Trial Outcomes & Findings for A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers (NCT NCT06378008)
NCT ID: NCT06378008
Last Updated: 2025-09-08
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's 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 (Day 0) was calculated by subtracting Baseline score from Day 56 score. A negative change from Baseline indicated improvement.
COMPLETED
NA
217 participants
Baseline (Day 0) and Day 56
2025-09-08
Participant Flow
This study was conducted at a single center in Canada.
A total of 217 participants were screened and enrolled of which 215 participants were randomized to receive treatment in 2 groups: Test Toothpaste group (107 participants) and Reference Toothpaste group (108 participants). 2 screened participants were not randomized in the study due to other reason (scheduling issue). All randomized participants completed the study.
Participant milestones
| Measure |
Test Toothpaste (Calcium Sodium Phosphosilicate [CSPS] Toothpaste)
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5.0 percent \[%\] weight by weight \[w/w\] CSPS and 1040 parts per million \[ppm\] fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
108
|
|
Overall Study
COMPLETED
|
107
|
108
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers
Baseline characteristics by cohort
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 13.53 • n=99 Participants
|
50.4 years
STANDARD_DEVIATION 12.76 • n=107 Participants
|
48.4 years
STANDARD_DEVIATION 13.26 • n=206 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
48 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
41 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and Day 56Population: mITT population included all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline DH efficacy assessment.
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's 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 (Day 0) was calculated by subtracting Baseline score from Day 56 score. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
|
-2.00 score on a scale
Standard Error 0.065
|
-0.20 score on a scale
Standard Error 0.065
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 56Population: mITT Population.
Tactile sensitivity was assessed for the 2 test teeth selected at Baseline by the examiner 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 dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the 2 'Test Teeth' selected at Baseline by the examiner. 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56
|
56.79 grams
Standard Error 1.721
|
3.92 grams
Standard Error 1.713
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Days 3, 7, 14 and 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's 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 2 'Test Teeth' selected at Baseline by examiner. Lower score=low degree of sensitivity. 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28
Change from Baseline at Day 3
|
-0.31 score on a scale
Standard Error 0.038
|
-0.12 score on a scale
Standard Error 0.038
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28
Change from Baseline at Day 7
|
-0.73 score on a scale
Standard Error 0.045
|
-0.12 score on a scale
Standard Error 0.045
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28
Change from Baseline at Day 14
|
-1.37 score on a scale
Standard Error 0.065
|
-0.14 score on a scale
Standard Error 0.065
|
|
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28
Change from Baseline at Day 28
|
-1.76 score on a scale
Standard Error 0.066
|
-0.20 score on a scale
Standard Error 0.066
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Days 3, 7, 14 and 28Population: mITT Population.
Tactile sensitivity was assessed for the 2 test teeth selected at Baseline by the examiner 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 dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20 g. Tactile threshold (g) was derived as the mean value for the 2 'Test Teeth' selected at Baseline by the examiner. 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Tactile Threshold (g) at Days 3, 7, 14 and 28
Change from Baseline at Day 3
|
8.05 grams
Standard Error 0.500
|
0.91 grams
Standard Error 0.497
|
|
Adjusted Mean Change From Baseline in Tactile Threshold (g) at Days 3, 7, 14 and 28
Change from Baseline at Day 7
|
16.79 grams
Standard Error 0.788
|
2.39 grams
Standard Error 0.784
|
|
Adjusted Mean Change From Baseline in Tactile Threshold (g) at Days 3, 7, 14 and 28
Change from Baseline at Day 14
|
28.56 grams
Standard Error 1.127
|
2.76 grams
Standard Error 1.121
|
|
Adjusted Mean Change From Baseline in Tactile Threshold (g) at Days 3, 7, 14 and 28
Change from Baseline at Day 28
|
44.08 grams
Standard Error 1.597
|
3.09 grams
Standard Error 1.590
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT Population.
