Trial Outcomes & Findings for A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome (NCT NCT06048809)
NCT ID: NCT06048809
Last Updated: 2025-07-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Baseline (Day 1)
Results posted on
2025-07-10
Participant Flow
This study was conducted at a single center in the United States.
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.
Participant milestones
| Measure |
Test Product (Sensodyne Repair and Protect)
Participants were instructed to apply a ribbon of test product (Sensodyne Repair and Protect toothpaste) containing 1100 parts per million \[ppm\] fluoride as stannous fluoride (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.
|
Reference Product (Colgate Cavity Protection)
Participants were instructed to apply a ribbon of reference product (Colgate Cavity Protection toothpaste) containing 1100 ppm fluoride as sodium monofluorophosphate \[SMFP\] 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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Test Product (Sensodyne Repair and Protect)
Participants were instructed to apply a ribbon of test product (Sensodyne Repair and Protect toothpaste) containing 1100 parts per million \[ppm\] fluoride as stannous fluoride (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.
|
Reference Product (Colgate Cavity Protection)
Participants were instructed to apply a ribbon of reference product (Colgate Cavity Protection toothpaste) containing 1100 ppm fluoride as sodium monofluorophosphate \[SMFP\] 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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome
Baseline characteristics by cohort
| Measure |
Test Product (Sensodyne Repair and Protect)
n=28 Participants
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.
|
Reference Product (Colgate Cavity Protection)
n=27 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 11.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Test Product (Sensodyne Repair and Protect)
n=25 Participants
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.
|
Reference Product (Colgate Cavity Protection)
n=26 Participants
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.
|
|---|---|---|
|
Alpha Diversity at Baseline (Day 1)
|
3.7 Shannon index
Interval 3.3 to 3.9
|
3.5 Shannon index
Interval 3.1 to 3.9
|
PRIMARY outcome
Timeframe: Week 6Population: Microbiome Population.
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.
Outcome measures
| Measure |
Test Product (Sensodyne Repair and Protect)
n=25 Participants
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.
|
Reference Product (Colgate Cavity Protection)
n=26 Participants
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.
|
|---|---|---|
|
Alpha Diversity at Week 6
|
3.8 Shannon index
Interval 3.3 to 4.0
|
3.6 Shannon index
Interval 3.2 to 4.0
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Microbiome Population.
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.
Outcome measures
| Measure |
Test Product (Sensodyne Repair and Protect)
n=25 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Microbiome Population.
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.
Outcome measures
| Measure |
Test Product (Sensodyne Repair and Protect)
n=26 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
Adverse Events
Test Product (Sensodyne Repair and Protect)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Reference Product (Colgate Cavity Protection)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product (Sensodyne Repair and Protect)
n=28 participants at risk
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.
|
Reference Product (Colgate Cavity Protection)
n=27 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
3.6%
1/28 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/27 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
3.6%
1/28 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/27 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
TONGUE EXFOLIATION
|
3.6%
1/28 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/27 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Immune system disorders
SUNSCREEN SENSITIVITY
|
3.6%
1/28 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/27 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Skin and subcutaneous tissue disorders
PERIORAL DERMATITIS
|
3.6%
1/28 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
0.00%
0/27 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 51 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER