N/A
N=161
A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
Dental Plaque · Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT06602466 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Adjusted Mean Bleeding Index (BI) at Week 4 — 0.19; 0.21 score on a scale — p=0.2992
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test toothpaste (Drug); Colgate Cavity Protection Toothpaste (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Bleeding Index (BI) at Week 4 |
0.19; 0.21 | 0.2992 |
| SECONDARY Adjusted Mean Number of Bleeding Sites (NBS) at Week 4 |
30.0; 32.5 | 0.3612 |
| SECONDARY Adjusted Mean Modified Gingival Index (MGI) at Week 4 |
1.79; 1.83 | 0.0117 sig |
| SECONDARY Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4 |
2.64; 2.62 | 0.7616 |
| SECONDARY Adjusted Mean Interproximal TPI at Week 4 |
3.03; 3.03 | 0.9321 |
Summary
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.
Eligibility Criteria
Inclusion Criteria
- Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Biological sex at birth was male or female.
- Aged 18 to 70 years inclusive, at the signing of the informed consent.
- Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures.
- 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 individual's ability to understand and follow study procedures and requirements.
- Participant oral health that meets all the following:
At Screening (Visit 1):
- Participant with at least 20 natural, permanent teeth, (excluding 3rd molars).
- Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
- A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner.
- Overall MGI less than or equal to ( =) 1.75 to = 1.5
Exclusion Criteria
- 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 or psychiatric condition or laboratory abnormality 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 has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
- A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
- A participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to any 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 vaper) who stopped within 6 months of Screening.
- A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- A participant who is 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 have directly influenced gingival bleeding.
- A participant who has a bleeding disorder that could have 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 (for example, 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
Data sourced from ClinicalTrials.gov (NCT06602466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.