Trial Outcomes & Findings for Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth (NCT NCT05243745)

Results Overview

Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter(mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Baseline (Day 0)

Results posted on

2024-09-20

Participant Flow

The study was conducted at a single center in the United Kingdom.

A total of 133 participants were screened of which 120 participants were randomized to a treatment with either one of the 4 products: test product (combination toothpaste of 3 percent \[%\] methyl vinyl ether/maleic anhydride co-polymer \[PVM/MA\] + 5% Potassium Nitrate \[KNO3\]), comparator 1 (toothpaste containing 3% PVM/MA), comparator 2 (toothpaste containing 5% KNO3), or negative control (a regular fluoride toothpaste).

Participant milestones

Participant milestones
Measure	Test Product Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3 % PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 1 Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Overall Study STARTED	29	31	31	29
Overall Study COMPLETED	29	31	30	28
Overall Study NOT COMPLETED	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Product Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3 % PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 1 Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Overall Study Withdrawal by Subject	0	0	0	1
Overall Study Unable to Attend Visit 6	0	0	1	0

Baseline Characteristics

Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Total n=120 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 13.93 • n=5 Participants	41.5 years STANDARD_DEVIATION 12.20 • n=7 Participants	41.9 years STANDARD_DEVIATION 14.29 • n=5 Participants	40.9 years STANDARD_DEVIATION 15.10 • n=4 Participants	42.2 years STANDARD_DEVIATION 13.80 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	25 Participants n=7 Participants	26 Participants n=5 Participants	22 Participants n=4 Participants	91 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	29 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	25 Participants n=5 Participants	29 Participants n=7 Participants	26 Participants n=5 Participants	24 Participants n=4 Participants	104 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: The modified intent-to-treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one post-baseline clinical performance assessment (Schiff sensitivity assessment or Tactile sensitivity assessment).

Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 millimeter(mm) coronal to gingival margin from a distance of approximately 1 centimeter(cm). Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)	2.44 score on a scale Standard Deviation 0.442	2.44 score on a scale Standard Deviation 0.442	2.34 score on a scale Standard Deviation 0.356	2.43 score on a scale Standard Deviation 0.438

PRIMARY outcome

Timeframe: Day 3

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3	1.41 score on a scale Standard Deviation 0.681	1.88 score on a scale Standard Deviation 0.456	2.09 score on a scale Standard Deviation 0.431	1.31 score on a scale Standard Deviation 0.618

PRIMARY outcome

Timeframe: Day 14

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=27 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14	1.00 score on a scale Standard Deviation 0.567	1.37 score on a scale Standard Deviation 0.414	2.10 score on a scale Standard Deviation 0.387	0.69 score on a scale Standard Deviation 0.419

PRIMARY outcome

Timeframe: Day 28

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=26 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=25 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28	0.92 score on a scale Standard Deviation 0.588	1.13 score on a scale Standard Deviation 0.414	2.10 score on a scale Standard Deviation 0.375	0.52 score on a scale Standard Deviation 0.510

PRIMARY outcome

Timeframe: Day 56

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Evaporative (air) sensitivity was assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3; 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Mean was calculated once by selecting 2 test teeth located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56	0.69 score on a scale Standard Deviation 0.441	1.17 score on a scale Standard Deviation 0.547	2.02 score on a scale Standard Deviation 0.396	0.33 score on a scale Standard Deviation 0.449

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: The mITT population.

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (grams \[g\]). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)	11.94 grams Standard Deviation 3.577	12.74 grams Standard Deviation 4.049	12.24 grams Standard Deviation 3.681	12.76 grams Standard Deviation 3.429

PRIMARY outcome

Timeframe: Day 3

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3	40.00 grams Standard Deviation 9.718	27.59 grams Standard Deviation 9.026	22.14 grams Standard Deviation 7.985	46.38 grams Standard Deviation 12.528

PRIMARY outcome

Timeframe: Day 14

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=27 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14	48.62 grams Standard Deviation 8.752	40.33 grams Standard Deviation 8.087	24.83 grams Standard Deviation 7.498	58.15 grams Standard Deviation 11.107

PRIMARY outcome

Timeframe: Day 28

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=26 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=25 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28	51.83 grams Standard Deviation 9.237	48.50 grams Standard Deviation 8.320	25.38 grams Standard Deviation 5.463	62.60 grams Standard Deviation 12.675

PRIMARY outcome

Timeframe: Day 56

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56	58.23 grams Standard Deviation 11.514	48.83 grams Standard Deviation 9.886	28.57 grams Standard Deviation 6.920	67.93 grams Standard Deviation 12.992

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: The mITT population.

Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) at Baseline (Day 0)	3.68 sensitive teeth Standard Deviation 1.137	3.68 sensitive teeth Standard Deviation 1.249	3.24 sensitive teeth Standard Deviation 0.577	3.79 sensitive teeth Standard Deviation 1.373

PRIMARY outcome

Timeframe: Day 3

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Comparator 1 n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3	3.36 sensitive teeth Standard Deviation 1.367	3.72 sensitive teeth Standard Deviation 1.279	3.25 sensitive teeth Standard Deviation 0.585	3.48 sensitive teeth Standard Deviation 1.573

PRIMARY outcome

Timeframe: Day 14

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Comparator 1 n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=27 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14	3.10 sensitive teeth Standard Deviation 1.496	3.60 sensitive teeth Standard Deviation 1.303	3.24 sensitive teeth Standard Deviation 0.577	2.59 sensitive teeth Standard Deviation 1.394

PRIMARY outcome

Timeframe: Day 28

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Comparator 1 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=26 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=25 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28	2.93 sensitive teeth Standard Deviation 1.617	3.30 sensitive teeth Standard Deviation 1.466	3.27 sensitive teeth Standard Deviation 0.604	2.24 sensitive teeth Standard Deviation 2.026

PRIMARY outcome

Timeframe: Day 56

Population: The mITT population. Here, overall number analyzed is the number of participants with data available for analyses for this outcome measure.

Sensitive teeth were defined as teeth with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus). A decrease in the mean number of sensitive teeth indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=30 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=28 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56	2.35 sensitive teeth Standard Deviation 1.380	3.17 sensitive teeth Standard Deviation 1.621	3.25 sensitive teeth Standard Deviation 0.585	1.72 sensitive teeth Standard Deviation 1.771

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface,approximately 1-2 mm coronal to gingival margin from approximately 1 cm. Participant response to stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative stimulus. Score ranged from 0-3;0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of stimulus. A decrease in Schiff sensitivity score indicated an improvement in sensitivity. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56 Baseline (Day 0)	2.44 score on a scale Standard Deviation 0.442	2.44 score on a scale Standard Deviation 0.442	2.34 score on a scale Standard Deviation 0.356	2.43 score on a scale Standard Deviation 0.438
Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-1.04 score on a scale Standard Deviation 0.666	-0.57 score on a scale Standard Deviation 0.513	-0.25 score on a scale Standard Deviation 0.347	-1.12 score on a scale Standard Deviation 0.622
Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-1.43 score on a scale Standard Deviation 0.513	-1.05 score on a scale Standard Deviation 0.531	-0.24 score on a scale Standard Deviation 0.344	-1.70 score on a scale Standard Deviation 0.505
Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-1.53 score on a scale Standard Deviation 0.556	-1.32 score on a scale Standard Deviation 0.445	-0.29 score on a scale Standard Deviation 0.404	-1.94 score on a scale Standard Deviation 0.441
Change From Baseline in Schiff Sensitivity Score at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-1.74 score on a scale Standard Deviation 0.546	-1.28 score on a scale Standard Deviation 0.552	-0.34 score on a scale Standard Deviation 0.361	-2.10 score on a scale Standard Deviation 0.507

