The purpose of this study is to evaluate changes in oral health-related quality of life (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the use of anti-sensitivity toothpaste for 24 weeks.
This study will be a virtual, prospective, twenty-four weeks, open label study in participants with DH (self-reported symptoms). Participants self-perception of DH will be evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity Experience Questionnaire-48 \[DHEQ-48\]) at baseline, 4, 8, 12, 16, 20 and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
655
Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion.
GSK Investigational Site
Orlando, Florida, United States
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)
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
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.
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Time frame: Week 8
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12
All the participants scored question No. 1 to 3 (\[Q1: On a scale of 1 to 10 how intense are the sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, \[Q2: On a scale of 1 to 10 how bothered are you by any sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered\], \[Q3: On a scale of 1 to 10 how well can you tolerate sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all\]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16
All the participants scored question No. 1 to 3 (\[Q1: On a scale of 1 to 10 how intense are the sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, \[Q2: On a scale of 1 to 10 how bothered are you by any sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered\], \[Q3: On a scale of 1 to 10 how well can you tolerate sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all\]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20
All the participants scored question No. 1 to 3 (\[Q1: On a scale of 1 to 10 how intense are the sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, \[Q2: On a scale of 1 to 10 how bothered are you by any sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered\], \[Q3: On a scale of 1 to 10 how well can you tolerate sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all\]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24
All the participants scored question No. 1 to 3 (\[Q1: On a scale of 1 to 10 how intense are the sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, \[Q2: On a scale of 1 to 10 how bothered are you by any sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered\], \[Q3: On a scale of 1 to 10 how well can you tolerate sensations?\] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all\]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0)
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24
All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0)
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24
All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0)
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24
All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0)
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24
All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0)
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24
All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0)
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24
All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0)
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24
All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0)
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.
Time frame: Baseline (Day 0)
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 4
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 8
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 12
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 16
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 20
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24
All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.
Time frame: Week 24