Toothpaste for Gum Disease
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.12345Why 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.678910
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
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 assess its effect on gingivitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
4
Treatment groups
Experimental Treatment
Active Control
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
0.454% stannous fluoride, 0.533% zinc citrate
0.76% Sodium Monofluorophosphate
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
Published Research Related to This Trial
Citations
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.
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 ...
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/s12903-024-03981-9Efficacy 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 ...
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 ...
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 ...
Toothpastes
All toothpastes with a claim of cavity protection with the ADA Seal of Acceptance must contain fluoride. In addition to fluoride, ...
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-20066098Sodium 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.
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 ...
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