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

Tactile sensitivity was assessed for teeth using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline, the maximum force was 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit, the tactile threshold was recorded as \>20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A positive change from Baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56 Baseline (Day 0)	11.94 grams Standard Deviation 3.577	12.74 grams Standard Deviation 4.049	12.24 grams Standard Deviation 3.681	12.76 grams Standard Deviation 3.429
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56 Change from Baseline at Day 3	27.86 grams Standard Deviation 10.131	15.34 grams Standard Deviation 7.898	9.82 grams Standard Deviation 8.442	33.62 grams Standard Deviation 11.642
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56 Change from Baseline at Day 14	36.55 grams Standard Deviation 8.462	27.50 grams Standard Deviation 8.279	12.59 grams Standard Deviation 7.975	45.19 grams Standard Deviation 9.556
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56 Change from Baseline at Day 28	40.17 grams Standard Deviation 9.421	36.00 grams Standard Deviation 7.812	13.85 grams Standard Deviation 5.883	49.60 grams Standard Deviation 12.493
Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56 Change from Baseline at Day 56	46.29 grams Standard Deviation 12.448	36.00 grams Standard Deviation 10.372	16.61 grams Standard Deviation 8.057	55.17 grams Standard Deviation 12.711

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

The DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of two sections. Section 1 included 9 questions about participant's sensitive teeth and the impact it has on participant's everyday life. All participants scored question number 7 to 9. Question (Q)7 (On a scale of 1 to 10 how intense are the sensations) was scored from 1=not at all intense to 10=worst imaginable; Q8 (On a scale of 1 to 10 how bothered are you by any sensations?) was scored from 1=not at all bothered to 10=extremely bothered; Q9 (On a scale of 1 to 10 how well you can tolerate the sensations?) was scored from 1=can easily tolerate to 10=can't tolerate at all. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated an improvement (less impact of tooth sensitivity on participant's everyday life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q7 (On a scale of 1 to 10 how intense are the sensations?): Baseline (Day 0)	5.32 score on a scale Standard Deviation 1.939	4.77 score on a scale Standard Deviation 1.668	4.86 score on a scale Standard Deviation 1.552	5.66 score on a scale Standard Deviation 1.987
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q7 (On a scale of 1 to 10 how intense are the sensations?): Change from Baseline at Day 3	0.04 score on a scale Standard Deviation 1.036	-0.28 score on a scale Standard Deviation 0.841	-0.21 score on a scale Standard Deviation 1.343	-0.62 score on a scale Standard Deviation 1.208
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q7 (On a scale of 1 to 10 how intense are the sensations?): Change from Baseline at Day 14	-0.83 score on a scale Standard Deviation 1.947	-1.00 score on a scale Standard Deviation 1.114	-0.45 score on a scale Standard Deviation 1.703	-1.37 score on a scale Standard Deviation 1.757
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q7 (On a scale of 1 to 10 how intense are the sensations?): Change from Baseline at Day 28	-0.93 score on a scale Standard Deviation 1.617	-1.10 score on a scale Standard Deviation 1.373	-0.81 score on a scale Standard Deviation 1.575	-1.04 score on a scale Standard Deviation 1.791
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q7 (On a scale of 1 to 10 how intense are the sensations?): Change from Baseline at Day 56	-1.39 score on a scale Standard Deviation 1.838	-1.77 score on a scale Standard Deviation 1.431	-0.86 score on a scale Standard Deviation 1.820	-1.07 score on a scale Standard Deviation 1.850
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q8 (On a scale of 1 to 10 how bothered are you by any sensations?): Baseline (Day 0)	4.97 score on a scale Standard Deviation 2.008	4.52 score on a scale Standard Deviation 2.111	4.41 score on a scale Standard Deviation 2.009	5.10 score on a scale Standard Deviation 2.540
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q8 (On a scale of 1 to 10 how bothered are you by any sensations?): Change from Baseline at Day 3	-0.18 score on a scale Standard Deviation 1.335	-0.34 score on a scale Standard Deviation 1.143	0.00 score on a scale Standard Deviation 1.491	-0.21 score on a scale Standard Deviation 1.082
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q8 (On a scale of 1 to 10 how bothered are you by any sensations?): Change from Baseline at Day 14	-0.76 score on a scale Standard Deviation 1.766	-0.83 score on a scale Standard Deviation 1.085	-0.21 score on a scale Standard Deviation 1.719	-0.59 score on a scale Standard Deviation 2.206
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q8 (On a scale of 1 to 10 how bothered are you by any sensations?): Change from Baseline at Day 28	-1.00 score on a scale Standard Deviation 1.390	-0.83 score on a scale Standard Deviation 1.533	-0.46 score on a scale Standard Deviation 1.529	-0.48 score on a scale Standard Deviation 1.896
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q8 (On a scale of 1 to 10 how bothered are you by any sensations?): Change from Baseline at Day 56	-1.06 score on a scale Standard Deviation 1.413	-1.63 score on a scale Standard Deviation 1.351	-0.57 score on a scale Standard Deviation 2.150	-0.52 score on a scale Standard Deviation 1.883
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q9 (On a scale of 1 to 10 how well can you tolerate sensations?): Baseline (Day 0)	4.39 score on a scale Standard Deviation 2.261	3.77 score on a scale Standard Deviation 2.202	3.83 score on a scale Standard Deviation 2.054	4.93 score on a scale Standard Deviation 2.563
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q9 (On a scale of 1 to 10 how well can you tolerate sensations?): Change from Baseline at Day 3	0.29 score on a scale Standard Deviation 1.150	0.17 score on a scale Standard Deviation 1.605	0.18 score on a scale Standard Deviation 2.178	-0.14 score on a scale Standard Deviation 2.065
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q9 (On a scale of 1 to 10 how well can you tolerate sensations?): Change from Baseline at Day 14	0.24 score on a scale Standard Deviation 1.845	-0.27 score on a scale Standard Deviation 1.143	0.48 score on a scale Standard Deviation 2.707	-0.81 score on a scale Standard Deviation 2.058
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q9 (On a scale of 1 to 10 how well can you tolerate sensations?): Change from Baseline at Day 28	-0.17 score on a scale Standard Deviation 1.913	-0.47 score on a scale Standard Deviation 2.013	-0.27 score on a scale Standard Deviation 2.201	-0.76 score on a scale Standard Deviation 1.535
Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56 Q9 (On a scale of 1 to 10 how well can you tolerate sensations?): Change from Baseline at Day 56	-0.10 score on a scale Standard Deviation 2.119	-0.90 score on a scale Standard Deviation 2.155	-0.29 score on a scale Standard Deviation 2.692	-0.52 score on a scale Standard Deviation 2.148

