Oral Health
Conditions
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.
Interventions
OTHERStannous Fluoride Toothpaste (Sensodyne Repair and Protect)
Sensodyne Repair and Protect toothpaste containing 1100 ppm fluoride as SnF2.
OTHERRegular Fluoride Toothpaste (Colgate Cavity Protection)
Colgate Cavity Protection containing 1100 ppm fluoride as SMFP.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single center in the United States.
Pre-assignment details
A total of 59 participants were screened of which 56 participants were enrolled, and 55 participants were randomized to receive treatment in 2 groups: Test Product group (28 participants) and Reference Product group (27 participants). 4 screened participants were not randomized (3 participants did not meet the study criteria and 1 participant was lost to follow-up). A total of 51 randomized participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Product (Sensodyne Repair and Protect) Participants were instructed to apply a ribbon of test product (Sensodyne Repair and Protect toothpaste) containing 1100 ppm fluoride as SnF2 across the full brush head of toothbrush provided and brush their teeth for one timed minute twice daily (morning and evening) in their usual manner for 6 weeks. | 28 |
| Reference Product (Colgate Cavity Protection) Participants were instructed to apply a ribbon of reference product (Colgate Cavity Protection toothpaste) containing 1100 ppm fluoride as SMFP across the full brush head of toothbrush provided and brush their teeth for one timed minute twice daily (morning and evening) in their usual manner for 6 weeks. | 27 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Test Product (Sensodyne Repair and Protect) | Reference Product (Colgate Cavity Protection) | Total |
|---|---|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 12.11 | 46.2 years STANDARD_DEVIATION 10.85 | 44.2 years STANDARD_DEVIATION 11.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 27 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 |
| other Total, other adverse events | 3 / 28 | 0 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 |
Outcome results
Primary
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.
Time frame: Baseline and Week 6
Population: Microbiome Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Streptococcus chosunense | -0.62541 log fold change | Standard Error 0.443126 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Abiotrophia defectiva | -0.77816 log fold change | Standard Error 0.417556 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Saccharibacteria_(TM7)_[G1] bacterium_HMT_346 | 0.819312 log fold change | Standard Error 0.441412 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Olsenella sp._HMT_807 | 0.742059 log fold change | Standard Error 0.409411 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Fusobacterium nucleatum_nucleatum_subspecies(subsp.)_animalis | 0.725497 log fold change | Standard Error 0.414044 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Bergeyella sp._HMT_322 | -0.45915 log fold change | Standard Error 0.274711 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Peptostreptococcaceae_[XI][G-1] [Eubacterium]_infirmum | 0.529594 log fold change | Standard Error 0.318012 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Prevotella sp._HMT_317 | 0.754675 log fold change | Standard Error 0.469454 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Bacteroidales_[G-2] bacterium_HMT_274 | 0.656014 log fold change | Standard Error 0.409449 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Actinomyces sp._HMT_175_nov 97.951% | -0.575 log fold change | Standard Error 0.360622 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Slackia exigua | 0.476852 log fold change | Standard Error 0.307014 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Granulicatella adiacens | -0.42768 log fold change | Standard Error 0.277858 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Prevotella oris | 0.604954 log fold change | Standard Error 0.393279 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Streptococcus sp._HMT_064 | -0.65561 log fold change | Standard Error 0.436817 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Schaalia odontolyticus | -0.74594 log fold change | Standard Error 0.511306 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Mogibacterium diversum | 0.490377 log fold change | Standard Error 0.338375 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Prevotella denticola | 0.592222 log fold change | Standard Error 0.410061 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Absconditabacteria_(SR1)_[G-1] bacterium_HMT_875 | -0.35571 log fold change | Standard Error 0.24693 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Reference Product) | Prevotella nigrescens | 0.57069 log fold change | Standard Error 0.400784 |
Comparison: Abiotrophia defectiva: Change from Baseline at Week 6p-value: 0.062378ANCOM-BC2
