Trial Outcomes & Findings for A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management (NCT NCT06045026)
NCT ID: NCT06045026
Last Updated: 2025-04-24
Results Overview
Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
536 participants
Primary outcome timeframe
Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Results posted on
2025-04-24
Participant Flow
This study was conducted at one decentralized center in the United States.
A total of 680 participants were screened, of which 536 participants were enrolled, and 460 participants completed the study. A total of 76 participants discontinued from the study.
Participant milestones
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
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|---|---|
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Overall Study
STARTED
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536
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Overall Study
Safety Population
|
498
|
|
Overall Study
Modified Intent-to-treat (mITT) Population
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491
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Overall Study
COMPLETED
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460
|
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Overall Study
NOT COMPLETED
|
76
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Reasons for withdrawal
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
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|---|---|
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Overall Study
Lost to Follow-up
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60
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|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Withdrawal by Subject
|
3
|
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Overall Study
Enrollment closed
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1
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Baseline Characteristics
A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management
Baseline characteristics by cohort
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=498 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
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|---|---|
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Age, Continuous
|
38.6 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
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405 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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437 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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265 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African-American
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161 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian or Asian Indian
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed or Multiple Ethnic Groups
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population included all participants who completed at least one use of study product and had at least 1 post-baseline derived DHEQ total score. The Mixed Model with Repeated Measures (MMRM) included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
The DHEQ is a condition-specific measure of oral-health related quality-of-life (OHrQoL) in relation to dentin hypersensitivity (DH). Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better quality of life in relation to DH. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL.
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
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|---|---|
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Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-62.0 score on a scale
Standard Error 2.20
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-21.9 score on a scale
Standard Error 1.52
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-35.4 score on a scale
Standard Error 1.72
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-44.5 score on a scale
Standard Error 1.94
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-51.6 score on a scale
Standard Error 2.05
|
|
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-55.1 score on a scale
Standard Error 2.12
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PRIMARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
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|---|---|
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Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-6.1 score on a scale
Standard Error 0.27
|
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Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-7.2 score on a scale
Standard Error 0.28
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Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-2.6 score on a scale
Standard Error 0.20
|
|
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-4.7 score on a scale
Standard Error 0.24
|
|
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-7.9 score on a scale
Standard Error 0.29
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Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-8.5 score on a scale
Standard Error 0.30
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PRIMARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-18.6 score on a scale
Standard Error 0.77
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|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-20.3 score on a scale
Standard Error 0.79
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|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-7.4 score on a scale
Standard Error 0.58
|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-12.6 score on a scale
Standard Error 0.66
|
|
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-15.9 score on a scale
Standard Error 0.73
|
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Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-22.9 score on a scale
Standard Error 0.83
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Social Impact domain of DHEQ evaluates 'the way the sensations affect participants when they are with other people or in certain situations.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
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Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-5.7 score on a scale
Standard Error 0.30
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-6.6 score on a scale
Standard Error 0.31
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-8.1 score on a scale
Standard Error 0.33
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-2.9 score on a scale
Standard Error 0.25
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-4.6 score on a scale
Standard Error 0.29
|
|
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-7.2 score on a scale
Standard Error 0.32
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Emotional Impact Domain of DHEQ evaluated 'the way the sensations in participant's teeth make them feel.' It included 8 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL (less impact of sensations on participant's emotions).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
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|---|---|
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Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-6.2 score on a scale
Standard Error 0.42
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-9.6 score on a scale
Standard Error 0.47
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-11.6 score on a scale
Standard Error 0.52
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-13.2 score on a scale
Standard Error 0.54
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-13.6 score on a scale
Standard Error 0.55
|
|
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-15.4 score on a scale
Standard Error 0.58
|
PRIMARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-2.9 score on a scale
Standard Error 0.29
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-3.9 score on a scale
Standard Error 0.29
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-5.2 score on a scale
Standard Error 0.33
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-5.9 score on a scale
Standard Error 0.34
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-6.1 score on a scale
Standard Error 0.35
|
|
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-7.1 score on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
DHEQ Section 1 included 3 questions about participant's sensitive teeth and its impact on everyday life. Participants scored Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in intensity, botheration and tolerability of sensations.
