Trial Outcomes & Findings for Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health (NCT NCT02752958)
NCT ID: NCT02752958
Last Updated: 2018-08-27
Results Overview
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
COMPLETED
NA
75 participants
At Baseline and Week 4
2018-08-27
Participant Flow
This study had 2 centers in United Kingdom (UK) but, all the participants were recruited from the 1 center only.
A total of 163 participants were screened, of which 75 participants were enrolled and randomized in the study. A total of 88 participants were not randomized in study as 53 participants did not meet study criteria, 1 participant had adverse event (AE), 3 were lost to follow up, 6 had protocol violation and 25 due to other reason (not specified).
Participant milestones
| Measure |
Overall Study: Stannous Fluoride
This was a non-comparative design study, all the participants applied dentifrice containing 0.454% weight by weight (w/w) stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Overall Study: Stannous Fluoride
This was a non-comparative design study, all the participants applied dentifrice containing 0.454% weight by weight (w/w) stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Other (Reason not specified)
|
2
|
Baseline Characteristics
Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health
Baseline characteristics by cohort
| Measure |
Stannous Fluoride
n=75 Participants
Participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening).
|
|---|---|
|
Age, Continuous
|
38.2 Years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4
At Baseline
|
142.41 Score on a Scale
Standard Deviation 36.084
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4
At Week 4
|
135.24 Score on a Scale
Standard Deviation 34.745
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4
Change from Baseline at Week 4
|
-6.28 Score on a Scale
Standard Deviation 22.852
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8
At Baseline
|
142.41 Score on a Scale
Standard Deviation 36.084
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8
At Week 8
|
126.58 Score on a Scale
Standard Deviation 42.131
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8
Change from Baseline at Week 8
|
-16.33 Score on a Scale
Standard Deviation 32.512
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12
At Baseline
|
142.41 Score ona Scale
Standard Deviation 36.084
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12
At Week 12
|
120.39 Score ona Scale
Standard Deviation 44.694
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12
Change from Baseline at Week 12
|
-22.54 Score ona Scale
Standard Deviation 39.724
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16
At Baseline
|
142.41 Score ona Scale
Standard Deviation 36.084
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16
At Week 16
|
115.36 Score ona Scale
Standard Deviation 43.977
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16
Change from Baseline at Week 16
|
-27.68 Score ona Scale
Standard Deviation 38.654
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20
At Week 20
|
112.32 Score on a Scale
Standard Deviation 49.163
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20
Change from Baseline at Week 20
|
-30.58 Score on a Scale
Standard Deviation 42.591
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20
At Baseline
|
142.41 Score on a Scale
Standard Deviation 36.084
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment
All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24
Change from Baseline at Week 24
|
-31.70 Score on a Scale
Standard Deviation 44.268
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24
At Week 24
|
111.20 Score on a Scale
Standard Deviation 50.179
|
|
Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24
At Baseline
|
142.41 Score on a Scale
Standard Deviation 36.084
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4
At Baseline
|
19.55 Score on a scale
Standard Deviation 5.088
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4
At Week 4
|
18.24 Score on a scale
Standard Deviation 4.707
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4
Change from Baseline at Week 4
|
-1.21 Score on a scale
Standard Deviation 4.021
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8
At Baseline
|
19.55 Score ona scale
Standard Deviation 5.088
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8
At Week 8
|
16.86 Score ona scale
Standard Deviation 5.712
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8
Change from Baseline at Week 8
|
-2.75 Score ona scale
Standard Deviation 4.924
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12
At Baseline
|
19.55 Score on a scale
Standard Deviation 5.088
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12
At Week 12
|
16.31 Score on a scale
Standard Deviation 6.147
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12
Change from Baseline at Week 12
|
-3.19 Score on a scale
Standard Deviation 5.619
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16
At Baseline
|
19.55 Score on a Scale
Standard Deviation 5.088
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16
At Week 16
|
15.55 Score on a Scale
Standard Deviation 5.786
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16
Change from Baseline at Week 16
|
-3.98 Score on a Scale
Standard Deviation 5.284
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20
At Baseline
|
19.55 Score on a Scale
Standard Deviation 5.088
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20
At Week 20
|
15.50 Score on a Scale
Standard Deviation 6.422
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20
Change from Baseline at Week 20
|
-3.94 Score on a Scale
Standard Deviation 5.865
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24
Change from Baseline at Week 24
|
-4.53 Score on a Scale
Standard Deviation 5.717
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24
At Baseline
|
19.55 Score on a Scale
Standard Deviation 5.088
|
|
Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24
At Week 24
|
14.91 Score on a Scale
Standard Deviation 6.738
