A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome

NCT06048809 | Completed Results

• 1 other identifier: 300101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Health

Outcome Measures

Primary Outcomes (4)

• Alpha Diversity at Baseline (Day 1)

  Alpha diversity was defined as species diversity in sites or habitats and was used to describe the overall oral bacterial composition. Samples were collected from 4 different areas of mouth (tongue, supragingival plaque, subgingival surface, and saliva) and microbial profiling (16S ribosomal ribonucleic acid \[rRNA\] gene amplicon analysis) was performed to identify the bacteria present within a given sample down to the genus and/or species level. Alpha diversity (overall) was measured using Shannon index. Shannon Index was derived as the negative of the sum of the p\*ln(p) across all species in the sample where p was the proportion of the sample made up from each species. Index scores ranged from 0 to ln(S) where S was the number of species in the sample. Higher values indicated greater diversity and a more complex community with a more even distribution of species. Lower values indicated lower diversity, suggesting dominance by a few species or a less complex community.

  Baseline (Day 1)

• Alpha Diversity at Week 6

  Alpha diversity was defined as species diversity in sites or habitats and was used to describe the overall oral bacterial composition. Samples were collected from 4 different areas of mouth (tongue, supragingival plaque, subgingival surface, and saliva) and microbial profiling (16S rRNA gene amplicon analysis) was performed to identify the bacteria present within a given sample down to the genus and/or species level. Alpha diversity (overall) was measured using Shannon index. Shannon Index was derived as the negative of the sum of the p\*ln(p) across all species in the sample where p was the proportion of the sample made up from each species. Index scores ranged from 0 to ln(S) where S was the number of species in the sample. Higher values indicated greater diversity and a more complex community with a more even distribution of species. Lower values indicated lower diversity, suggesting dominance by a few species or a less complex community.

  Week 6

• Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product)

  Analysis of Compositions of Microbiomes with Bias Correction, version 2 (ANCOM-BC2) method was used to identify bacterial species that were differentially abundant between Baseline and Week 6. Samples were collected from 4 different areas of mouth (tongue, supragingival plaque, subgingival surface, and saliva) at the indicated timepoints, and differential abundance analysis was performed. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 6. Baseline was defined as Day 1. Log-fold change from Baseline in abundance (overall) for each bacterial group was reported.

  Baseline and Week 6

• Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product)

  ANCOM-BC2 method was used to identify bacterial species that were differentially abundant between Baseline and Week 6. Samples were collected from 4 different areas of mouth (tongue, supragingival plaque, subgingival surface, and saliva) at the indicated timepoints, and differential abundance analysis was performed. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 6. Baseline was defined as Day 1. Log-fold change from Baseline in abundance (overall) for each bacterial group was reported.

  Baseline and Week 6

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will be instructed to brush their teeth with the test toothpaste (Sensodyne Repair and Protect containing 1100 parts per million \[ppm\] fluoride as SnF2) for 1-timed minute twice a day (morning and evening) in their usual manner for 6 weeks. Participants will record each brushing in the diary provided.

Other: Stannous Fluoride Toothpaste (Sensodyne Repair and Protect)

Reference Toothpaste

ACTIVE COMPARATOR

Participants will be instructed to brush their teeth with the reference toothpaste (Colgate Cavity Protection containing 1100 ppm fluoride as sodium monofluorophosphate \[SMFP\]) for 1-timed minute twice a day (morning and evening) in their usual manner for 6 weeks. Participants will record each brushing in the diary provided.

Other: Regular Fluoride Toothpaste (Colgate Cavity Protection)

Interventions

Stannous Fluoride Toothpaste (Sensodyne Repair and Protect) OTHER

Sensodyne Repair and Protect toothpaste containing 1100 ppm fluoride as SnF2.

Test Toothpaste

Regular Fluoride Toothpaste (Colgate Cavity Protection) OTHER

Colgate Cavity Protection containing 1100 ppm fluoride as SMFP.

Reference Toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: April 10, 2024
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1)