Trial Outcomes & Findings for A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers (NCT NCT06354270)
NCT ID: NCT06354270
Last Updated: 2025-06-25
Results Overview
Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 56 score. A negative change from Baseline indicated improvement in sensitivity.
COMPLETED
NA
115 participants
Baseline (Day 0) and Day 56
2025-06-25
Participant Flow
This study was conducted at a single center in the United States.
A total of 119 participants were screened of which 115 participants were enrolled, and 113 participants were randomized to receive treatment in 2 groups: Test Toothpaste group (57 participants) and Reference Toothpaste group (56 participants). 6 participants were not randomized (4 participants did not meet the study criteria, 2 participants withdrew consent). A total of 112 randomized participants completed the study.
Participant milestones
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
Participants were instructed to apply a ribbon of test toothpaste containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
|
Overall Study
COMPLETED
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
Participants were instructed to apply a ribbon of test toothpaste containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Anti-Sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers
Baseline characteristics by cohort
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 13.72 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Day 56Population: mITT Population.
Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 56 score. A negative change from Baseline indicated improvement in sensitivity.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
|
-1.40 score on a scale
Standard Error 0.078
|
-0.33 score on a scale
Standard Error 0.078
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 56Population: mITT Population.
Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 56 value. A positive change from Baseline indicated improvement in sensitivity.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56
|
41.13 grams
Standard Error 2.347
|
4.41 grams
Standard Error 2.347
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 28Population: mITT population.
Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 28 score. A negative change from Baseline indicated improvement in sensitivity.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28
|
-0.79 score on a scale
Standard Error 0.059
|
-0.17 score on a scale
Standard Error 0.059
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 28Population: mITT Population.
Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram (g) for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 28 value. A positive change from Baseline indicated an improvement in sensitivity.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold (g) at Day 28
|
16.75 grams
Standard Error 1.505
|
2.45 grams
Standard Error 1.505
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
The DHEQ is a condition-specific measure of Oral Health-Related Quality of Life (OHrQoL) used to investigate the impacts of tooth sensitivity on everyday life. DHEQ section 1, questions 7-9 were about participant's sensitive teeth and its impact on their everyday life. Participants scored Q7 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q8 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q9 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in sensitivity and its impact on everyday life.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56
Q7 (How intense are the sensations?): Change from Baseline at Day 28
|
-0.68 score on a scale
Standard Error 0.167
|
-0.25 score on a scale
Standard Error 0.190
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56
Q7 (How intense are the sensations?): Change from Baseline at Day 56
|
-1.02 score on a scale
Standard Error 0.215
|
-0.52 score on a scale
Standard Error 0.265
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56
Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28
|
-0.63 score on a scale
Standard Error 0.177
|
-0.48 score on a scale
Standard Error 0.218
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56
Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56
|
-1.14 score on a scale
Standard Error 0.197
|
-0.89 score on a scale
Standard Error 0.263
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56
Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28
|
-0.04 score on a scale
Standard Error 0.205
|
0.61 score on a scale
Standard Error 0.278
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56
Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56
|
-0.41 score on a scale
Standard Error 0.284
|
0.46 score on a scale
Standard Error 0.306
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
The DHEQ is a condition-specific measure of OHrQoL used to investigate the impacts of tooth sensitivity on everyday life. Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better OHrQoL. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
Change from Baseline at Day 28
|
-3.16 score on a scale
Standard Error 3.473
|
-3.66 score on a scale
Standard Error 3.399
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
Change from Baseline at Day 56
|
-16.75 score on a scale
Standard Error 4.414
|
-16.34 score on a scale
Standard Error 4.273
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
Change from Baseline at Day 28
|
-0.20 score on a scale
Standard Error 0.502
|
-0.84 score on a scale
Standard Error 0.552
|
|
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
Change from Baseline at Day 56
|
-3.02 score on a scale
Standard Error 0.614
|
-2.48 score on a scale
Standard Error 0.686
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
Change from Baseline at Day 28
|
-0.48 score on a scale
Standard Error 1.488
|
-0.88 score on a scale
Standard Error 1.580
|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
Change from Baseline at Day 56
|
-5.96 score on a scale
Standard Error 1.768
|
-5.54 score on a scale
Standard Error 1.817
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Social impact domain of DHEQ evaluated 'the way the sensations affected participants when they were with other people or in certain situations.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life).