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Section 2 included 15 questions about the ways in which sensations in participant's teeth affected them in their daily life. Questions were grouped into the following domains: Restrictions(Q1-3), Adaptation(Q4-6), Social Impact(Q7-9), Emotional Impact(Q10-12), and Identity(Q13-15). All participants scored 15 questions 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. Total score was derived from the sum of scores in single domains and ranged from 15 to 105. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting Baseline value from value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56 Baseline (Day 0)	60.06 score on a scale Standard Deviation 18.703	57.19 score on a scale Standard Deviation 17.651	61.79 score on a scale Standard Deviation 19.580	67.41 score on a scale Standard Deviation 17.235
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-1.71 score on a scale Standard Deviation 11.132	-1.93 score on a scale Standard Deviation 3.283	-0.71 score on a scale Standard Deviation 11.524	0.62 score on a scale Standard Deviation 7.370
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-4.41 score on a scale Standard Deviation 12.701	-6.00 score on a scale Standard Deviation 11.750	-1.55 score on a scale Standard Deviation 11.624	-0.48 score on a scale Standard Deviation 10.271
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-4.53 score on a scale Standard Deviation 14.176	-7.63 score on a scale Standard Deviation 13.071	-3.04 score on a scale Standard Deviation 13.250	-1.80 score on a scale Standard Deviation 11.979
Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-8.61 score on a scale Standard Deviation 16.508	-10.67 score on a scale Standard Deviation 14.456	-4.00 score on a scale Standard Deviation 13.411	-2.38 score on a scale Standard Deviation 13.808

