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

135 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug for gum disease?

Research shows that stannous fluoride, a key ingredient in the treatment, is effective in reducing plaque and gingivitis (gum inflammation) due to its antimicrobial properties. Studies have demonstrated that it can kill a high percentage of bacteria in the mouth and reduce plaque regrowth, which helps improve oral health. ^{1 2 3 4 5}

Is fluoride dentifrice safe for humans?

Research on stannous fluoride dentifrice, used for gum disease, shows it is generally safe for humans, as it has been widely used in dentistry to prevent cavities and gum inflammation. ^{1 3 5 6 7}

How does the drug 0.454% Stannous Fluoride Dentifrice differ from other treatments for gum disease?

This drug is unique because it combines stannous fluoride, known for its antimicrobial properties, with sodium hexametaphosphate, which helps in whitening teeth and controlling calculus (tartar). This combination not only fights cavities and gum disease but also offers cosmetic benefits like stain removal, making it a multi-benefit option for oral health. ^{1 2 3 4 8}

What is the purpose of this trial?

This exploratory study will consist of two parts: Phase 1 (sample collection/screening) and Phase 2 (sample collection/product efficacy testing). The purpose of Phase 1 is to understand the association of gingivitis to systemic biomarkers and to screen subjects for Phase 2. The purpose of Phase 2 is to assess the causal effect of oral hygiene intervention on gingivitis and systemic biomarkers.

Research Team

Salus Research

Principal Investigator

Salus Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

The scientific rationale and development of an optimized stannous fluoride dentifrice, Part 1. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Sustained antibacterial actions of a new stabilized stannous fluoride dentifrice containing sodium hexametaphosphate. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a stabilized stannous fluoride dentifrice on clinical, immunomodulatory, and microbial outcomes in a human experimental gingivitis model. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months. [2020]

7. United States 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. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Stannous fluoride dentifrice with sodium hexametaphosphate: review of laboratory, clinical and practice-based data. [2016]