Dentin Sensitivity
Conditions
Brief summary
This study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) on oral health related quality of life (OHrQoL) in a population of self-reported dentin hypersensitivity (DH) sufferers. Data generated will provide real world information on the DH experience and DH management with a daily use anti-sensitivity treatment.
Detailed description
This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste). OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.
Interventions
OTHERStannous fluoride
Anti-sensitivity toothpaste containing 0.454% Stannous Fluoride
Sponsors
HALEON
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant who has provided consent indicating they have been informed of all pertinent aspects of the study. * All genders who, at the time of screening, are aged between 18 and 65 years (inclusive). * Participant who is willing to complete all the assigned activities. * Participant who is able to independently complete all the assigned activities on their smart devices. * Participant who has tooth sensitivity (self-reported symptoms).
Exclusion criteria
* Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include: 1. Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux. 2. Participant with full or partial denture(s). 3. Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease. 4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis. 5. Participant who has been informed by a DHCP that they have active caries. 6. Participant with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications (more than 3 days a week). * Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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. |
| Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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). |
| Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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). |
| Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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). |
| Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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). |
| Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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. |
| Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline | Baseline (Week 0) | 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. |
| Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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. |
| 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 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24 | 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). |
| 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 | Baseline (Week 0) and Week 24 | 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. |
| Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24 | Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24 | 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). |
| Satisfaction Numeric Rating Scale (NRS) Score at Week 24 | Week 24 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at one decentralized center in the United States.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) 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. | 498 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Enrollment closed | 1 |
| Overall Study | Lost to Follow-up | 60 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 437 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian or Asian Indian | 38 Participants |
| Race/Ethnicity, Customized Black or African-American | 161 Participants |
| Race/Ethnicity, Customized Mixed or Multiple Ethnic Groups | 24 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 3 Participants |
| Race/Ethnicity, Customized White | 265 Participants |
| Sex: Female, Male Female | 405 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 536 |
| other Total, other adverse events | 42 / 498 |
| serious Total, serious adverse events | 1 / 498 |
Outcome results
Primary
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Primary
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Primary
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Primary
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.2 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.3 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Primary
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.3 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Primary
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 2.2 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Secondary
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
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).
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Change from Baseline at Week 4p-value: 0.01Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Secondary
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
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.
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Comparison: Q1 (How intense are the sensations?): Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q1 (How intense are the sensations?): Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q1 (How intense are the sensations?): Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q1 (How intense are the sensations?): Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q1 (How intense are the sensations?): Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q1 (How intense are the sensations?): Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Secondary
Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24
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).
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.1 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.1 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.1 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 0.1 |
Comparison: Change from Baseline at Week 1p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 2p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 4p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 8p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 12p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 16p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 20p-value: <0.0001Mixed Model with Repeated Measures
Comparison: Change from Baseline at Week 24p-value: <0.0001Mixed Model with Repeated Measures
Secondary
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline
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.
Time frame: Baseline (Week 0)
Population: mITT population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline | Q1: How frequently do you normally brush your teeth? - Less Often | 2 Participants |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline | Q8: What type of toothbrush do you use? - Manual toothbrush | 255 Participants |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline | Q8: What type of toothbrush do you use? - Power toothbrush | 137 Participants |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
Secondary
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
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.
Time frame: Baseline (Week 0) and Week 24
Population: mITT population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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 |
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | 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
Satisfaction Numeric Rating Scale (NRS) Score at Week 24
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.
Time frame: Week 24
Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-sensitivity Toothpaste (Sensodyne Repair and Protect) | Satisfaction Numeric Rating Scale (NRS) Score at Week 24 | 7.8 score on a scale | Standard Deviation 2.1 |