Stannous Fluoride Toothpaste for Gum Disease

Overseen By Haleon Response Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HALEON

Must not be taking: Antibiotics, Anti-bacterial, Anti-inflammatories, others

Disqualifiers: Cardiovascular diseases, Diabetes, Liver disorders, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test an experimental toothpaste containing 0.454% Stannous Fluoride to determine if it improves gum health and reduces plaque more effectively than regular fluoride toothpaste. Participants will use one of the two toothpastes twice daily for 12 weeks. The trial seeks individuals with localized gingivitis, characterized by gum inflammation from plaque, who have shown 10-30% bleeding sites during a gum health assessment. As an unphased trial, this study offers participants the chance to contribute to significant research on dental health.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take antibiotics within 28 days before the study or any anti-bacterial oral care products within 2 weeks of screening. Additionally, if you are on medications like anti-inflammatories or anticoagulants that could affect your gums or plaque, you might need to stop them as well.

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

Research has shown that stannous fluoride toothpaste, like the one being tested, is usually well-tolerated. In past studies, people using toothpaste with 0.454% stannous fluoride reported no major safety issues. These studies found no serious side effects, indicating that the toothpaste is safe for most people.

One study showed better gum health after just two weeks of use. Another study over six months found that this toothpaste significantly reduced gum inflammation. These findings suggest that the toothpaste is safe to use and can improve oral health without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the test toothpaste for gum disease because it features stannous fluoride, an active ingredient known for its antibacterial properties. Unlike typical fluoride toothpastes that mainly focus on preventing cavities, stannous fluoride actively targets bacteria responsible for gum disease, potentially reducing inflammation and bleeding more effectively. This makes the test toothpaste a promising option for those looking for a dual-action product that not only protects against cavities but also actively combats gum disease.

What evidence suggests that this toothpaste is effective for gum disease?

Research shows that toothpaste with 0.454% stannous fluoride can improve gum health. Studies have found that using this toothpaste reduces plaque and gum inflammation (gingivitis) in as little as two weeks. One study noted significant improvements in gum health for people with localized gingivitis after three weeks of use. Another trial showed that it reduced gum inflammation more effectively than regular toothpaste. In this trial, participants will use either the test toothpaste containing stannous fluoride or a reference toothpaste to evaluate their effectiveness in managing gum disease and improving oral health. These findings suggest that stannous fluoride toothpaste can effectively manage gum disease and improve oral health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with plaque-induced gingivitis. Participants should have a certain level of gum inflammation and plaque buildup but otherwise maintain good oral hygiene. Specific details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

My oral health is good.

Participant has provided a signed and dated informed consent document

My gender or biological sex does not exclude me from participating.

Exclusion Criteria

Participant has a history of substance abuse or severe oral conditions

Participant has certain dental conditions

Participant is an employee of the investigational site or their immediate family

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants brush their teeth with either the test or reference toothpaste twice daily for 12 weeks

12 weeks

Regular visits for assessment at Baseline, Week 6, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Test Toothpaste

Trial Overview The study compares an experimental toothpaste containing Stannous Fluoride to a regular fluoride toothpaste (Colgate Cavity Protection). The goal is to see if the experimental toothpaste better improves gum health and reduces plaque.

How Is the Trial Designed?

Group I: Test Toothpaste Experimental Treatment 1 Intervention

Participants will brush their teeth with full ribbon of test toothpaste applied on head of toothbrush provided for one timed minute twice a day (morning and evening) for 12 weeks.

Group II: Reference Toothpaste Active Control 1 Intervention

Participants will brush their teeth with full ribbon of reference toothpaste applied on head of toothbrush provided for one timed minute twice a day (morning and evening) for 12 weeks.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+

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 results of this clinical trial showed statistically significantly improved clinical outcomes for reduction of gingival inflammation and improvement in ...

4. 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 ...

5. haleonhealthpartner.com haleonhealthpartner.com/en-us/news-events/news/parodontax-stannous-clinical-study/

parodontax Clinical Study - Gum Disease Clinically proven to improve gum health outcomes from 3 weeks in patients with localized gingivitis without professional cleaning, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8436562/

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.

7. dentalcare.com dentalcare.com/en-us/stannous-fluoride

Crest Stannous Fluoride Toothpaste Formula Overview There is no relative degree of safety between 0 and 250, so a dentifrice with an RDA of 200 is as safe as one with a RDA of 50. Clinical evidence actually ...

8. withpower.com withpower.com/trial/phase-4-gingivitis-7-2025-61fc3

Stannous Fluoride Toothpaste for Gum Disease The primary objective of this study is to evaluate the effect of two 0.454% stannous fluoride dentifrices on gingivitis relative to a negative control ...