Trial Outcomes & Findings for Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers (NCT NCT06359028)
NCT ID: NCT06359028
Last Updated: 2025-06-24
Results Overview
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicated an improvement.
COMPLETED
NA
111 participants
Baseline and Day 56
2025-06-24
Participant Flow
This study was conducted at a single center in the United States.
A total of 126 participants were screened into the study, 111 participants were enrolled, 104 participants were randomized to a treatment (53 participants in the test toothpaste group and 51 participants in the reference toothpaste group) and 102 participants completed the study (51 participants in the test toothpaste group and 51 participants in the reference toothpaste group).
Participant milestones
| Measure |
Test Toothpaste
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 milliliter (ml) water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Test Toothpaste
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 milliliter (ml) water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
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
n=53 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 9.93 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 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
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 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 and Day 56Population: Modified Intent-To-Treat (mITT) population included all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline dentin hypersensitivity (DH) efficacy assessment. Only those participants with data available at the specified time points were analyzed.
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicated an improvement.
Outcome measures
| Measure |
Test Toothpaste
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
|
-2.25 score on a scale
Standard Error 0.080
|
-0.31 score on a scale
Standard Error 0.080
|
SECONDARY outcome
Timeframe: Baseline and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram (g). 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. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 56 value.
Outcome measures
| Measure |
Test Toothpaste
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Day 56
|
60.07 gram
Standard Error 2.539
|
2.70 gram
Standard Error 2.544
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: mITT Population.
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 28 score. A decrease in Schiff sensitivity score indicated an improvement.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28
|
-1.75 score on a scale
Standard Error 0.085
|
-0.10 score on a scale
Standard Error 0.086
|
SECONDARY outcome
Timeframe: Baseline and Day 28Population: mITT Population.
Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram. 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. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 28 value.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold at Day 28
|
36.59 gram
Standard Error 3.009
|
1.23 gram
Standard Error 3.038
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
DHEQ section 1, questions 7-9 were about teeth sensation and its impact on 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). Thus, the total score ranged from 3 to 30; where the lower score indicated less sensitivity and less impact on everyday life. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
Q7, Day 56
|
-2.83 score on a scale
Standard Error 0.217
|
-0.71 score on a scale
Standard Error 0.225
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
Q7, Day 28
|
-1.44 score on a scale
Standard Error 0.216
|
-0.61 score on a scale
Standard Error 0.199
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
Q8, Day 28
|
-1.69 score on a scale
Standard Error 0.224
|
-0.53 score on a scale
Standard Error 0.216
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
Q8, Day 56
|
-3.04 score on a scale
Standard Error 0.222
|
-0.78 score on a scale
Standard Error 0.226
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
Q9, Day 28
|
-0.46 score on a scale
Standard Error 0.260
|
-0.12 score on a scale
Standard Error 0.216
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
Q9, Day 56
|
-1.96 score on a scale
Standard Error 0.260
|
-0.43 score on a scale
Standard Error 0.269
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
The DHEQ was a condition-specific measure of Oral Health-related Quality of Life (OHrQoL) in relation to DH which consisted of a total of 34 questions in section 2 grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34), each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 34 to 238; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
Day 56
|
-34.56 score on a scale
Standard Error 5.296
|
-8.94 score on a scale
Standard Error 3.394
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
Day 28
|
-14.79 score on a scale
Standard Error 3.833
|
-7.47 score on a scale
Standard Error 2.678
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Restrictions domain in DHEQ evaluated the ways in which any sensations in teeth affected participant's daily life. This consisted of 4 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 4 to 28; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
Day 28
|
-2.27 score on a scale
Standard Error 0.634
|
-1.20 score on a scale
Standard Error 0.444
|
|
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
Day 56
|
-4.94 score on a scale
Standard Error 0.742
|
-1.90 score on a scale
Standard Error 0.492
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Adaptation domain in DHEQ evaluated 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This consisted of 12 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 12 to 84; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
Day 28
|
-6.45 score on a scale
Standard Error 1.600
|
-1.73 score on a scale
Standard Error 1.396
|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
Day 56
|
-12.42 score on a scale
Standard Error 2.530
|
-3.31 score on a scale
Standard Error 1.726
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Social Impact domain in DHEQ evaluated the way the sensations affected participants when they were with other people or in certain situations. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
Day 28
|
-1.23 score on a scale
Standard Error 0.644
|
-0.94 score on a scale
Standard Error 0.552
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
Day 56
|
-3.63 score on a scale
Standard Error 0.771
|
-0.24 score on a scale
Standard Error 0.587
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Emotional Impact Domain in DHEQ evaluated the way the sensations in participant's teeth made them feel. This consisted of 8 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 8 to 56; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
Day 28
|
-4.10 score on a scale
Standard Error 1.089
|
-3.33 score on a scale
Standard Error 0.957
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
Day 56
|
-10.23 score on a scale
Standard Error 1.340
|
-2.98 score on a scale
Standard Error 0.958
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Identity Domain in DHEQ evaluated what the sensations in participant's teeth meant for them. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
Day 28
|
-0.69 score on a scale
Standard Error 0.666
|
-0.27 score on a scale
Standard Error 0.517
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
Day 56
|
-3.34 score on a scale
Standard Error 0.735
|
-0.51 score on a scale
Standard Error 0.725
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Global Oral Health was evaluated using a single question which asked about the overall health of participant's mouth, teeth, and gums. The scale ranged from 1 (excellent) to 6 (Very poor), where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56
Day 28
|
-0.15 score on a scale
Standard Error 0.076
|
-0.10 score on a scale
Standard Error 0.100
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56
Day 56
|
-0.23 score on a scale
Standard Error 0.082
|
-0.06 score on a scale
Standard Error 0.074
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 56Population: mITT Population. Only those participants with data available at the specified time points were analyzed.
Effect on life was evaluated using 4 questions which asked how much the sensations in teeth affected participant's life overall. The scale ranged from 0 (not at all) to 4 (Very much) and thus, the total score ranged from 0 to 16; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoint minus score at baseline.
Outcome measures
| Measure |
Test Toothpaste
n=52 Participants
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 Participants
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56
Day 56
|
-1.93 score on a scale
Standard Error 0.277
|
-0.71 score on a scale
Standard Error 0.261
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56
Day 28
|
-0.80 score on a scale
Standard Error 0.253
|
-0.53 score on a scale
Standard Error 0.311
|
Adverse Events
Test Toothpaste
Reference Toothpaste (Negative Control)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Toothpaste
n=53 participants at risk
Participants were instructed to dose the toothbrush with a ribbon of test toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
Reference Toothpaste (Negative Control)
n=51 participants at risk
Participants were instructed to dose the toothbrush with a ribbon of reference toothpaste, across the full brush head and to brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wished to rinse after brushing were instructed to rinse with 10 ml water using the graduated rinsing cup provided.
|
|---|---|---|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
5.9%
3/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
HYPERAESTHESIA TEETH
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
2.0%
1/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
0.00%
0/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
LIP SWELLING
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
0.00%
0/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
ORAL DISORDER
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
0.00%
0/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
0.00%
0/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.9%
1/53 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of AE where the adverse outcome is serious.
|
0.00%
0/51 • From signing of informed consent form until 5 days after the last administration of study product or the last study procedure (up to approximately 90 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) is a particular category of 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