N/A
Completed N=152
A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
Source: ClinicalTrials.gov NCT06143670 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12 — -14.6 bleeding sites — p=<0.0001
Summary
The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12 |
-14.6 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product) |
-14.6; 2.2 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product) |
-14.8; 1.2; -16.7; 0.9 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.30; -0.02; -0.29; -0.10; -0.32; -0.03 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.23; -0.02; -0.25; -0.09; -0.28; -0.04 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.12; 0.01; -0.14; 0.01; -0.12; 0.01 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.51; 0.12; -0.71; -0.07; -0.71; -0.03 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant 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.
- Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
- A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/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.
- Participant oral health that meets all the following:
At Screening (Visit 1):
- Participant with at least 20 natural, permanent teeth.
- Participant with at least 40 evaluable surfaces for MGI, BI, and TPI (An evaluable surface is defined as having two thirds of the natural tooth surface gradable for the selected clinical indices. The following will not be included in the evaluable surface count: third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices).
- A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination.
At Baseline (Visit 2):
- A participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
- A participant with 10% to 30% bleeding sites (following BI).
- A participant with mean whole mouth TPI score >=1.5.
Exclusion Criteria
- 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 sponsor's 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 a pregnant female (self-reported) or is intending to become pregnant over the duration of the study.
- A participant who is a breastfeeding female.
- A participant who is known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant who is unwilling or unable to comply with the lifestyle considerations.
- Participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening.
- 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 medica
Data sourced from ClinicalTrials.gov (NCT06143670). 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. Informational only — not medical advice.