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8
|
-2.3 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12
|
-2.7 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20
|
-3.1 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q1 (How intense are the sensations?): Change from Baseline at Week 4
|
-1.3 score on a scale
Standard Error 0.07
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q1 (How intense are the sensations?): Change from Baseline at Week 8
|
-1.9 score on a scale
Standard Error 0.07
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q1 (How intense are the sensations?): Change from Baseline at Week 12
|
-2.2 score on a scale
Standard Error 0.07
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q1 (How intense are the sensations?): Change from Baseline at Week 16
|
-2.4 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q1 (How intense are the sensations?): Change from Baseline at Week 20
|
-2.5 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q1 (How intense are the sensations?): Change from Baseline at Week 24
|
-2.9 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4
|
-1.6 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16
|
-3.0 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24
|
-3.4 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4
|
-0.9 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8
|
-1.4 score on a scale
Standard Error 0.08
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12
|
-1.7 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16
|
-2.0 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20
|
-2.1 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24
Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24
|
-2.4 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Global Oral Health was evaluated using a single question of DHEQ. Participants rated the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicated better oral health. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in global oral health.
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-0.1 score on a scale
Standard Error 0.03
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-0.2 score on a scale
Standard Error 0.03
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-0.1 score on a scale
Standard Error 0.03
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-0.2 score on a scale
Standard Error 0.04
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-0.3 score on a scale
Standard Error 0.04
|
|
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-0.3 score on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
Effect on life was evaluated using 4 questions of DHEQ (Section 2, Q36-39) about how much the sensations in teeth affected participant's life overall. Participants scored each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranged from 0 to 16, where lower score indicated less effect of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall quality of life (less effect of sensations on participant's life overall).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-4.2 score on a scale
Standard Error 0.17
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-4.6 score on a scale
Standard Error 0.17
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-2.0 score on a scale
Standard Error 0.14
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-3.2 score on a scale
Standard Error 0.15
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-3.8 score on a scale
Standard Error 0.17
|
|
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-5.1 score on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 24Population: mITT population. Only those participants available at the indicated timepoints were analyzed.
The DHEQ is a condition-specific measure of OHrQoL in relation to DH. Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1(strongly disagree) to 7(strongly agree) where lower score indicated better quality of life in relation to DH. Scores 5 to 7 indicated agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree. Percentage of participants with scores 5 to 7 for each statement in the 5 DHEQ domains were reported.
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q2 (Restrictions): At Week 24
|
27.6 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q3 (Restrictions): At Baseline
|
85.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q3 (Restrictions): At Week 24
|
36.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q4 (Restrictions): At Baseline
|
97.6 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q4 (Restrictions): At Week 24
|
53.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q8 (Adaptation): At Week 24
|
31.3 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q9 (Adaptation): At Baseline
|
69.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q13 (Adaptation): At Baseline
|
92.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q15 (Adaptation): At Baseline
|
79.8 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q15 (Adaptation): At Week 24
|
38.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q17 (Social Impact): At Baseline
|
73.3 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q17 (Social Impact): At Week 24
|
30.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q18 (Social Impact): At Baseline
|
81.1 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q18 (Social Impact): At Week 24
|
28.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q19 (Social Impact): At Baseline
|
58.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q20 (Social Impact): At Baseline
|
28.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q20 (Social Impact): At Week 24
|
14.1 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q21 (Social Impact): At Baseline
|
75.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q24 (Emotional Impact): At Week 24
|
52.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q25 (Emotional Impact): At Baseline
|
66.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q25 (Emotional Impact): At Week 24
|
33.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q27 (Emotional Impact): At Baseline
|
98.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q27 (Emotional Impact): At Week 24
|
55.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q28 (Emotional Impact): At Baseline
|
54.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q31 (Identity): At Week 24
|
32.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q32 (Identity): At Week 24
|
37.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q33 (Identity): At Baseline
