Real-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief

The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants scored each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at Week 24.

Restrictions domain of DHEQ evaluates 'the ways in which any sensations in teeth affects participants in their daily life'. It includes 4 questions, each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree, resulting in a total score ranging from 4 to 28. A lower score indicates that sensations have less effect on daily life. Changes from a baseline will be calculated by subtracting the baseline score from the score at Week 24.

Adaptation domain of DHEQ evaluates 'the ways in which the sensations in teeth forces participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. It includes 12 questions, each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranges from 12 to 84, where lower score indicates less effect of sensations on participant's daily life. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

Social Impact domain of DHEQ assesses how sensations affect participants in social situations. It includes 5 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35. A lower score indicates less effect of sensations on participant's social life. Change from baseline is calculated by subtracting the baseline score from score at Week 24.

Emotional Impact Domain of DHEQ is used to assess the emotional impact of sensations in participant's teeth. It includes 8 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them'. It includes 5 questions each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35, where lower score indicates less impact of sensations on participant's identity. Change from baseline is calculated by subtracting the baseline score from score at Week 24.

Impact on Everyday Life section of DHEQ includes 3 questions about participant's sensitive teeth and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranges from 1 to 10; where lower scores indicate less intense, less bothersome and tolerable sensations. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from baseline will be calculated by subtracting the baseline score from score at Week 24.

Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

Impact on Everyday Life section of DHEQ includes 3 questions about participant's sensitive teeth and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranges from 1 to 10; where lower scores indicate less intense, less bothersome and tolerable sensations. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants scored each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.

Restrictions domain of DHEQ evaluates 'the ways in which any sensations in teeth affects participants in their daily life'. It includes 4 questions, each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree, resulting in a total score ranging from 4 to 28. A lower score indicates that sensations have less effect on daily life. Changes from a baseline will be calculated by subtracting the baseline score from the score at the indicated timepoints.

Adaptation domain of DHEQ evaluates 'the ways in which the sensations in teeth forces participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. It includes 12 questions, each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranges from 12 to 84, where lower score indicates less effect of sensations on participant's daily life. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

Social Impact domain of DHEQ assesses how sensations affect participants in social situations. It includes 5 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35. A lower score indicates less effect of sensations on participant's social life. Change from baseline is calculated by subtracting the baseline score from score at the indicated timepoints.

Emotional Impact Domain of DHEQ is used to assess the emotional impact of sensations in participant's teeth. It includes 8 questions each will be scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them'. It includes 5 questions each will be scored using 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score ranges from 5 to 35, where lower score indicates less impact of sensations on participant's identity. Change from baseline is calculated by subtracting the baseline score from score at the indicated timepoints.

Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from baseline will be calculated by subtracting the baseline score from score at the indicated timepoints.

Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

The DHEQ is a condition-specific measure of OHrQoL in relation to DH. Five DHEQ domains include 34 questions grouped into separate domains: Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity. Participants will score each question using a 7-point scale ranging from 1(strongly disagree) to 7(strongly agree) where lower score indicates better quality of life in relation to DH. Scores 5 to 7 indicates agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree. Percentage of participants with scores 5 to 7 for each statement in the 5 DHEQ domains will be reported.

NPRS is an 11-point segmented numeric version of a Visual Analogue Scale from which the participant will select a score from 0 to 10 that best reflected the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher score is an indication of greater pain intensity. Change from Baseline will be calculated by subtracting the Baseline score from score at the indicated timepoints.

Participants will be asked to rate their satisfaction with the DH treatment using NRS. NRS is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the participant sought help from treatment. The score ranged from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicate greater satisfaction with DH treatment.