Stannous Fluoride Toothpaste for Gum Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of two kinds of toothpaste with stannous fluoride against gum disease compared to regular toothpaste. The goal is to determine if these special toothpastes can reduce gingivitis symptoms (gum inflammation) after 12 weeks of use. Individuals with mild to moderate gum disease and noticeable bleeding when brushing might be suitable for this study. Participants must use only the study's toothpaste and avoid other dental products during the trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain medications like antibiotics, anti-inflammatories, or anti-coagulants within 4 weeks before starting the study.
What is the safety track record for the stannous fluoride dentifrices?
Studies have shown that stannous fluoride toothpaste is safe for use. This toothpaste helps prevent gum disease and cavities. Research indicates it can reduce gum swelling and combat bacteria that cause plaque. Stannous fluoride works by killing bacteria and inhibiting their growth.
The toothpaste in this trial contains 0.454% stannous fluoride. This concentration has been studied and found effective in controlling gum disease and bleeding. No major safety issues have emerged in these studies, so it is considered safe for daily use.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the stannous fluoride toothpaste for gum disease because it uses 0.454% stannous fluoride, which is known for its antimicrobial properties. Unlike standard toothpastes that often use sodium monofluorophosphate as the active ingredient, stannous fluoride not only helps prevent cavities but also targets bacteria that cause gum disease. This dual action could offer a more comprehensive approach to oral health, potentially reducing gum inflammation and improving overall gum health more effectively than current options.
What is the effectiveness track record for stannous fluoride toothpaste in treating gum disease?
This trial will compare different toothpaste formulations for their effectiveness in reducing gum disease. Research has shown that stannous fluoride toothpaste, which participants in this trial may receive, helps reduce gum disease. Specifically, studies have found that using toothpaste with 0.454% stannous fluoride can decrease plaque and gum inflammation after just two weeks. Over six months, participants have demonstrated noticeable improvements in gum health and a reduction in harmful substances in the mouth. This toothpaste can also help reverse gum inflammation and reduce bleeding gums. Overall, stannous fluoride toothpaste is a strong tool for fighting gingivitis and improving oral health.46789
Who Is on the Research Team?
Nachnani
Principal Investigator
University Health Resources Group, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with gum disease or dental conditions who want to test the effectiveness of different toothpastes. Participants should be willing to use one of the study toothpastes regularly and attend follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the assigned dentifrice for 12 weeks to evaluate anti-gingivitis efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Test Stannous Fluoride Dentifrice
Find a Clinic Near You
Who Is Running the Clinical Trial?
Procter and Gamble
Lead Sponsor
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