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28, 56

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

DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Restriction domain(Q1 to 3) of Section 2 consisted of following questions: Q1:Having sensation in my teeth takes a lot of the pleasure out of eating and drinking; Q2:It takes a long time to finish some foods and drinks because of sensations in my teeth; Q3:There have been times when I have had problems eating ice cream because of these sensations. All participants scored Q1 to 3 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. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting Baseline value from value at each indicated timepoint. A negative change from Baseline indicated improvement(less impact of sensations on participant's daily life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56 Baseline (Day 0)	13.32 score on a scale Standard Deviation 4.854	12.03 score on a scale Standard Deviation 4.505	13.72 score on a scale Standard Deviation 4.651	15.14 score on a scale Standard Deviation 3.916
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-0.50 score on a scale Standard Deviation 2.963	-0.21 score on a scale Standard Deviation 1.989	0.29 score on a scale Standard Deviation 3.029	0.10 score on a scale Standard Deviation 1.655
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-1.52 score on a scale Standard Deviation 3.334	-1.13 score on a scale Standard Deviation 3.148	0.03 score on a scale Standard Deviation 2.970	-0.85 score on a scale Standard Deviation 3.110
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-1.13 score on a scale Standard Deviation 3.411	-1.47 score on a scale Standard Deviation 3.148	-1.04 score on a scale Standard Deviation 2.807	-0.44 score on a scale Standard Deviation 3.809
Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-1.90 score on a scale Standard Deviation 3.736	-2.27 score on a scale Standard Deviation 3.877	-0.50 score on a scale Standard Deviation 3.085	-0.83 score on a scale Standard Deviation 3.174

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Adaptation domain (Q4 to 6) of Section 2 consisted of following questions: Q4: I have to change the way I eat or drink certain things; Q5: I have to be careful how I breathe on a cold day; Q6: When eating some foods, I have made sure they don't touch certain teeth. All participants scored Q4 to 6 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. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56 Baseline (Day 0)	13.48 score on a scale Standard Deviation 4.335	13.26 score on a scale Standard Deviation 4.000	13.38 score on a scale Standard Deviation 4.135	14.55 score on a scale Standard Deviation 4.197
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-0.93 score on a scale Standard Deviation 3.005	-0.62 score on a scale Standard Deviation 1.720	0.00 score on a scale Standard Deviation 2.944	0.17 score on a scale Standard Deviation 2.054
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-1.24 score on a scale Standard Deviation 3.313	-2.30 score on a scale Standard Deviation 3.153	-0.62 score on a scale Standard Deviation 3.570	-0.07 score on a scale Standard Deviation 3.292
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-1.57 score on a scale Standard Deviation 4.360	-2.10 score on a scale Standard Deviation 4.063	-0.85 score on a scale Standard Deviation 3.068	-0.64 score on a scale Standard Deviation 3.581
Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-2.19 score on a scale Standard Deviation 4.629	-3.33 score on a scale Standard Deviation 3.809	-1.14 score on a scale Standard Deviation 3.638	-0.79 score on a scale Standard Deviation 3.940