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4
At Baseline
|
53.12 Score on a scale
Standard Deviation 13.582
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4
At Week 4
|
51.42 Score on a scale
Standard Deviation 13.596
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4
Change from Baseline at Week 4
|
-1.46 Score on a scale
Standard Deviation 9.711
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8
At Baseline
|
53.12 Score on a scale
Standard Deviation 13.582
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8
At Week 8
|
46.43 Score on a scale
Standard Deviation 16.453
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8
Change from Baseline at Week 8
|
-6.80 Score on a scale
Standard Deviation 12.678
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12
At Baseline
|
53.12 Score on a scale
Standard Deviation 13.582
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12
At Week 12
|
45.04 Score on a scale
Standard Deviation 16.985
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12
Change from Baseline at Week 12
|
-8.27 Score on a scale
Standard Deviation 14.998
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16
At Baseline
|
53.12 Score on a Scale
Standard Deviation 13.582
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16
At Week 16
|
42.59 Score on a Scale
Standard Deviation 16.966
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16
Change from Baseline at Week 16
|
-10.45 Score on a Scale
Standard Deviation 15.037
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20
At Baseline
|
53.12 Score ona scale
Standard Deviation 13.582
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20
At Week 20
|
41.89 Score ona scale
Standard Deviation 18.607
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20
Change from Baseline at Week 20
|
-11.48 Score ona scale
Standard Deviation 15.304
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24
At Baseline
|
53.12 Score on a scale
Standard Deviation 13.582
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24
At Week 24
|
41.67 Score on a scale
Standard Deviation 19.449
|
|
Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24
Change from Baseline at Week 24
|
-11.71 Score on a scale
Standard Deviation 16.270
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4
At Baseline
|
17.99 Score on a Scale
Standard Deviation 6.138
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4
At Week 4
|
17.30 Score on a Scale
Standard Deviation 6.110
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4
Change from Baseline at Week 4
|
-0.57 Score on a Scale
Standard Deviation 4.265
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8
At Baseline
|
17.99 Score on a scale
Standard Deviation 6.138
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8
At Week 8
|
16.32 Score on a scale
Standard Deviation 6.701
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8
Change from Baseline at Week 8
|
-1.67 Score on a scale
Standard Deviation 5.524
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12
At Baseline
|
17.99 Score on a scale
Standard Deviation 6.138
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12
At Week 12
|
15.60 Score on a scale
Standard Deviation 6.787
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12
Change from Baseline at Week 12
|
-2.64 Score on a scale
Standard Deviation 6.459
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16
At Baseline
|
17.99 Score ona Scale
Standard Deviation 6.138
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16
At Week 16
|
14.44 Score ona Scale
Standard Deviation 6.528
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16
Change from Baseline at Week 16
|
-3.62 Score ona Scale
Standard Deviation 6.144
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20
At Baseline
|
17.99 Score on a scale
Standard Deviation 6.138
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20
At Week 20
|
13.79 Score on a scale
Standard Deviation 7.312
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20
Change from Baseline at Week 20
|
-4.33 Score on a scale
Standard Deviation 6.971
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24
At Baseline
|
17.99 Score on a scale
Standard Deviation 6.138
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24
At week 24
|
13.88 Score on a scale
Standard Deviation 7.154
|
|
Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24
Change from Baseline at Week 24
|
-4.24 Score on a scale
Standard Deviation 6.730
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4
At Baseline
|
35.48 Score on a Scale
Standard Deviation 9.106
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4
At Week 4
|
32.64 Score on a Scale
Standard Deviation 8.388
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4
Change from Baseline at Week 4
|
-2.40 Score on a Scale
Standard Deviation 6.649
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment
All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8
At Baseline
|
35.48 Score on a scale
Standard Deviation 9.106
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8
At Week 8
|
31.42 Score on a scale
Standard Deviation 10.322
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8
Change from Baseline at Week 8
|
-4.30 Score on a scale
Standard Deviation 8.742
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment
All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12
At Baseline
|
35.48 Score on a Scale
Standard Deviation 9.106
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12
At Week 12
|
28.79 Score on a Scale
Standard Deviation 11.518
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12
Change from Baseline at Week 12
|
-6.86 Score on a Scale
Standard Deviation 11.119
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessm
All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16
At Baseline
|
35.48 Score on a scale
Standard Deviation 9.106
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16
At Week 16
|
28.24 Score on a scale
Standard Deviation 10.722
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16
Change from Baseline at Week 16
|
-7.33 Score on a scale