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
Change from Baseline at Day 28
|
-0.96 score on a scale
Standard Error 0.601
|
-0.23 score on a scale
Standard Error 0.497
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
Change from Baseline at Day 56
|
-2.29 score on a scale
Standard Error 0.716
|
-1.86 score on a scale
Standard Error 0.643
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Emotional impact domain of DHEQ evaluated 'the way the sensations in participant's teeth made them feel.' It included 8 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's emotions).
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
Change from Baseline at Day 28
|
-1.39 score on a scale
Standard Error 0.994
|
-0.80 score on a scale
Standard Error 0.947
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
Change from Baseline at Day 56
|
-4.59 score on a scale
Standard Error 1.175
|
-4.59 score on a scale
Standard Error 1.132
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Identity domain of DHEQ evaluated 'what the sensations in participant's teeth meant for them.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity).
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
Change from Baseline at Day 28
|
-0.13 score on a scale
Standard Error 0.528
|
-0.91 score on a scale
Standard Error 0.591
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
Change from Baseline at Day 56
|
-0.89 score on a scale
Standard Error 0.714
|
-1.87 score on a scale
Standard Error 0.672
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Global oral health was evaluated using a single question of DHEQ. Participants rated the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicated better oral health. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall oral health.
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56
Change from Baseline at Day 28
|
0.00 score on a scale
Standard Error 0.083
|
-0.21 score on a scale
Standard Error 0.107
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56
Change from Baseline at Day 56
|
-0.20 score on a scale
Standard Error 0.100
|
-0.36 score on a scale
Standard Error 0.102
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT population.
Effect on life overall was evaluated using 4 questions of DHEQ about how much the sensations in teeth affected participant's life overall. Participants scored each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranged from 0 to 16, where lower score indicated less impact of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's life overall).
Outcome measures
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 Participants
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56
Change from Baseline at Day 28
|
-0.70 score on a scale
Standard Error 0.285
|
-0.25 score on a scale
Standard Error 0.297
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56
Change from Baseline at Day 56
|
-1.66 score on a scale
Standard Error 0.288
|
-1.37 score on a scale
Standard Error 0.321
|
Adverse Events
Test Toothpaste (Stannous Fluoride Toothpaste)
Reference Toothpaste (Regular Fluoride Toothpaste)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Toothpaste (Stannous Fluoride Toothpaste)
n=57 participants at risk
Participants were instructed to apply a ribbon of test toothpaste containing 0.454% w/w SnF2 across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days making sure to brush the sensitive areas of the 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=56 participants at risk
Participants were instructed to apply a ribbon of reference toothpaste (regular fluoride toothpaste) across the full brush head of the toothbrush provided and brush their teeth for at least 1 timed minute twice-daily (morning and evening) for 56 days.
|
|---|---|---|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/57 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 93 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 an acclimatization product (or medical device), whether or not considered related to the study product, including an acclimatization product (or medical device). A serious adverse event (SAE) was a particular category of AE where the adverse outcome was serious.
|
1.8%
1/56 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 93 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 an acclimatization product (or medical device), whether or not considered related to the study product, including an acclimatization product (or medical device). A serious adverse event (SAE) was a particular category of AE where the adverse outcome was serious.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/57 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 93 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 an acclimatization product (or medical device), whether or not considered related to the study product, including an acclimatization product (or medical device). A serious adverse event (SAE) was a particular category of AE where the adverse outcome was serious.
|
1.8%
1/56 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 93 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 an acclimatization product (or medical device), whether or not considered related to the study product, including an acclimatization product (or medical device). A serious adverse event (SAE) was a particular category of AE where the adverse outcome was 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