N/A
N=55
A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome
Oral Health
Bottom Line
View on ClinicalTrials.gov: NCT06048809 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Alpha Diversity at Baseline (Day 1) — 3.7; 3.5 Shannon index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stannous Fluoride Toothpaste (Sensodyne Repair and Protect) (Other); Regular Fluoride Toothpaste (Colgate Cavity Protection) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HALEON
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alpha Diversity at Baseline (Day 1) |
3.7; 3.5 | — |
| PRIMARY Alpha Diversity at Week 6 |
3.8; 3.6 | — |
| PRIMARY Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) |
-1.44299; -1.15069; -1.00158; -1.04854; -0.99362; -1.09495 | 0.0000236 sig |
| PRIMARY Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) |
-0.77816; 0.819312; 0.742059; 0.725497; -0.45915; 0.529594 | 0.062378 |
Summary
The aim of this study is to evaluate the effect of a toothpaste containing stannous fluoride (SnF2) over time on the oral bacterial composition and activity and to explore its effect in comparison to a regular fluoride toothpaste.
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 male or female who, at the time of screening, is aged 18-65 years, inclusive.
- Participant who is willing and able to comply with scheduled visits, sampling schedule, treatment plan and other study procedures.
- Participant, in the opinion of the investigator or medically qualified designee, in good general and mental health.
At Screening (Visit 1):
- Participant with at least 20 natural, permanent teeth (excluding 3rd molars).
- Participant with at least 40 evaluable surfaces.
- Overall mean Turesky Modified Quigley and Hein Plaque Index (TPI) score greater than or equal to (>=) 1.5.
- Participants with 10% less than (<) bleeding sites (BS) < 30%
Exclusion Criteria
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or otherwise supervised by the investigator, or a member of their immediate family; or a sponsor 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) in the 30 days prior to study entry and/or who is participating in other studies 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 with any medical/oral condition which, in the opinion of the investigator or medically qualified designee, could impact study outcomes (for example, oral dryness or could directly influence gingival bleeding).
- A participant taking daily doses of medication/having daily treatments which, in the opinion of the investigator or medically qualified designee, could impact study outcomes (for example, is causing oral dryness).
- A participant who is pregnant (self-reported; no pregnancy test required) or intending to become pregnant over the course of the study.
- A 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 who is unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
- A participant who has difficulty complying with study procedures and examinations, such as excessive gagging during oral assessments.
- A participant who has had routine dental prophylaxis within 12 weeks of Screening.
- A participant who has undergone a tooth bleaching procedure (at-home or professional) within 8 weeks of Screening.
- A participant with any of the following which, in the opinion of the investigator or medically qualified designee, could impact study outcomes or the oral health of the participants if they were to participate in the study:
- Severe gingivitis.
- Signs of active periodontal disease or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
- Active caries.
- Evidence of gross intra-oral neglect or the need for extensive dental therapy.
- Restorations in a poor state of repair or metal fillings.
- Any dental condition (example, malalignment, overcrowding)
- High levels of extrinsic dental stain or calculus deposits.
- A participant with the following:
- A tongue or lip piercing.
- Multiple dental implants which, in the opinion of the investigator or me
Data sourced from ClinicalTrials.gov (NCT06048809). 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.