|
63.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q33 (Identity): At Week 24
|
32.8 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q1 (Restrictions): At Baseline
|
95.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q1 (Restrictions): At Week 24
|
48.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q2 (Restrictions): At Baseline
|
68.8 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q5 (Adaptation): At Baseline
|
96.3 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q5 (Adaptation): At Week 24
|
46.1 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q6 (Adaptation): At Baseline
|
77.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q6 (Adaptation): At Week 24
|
31.1 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q7 (Adaptation): At Baseline
|
87.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q7 (Adaptation): At Week 24
|
40.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q8 (Adaptation): At Baseline
|
68.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q9 (Adaptation): At Week 24
|
35.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q10 (Adaptation): At Baseline
|
54.6 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q10 (Adaptation): At Week 24
|
23.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q11 (Adaptation): At Baseline
|
89.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q11 (Adaptation): At Week 24
|
41.3 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q12 (Adaptation): At Baseline
|
61.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q12 (Adaptation): At Week 24
|
25.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q13 (Adaptation): At Week 24
|
48.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q14 (Adaptation): At Baseline
|
71.1 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q14 (Adaptation): At Week 24
|
35.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q16 (Adaptation): At Baseline
|
77.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q16 (Adaptation): At Week 24
|
33.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q19 (Social Impact): At Week 24
|
23.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q21 (Social Impact): At Week 24
|
44.8 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q22 (Emotional Impact): At Baseline
|
84.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q22 (Emotional Impact): At Week 24
|
30.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q23 (Emotional Impact): At Baseline
|
91.0 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q23 (Emotional Impact): At Week 24
|
43.3 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q24 (Emotional Impact): At Baseline
|
96.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q26 (Emotional Impact): At Baseline
|
58.2 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q26 (Emotional Impact): At Week 24
|
33.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q28 (Emotional Impact): At Week 24
|
25.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q29 (Emotional Impact): At Baseline
|
81.5 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q29 (Emotional Impact): At Week 24
|
35.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q30 (Identity): At Baseline
|
50.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q30 (Identity): At Week 24
|
27.4 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q31 (Identity): At Baseline
|
60.9 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q32 (Identity): At Baseline
|
63.7 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q34 (Identity): At Baseline
|
72.1 percentage of participants
|
|
Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24
Q34 (Identity): At Week 24
|
35.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24Population: mITT population. The MMRM included all participants in the mITT population in each analysis. Number analyzed represents the number of participants with non-missing data in the MMRM at the indicated timepoint.
NPRS was an 11-point segmented numeric version of a Visual Analogue Scale from which the participant selected a score from 0 to 10 that best reflected the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher scores indicated of greater pain intensity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (reduction in pain intensity).
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 8
|
-2.2 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 1
|
-1.3 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 2
|
-1.5 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 4
|
-1.6 score on a scale
Standard Error 0.09
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 12
|
-2.4 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 16
|
-2.7 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 20
|
-2.8 score on a scale
Standard Error 0.10
|
|
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change from Baseline at Week 24
|
-3.2 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Week 24Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
Participants were asked to rate their satisfaction with the DH treatment using NRS. NRS is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the participant sought help from treatment. The score ranged from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicated greater satisfaction with DH treatment.
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=459 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Satisfaction Numeric Rating Scale (NRS) Score at Week 24
|
7.8 score on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: mITT population.
Participants described their oral hygiene habits by completion of an OHQ. It included 9 questions: Q1:How frequently do you normally brush your teeth? Q2:Have you had a professional or self-applied tooth whitening treatment in the last 2 weeks? Q3:Have you had a professional tooth cleaning in the last 2 weeks? Q4:Have you ever been diagnosed with sensitive teeth by a dentist? Q5: When was the last time you visited a dentist/hygienist? Q6:Do you use a toothpaste designed specifically for sensitive teeth? Q7:What brand of toothpaste do you most frequently use? Q8:What type of toothbrush do you use? Q9:Can you tell me if you have any of the following: Cracked tooth/ teeth Chipped tooth/teeth, Cold sores, Grinding teeth, Gum swelling/inflammation, Receding gums, Painful/tender gums when brushing, Ulcers in the mouth, Stained/yellow teeth, Seeing blood when you spit when you brush your teeth, Bad breath, None of these. Number of Participants with OHQ Responses at Baseline were reported.