The DHEQ is a validated, condition-specific measure of Oral Health-Related Quality of Life (OHRQoL) in relation to DH. 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 score 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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) at Days 28 and 56
Q7 (How intense are the sensations?): Change from Baseline at Day 28
|
-0.60 score on a scale
Standard Error 0.167
|
-0.26 score on a scale
Standard Error 0.143
|
|
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 (How intense are the sensations?): Change from Baseline at Day 56
|
-0.77 score on a scale
Standard Error 0.213
|
-0.18 score on a scale
Standard Error 0.161
|
|
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 (How bothered are you by any sensations?): Change from Baseline at Day 28
|
-0.63 score on a scale
Standard Error 0.196
|
-0.53 score on a scale
Standard Error 0.159
|
|
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 (How bothered are you by any sensations?): Change from Baseline at Day 56
|
-0.86 score on a scale
Standard Error 0.222
|
-0.54 score on a scale
Standard Error 0.173
|
|
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 (How well can you tolerate sensations?): Change from Baseline at Day 28
|
-0.45 score on a scale
Standard Error 0.202
|
-0.29 score on a scale
Standard Error 0.166
|
|
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 (How well can you tolerate sensations?): Change from Baseline at Day 56
|
-0.63 score on a scale
Standard Error 0.206
|
0.18 score on a scale
Standard Error 0.211
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT Population.
DHEQ is a validated, condition-specific measure of OHRQoL in relation to DH. Section 2 of DHEQ included 34 questions grouped into 5 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 as sum of all questions (Q1 to Q34) score 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 56 days.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56
Change from Baseline at Day 28
|
-5.77 score on a scale
Standard Error 2.756
|
-3.22 score on a scale
Standard Error 2.689
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56
Change from Baseline at Day 56
|
-18.71 score on a scale
Standard Error 3.465
|
-12.48 score on a scale
Standard Error 3.205
|
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 participant's teeth affected them 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-0.87 score on a scale
Standard Error 0.367
|
0.05 score on a scale
Standard Error 0.452
|
|
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
|
-2.82 score on a scale
Standard Error 0.503
|
-1.73 score on a scale
Standard Error 0.491
|
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 participant's teeth had forced them 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. 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-2.71 score on a scale
Standard Error 1.176
|
-0.57 score on a scale
Standard Error 1.059
|
|
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
|
-7.49 score on a scale
Standard Error 1.473
|
-4.46 score on a scale
Standard Error 1.294
|
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. 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 the score at each indicated timepoint. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-0.23 score on a scale
Standard Error 0.454
|
-0.36 score on a scale
Standard Error 0.503
|
|
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
|
-2.18 score on a scale
Standard Error 0.533
|
-1.41 score on a scale
Standard Error 0.480
|
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. Lower score indicated less effect of sensations on participant's emotions. 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-1.52 score on a scale
Standard Error 0.794
|
-1.54 score on a scale
Standard Error 0.743
|
|
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
|
-5.02 score on a scale
Standard Error 0.918
|
-3.51 score on a scale
Standard Error 0.820
|
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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-0.43 score on a scale
Standard Error 0.509
|
-0.80 score on a scale
Standard Error 0.475
|
|
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
|
-1.21 score on a scale
Standard Error 0.568
|
-1.37 score on a scale
Standard Error 0.489
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT Population.
Global Oral Health was evaluated using a single question of DHEQ about overall health of participant's mouth, teeth, and gums. 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.
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-0.06 score on a scale
Standard Error 0.070
|
-0.06 score on a scale
Standard Error 0.055
|
|
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
|
-0.07 score on a scale
Standard Error 0.070
|
-0.10 score on a scale
Standard Error 0.072
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28 and Day 56Population: mITT Population.
Effect on Life was evaluated using 4 questions 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
Outcome measures
| Measure |
Test Toothpaste (CSPS Toothpaste)
n=107 Participants
Participants were instructed to apply a ribbon of Test toothpaste (Toothpaste containing 5% w/w CSPS and 1040 ppm fluoride as sodium monofluorophosphate) and 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 2 'Test teeth' carefully first.
|
Reference Toothpaste (Regular Fluoride Toothpaste)
n=108 Participants
Participants were instructed to apply a ribbon of Reference toothpaste (Regular fluoride toothpaste containing 1100 ppm fluoride as sodium fluoride) and brush the entire dentition thoroughly for at least 1-timed minute, twice-daily (morning and evening) for approximately 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
|
-0.45 score on a scale
Standard Error 0.272
|
-0.63 score on a scale
Standard Error 0.225
|
|
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
|
-1.04 score on a scale
Standard Error 0.303
|
-0.87 score on a scale
Standard Error 0.247
|
Adverse Events
Test Toothpaste (CSPS Toothpaste)
Reference Toothpaste (Regular Fluoride Toothpaste)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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