Dentin Sensitivity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERPotassium Nitrate + Sodium Fluoride
Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion.
Sponsors
HALEON
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of consent indicating that the participant has been informed of all pertinent aspects of the study. * The participant must be able to complete all activities as shown in the Schedule of Activities independently on their smart devices. * Participant who has tooth sensitivity (self-reported symptoms).
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 who has been/is on multiple prescription medications to treat severe acid reflux on regular basis or considered surgery for acid reflux * A participant with full or partial denture * A participant who has undergone treatment within 6 months of screening or is currently under treatment for periodontal or gum disease * A participant with active periodontitis * A participant with active caries * A participant with any chronic and/or severe painful health conditions which lead to regular use pain medications (more than 3 days a week) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 | 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. |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 | 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. |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 | 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. |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 | 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. |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 | 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. |
| Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24 | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0) | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4 | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8 | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12 | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16 | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20 | 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. |
| Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
A total of 801 participants were screened, 655 were enrolled, and 557 completed the study. A total of 98 participants discontinued the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 577 |
| Total | 577 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Baseline Tasks Expired | 41 |
| Overall Study | Lost to Follow-up | 47 |
| Overall Study | Participant withdrawn in error | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Sensodyne Fresh Mint Toothpaste |
|---|---|
| Age, Continuous | 35.84 years STANDARD_DEVIATION 10.875 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 86 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 483 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 63 Participants |
| Race (NIH/OMB) Black or African American | 118 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race (NIH/OMB) White | 353 Participants |
| Sex: Female, Male Female | 446 Participants |
| Sex: Female, Male Male | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 584 |
| other Total, other adverse events | 41 / 584 |
| serious Total, serious adverse events | 2 / 584 |
Outcome results
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 | Q1: How intense are the sensation | 3.61 Score on a scale | Standard Deviation 1.835 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 | Q2: How bothered are you by any sensation | 3.55 Score on a scale | Standard Deviation 2.007 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12 | Q3: How well can you tolerate sensations | 3.33 Score on a scale | Standard Deviation 1.949 |
p-value: <0.000195% CI: [-2.43, -2.15]ANOVA
p-value: <0.000195% CI: [-2.79, -2.47]ANOVA
p-value: <0.000195% CI: [-2.02, -1.7]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 | Q1: How intense are the sensation | 3.34 Score on a scale | Standard Deviation 1.892 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 | Q2: How bothered are you by any sensation | 3.26 Score on a scale | Standard Deviation 1.978 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16 | Q3: How well can you tolerate sensations | 3.14 Score on a scale | Standard Deviation 2.018 |
p-value: <0.000195% CI: [-3.05, -2.73]ANOVA
p-value: <0.000195% CI: [-2.2, -1.87]ANOVA
p-value: <0.000195% CI: [-2.68, -2.4]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 | Q1: How intense are the sensation | 3.20 Score on a scale | Standard Deviation 1.959 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 | Q2: How bothered are you by any sensation | 3.18 Score on a scale | Standard Deviation 2.041 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20 | Q3: How well can you tolerate sensations | 3.02 Score on a scale | Standard Deviation 2.015 |
p-value: <0.000195% CI: [-2.84, -2.55]ANOVA
p-value: <0.000195% CI: [-3.15, -2.83]ANOVA
p-value: <0.000195% CI: [-2.35, -2.02]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 | Q1: How intense are the sensation | 2.96 Score on a scale | Standard Deviation 1.861 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 | Q2: How bothered are you by any sensation | 2.93 Score on a scale | Standard Deviation 1.969 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24 | Q3: How well can you tolerate sensations | 2.81 Score on a scale | Standard Deviation 1.957 |
p-value: <0.000195% CI: [-3.08, -2.79]ANOVA
p-value: <0.000195% CI: [-3.4, -3.08]ANOVA
p-value: <0.000195% CI: [-2.53, -2.21]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 | Q1: How intense are the sensation | 4.54 Score on a scale | Standard Deviation 1.949 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 | Q2: How bothered are you by any sensation | 4.51 Score on a scale | Standard Deviation 2.149 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4 | Q3: How well can you tolerate sensations | 3.98 Score on a scale | Standard Deviation 2.095 |
p-value: <0.000195% CI: [-1.47, -1.19]ANOVA
p-value: <0.000195% CI: [-1.77, -1.45]ANOVA
p-value: <0.000195% CI: [-1.33, -1]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 | Q1: How intense are the sensation | 4.06 Score on a scale | Standard Deviation 1.924 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 | Q2: How bothered are you by any sensation | 3.99 Score on a scale | Standard Deviation 2.183 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8 | Q3: How well can you tolerate sensations | 3.74 Score on a scale | Standard Deviation 2.14 |
p-value: <0.000195% CI: [-1.98, -1.7]ANOVA
p-value: <0.000195% CI: [-2.33, -2.02]ANOVA
p-value: <0.000195% CI: [-1.61, -1.29]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) | Q1: How intense are the sensation | 5.90 score on a scale | Standard Deviation 1.731 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) | Q2: How bothered are you by any sensation | 6.17 score on a scale | Standard Deviation 2.045 |
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0) | Q3: How well can you tolerate sensations | 5.20 score on a scale | Standard Deviation 2.088 |
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.
Time frame: Baseline (Day 0)
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0) | 59.33 Score on a scale | Standard Deviation 13.761 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12 | 44.71 Score on a scale | Standard Deviation 17.749 |
p-value: <0.000195% CI: [-15.66, -13.42]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16 | 42.71 Score on a scale | Standard Deviation 18.378 |
p-value: <0.000195% CI: [-17.67, -15.41]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20 | 41.59 Score on a scale | Standard Deviation 18.911 |
p-value: <0.000195% CI: [-18.87, -16.58]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24 | 40.48 Score on a scale | Standard Deviation 18.578 |
p-value: <0.000195% CI: [-19.96, -17.72]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4 | 52.34 Score on a scale | Standard Deviation 15.206 |
p-value: <0.000195% CI: [-7.46, -5.2]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8 | 47.80 Score on a scale | Standard Deviation 17.266 |
p-value: <0.000195% CI: [-12.64, -10.41]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0) | 8.52 Score on a scale | Standard Deviation 3.326 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12 | 5.41 Score on a scale | Standard Deviation 3.41 |
p-value: <0.000195% CI: [-3.35, -2.84]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16 | 5.05 Score on a scale | Standard Deviation 3.404 |
p-value: <0.000195% CI: [-3.69, -3.19]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20 | 4.69 Score on a scale | Standard Deviation 3.362 |
p-value: <0.000195% CI: [-4.06, -3.55]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24 | 4.25 Score on a scale | Standard Deviation 3.421 |
p-value: <0.000195% CI: [-4.51, -4]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4 | 6.71 Score on a scale | Standard Deviation 3.19 |
p-value: <0.000195% CI: [-1.95, -1.45]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8 | 5.81 Score on a scale | Standard Deviation 3.304 |
p-value: <0.000195% CI: [-2.94, -2.44]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0) | 41.10 Score on a scale | Standard Deviation 8.279 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12 | 30.48 Score on a scale | Standard Deviation 11.959 |
p-value: <0.000195% CI: [-11.35, -9.75]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16 | 29.43 Score on a scale | Standard Deviation 12.425 |
p-value: <0.000195% CI: [-12.41, -10.79]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20 | 28.42 Score on a scale | Standard Deviation 12.63 |
p-value: <0.000195% CI: [-13.45, -11.81]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24 | 27.18 Score on a scale | Standard Deviation 12.641 |
p-value: <0.000195% CI: [-14.69, -13.08]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4 | 35.42 Score on a scale | Standard Deviation 10.132 |
p-value: <0.000195% CI: [-6.06, -4.44]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8 | 32.55 Score on a scale | Standard Deviation 11.197 |
p-value: <0.000195% CI: [-9.32, -7.72]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0) | 2.90 Score on a scale | Standard Deviation 0.935 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12 | 2.74 Score on a scale | Standard Deviation 0.906 |
p-value: <0.000195% CI: [-0.23, -0.1]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16 | 2.72 Score on a scale | Standard Deviation 0.904 |
p-value: <0.000195% CI: [-0.24, -0.11]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20 | 2.69 Score on a scale | Standard Deviation 0.917 |
p-value: <0.000195% CI: [-0.26, -0.13]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24 | 2.65 Score on a scale | Standard Deviation 0.898 |
p-value: <0.000195% CI: [-0.31, -0.18]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4 | 2.83 Score on a scale | Standard Deviation 0.887 |
p-value: 0.109195% CI: [-0.12, 0.01]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8 | 2.78 Score on a scale | Standard Deviation 0.883 |
p-value: <0.000195% CI: [-0.19, -0.06]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0) | 21.86 Score on a scale | Standard Deviation 7.8 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12 | 17.82 Score on a scale | Standard Deviation 8.573 |
p-value: <0.000195% CI: [-4.53, -3.44]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16 | 17.24 Score on a scale | Standard Deviation 8.754 |
p-value: <0.000195% CI: [-5.1, -4]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20 | 16.76 Score on a scale | Standard Deviation 8.708 |
p-value: <0.000195% CI: [-5.6, -4.48]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24 | 15.78 Score on a scale | Standard Deviation 8.765 |
p-value: <0.000195% CI: [-6.62, -5.53]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4 | 19.68 Score on a scale | Standard Deviation 7.847 |
p-value: <0.000195% CI: [-2.43, -1.33]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8 | 18.66 Score on a scale | Standard Deviation 8.402 |
p-value: <0.000195% CI: [-3.74, -2.65]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0) | 21.56 Score on a scale | Standard Deviation 4.417 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12 | 15.80 Score on a scale | Standard Deviation 6.344 |
p-value: <0.000195% CI: [-6.13, -5.28]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16 | 15.04 Score on a scale | Standard Deviation 6.512 |
p-value: <0.000195% CI: [-6.88, -6.02]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20 | 14.52 Score on a scale | Standard Deviation 6.724 |
p-value: <0.000195% CI: [-7.45, -6.58]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24 | 14.11 Score on a scale | Standard Deviation 6.774 |
p-value: <0.000195% CI: [-7.87, -7.01]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4 | 18.92 Score on a scale | Standard Deviation 5.432 |
p-value: <0.000195% CI: [-2.88, -2.02]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8 | 17.28 Score on a scale | Standard Deviation 6.068 |
p-value: <0.000195% CI: [-4.69, -3.85]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0) | 21.35 Score on a scale | Standard Deviation 6.847 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12 | 16.61 Score on a scale | Standard Deviation 7.708 |
p-value: <0.000195% CI: [-5.15, -4.2]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16 | 16.06 Score on a scale | Standard Deviation 7.713 |
p-value: <0.000195% CI: [-5.72, -4.76]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20 | 15.68 Score on a scale | Standard Deviation 7.785 |
p-value: <0.000195% CI: [-6.12, -5.14]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24 | 15.08 Score on a scale | Standard Deviation 7.722 |
p-value: <0.000195% CI: [-6.72, -5.77]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4 | 18.95 Score on a scale | Standard Deviation 7.026 |
p-value: <0.000195% CI: [-2.52, -1.56]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8 | 17.64 Score on a scale | Standard Deviation 7.531 |
p-value: <0.000195% CI: [-4.17, -3.22]ANOVA
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.
Time frame: Baseline (Day 0)
Population: mITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0) | 165.20 Score on a scale | Standard Deviation 35.554 |
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.
Time frame: Week 12
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12 | 125.41 Score on a scale | Standard Deviation 47.315 |
p-value: <0.000195% CI: [-42.3, -36.59]ANOVA
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.
Time frame: Week 16
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16 | 120.48 Score on a scale | Standard Deviation 49.014 |
p-value: <0.000195% CI: [-47.24, -41.49]ANOVA
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.
Time frame: Week 20
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20 | 116.98 Score on a scale | Standard Deviation 50.437 |
p-value: <0.000195% CI: [-50.96, -45.12]ANOVA
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.
Time frame: Week 24
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24 | 112.62 Score on a scale | Standard Deviation 50.25 |
p-value: <0.000195% CI: [-55.33, -49.62]ANOVA
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.
Time frame: Week 4
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4 | 145.31 Score on a scale | Standard Deviation 39.881 |
p-value: <0.000195% CI: [-20.81, -15.05]ANOVA
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.
Time frame: Week 8
Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensodyne Fresh Mint Toothpaste | Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8 | 133.93 Score on a scale | Standard Deviation 45.319 |
p-value: <0.000195% CI: [-34.04, -28.36]ANOVA