Standard Deviation 10.316
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme
All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20
At Baseline
|
35.48 Score on a scale
Standard Deviation 9.106
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20
At week 20
|
27.32 Score on a scale
Standard Deviation 12.800
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20
Change from Baseline at Week 20
|
-8.17 Score on a scale
Standard Deviation 11.493
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment
All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24
At Baseline
|
35.48 Score on a scale
Standard Deviation 9.106
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24
At Week 24
|
27.03 Score on a scale
Standard Deviation 12.701
|
|
Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24
Change from Baseline at Week 24
|
-8.45 Score on a scale
Standard Deviation 12.158
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4
At Baseline
|
16.27 Score on a scale
Standard Deviation 7.256
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4
At Week 4
|
15.66 Score on a scale
Standard Deviation 7.300
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4
Change from Baseline at Week 4
|
-0.64 Score on a scale
Standard Deviation 5.804
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8
At Baseline
|
16.27 Score on a scale
Standard Deviation 7.256
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8
At Week 8
|
15.55 Score on a scale
Standard Deviation 7.295
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8
Change from Baseline at Week 8
|
-0.81 Score on a scale
Standard Deviation 6.314
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12
At Baseline
|
16.27 Score on a scale
Standard Deviation 7.256
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12
At Week 12
|
14.64 Score on a scale
Standard Deviation 7.404
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12
Change from Baseline at Week 12
|
-1.83 Score on a scale
Standard Deviation 7.305
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3 disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16
At Baseline
|
16.27 Score ona scale
Standard Deviation 7.256
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16
At Week 16
|
14.55 Score ona scale
Standard Deviation 8.079
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16
Change from Baseline at Week 16
|
-2.29 Score ona scale
Standard Deviation 8.105
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20
At Baseline
|
16.27 Score on a scale
Standard Deviation 7.256
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20
At Week 20
|
13.82 Score on a scale
Standard Deviation 8.320
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20
Change from Baseline at Week 20
|
-2.65 Score on a scale
Standard Deviation 8.950
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme
All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24
At Baseline
|
16.27 Score on a scale
Standard Deviation 7.256
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24
At Week 24
|
13.71 Score on a scale
Standard Deviation 8.364
|
|
Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24
Change from Baseline at Week 24
|
-2.76 Score on a scale
Standard Deviation 8.769
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme
All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4
At Baseline
|
3.38 Score on a scale
Standard Deviation 0.926
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4
At Week 4
|
3.24 Score on a scale
Standard Deviation 0.889
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4
Change from Baseline at Week 4
|
-0.14 Score on a scale
Standard Deviation 0.654
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8
At Baseline
|
3.38 Score on a scale
Standard Deviation 0.926
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8
At Week 8
|
3.32 Score on a scale
Standard Deviation 0.947
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8
Change from Baseline at Week 8
|
-0.04 Score on a scale
Standard Deviation 0.721
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12
At Baseline
|
3.38 Score on a scale
Standard Deviation 0.926
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12
At Week 12
|
3.27 Score on a scale
Standard Deviation 0.850
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12
Change from Baseline at Week 12
|
-0.12 Score on a scale
Standard Deviation 0.697
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16
At Baseline
|
3.38 Score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16
At Week 16
|
3.24 Score on a scale
Standard Deviation 0.912
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16
Change from Baseline at Week 16
|
-0.14 Score on a scale
Standard Deviation 0.788
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20
At Baseline
|
3.38 Score on a scale
Standard Deviation 0.926
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20
At Week 20
|
3.29 Score on a scale
Standard Deviation 0.941
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20
Change from Baseline at Week 20
|
-0.11 Score on a scale
Standard Deviation 0.831
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24
At Baseline
|
3.38 Score on a scale
Standard Deviation 0.926
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24
At Week 24
|
3.24 Score on a scale
Standard Deviation 0.946
|
|
Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24
Change from Baseline at Week 24
|
-0.15 Score on a scale
Standard Deviation 0.755
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4
At Baseline
|
6.56 Score on a scale
Standard Deviation 3.539
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4
At Week 4
|
5.88 Score on a scale
Standard Deviation 3.278
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4
Change from Baseline at Week 4
|
-0.64 Score on a scale
Standard Deviation 2.515
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8
At Baseline
|
6.56 Score on a scale
Standard Deviation 3.539
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8
At Week 8
|
5.12 Score on a scale
Standard Deviation 3.292