Outcome measures
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=491 Participants
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q1: How frequently do you normally brush your teeth? - Twice a day
|
394 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q2: Have you had a professional or self-applied tooth whitening treatment in the last 2 weeks? -Yes
|
2 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q2: Have you had a professional or self-applied tooth whitening treatment in the last 2 weeks? - No
|
489 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q3: Have you had a professional tooth cleaning in the last 2 weeks? - Yes
|
12 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q4: Have you ever been diagnosed with sensitive teeth by a dentist? - No
|
308 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q5: When was the last time you visited a dentist/hygienist? - Within 6 months
|
256 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q5: When was the last time you visited a dentist/hygienist? - Within the last year
|
137 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q5: When was the last time you visited a dentist/hygienist? - Between 2 and 3 years
|
25 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q6: Do you use a toothpaste designed specifically for sensitive teeth? - Yes
|
91 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Private Label Toothpaste
|
6 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Toms Of Maine Toothpaste
|
14 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q8: What type of toothbrush do you use? - Manual toothbrush
|
255 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q8: What type of toothbrush do you use? - Both - manual and power brushes
|
99 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Chipped tooth or teeth
|
51 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Grinding teeth
|
65 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Gum swelling or inflammation
|
23 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - None of these
|
257 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Painful/tender gums when brushing
|
70 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Receding gums
|
41 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q1: How frequently do you normally brush your teeth? - 3 or more times a day
|
47 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q1: How frequently do you normally brush your teeth? - Once a day
|
48 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q1: How frequently do you normally brush your teeth? - Less Often
|
2 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q3: Have you had a professional tooth cleaning in the last 2 weeks? - No
|
479 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q4: Have you ever been diagnosed with sensitive teeth by a dentist? - Yes
|
183 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q5: When was the last time you visited a dentist/hygienist? - Within 2 years
|
46 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q5: When was the last time you visited a dentist/hygienist? - More than 3 years ago
|
27 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q6: Do you use a toothpaste designed specifically for sensitive teeth? - No
|
239 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q6: Do you use a toothpaste designed specifically for sensitive teeth? - Sometimes
|
149 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q6: Do you use a toothpaste designed specifically for sensitive teeth? - Unknown
|
12 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Act Toothpaste
|
1 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Aquafresh Toothpaste
|
3 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Arm & Hammer Toothpaste
|
20 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Biotene Toothpaste
|
1 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Burts Bees Toothpaste
|
6 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Colgate Toothpaste
|
168 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Crest Toothpaste
|
157 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Hello Toothpaste
|
9 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Jason Toothpaste
|
2 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Orajel Toothpaste
|
3 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Other Brand Toothpaste
|
18 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Parodontax Toothpaste
|
9 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Rembrandt Toothpaste
|
1 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Sensodyne Pronamel Toothpaste
|
33 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Sensodyne Toothpaste
|
38 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q7: What brand of toothpaste do you most frequently use? - Therabreath Toothpaste
|
2 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q8: What type of toothbrush do you use? - Power toothbrush
|
137 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Bad breath
|
41 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Cold sores
|
5 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Cracked tooth or teeth
|
19 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Seeing blood when you spit/brush your teeth
|
61 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Stained/yellow teeth
|
95 Participants
|
|
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
Q9: Can you tell me if you have any of the following? - Ulcers in the mouth
|
3 Participants
|
Adverse Events
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=498 participants at risk
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
Other adverse events
| Measure |
Anti-sensitivity Toothpaste (Sensodyne Repair and Protect)
n=498 participants at risk
Participants were instructed to brush their teeth (sensitive areas first) with anti-sensitivity toothpaste containing 0.454% SnF2 for at least 1 minute twice daily (morning and evening, not more than 3 times a day) according to the directions on the commercial pack for up to 24 weeks.
|
|---|---|
|
Infections and infestations
Covid-19
|
1.2%
6/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.80%
4/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Gingivitis
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Nasopharyngitis
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Sinusitis
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Conjunctivitis
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Influenza
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Lyme Disease
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Oral Herpes
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Pharyngitis
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Infections and infestations
Tooth Abscess
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.60%
3/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Gastrointestinal disorders
Toothache
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Gastrointestinal disorders
Dental Caries
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Gastrointestinal disorders
Hyperaesthesia Teeth
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Surgical and medical procedures
Tooth Extraction
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Surgical and medical procedures
Salpingectomy
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Psychiatric disorders
Depression
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Immune system disorders
Hypersensitivity
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.40%
2/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Nervous system disorders
Headache
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Renal and urinary disorders
Renal Cyst
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Investigations
Progesterone Decreased
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Metabolism and nutrition disorders
Gout
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
|
Vascular disorders
Hypertension
|
0.20%
1/498 • From Baseline (Week 0) up to Week 24 (up to approximately 168 days)
An adverse event (AE) was defined as any untoward medical occurrence in a study participant, temporally associated with the use of a study product, whether or not considered related to the study product. A Serious AE (SAE) was a particular category of an AE where the adverse outcome was serious. All-Cause Mortality included all enrolled participants. Serious and Other AEs: Safety population included all participants who completed at least 1 use of study product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER