Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate changes in oral health-related quality of life (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the use of anti-sensitivity toothpaste for 24 weeks.
This study will be a virtual, prospective, twenty-four weeks, open label study in participants with DH (self-reported symptoms). Participants self-perception of DH will be evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity Experience Questionnaire-48 [DHEQ-48]) at baseline, 4, 8, 12, 16, 20 and 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Other | Participants will be asked to follow commercial tube instructions as recommended for sensitivity relief: "Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing, Spit out after brushing." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Nitrate + Sodium Fluoride | Other | Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense were the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1 is equal to (=) not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered were you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well could you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in Oral Health-related Quality of Life (OHrQoL). Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense were the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered were you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well could you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
A participant whose sensitivity could be caused by other factors or clinical pathology as established by the screening questionnaire, which also includes:
A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: potassium nitrate (5 percent [%]), sodium fluoride (0.15% weight/volume [w/v] fluoride ion), water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | OBVIO HEALTH USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Orlando | Florida | 32817 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Not provided
A total of 801 participants were screened, 655 were enrolled, and 557 completed the study. A total of 98 participants discontinued the study.
This was a decentralized, prospective, 24-weeks, open label study in participants with dentine hypersensitivity (DH) (self-reported symptoms). All the participants were recruited through social media and other digital platforms.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sensodyne Fresh Mint Toothpaste | Participants were asked to follow commercial tube instructions as recommended for sensitivity relief. Participants applied dentifrice containing 5 percent (%) weight/weight (w/w) potassium nitrate and 0.15% weight/volume (w/v) sodium fluoride oral topically for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The modified Intent-To-Treat (mITT) population included all participants who had received at least one dose of study product and have at least one post baseline Dentine Hypersensitivity Experience Questionnaire (DHEQ)-48 questionnaire data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sensodyne Fresh Mint Toothpaste | Participants were asked to follow commercial tube instructions as recommended for sensitivity relief. Participants applied dentifrice containing 5% w/w potassium nitrate and 0.15% w/v sodium fluoride oral topically for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense were the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1 is equal to (=) not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered were you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well could you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in Oral Health-related Quality of Life (OHrQoL). Baseline was defined as Day 0 value. | mITT Population | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) |
|
From screening up to Week 24, up to approximately 168 days
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sensodyne Fresh Mint Toothpaste | Participants were asked to follow commercial tube instructions as recommended for sensitivity relief. Participants applied dentifrice containing 5% w/w potassium nitrate and 0.15% w/v sodium fluoride oral topically for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +447880182593 | ww.clinical-trial-register@haleon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2022 | Apr 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2022 | Apr 17, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C097427 | Sensodyne |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 8 |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0) | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0) | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0) | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0) | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0) | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0) | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0) | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0) | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | Baseline (Day 0) |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | Week 4 |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | Week 8 |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | Week 12 |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | Week 16 |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | Week 20 |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | Week 24 |
| Baseline Tasks Expired |
|
| Participant withdrawn in error |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sensodyne Fresh Mint Toothpaste |
Participants were asked to follow commercial tube instructions as recommended for sensitivity relief. Participants applied dentifrice containing 5% w/w potassium nitrate and 0.15% w/v sodium fluoride oral topically for 24 weeks. |
|
|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense were the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered were you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well could you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 | All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0) | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT Population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24 | All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0) | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT Population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24 | All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0) | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT Population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24 | All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0) | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24 | All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0) | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24 | All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0) | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24 | All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0) | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT Population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24 | All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0) | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value. | mITT Population | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) |
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 4 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 20 |
|
|
|
|
| Primary | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24 | All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. | mITT Population. Only those participants available at the indicated timepoints were analyzed. | Posted | Mean | Standard Deviation | Score on a scale | Week 24 |
|
|
|
|
| 0 |
| 584 |
| 2 |
| 584 |
| 41 |
| 584 |
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | Systematic Assessment |
|
| Attention Deficit Hyperactivity Disorder | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Post-Traumatic Stress Disorder | Psychiatric disorders | Systematic Assessment |
|
| Borderline Personality Disorder | Psychiatric disorders | Systematic Assessment |
|
| Hallucination, Auditory | Psychiatric disorders | Systematic Assessment |
|
| Hallucination, Visual | Psychiatric disorders | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperaesthesia Teeth | Gastrointestinal disorders | Systematic Assessment |
|
| Lip Dry | Gastrointestinal disorders | Systematic Assessment |
|
| Lip Oedema | Gastrointestinal disorders | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Subdural Haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint Effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tonsillolith | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Polycystic Ovaries | Reproductive system and breast disorders | Systematic Assessment |
|
| Perioral Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
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.
|
| <.0001 |
| Mean Difference (Final Values) |
| -1.61 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -1.77 |
| -1.45 |
Q2: How bothered are you by any sensation |
| Other |
| ANOVA | <.0001 | Mean Difference (Final Values) | -1.17 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -1.33 | -1.00 | Q3: How well can you tolerate sensations | Other |
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.17 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -2.33 |
| -2.02 |
Q2: How bothered are you by any sensation |
| Other |
| ANOVA | <.0001 | Mean Difference (Final Values) | -1.45 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -1.61 | -1.29 | Q3: How well can you tolerate sensations | Other |
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.63 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -2.79 |
| -2.47 |
Q2: How bothered are you by any sensation |
| Other |
| ANOVA | <.0001 | Mean Difference (Final Values) | -1.86 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -2.02 | -1.70 | Q3: How well can you tolerate sensations | Other |
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.89 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -3.05 |
| -2.73 |
Q2: How bothered are you by any sensation |
| Other |
| ANOVA | <.0001 | Mean Difference (Final Values) | -2.04 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -2.20 | -1.87 | Q3: How well can you tolerate sensations | Other |
|
| <.0001 |
| Mean Difference (Final Values) |
| -2.99 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -3.15 |
| -2.83 |
Q2: How bothered are you by any sensation |
| Other |
| ANOVA | <.0001 | Mean Difference (Final Values) | -2.18 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -2.35 | -2.02 | Q3: How well can you tolerate sensations | Other |
|
| <.0001 |
| Median Difference (Final Values) |
| -3.24 |
| Standard Error of the Mean |
| 0.09 |
| 2-Sided |
| 95 |
| -3.40 |
| -3.08 |
Q2: How bothered are you by any sensation |
| Other |
| ANOVA | <.0001 | Mean Difference (Final Values) | -2.37 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -2.53 | -2.21 | Q3: How well can you tolerate sensations | Other |