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Social Impact domain(Q7 to 9) of Section 2 consisted of following questions: Q7:Because of sensations I take longer than others to finish meal; Q8:I have to be careful what I eat when I am with others because of sensation in my teeth; Q9:Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. All participants scored Q7 to 9 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. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting Baseline value from value at each indicated timepoint. A negative change from Baseline indicated improvement(less impact of sensations on participant's daily life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56 Baseline (Day 0)	10.26 score on a scale Standard Deviation 4.099	9.74 score on a scale Standard Deviation 3.803	10.59 score on a scale Standard Deviation 4.961	11.38 score on a scale Standard Deviation 4.354
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-0.04 score on a scale Standard Deviation 2.457	-0.38 score on a scale Standard Deviation 2.060	-0.32 score on a scale Standard Deviation 2.420	0.38 score on a scale Standard Deviation 2.007
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-0.62 score on a scale Standard Deviation 3.075	-0.57 score on a scale Standard Deviation 2.473	-0.03 score on a scale Standard Deviation 2.368	0.67 score on a scale Standard Deviation 2.094
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-0.17 score on a scale Standard Deviation 3.705	-1.00 score on a scale Standard Deviation 2.792	-0.38 score on a scale Standard Deviation 3.579	-0.04 score on a scale Standard Deviation 2.525
Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-1.00 score on a scale Standard Deviation 3.733	-1.43 score on a scale Standard Deviation 2.873	-0.57 score on a scale Standard Deviation 2.974	0.38 score on a scale Standard Deviation 3.156

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Emotional Impact domain (Q10 to 12) of Section 2 consisted of following questions: Q10: I have been anxious that something I eat, or drink might cause sensations in my teeth; Q11: The sensations in my teeth have been irritating; Q12: The sensations in my teeth have been annoying. All participants scored Q10 to 12 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. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56 Baseline (Day 0)	13.10 score on a scale Standard Deviation 4.452	12.45 score on a scale Standard Deviation 3.695	13.38 score on a scale Standard Deviation 4.716	14.93 score on a scale Standard Deviation 3.474
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-0.04 score on a scale Standard Deviation 3.156	-0.31 score on a scale Standard Deviation 2.189	0.25 score on a scale Standard Deviation 4.151	0.17 score on a scale Standard Deviation 3.402
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-0.69 score on a scale Standard Deviation 3.444	-1.20 score on a scale Standard Deviation 3.284	-0.07 score on a scale Standard Deviation 3.990	-0.48 score on a scale Standard Deviation 3.081
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-0.63 score on a scale Standard Deviation 3.378	-1.70 score on a scale Standard Deviation 3.743	-0.38 score on a scale Standard Deviation 5.146	-0.64 score on a scale Standard Deviation 2.856
Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-1.81 score on a scale Standard Deviation 4.293	-2.77 score on a scale Standard Deviation 3.892	-0.57 score on a scale Standard Deviation 4.367	-0.48 score on a scale Standard Deviation 3.631

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

DHEQ was a validated, condition-specific measure of the impacts of tooth sensitivity on everyday life. It consisted of 2 sections. Identity domain (Q13 to 15) of Section 2 consisted of following questions: Q13: Having these sensations in my teeth makes me feel old; Q14: Having these sensations in my teeth makes me feel damaged; Q15: Having these sensations in my teeth makes me feel as though I am unhealthy. All participants scored Q13 to 15 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. Total score ranged from 3 to 21. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's daily life).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56 Baseline (Day 0)	9.90 score on a scale Standard Deviation 4.392	9.71 score on a scale Standard Deviation 4.451	10.72 score on a scale Standard Deviation 4.963	11.41 score on a scale Standard Deviation 5.124
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-0.21 score on a scale Standard Deviation 2.794	-0.41 score on a scale Standard Deviation 1.862	-0.93 score on a scale Standard Deviation 2.595	-0.21 score on a scale Standard Deviation 2.704
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-0.34 score on a scale Standard Deviation 3.528	-0.80 score on a scale Standard Deviation 2.280	-0.86 score on a scale Standard Deviation 3.193	0.26 score on a scale Standard Deviation 3.265
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-1.03 score on a scale Standard Deviation 3.409	-1.37 score on a scale Standard Deviation 2.220	-0.38 score on a scale Standard Deviation 2.886	-0.04 score on a scale Standard Deviation 2.746
Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-1.71 score on a scale Standard Deviation 3.349	-0.87 score on a scale Standard Deviation 3.277	-1.21 score on a scale Standard Deviation 3.190	-0.66 score on a scale Standard Deviation 3.330

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

The NRS was a segmented numeric version of the visual analog scale (VAS) in which a participant selected a number from 0 to 10 that best reflected the intensity of the discomfort caused by sensitivity in their teeth, where 0=no discomfort and 10=worst discomfort imaginable. Lower score indicated less discomfort caused by the sensitivity.

