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A Study on Stannous Fluoride Dentifrice for Gum Health

This study is looking at how well an experimental toothpaste, called Test Dentifrice (containing 0.454% w/w Stannous Fluoride), works to improve gum health. It's being compared to a regular fluoride toothpaste (Colgate Cavity Protection Dentifrice). The study aims to see if the experimental toothpaste can reduce gingivitis (gum inflammation) and plaque buildup in people with mild to moderate gingivitis. To join, you need to be at least 18 years old, willing to sign a consent form, and able to follow the study's schedule and procedures. The main goal is to measure the change in gum health after 8 weeks. The current status of this study is unclear.

Study design
This is an 8-week, randomized study comparing two toothpastes, with approximately 110 participants. The examiner will not know which toothpaste each participant is using.
What's involved
You would use one of the study toothpastes twice daily for 8 weeks and attend scheduled visits.
Compensation
Not stated in the trial record.
Follow-up
Your gum health will be measured at the beginning and again at Week 8.

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NCT07704905

A Study to Investigate the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health

Not Yet Recruiting
NAAges 18+InterventionalTreatment
HALEON
~110 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Test DentifriceReference Dentifrice (Colgate Cavity Protection Dentifrice)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8
Measured over Baseline and Week 8

Conditions

Dental Plaque
Gingivitis

Explore related trials

Dental PlaqueGingivitis

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Jeffery L Milleman, DDS · PRINCIPAL_INVESTIGATOR · Salus Research Inc

Who to contact

Haleon Response Center
[email protected]
+441932959500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.
A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.
A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.

Exclusion

A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (Example(e.g.), cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.
A female participant who is breastfeeding.
A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.
A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening.
A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, paan containing tobacco, nicotine-based e-cigarettes).
A participant who has diagnosed xerostomia or is taking any medication that in the view of the investigator, is causing xerostomia.
A participant who has a medical condition which could directly influenced gingival bleeding (e.g., type 2 diabetes).
A participant who has a bleeding disorder that could affected study outcomes and/or participant safety.
A participant who has a recent history (within the last year) of alcohol or other substance abuse.
A participant who has a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition.
Dental exclusions:
A participant who has previously been enrolled in this study.
A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

What this trial measures

  • Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8Baseline and Week 8

    The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores indicate symptom improvement.