Comparison: Saccharibacteria\_(TM7)\_\[G1\] bacterium\_HMT\_346: Change from Baseline at Week 6p-value: 0.063437ANCOM-BC2
Comparison: Olsenella sp.\_HMT\_807: Change from Baseline at Week 6p-value: 0.069908ANCOM-BC2
Comparison: Fusobacterium nucleatum\_nucleatum\_subsp.\_animalis: Change from Baseline at Week 6p-value: 0.079736ANCOM-BC2
Comparison: Bergeyella sp.\_HMT\_322: Change from Baseline at Week 6p-value: 0.094642ANCOM-BC2
Comparison: Peptostreptococcaceae\_\[XI\]\[G-1\] \[Eubacterium\]\_infirmum: Change from Baseline at Week 6p-value: 0.095848ANCOM-BC2
Comparison: Prevotella sp.\_HMT\_317: Change from Baseline at Week 6p-value: 0.107931ANCOM-BC2
Comparison: Bacteroidales\_\[G-2\] bacterium\_HMT\_274: Change from Baseline at Week 6p-value: 0.109114ANCOM-BC2
Comparison: Actinomyces sp.\_HMT\_175\_nov 97.951%: Change from Baseline at Week 6p-value: 0.11083ANCOM-BC2
Comparison: Slackia exigua: Change from Baseline at Week 6p-value: 0.120377ANCOM-BC2
Comparison: Granulicatella adiacens: Change from Baseline at Week 6p-value: 0.123758ANCOM-BC2
Comparison: Prevotella oris: Change from Baseline at Week 6p-value: 0.123992ANCOM-BC2
Comparison: Streptococcus sp.\_HMT\_064: Change from Baseline at Week 6p-value: 0.133385ANCOM-BC2
Comparison: Schaalia odontolyticus: Change from Baseline at Week 6p-value: 0.144598ANCOM-BC2
Comparison: Mogibacterium diversum: Change from Baseline at Week 6p-value: 0.147278ANCOM-BC2
Comparison: Prevotella denticola: Change from Baseline at Week 6p-value: 0.148674ANCOM-BC2
Comparison: Absconditabacteria\_(SR1)\_\[G-1\] bacterium\_HMT\_875: Change from Baseline at Week 6p-value: 0.149722ANCOM-BC2
Comparison: Prevotella nigrescens: Change from Baseline at Week 6p-value: 0.154465ANCOM-BC2
Comparison: Streptococcus chosunense: Change from Baseline at Week 6p-value: 0.158139ANCOM-BC2
Primary
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.
Time frame: Baseline and Week 6
Population: Microbiome Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Haemophilus parainfluenzae | -1.44299 log fold change | Standard Error 0.341277 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Neisseria elongata | -1.15069 log fold change | Standard Error 0.391919 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Aggregatibacter species (sp.)_Human Microbial Taxon (HMT)_898 | -1.00158 log fold change | Standard Error 0.356817 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Parvimonas sp._HMT_110 | -1.04854 log fold change | Standard Error 0.386699 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Aggregatibacter aphrophilus | -0.99362 log fold change | Standard Error 0.3691 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Kingella oralis | -1.09495 log fold change | Standard Error 0.409102 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Haemophilus sp._HMT_036 | -0.89269 log fold change | Standard Error 0.364569 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Haemophilus haemolyticus | -0.94098 log fold change | Standard Error 0.403023 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Neisseria mucosa | -0.77591 log fold change | Standard Error 0.333405 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Parvimonas sp._HMT_393_nov_97.053 percent (%) | -0.95005 log fold change | Standard Error 0.411073 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Ottowia sp._HMT_894 | -0.74756 log fold change | Standard Error 0.3261 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Cryptobacterium curtum | 0.75985 log fold change | Standard Error 0.334759 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Lautropia mirabilis | -0.92156 log fold change | Standard Error 0.408231 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Haemophilus paraphrohaemolyticus | -0.68962 log fold change | Standard Error 0.307868 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Capnocytophaga sp._HMT_332 | -0.68115 log fold change | Standard Error 0.306965 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Neisseria flavescens | -1.11659 log fold change | Standard Error 0.509096 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Capnocytophaga gingivalis_nov_96.429% | -0.72364 log fold change | Standard Error 0.34236 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Capnocytophaga sputigena | -0.83191 log fold change | Standard Error 0.399852 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Haemophilus sputorum | -0.81061 log fold change | Standard Error 0.390197 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Capnocytophaga gingivalis_nov_90.546% | -0.64962 log fold change | Standard Error 0.313955 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Prevotella denticola | 0.908887 log fold change | Standard Error 0.458641 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Aggregatibacter sp._HMT_513 | -0.81317 log fold change | Standard Error 0.418317 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Veillonella