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8
Change from Baseline at Week 8
|
-1.43 Score on a scale
Standard Deviation 2.757
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
: All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12
At Baseline
|
6.56 Score on a scale
Standard Deviation 3.539
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12
At Week 12
|
4.70 Score on a scale
Standard Deviation 3.276
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12
Change from Baseline at Week 12
|
-1.87 Score on a scale
Standard Deviation 3.139
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16
At Baseline
|
6.56 Score on a scale
Standard Deviation 3.539
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16
At Week 16
|
4.42 Score on a scale
Standard Deviation 3.054
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16
Change from Baseline at Week 16
|
-2.12 Score on a scale
Standard Deviation 3.218
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20
At Baseline
|
6.56 Score on a scale
Standard Deviation 3.539
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20
At Week 20
|
4.29 Score on a scale
Standard Deviation 3.436
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20
Change from Baseline at Week 20
|
-2.32 Score on a scale
Standard Deviation 3.613
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24
At Baseline
|
6.56 Score on a scale
Standard Deviation 3.539
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24
At Week 24
|
4.29 Score on a scale
Standard Deviation 3.281
|
|
Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24
Change from Baseline at Week 24
|
-2.32 Score on a scale
Standard Deviation 3.407
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4
At Baseline
|
5.78 Score on a scale
Standard Deviation 1.677
|
|
Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4
At Week 4
|
4.85 Score on a scale
Standard Deviation 1.598
|
|
Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4
Change from Baseline at Week 4
|
-0.88 Score on a scale
Standard Deviation 1.805
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8
At Baseline
|
5.78 Score on a scale
Standard Deviation 1.677
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8
At Week 8
|
4.49 Score on a scale
Standard Deviation 1.720
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8
Change from Baseline at Week 8
|
-1.26 Score on a scale
Standard Deviation 1.968
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12
At Baseline
|
5.78 Score on a scale
Standard Deviation 1.677
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12
At Week 12
|
4.01 Score on a scale
Standard Deviation 1.830
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12
Change from Baseline at Week 12
|
-1.73 Score on a scale
Standard Deviation 2.139
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16
At Baseline
|
5.78 Score on a scale
Standard Deviation 1.677
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16
At Week 16
|
3.74 Score on a scale
Standard Deviation 1.809
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16
Change from Baseline at Week 16
|
-1.98 Score on a scale
Standard Deviation 2.042
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20
At Baseline
|
5.78 Score on a scale
Standard Deviation 1.677
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20
At Week 20
|
3.67 Score on a scale
Standard Deviation 1.940
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20
Change from Baseline at Week 20
|
-2.06 Score on a scale
Standard Deviation 2.045
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24
At Baseline
|
5.78 Score on a scale
Standard Deviation 1.677
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24
At Week 24
|
3.52 Score on a scale
Standard Deviation 1.791
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24
Change from Baseline at Week 24
|
-2.21 Score on a scale
Standard Deviation 2.116
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4
At Baseline
|
5.93 Score on a scale
Standard Deviation 2.226
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4
At Week 4
|
4.69 Score on a scale
Standard Deviation 1.924
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4
Change from Baseline at Week 4
|
-1.22 Score on a scale
Standard Deviation 2.014
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8
At Baseline
|
5.93 Score on a scale
Standard Deviation 2.226
|
|
Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8
At Week 8
|
4.51 Score on a scale
Standard Deviation 1.960
|
|
Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8
Change from Baseline at Week 8
|
-1.45 Score on a scale
Standard Deviation 2.304
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12
At Baseline
|
5.93 Score on a scale
Standard Deviation 2.226
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12
At Week 12
|
3.99 Score on a scale
Standard Deviation 2.054
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12
Change from Baseline at Week 12
|
-1.94 Score on a scale
Standard Deviation 2.670
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16
At Baseline
|
5.93 Score on a scale
Standard Deviation 2.226
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16
At Week 16
|
3.55 Score on a scale
Standard Deviation 1.773
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16
Change from Baseline at Week 16
|
-2.35 Score on a scale
Standard Deviation 2.657
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20
At Baseline
|
5.93 Score on a scale
Standard Deviation 2.226
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20
At Week 20
|
3.70 Score on a scale
Standard Deviation 2.068
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20
Change from Baseline at Week 20
|
-2.20 Score on a scale
Standard Deviation 2.591
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24
At Baseline
|
5.93 Score on a Scale
Standard Deviation 2.226
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24
At Week 24
|
3.41 Score on a Scale
Standard Deviation 1.848
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24
Change from Baseline at Week 24
|
-2.48 Score on a Scale
