120 Participants Needed

Toothpaste for Gum Disease

CT
Overseen ByClinical Trial Manager
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

Trial Summary

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.

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

Research shows that toothpaste containing stannous fluoride can help reduce gingivitis (gum inflammation) and plaque, which are common issues in gum disease. Additionally, stannous fluoride has been found to protect teeth enamel from acid damage and improve oral health by affecting the oral microbiome (the community of bacteria in the mouth).12345

Is stannous fluoride dentifrice safe for humans?

Stannous fluoride dentifrice has been studied for its effects on gum health and is generally considered safe for human use, as it is commonly used in dental products to prevent cavities and gum disease.25678

How is this toothpaste treatment for gum disease different from other treatments?

This toothpaste is unique because it combines stannous fluoride, which fights bacteria and prevents cavities, with sodium hexametaphosphate, which helps whiten teeth and control tartar. This combination not only addresses gum disease but also offers cosmetic benefits like stain removal.2891011

What is the purpose of this trial?

The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.

Research Team

AS

All Sum Research

Principal Investigator

All Sum Research

Eligibility Criteria

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
See 7 more

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.
See 8 more

Timeline

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

Treatment Details

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.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Experimental #2Experimental Treatment1 Intervention
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
Group II: Experimental #1Experimental Treatment1 Intervention
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
Group III: Positive ControlActive Control1 Intervention
0.454% stannous fluoride, 0.533% zinc citrate
Group IV: Negative ControlActive Control1 Intervention
0.76% Sodium Monofluorophosphate

Find a Clinic Near You

Who Is Running the Clinical Trial?

Procter and Gamble

Lead Sponsor

Trials
150
Recruited
77,000+
Marc Pritchard profile image

Marc Pritchard

Procter and Gamble

Chief Marketing Officer since 2008

B.S. in Finance from Indiana University, Bloomington

Jon R. Moeller profile image

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

References

Enamel protection from acid challenge--benefits of marketed fluoride dentifrices. [2013]
A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis. [2014]
Occlusion of dentinal tubules on periodontally involved teeth by dentifrice containing stannous fluoride and sodium fluoride. [2023]
The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months. [2020]
Effects of a stabilized stannous fluoride dentifrice on clinical, immunomodulatory, and microbial outcomes in a human experimental gingivitis model. [2023]
A clinical study to measure anti-erosion properties of a stabilized stannous fluoride dentifrice relative to a sodium fluoride/triclosan dentifrice. [2022]
The effect of a dentifrice and mouth rinse combination containing amine fluoride/stannous fluoride on plaque and gingivitis: a 6-month field study. [2013]
Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice. [2015]
Evaluation of the Oral Tolerance of Three Fluoride Toothpaste Formulations in a Dry Mouth Population: Results from Two Randomized Studies. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Control of Established Gingivitis and Dental Plaque Using a 1450 ppm Fluoride/Zinc-based Dentifrice: A Randomized Clinical Study. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Stannous fluoride dentifrice with sodium hexametaphosphate: review of laboratory, clinical and practice-based data. [2016]
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