Trial Outcomes & Findings for A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste (NCT NCT04964063)

NCT ID: NCT04964063

Last Updated: 2024-01-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 655 participants
• Primary outcome timeframe: Baseline (Day 0)
• Results posted on: 2024-01-22

Participant Flow

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.

A total of 801 participants were screened, 655 were enrolled, and 557 completed the study. A total of 98 participants discontinued the study.

Participant milestones

Measure	Sensodyne Fresh Mint Toothpaste Participants were asked to follow commercial tube instructions as recommended for sensitivity relief. Participants applied dentifrice containing 5 percent (%) weight/weight (w/w) potassium nitrate and 0.15% weight/volume (w/v) sodium fluoride oral topically for 24 weeks.
Overall Study STARTED	655
Overall Study COMPLETED	557
Overall Study NOT COMPLETED	98

Reasons for withdrawal

Measure	Sensodyne Fresh Mint Toothpaste Participants were asked to follow commercial tube instructions as recommended for sensitivity relief. Participants applied dentifrice containing 5 percent (%) weight/weight (w/w) potassium nitrate and 0.15% weight/volume (w/v) sodium fluoride oral topically for 24 weeks.
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	47
Overall Study Withdrawal by Subject	5
Overall Study Baseline Tasks Expired	41
Overall Study Participant withdrawn in error	1

Baseline Characteristics

A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste

Baseline characteristics by cohort

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
Age, Continuous	35.84 years STANDARD_DEVIATION 10.875 • n=5 Participants
Sex: Female, Male Female	446 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	483 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants
Race (NIH/OMB) Asian	63 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	118 Participants n=5 Participants
Race (NIH/OMB) White	353 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT Population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
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
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
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 outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
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
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
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

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
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
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
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 2.140

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
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
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
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

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
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
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
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

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
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
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
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

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
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
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
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

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT Population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
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 outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4	145.31 Score on a scale Standard Deviation 39.881

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8	133.93 Score on a scale Standard Deviation 45.319

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12	125.41 Score on a scale Standard Deviation 47.315

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16	120.48 Score on a scale Standard Deviation 49.014

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20	116.98 Score on a scale Standard Deviation 50.437

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24	112.62 Score on a scale Standard Deviation 50.250

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT Population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0)	21.56 Score on a scale Standard Deviation 4.417

PRIMARY outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4	18.92 Score on a scale Standard Deviation 5.432

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8	17.28 Score on a scale Standard Deviation 6.068

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12	15.80 Score on a scale Standard Deviation 6.344

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16	15.04 Score on a scale Standard Deviation 6.512

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20	14.52 Score on a scale Standard Deviation 6.724

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24	14.11 Score on a scale Standard Deviation 6.774

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT Population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0)	59.33 Score on a scale Standard Deviation 13.761

PRIMARY outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4	52.34 Score on a scale Standard Deviation 15.206

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8	47.80 Score on a scale Standard Deviation 17.266

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12	44.71 Score on a scale Standard Deviation 17.749

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16	42.71 Score on a scale Standard Deviation 18.378

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20	41.59 Score on a scale Standard Deviation 18.911

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24	40.48 Score on a scale Standard Deviation 18.578

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
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 outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4	18.95 Score on a scale Standard Deviation 7.026

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8	17.64 Score on a scale Standard Deviation 7.531

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12	16.61 Score on a scale Standard Deviation 7.708

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16	16.06 Score on a scale Standard Deviation 7.713

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20	15.68 Score on a scale Standard Deviation 7.785

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24	15.08 Score on a scale Standard Deviation 7.722

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
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 outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4	35.42 Score on a scale Standard Deviation 10.132

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8	32.55 Score on a scale Standard Deviation 11.197

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12	30.48 Score on a scale Standard Deviation 11.959

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16	29.43 Score on a scale Standard Deviation 12.425

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20	28.42 Score on a scale Standard Deviation 12.630