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56 Baseline (Day 0)	5.1 score on a scale Standard Deviation 1.98	4.6 score on a scale Standard Deviation 1.69	4.3 score on a scale Standard Deviation 2.24	5.3 score on a scale Standard Deviation 2.55
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56 Day 3	5.0 score on a scale Standard Deviation 2.05	4.2 score on a scale Standard Deviation 1.68	4.5 score on a scale Standard Deviation 1.80	4.9 score on a scale Standard Deviation 2.50
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56 Day 14	4.5 score on a scale Standard Deviation 1.92	3.5 score on a scale Standard Deviation 1.50	4.3 score on a scale Standard Deviation 2.04	4.4 score on a scale Standard Deviation 2.41
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56 Day 28	4.0 score on a scale Standard Deviation 2.19	3.2 score on a scale Standard Deviation 1.95	4.2 score on a scale Standard Deviation 1.56	4.6 score on a scale Standard Deviation 2.33
Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56 Day 56	3.6 score on a scale Standard Deviation 2.23	2.7 score on a scale Standard Deviation 1.80	3.8 score on a scale Standard Deviation 2.18	4.4 score on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline (Day 0), Days 3, 14, 28 and 56

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

The NRS was a segmented numeric version of the VAS in which a participant selected a number from 0 to 10 that best reflected the intensity of the discomfort caused by sensitivity in their teeth, where 0=no discomfort and 10=worst discomfort imaginable. Lower score indicated less discomfort caused by the sensitivity. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. A negative change from Baseline indicated improvement (reduction in discomfort caused by sensitivity).

Outcome measures

Outcome measures
Measure	Comparator 1 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 1 was a toothpaste containing 3% PVM/MA. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Comparator 2 n=31 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Comparator 2 was a toothpaste containing 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Negative Control n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Negative control was a regular fluoride toothpaste. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.	Test Product n=29 Participants Participants were dosed by the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion. Test product was a combination toothpaste of 3% PVM/MA + 5% KNO3. Participants were instructed to brush their two selected 'test teeth' first, followed by the whole mouth for one timed minute, twice daily (morning and evening) for 8 weeks. Participants were permitted to rinse with water post-brushing.
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56 Change from Baseline at Day 3	-0.1 score on a scale Standard Deviation 1.36	-0.4 score on a scale Standard Deviation 1.35	0.2 score on a scale Standard Deviation 1.85	-0.5 score on a scale Standard Deviation 1.09
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56 Change from Baseline at Day 14	-0.7 score on a scale Standard Deviation 1.99	-1.1 score on a scale Standard Deviation 1.78	-0.0 score on a scale Standard Deviation 2.38	-0.9 score on a scale Standard Deviation 1.96
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56 Change from Baseline at Day 28	-1.1 score on a scale Standard Deviation 2.09	-1.4 score on a scale Standard Deviation 1.91	-0.3 score on a scale Standard Deviation 2.23	-0.9 score on a scale Standard Deviation 1.67
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56 Change from Baseline at Day 56	-1.5 score on a scale Standard Deviation 2.32	-1.9 score on a scale Standard Deviation 1.54	-0.6 score on a scale Standard Deviation 2.26	-0.9 score on a scale Standard Deviation 2.09
Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56 Baseline (Day 0)	5.1 score on a scale Standard Deviation 1.98	4.6 score on a scale Standard Deviation 1.69	4.3 score on a scale Standard Deviation 2.24	5.3 score on a scale Standard Deviation 2.55

Adverse Events

Test Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Haleon Response Center

HALEON

Phone: +441932 95 95 00

Email: [email protected]

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