sp._HMT_780 | -0.62127 log fold change | Standard Error 0.323856 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Neisseria perflava | -0.98271 log fold change | Standard Error 0.519658 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Slackia exigua | 0.61058 log fold change | Standard Error 0.333686 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Shuttleworthia satelles | 0.615042 log fold change | Standard Error 0.34007 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Aggregatibacter sp._HMT_458 | -0.75679 log fold change | Standard Error 0.423703 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Ruminococcaceae_[G-1] bacterium_HMT_075 | 0.752979 log fold change | Standard Error 0.421849 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Campylobacter showae | -0.77501 log fold change | Standard Error 0.440186 |
| Test Product (Sensodyne Repair and Protect) | Adjusted Mean Change From Baseline in Abundance for Each Bacterial Group Assessed by Differential Abundance Analysis at Week 6 (Test Product) | Streptococcus sp._HMT_056 | -0.62733 log fold change | Standard Error 0.36379 |
Comparison: Haemophilus parainfluenzae: Change From Baseline at Week 6p-value: 0.0000236ANCOM-BC2
Comparison: Neisseria elongata: Change From Baseline at Week 6p-value: 0.0033243ANCOM-BC2
Comparison: Aggregatibacter sp.\_HMT\_898: Change From Baseline at Week 6p-value: 0.00500088ANCOM-BC2
Comparison: Parvimonas sp.\_HMT\_110: Change From Baseline at Week 6p-value: 0.0066975ANCOM-BC2
Comparison: Aggregatibacter aphrophilus: Change From Baseline at Week 6p-value: 0.00710228ANCOM-BC2
Comparison: Kingella oralis: Change From Baseline at Week 6p-value: 0.00744022ANCOM-BC2
Comparison: Haemophilus sp.\_HMT\_036: Change From Baseline at Week 6p-value: 0.01434037ANCOM-BC2
Comparison: Haemophilus haemolyticus: Change From Baseline at Week 6p-value: 0.01955327ANCOM-BC2
Comparison: Neisseria mucosa: Change From Baseline at Week 6p-value: 0.01995277ANCOM-BC2
Comparison: Parvimonas sp.\_HMT\_393\_nov\_97.053%: Change From Baseline at Week 6p-value: 0.02082528ANCOM-BC2
Comparison: Ottowia sp.\_HMT\_894: Change from Baseline at Week 6p-value: 0.02188156ANCOM-BC2
Comparison: Cryptobacterium curtum: Change From Baseline at Week 6p-value: 0.02321733ANCOM-BC2
Comparison: Lautropia mirabilis: Change from Baseline at Week 6p-value: 0.02397996ANCOM-BC2
Comparison: Haemophilus paraphrohaemolyticus: Change From Baseline at Week 6p-value: 0.02509094ANCOM-BC2
Comparison: Capnocytophaga sp.\_HMT\_332: Change From Baseline at Week 6p-value: 0.02648847ANCOM-BC2
Comparison: Neisseria flavescens: Change From Baseline at Week 6p-value: 0.02828764ANCOM-BC2
Comparison: Capnocytophaga gingivalis\_nov\_96.429%: Change From Baseline at Week 6p-value: 0.03454372ANCOM-BC2
Comparison: Capnocytophaga sputigena: Change From Baseline at Week 6p-value: 0.03747507ANCOM-BC2
Comparison: Haemophilus sputorum: Change From Baseline at Week 6p-value: 0.03776136ANCOM-BC2
Comparison: Capnocytophaga gingivalis\_nov\_90.546%: Change From Baseline at Week 6p-value: 0.03853215ANCOM-BC2
Comparison: Prevotella denticola: Change From Baseline at Week 6p-value: 0.04751303ANCOM-BC2
Comparison: Aggregatibacter sp.\_HMT\_513: Change From Baseline at Week 6p-value: 0.05190512ANCOM-BC2
Comparison: Veillonella sp.\_HMT\_780: Change From Baseline at Week 6p-value: 0.0550647ANCOM-BC2
Comparison: Neisseria perflava: Change From Baseline at Week 6p-value: 0.05861488ANCOM-BC2
Comparison: Slackia exigua: Change From Baseline at Week 6p-value: 0.06727926ANCOM-BC2
Comparison: Shuttleworthia satelles: Change from Baseline at Week 6p-value: 0.07051698ANCOM-BC2
Comparison: Aggregatibacter sp.\_HMT\_458: Change From Baseline at Week 6p-value: 0.0740793ANCOM-BC2
Comparison: Ruminococcaceae\_\[G-1\] bacterium\_HMT\_075: Change From Baseline at Week 6p-value: 0.07426973ANCOM-BC2
Comparison: Campylobacter showae: Change From Baseline at Week 6p-value: 0.07829888ANCOM-BC2
Comparison: Streptococcus sp.\_HMT\_056: Change From Baseline at Week 6p-value: 0.08462924ANCOM-BC2
Primary
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.
Time frame: Baseline (Day 1)
Population: Microbiome Population included all randomized participants who completed at least one use of the study product and had an evaluable microbiome result (at least one area at both Baseline and Week 6).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Product (Sensodyne Repair and Protect) | Alpha Diversity at Baseline (Day 1) | 3.7 Shannon index |
| Reference Product (Colgate Cavity Protection) | Alpha Diversity at Baseline (Day 1) | 3.5 Shannon index |
Primary
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.
Time frame: Week 6
Population: Microbiome Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Product (Sensodyne Repair and Protect) | Alpha Diversity at Week 6 | 3.8 Shannon index |
| Reference Product (Colgate Cavity Protection) | Alpha Diversity at Week 6 | 3.6 Shannon index |