Toothpaste for Gum Disease

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Procter and Gamble

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

Disqualifiers: Severe gingivitis, Advanced periodontal disease, 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 explores the effectiveness of new toothpaste formulas with hops extract in treating gum disease, specifically gingivitis. The study compares two experimental toothpastes with varying hops levels to regular toothpastes, including a common stannous fluoride one. It suits individuals with mild to moderate gum bleeding who have at least 20 teeth. Participants must agree to avoid other oral hygiene products during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antibiotics, anti-inflammatory drugs, anticoagulants, and medications that affect gum appearance or bleeding, at least one month before starting the study. If you regularly use anti-gingivitis treatments, you must also stop these at least one month prior to the trial.

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

Previous studies have shown that sodium fluoride toothpaste is safe for regular use in normal oral environments. It helps reduce dental problems, but excessive use, especially in children, can cause issues like teeth discoloration.

Sodium monofluorophosphate, found in many toothpastes, is also considered safe when used properly. It protects against cavities, and research suggests it can be used throughout life without major concerns.

Both ingredients are generally well-tolerated, making them safe choices for many people. It is important to follow usage instructions, such as not swallowing the toothpaste and rinsing the mouth after brushing. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for gum disease because they incorporate hops extract, which is not commonly used in dental care. Unlike standard toothpaste options that primarily rely on fluoride compounds like sodium fluoride or stannous fluoride, these new formulations combine sodium fluoride with hops extract, which is known for its anti-inflammatory properties. This could potentially enhance gum health by reducing inflammation while preventing cavities. The addition of hops extract may offer a dual-action approach, targeting both bacterial growth and inflammation, setting it apart from traditional fluoride-based treatments.

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

This trial will compare different toothpaste formulations for gum disease. Studies have shown that toothpaste with stannous fluoride (SnF2), included in the positive control arm of this trial, effectively reduces gum disease and plaque. It controls gum inflammation and plaque buildup better than regular toothpaste. Research suggests that sodium fluoride (NaF) toothpaste with hops extract, which participants in the experimental arms may receive, can also benefit gum health. Hops, a plant extract, may help reduce gum inflammation. Sodium monofluorophosphate (MFP) toothpaste, part of the negative control arm, helps reduce gum disease but might not be as effective as stannous fluoride in some cases. Overall, these toothpastes have shown promising results in improving gum health. ^{6 7 8 9 10}

Who Is on the Research Team?

All Sum Research

Principal Investigator

All Sum Research

Are You a Good Fit for This Trial?

This trial is for individuals with gingivitis or gum disease. Participants should be willing to use one of the three different toothpastes being tested over a period of 12 weeks. The specific eligibility criteria are not provided, but typically would include age range, general health status, and confirmation of gingivitis.

Inclusion Criteria

Agree to return for scheduled visits and follow the study procedures

Agree to refrain from any oral hygiene the morning of each visit

Provide written informed consent prior to participation and be given a signed copy of the informed consent form

Exclusion Criteria

Have a positive pregnancy test (Clearblue) at baseline or self-reported pregnancy during the study

Any diseases or condition that might interfere with the safe participation in the study according to the study investigator

I cannot undergo the procedures required in this study.

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 assess its effect on gingivitis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Fluoride Dentifrice
• Sodium monofluorophosphate dentifrice
• Stannous Fluoride Dentifrice

Trial Overview The study is testing the effectiveness of two experimental dentifrices containing hops extract against a positive control with Stannous Fluoride (SnF2) and a negative control without active ingredients for treating gingivitis over 12 weeks.

How Is the Trial Designed?

Group I: Experimental #2 Experimental Treatment 1 Intervention

0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]

Group II: Experimental #1 Experimental Treatment 1 Intervention

0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]

Group III: Positive Control Active Control 1 Intervention

0.454% stannous fluoride, 0.533% zinc citrate

Group IV: Negative Control Active Control 1 Intervention

0.76% Sodium Monofluorophosphate

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

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. 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.

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

Gingivitis efficacy of a 0.454% w/w stannous fluoride ... A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0300571225003306

A randomised, controlled, trial investigating the effect of ... A recent systematic review and meta-analysis [38] showed a significant improvement of gingival index, bleeding index, and plaque index in patients using 67 % ...

4. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-024-03981-9

Efficacy of an experimental toothpaste containing sodium ... Clinical studies have previously shown that the addition of sodium bicarbonate to a fluoride toothpaste, used twice daily, could reduce gingival ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8037529/

Recent Development of Active Ingredients in Mouthwashes ... Adding an SnF2 toothpaste to the daily oral care regimen has been shown to have multiple oral health benefits including reduction of dental ...

7. ada.org ada.org/resources/ada-library/oral-health-topics/toothpastes

Toothpastes All toothpastes with a claim of cavity protection with the ADA Seal of Acceptance must contain fluoride. In addition to fluoride, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1567576924013511

High concentrations of NaF aggravate periodontitis ... Recent studies have confirmed its safe use in normal oral environments. However, whether fluoride treatment affects the progression of ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/sodium-fluoride-oral-route-dental-route-oromucosal-route/description/drg-20066098

Sodium fluoride (oral route, dental route, oromucosal route) Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children. Geriatric.

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/idh.12904

The Complex World of Toothpaste Diversity, Meeting ... Nineteen toothpaste ingredients were identified to treat six oral conditions, including six types of fluoride. Evidence of efficacy of active ...