Standard Deviation 2.562
|
PRIMARY outcome
Timeframe: At Baseline and Week 4Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4
At Baseline
|
4.95 Score on a scale
Standard Deviation 2.040
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4
At Week 4
|
4.46 Score on a scale
Standard Deviation 1.861
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4
Change from Baseline at Week 4
|
-0.43 Score on a scale
Standard Deviation 1.885
|
PRIMARY outcome
Timeframe: At Baseline and Week 8Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8
At Baseline
|
4.95 Score on a scale
Standard Deviation 2.040
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8
At Week 8
|
4.29 Score on a scale
Standard Deviation 2.087
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8
Change from Baseline at Week 8
|
-0.67 Score on a scale
Standard Deviation 2.501
|
PRIMARY outcome
Timeframe: At Baseline and Week 12Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12
At Baseline
|
4.95 Score on a scale
Standard Deviation 2.040
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12
At Week 12
|
3.56 Score on a scale
Standard Deviation 1.878
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12
Change from Baseline at Week 12
|
-1.39 Score on a scale
Standard Deviation 2.373
|
PRIMARY outcome
Timeframe: At Baseline and Week 16Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16
At Baseline
|
4.95 Score on a scale
Standard Deviation 2.040
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16
At Week 16
|
3.47 Score on a scale
Standard Deviation 1.684
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16
Change from baseline at Week 16
|
-1.47 Score on a scale
Standard Deviation 2.374
|
PRIMARY outcome
Timeframe: At Baseline and Week 20Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20
At Baseline
|
4.95 Score on a scale
Standard Deviation 2.040
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20
At Week 20
|
3.76 Score on a scale
Standard Deviation 2.134
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20
Change from Baseline at Week 20
|
-1.17 Score on a scale
Standard Deviation 2.415
|
PRIMARY outcome
Timeframe: At Baseline and Week 24Population: The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.
All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.
Outcome measures
| Measure |
Stannous Fluoride
n=73 Participants
All the participants applied dentifrice containing 0.454% w/w stannous fluoride for 1 timed minute, twice daily (morning and evening) for 24 weeks.
|
|---|---|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24
At Baseline
|
4.95 Score on a scale
Standard Deviation 2.040
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24
At Week 24
|
3.36 Score on a scale
Standard Deviation 1.911
|
|
Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24
Change from baseline at Week 24
|
-1.56 Score on a scale
Standard Deviation 2.620
|
Adverse Events
Stannous Fluoride
Serious adverse events
| Measure |
Stannous Fluoride
n=75 participants at risk
Participants will brush with a full brush head of toothpaste for 1 timed minute (in their usual manner), twice daily (morning and evening) from baseline
|
|---|---|
|
Nervous system disorders
Syncope
|
1.3%
1/75 • Baseline to Week 24
|
Other adverse events
| Measure |
Stannous Fluoride
n=75 participants at risk
Participants will brush with a full brush head of toothpaste for 1 timed minute (in their usual manner), twice daily (morning and evening) from baseline
|
|---|---|
|
Infections and infestations
ORAL HERPES
|
9.3%
7/75 • Baseline to Week 24
|
|
Infections and infestations
GASTROENTERITIS
|
5.3%
4/75 • Baseline to Week 24
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.0%
3/75 • Baseline to Week 24
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
1.3%
1/75 • Baseline to Week 24
|
|
Infections and infestations
OTITIS MEDIA
|
1.3%
1/75 • Baseline to Week 24
|
|
Infections and infestations
TONSILLITIS BACTERIAL
|
1.3%
1/75 • Baseline to Week 24
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.3%
1/75 • Baseline to Week 24
|
|
Infections and infestations
PHARYNGITIS
|
1.3%
1/75 • Baseline to Week 24
|
|
Infections and infestations
CONJUNCTIVITIS
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.7%
5/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
5.3%
4/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
28.0%
21/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
LIP EXFOLIATION
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
LIP ULCERATION
|
2.7%
2/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
ORAL MUCOSAL ERYTHEMA
|
2.7%
2/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
VOMITING
|
2.7%
2/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
1.3%
1/75 • Baseline to Week 24
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
4.0%
3/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
4.0%
3/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
2.7%
2/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
EYELID INJURY
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
FACE INJURY
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC NECK SYNDROME
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
1.3%
1/75 • Baseline to Week 24
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
1.3%
1/75 • Baseline to Week 24
|
|
Nervous system disorders
HEADACHE
|
16.0%
12/75 • Baseline to Week 24
|
|
Product Issues
DEVICE FAILURE
|
4.0%
3/75 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.7%
2/75 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.3%
1/75 • Baseline to Week 24
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.3%
1/75 • Baseline to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
2.7%
2/75 • Baseline to Week 24
|
|
Ear and labyrinth disorders
EAR PAIN
|
1.3%
1/75 • Baseline to Week 24
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.3%
1/75 • Baseline to Week 24
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
1.3%
1/75 • Baseline to Week 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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