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24	27.18 Score on a scale Standard Deviation 12.641

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0)	21.86 Score on a scale Standard Deviation 7.800

PRIMARY outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4	19.68 Score on a scale Standard Deviation 7.847

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8	18.66 Score on a scale Standard Deviation 8.402

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12	17.82 Score on a scale Standard Deviation 8.573

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16	17.24 Score on a scale Standard Deviation 8.754

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20	16.76 Score on a scale Standard Deviation 8.708

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24	15.78 Score on a scale Standard Deviation 8.765

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT Population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
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 outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4	2.83 Score on a scale Standard Deviation 0.887

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8	2.78 Score on a scale Standard Deviation 0.883

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12	2.74 Score on a scale Standard Deviation 0.906

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16	2.72 Score on a scale Standard Deviation 0.904

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20	2.69 Score on a scale Standard Deviation 0.917

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24	2.65 Score on a scale Standard Deviation 0.898

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: mITT Population

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=577 Participants 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.
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 outcome

Timeframe: Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=546 Participants 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.
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4	6.71 Score on a scale Standard Deviation 3.190

PRIMARY outcome

Timeframe: Week 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=570 Participants 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.
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

PRIMARY outcome

Timeframe: Week 12

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=564 Participants 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.
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12	5.41 Score on a scale Standard Deviation 3.410

PRIMARY outcome

Timeframe: Week 16

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=549 Participants 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.
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

PRIMARY outcome

Timeframe: Week 20

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=522 Participants 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.
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

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

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.

Outcome measures

Measure	Sensodyne Fresh Mint Toothpaste n=560 Participants 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.
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

Adverse Events

Sensodyne Fresh Mint Toothpaste

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sensodyne Fresh Mint Toothpaste n=584 participants at risk 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.
Injury, poisoning and procedural complications Head Injury	0.17% 1/584 • Number of events 1 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Nervous system disorders Syncope	0.17% 1/584 • Number of events 1 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Anxiety	0.17% 1/584 • Number of events 1 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.

Other adverse events

Measure	Sensodyne Fresh Mint Toothpaste n=584 participants at risk 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.
Infections and infestations Covid-19	1.9% 11/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Infections and infestations Nasopharyngitis	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Infections and infestations Sinusitis	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Infections and infestations Influenza	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Infections and infestations Pharyngitis Streptococcal	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Attention Deficit Hyperactivity Disorder	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Insomnia	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Post-Traumatic Stress Disorder	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Borderline Personality Disorder	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Hallucination, Auditory	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Hallucination, Visual	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Gastrointestinal disorders Cheilitis	0.51% 3/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Gastrointestinal disorders Dental Caries	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Gastrointestinal disorders Hyperaesthesia Teeth	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Gastrointestinal disorders Lip Dry	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Gastrointestinal disorders Lip Oedema	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Injury, poisoning and procedural complications Ligament Sprain	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Injury, poisoning and procedural complications Overdose	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Injury, poisoning and procedural complications Subdural Haematoma	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Injury, poisoning and procedural complications Tooth Fracture	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Nervous system disorders Migraine	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Nervous system disorders Headache	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Metabolism and nutrition disorders Hypokalaemia	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Metabolism and nutrition disorders Vitamin D Deficiency	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Musculoskeletal and connective tissue disorders Back Pain	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Musculoskeletal and connective tissue disorders Joint Effusion	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Respiratory, thoracic and mediastinal disorders Tonsillolith	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Reproductive system and breast disorders Polycystic Ovaries	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Skin and subcutaneous tissue disorders Perioral Dermatitis	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Vascular disorders Hypotension	0.17% 1/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Psychiatric disorders Anxiety	0.34% 2/584 • From screening up to Week 24, up to approximately 168 days An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.

Additional Information

Haleon Response Center

HALEON

Phone: +447880182593

Email: ww.clinical-trial-register@haleon.com

Results disclosure agreements

• Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER