Fluoride Dentifrice for Gum Disease

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Procter and Gamble

Must not be taking: NSAIDs, Anti-inflammatories, Statins, others

Disqualifiers: Severe periodontal disease, Smoking, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different fluoride toothpaste formulas can improve gum health and affect overall health markers in the body. Participants will use either a toothpaste with stannous fluoride (0.454% Stannous Fluoride Dentifrice) or sodium monofluorophosphate (0.76% Sodium Monofluorophosphate Dentifrice) to determine which is more effective in treating gingivitis, a form of gum disease that causes redness and swelling. Individuals with persistent gum bleeding issues but no severe gum disease might be suitable for this study. Participants must follow specific dental care instructions and attend study visits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does restrict the use of certain medications like NSAIDs, anti-inflammatory drugs, and cholesterol-lowering supplements during the study. It's best to discuss your specific medications with the study team.

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

Research has shown that using stannous fluoride at a 0.454% concentration in toothpaste is generally safe. This ingredient appears in many dental products to help with sensitive teeth, protect enamel, and prevent gum disease. Studies have found it effective in reducing gum inflammation and plaque.

Most people tolerate stannous fluoride well, and it has been in toothpaste for a long time without serious side effects. Some might notice a temporary change in taste or slight tooth staining, but these effects are not harmful.

Sodium monofluorophosphate, used at a 0.76% concentration, is also common in toothpaste to prevent cavities and is considered safe. It has been used in dental care products for a long time without significant safety concerns for most users. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard toothpaste options for gum disease, which typically contain sodium monofluorophosphate, the treatment being studied uses stannous fluoride. Stannous fluoride is unique because it not only helps prevent cavities but also has antibacterial properties that can reduce gum inflammation and bleeding. Researchers are excited about this treatment because it targets both tooth and gum health simultaneously, offering a more comprehensive approach to managing gum disease.

What evidence suggests that this trial's treatments could be effective for gum disease?

Research has shown that toothpaste containing 0.454% stannous fluoride, which participants in this trial may receive, can reduce gum bleeding and gum disease. After 24 weeks of using this toothpaste, individuals experienced less gum bleeding compared to those using regular toothpaste. This trial will compare the effectiveness of 0.454% stannous fluoride toothpaste with 0.76% sodium monofluorophosphate toothpaste. The stannous fluoride toothpaste also reduces plaque, a sticky layer of bacteria that can lead to gum problems. Overall, stannous fluoride toothpaste proves more effective at controlling gum disease than standard toothpastes. ^{2 4 6 7 8}

Who Is on the Research Team?

Salus Research

Principal Investigator

Salus Research

Are You a Good Fit for This Trial?

This trial is for individuals with gum disease, specifically gingivitis. Participants will be screened based on their oral health and systemic biomarkers to see if they qualify for the second phase, which tests the effectiveness of two toothpaste types.

Inclusion Criteria

Agree to fast 12 hours prior to any visit with a blood collection

Provide informed consent and receive a signed copy of the informed consent form

Agree to not perform any oral hygiene for at least 12 hours prior to any visit with dental exams, saliva collection, and plaque collections

Exclusion Criteria

Smoking or vaping (regardless of content), use of smokeless tobacco, e-cigarettes, or nicotine patches

Having any of the following: fixed orthodontic appliances or attachments for aligner treatment, lower bonded retainers; removable partial dentures, peri/oral piercings, a pacemaker or other implanted device, unless deemed acceptable by the Investigator/Designee

Currently using recreational drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection/Product Efficacy Testing

Participants undergo sample collection and product efficacy testing to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 0.454% Stannous Fluoride Dentifrice
• 0.76% Sodium Monofluorophosphate Dentifrice

Trial Overview

The study is testing two kinds of toothpaste: one with 0.76% Sodium Monofluorophosphate and another with 0.454% Stannous Fluoride. It aims to determine how these products affect gingivitis and related systemic biomarkers over two phases.

How Is the Trial Designed?

Group I: Negative Control Active Control 1 Intervention

0.76% sodium monofluorophosphate

Group II: Test 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

Published Research Related to This Trial

A 2-year study involving 440 xerostomic adults found that a stannous fluoride (SnF2) dentifrice was as effective as a triclosan dentifrice in preventing clinical attachment loss (CAL) and promoting root caries remineralization.

Both dentifrices resulted in significant improvements in attachment levels and probing depth, with no statistically significant differences between the two treatments, indicating that SnF2 is a viable alternative for patients at high risk for periodontal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the prevention of periodontitis in xerostomic patients: a 2-year randomized clinical trial. Papas, A., He, T., Martuscelli, G., et al.[2015]

In a 6-month study involving 143 participants, a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice significantly reduced gingivitis by 21.7%, gingival bleeding by 57.1%, and plaque by 6.9% compared to a negative control dentifrice.

The study found no adverse effects on oral tissues or tooth staining, indicating that the dentifrice is safe for use in preventing gingivitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice. Mankodi, S., Bartizek, RD., Winston, JL., et al.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7098169/

Gingivitis efficacy of a 0.454% w/w stannous fluoride ...

After a dental prophylaxis and 24 weeks treatment a statistically significantly reduction in whole mouth gingival bleeding (BI) was observed for the 0.454% SnF2 ...

2.

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 ...

3.

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

A new dentifrice – or toothpaste – containing 0.454% stannous fluoride and 2.6% EDTA as an anti-tartar agent to reduce plaque index and gingival index.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32216778/

Gingivitis efficacy of a 0.454% w/w stannous fluoride ...

Conclusion: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra- ...

5.

aap.onlinelibrary.wiley.com

aap.onlinelibrary.wiley.com/doi/10.1002/JPER.22-0675

A randomized double‐blind clinical trial evaluating ...

A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with ...

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.

dentalcare.com

dentalcare.com/en-us/stannous-fluoride/oral-health/anti-gingivitis-activity

Stannous Fluoride Toothpaste Benefit: Anti Gingivitis

Over a 6-month period a 0.454% stabilized stannous fluoride (Crest® PRO-HEALTH™) dentifrice showed a statistically significant and clinically relevant effect on ...

8.

assets.ctfassets.net

assets.ctfassets.net/u2qv1tdtdbbu/UpcqJMzLhEaG3g1jMOk3s/458a94c2f9c813754a2147274aaa2545/Advanced_stabilized_stannous_flouride_dentifrice_technology.pdf

STABILIZED STANNOUS FLUORIDE DENTIFRICE

To compare a stabilized 0.454% stannous fluoride dentifrice to a 0.3% triclosan/sodium fluoride dentifrice for anti-plaque efficacy. This was a 6-week, ...