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

Not Applicable

Completed

Conditions: Oral Health

Registration Number: NCT06048809

Lead Sponsor: HALEON

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

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:
1. Severe gingivitis.
2. Signs of active periodontal disease or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
3. Active caries.
4. Evidence of gross intra-oral neglect or the need for extensive dental therapy.
5. Restorations in a poor state of repair or metal fillings.
6. Any dental condition (example, malalignment, overcrowding)
7. High levels of extrinsic dental stain or calculus deposits.
A participant with the following:
1. A tongue or lip piercing.
2. Multiple dental implants which, in the opinion of the investigator or medically qualified designee, could impact study outcomes.
3. Fixed bridge(s) or removable partial dentures.
4. 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)
1. A participant who has taken antibiotics within 4 weeks of Screening.
2. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alpha Diversity at Baseline (Day 1)	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	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)	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)	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.