Oral HealthNCT06048809
A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome
A study testing Stannous Fluoride Toothpaste (Sensodyne Repair and Protect) and Regular Fluoride Toothpaste (Colgate Cavity Protection) in people with Oral Health, run by HALEON at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Stannous Fluoride Toothpaste (Sensodyne Repair and Protect) and Regular Fluoride Toothpaste (Colgate Cavity Protection)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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%
Who cannot join
- 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.
Show all 37Show fewer
- 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 medically qualified designee, could impact study outcomes.
- Fixed bridge(s) or removable partial dentures.
- Has or has had fixed or removable orthodontic braces/bands or a fixed orthodontic retainer within 3 months of Screening.
- A participant who is unwilling to forgo use of an orthodontic retainer for the duration of the study, provided there would be no impact on the outcome of any previous, completed orthodontic treatment or the participant's well-being.
- Participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening (Visit 1).
- Participant who is a currently user of recreational drugs (example, cannabis) within 6 months of Screening.
- Participant who currently uses smokeless forms of tobacco (example, chewing tobacco, nicotine-based e-cigarettes) within 6 months of Screening.
- Visit 1 (Screening)
- A participant who has taken antibiotics within 4 weeks of Screening.
- Participant who has used an anti-bacterial mouthwash (example, chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health.
- Visit 2 (Baseline)
- 1. A participant who has taken antibiotics during the lead-in period (between Screening and Baseline).
- Participant with a recent history (within the last year) of alcohol or other substance abuse.
- A participant who has previously been enrolled in this study.
- Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Examiner Blind, Methodology Development Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome
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.
Read the detailed description
This will be a single-center, 6-week, randomized, controlled, analyst and examiner-blind, two treatment, parallel group design, methodology development clinical study, investigating the efficacy of a toothpaste containing 0.454 percent (%) SnF2 in healthy adult participants with mild-moderate gingivitis. The study will describe and compare the overall oral bacterial composition and activity following 6 weeks use of a 0.454 % SnF2 toothpaste and regular fluoride toothpaste (control) using microbial and functional profiling techniques. Participants will be instructed to brush twice daily (morning and evening) in their usual manner, for 1-timed minute, for 6 weeks and to record each brushing in the diary provided. Sufficient participants will be screened to ensure approximately 50 participants complete the entire study.
- Conditions
- Oral Health
- Being tested
- Stannous Fluoride Toothpaste (Sensodyne Repair and Protect), Regular Fluoride Toothpaste (Colgate Cavity Protection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stannous Fluoride Toothpaste (Sensodyne Repair and Protect)Other
Sensodyne Repair and Protect toothpaste containing 1100 ppm fluoride as SnF2.
Regular Fluoride Toothpaste (Colgate Cavity Protection)Other
Colgate Cavity Protection containing 1100 ppm fluoride as SMFP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Regular Fluoride Toothpaste (Colgate Cavity Protection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Apr 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048809
- Sponsor's protocol ID
- 300101
- Status last verified
- Jul 2025
- First submitted
- 15 Sep 2023
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Examiner Blind, Methodology Development Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome
- ClinicalTrials.gov ID
- NCT06048809
- Acronym / sponsor ID
- 300101
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a single-center, 6-week, randomized, controlled, analyst and examiner-blind, two treatment, parallel group design, methodology development clinical study, investigating the efficacy of a toothpaste containing 0.454 percent (%) SnF2 in healthy adult participants with mild-moderate gingivitis. The study will describe and compare the overall oral bacterial composition and activity following 6 weeks use of a 0.454 % SnF2 toothpaste and regular fluoride toothpaste (control) using microbial and functional profiling techniques. Participants will be instructed to brush twice daily (morning and evening) in their usual manner, for 1-timed minute, for 6 weeks and to record each brushing in the diary provided. Sufficient participants will be screened to ensure approximately 50 participants complete the entire study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Other: Stannous Fluoride Toothpaste (Sensodyne Repair and Protect)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. |
| Reference Toothpaste | Active comparator | Other: Regular Fluoride Toothpaste (Colgate Cavity Protection)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Participant with at least 20 natural, permanent teeth (excluding 3rd molars).
Key exclusion criteria (37 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stannous Fluoride Toothpaste (Sensodyne Repair and Protect)Sensodyne Repair and Protect toothpaste containing 1100 ppm fluoride as SnF2. | Other | Test Toothpaste |
| Regular Fluoride Toothpaste (Colgate Cavity Protection)Colgate Cavity Protection containing 1100 ppm fluoride as SMFP. | Other | Reference Toothpaste |
Primary outcome
Alpha Diversity at Baseline (Day 1)
Time frame: 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.
Alpha Diversity at Week 6
Time frame: 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.
Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product)
Time frame: Baseline and Week 6
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.
Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product)
Time frame: Baseline and Week 6
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Related trials for Oral Health
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stannous Fluoride Toothpaste (Sensodyne Repair and Protect) and Regular Fluoride Toothpaste (Colgate Cavity Protection) in people with Oral Health, run by HALEON at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha Diversity at Baseline (Day 1) (time frame: Baseline (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.