toothpaste, concentrating on its potential benefits for more patients.

What is the safety track record for Stannous Fluoride Toothpaste?

Research has shown that stannous fluoride toothpaste is safe for use. Studies have found that it helps prevent gum disease and cavities, and it reduces plaque and gum inflammation with regular use. These studies have reported no serious side effects, indicating that it is generally well-tolerated. This toothpaste performs as expected without causing harm, offering reassurance to those considering joining a clinical trial.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard fluoride toothpastes that are commonly used for gum disease, stannous fluoride toothpaste stands out because it combines the benefits of fluoride with the unique properties of stannous ions. These stannous ions not only help in preventing cavities but also possess antibacterial properties that target the bacteria responsible for gum disease. Researchers are excited about this treatment because it offers a dual-action approach—protecting teeth while actively fighting gum disease—potentially leading to healthier gums and stronger teeth.

What is the effectiveness track record for Stannous Fluoride Toothpaste in treating gum disease?

Research has shown that stannous fluoride toothpaste, which participants in this trial may use, helps reduce gum disease. Studies have found it reduces plaque, a sticky layer that can cause gum swelling. One study demonstrated that using this toothpaste can reduce bleeding gums by up to 95%. Another study revealed benefits within two weeks of use. Overall, stannous fluoride toothpaste has proven effective in improving gum health and delaying gingivitis.16789

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 65 years old.
I am in good overall health.
Availability for the duration of the study
See 3 more

Exclusion Criteria

I have gum disease with deep pockets, pus, loose teeth, or major bone loss.
I have used antibiotics or medicated mouthwash for an extended period in the past 3 months.
Current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Pre-30 days
1 visit (in-person)

Gingivitis Induction

Participants undergo gingivitis induction using a customized stent to prevent oral hygiene

14 days
Visits on Day 0, Day 3, Day 7, Day 14

Gingivitis Resolution

Participants resume oral hygiene to resolve gingivitis

14 days
Visits on Day 21, Day 28

Follow-up

Participants are monitored for changes in inflammation and oral microbiome

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Stannous Fluoride Toothpaste

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: ControlActive Control1 Intervention
Group II: TestActive Control1 Intervention

Find a Clinic Near You

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

The University of Texas Health Science Center, Houston

Collaborator

Trials
974
Recruited
361,000+

Citations

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

The results show that clinically beneficial reductions in plaque levels could be observed from two weeks of using stannous fluoride toothpaste, ...

Which toothpaste is best for gum disease prevention ...

The antimicrobial effect of stannous fluoride is effective at delaying the onset of gingivitis, but unfortunately it will happen eventually, ...

Stannous Fluoride Toothpaste for Gum Disease

This trial tests the effectiveness of two kinds of toothpaste with stannous fluoride against gum disease compared to regular toothpaste.

Does Stannous Fluoride Prevent Gum Disease?

Stannous fluoride is a form found to have notably superior antibacterial properties, better inhibiting plaque development and the gum inflammation that causes ...

Effectiveness of stannous fluoride in treating gingivitis

Moreover, the utilize of stabilized SnF2 toothpaste was found to have a useful effect on diminishing dental calculus, plaque, 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 ...

A randomised clinical study investigating efficacy of a ... - PMC

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

A Study to Evaluate the Efficacy of a Stannous Fluoride ...

This study will also explore whether a CPC mouthwash used with a SnF2 toothpaste could provide benefits in plaque accumulation reduction and gingival health ...

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

Dentifrices containing high bioavailable levels of stannous fluoride (SnF2) have proven effective for the treatment and prevention of gingivitis ...