Trial Outcomes & Findings for A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching (NCT NCT06608368)

Results Overview

The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the duration of their tooth sensitivity using the individual 100 mm LMS for duration. The scale was labelled with descriptive words related to duration and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the duration of sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

Up to Day 36

Results posted on

2025-12-15

Participant Flow

This study was conducted at a single center in Canada.

A total of 91 participants were screened of which 90 participants were enrolled and randomized to receive treatment in 3 groups: Test Dentifrice (31 participants), Positive Control Dentifrice (29 participants), and Reference Dentifrice (30 participants). A total of 88 participants completed the study.

Participant milestones

Participant milestones
Measure	Test Dentifrice (NovaMin Containing Dentifrice) Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5 percent (%) weight by weight (w/w) NovaMin (Calcium Sodium Phosphosilicate) and 1040 parts per million (ppm) fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Reference Dentifrice (Regular Fluoride Dentifrice) Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
Overall Study STARTED	31	29	30
Overall Study COMPLETED	31	27	30
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Dentifrice (NovaMin Containing Dentifrice) Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5 percent (%) weight by weight (w/w) NovaMin (Calcium Sodium Phosphosilicate) and 1040 parts per million (ppm) fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Reference Dentifrice (Regular Fluoride Dentifrice) Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
Overall Study Family Emergency	0	1	0
Overall Study Scheduling Issues	0	1	0

Baseline Characteristics

A Clinical Study Assessing the Effects of a Marketed Dentifrice on Tooth Sensitivity While Undergoing Tooth Bleaching

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=29 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Total n=90 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 14.46 • n=6009 Participants	48.8 years STANDARD_DEVIATION 13.02 • n=42 Participants	50.3 years STANDARD_DEVIATION 9.25 • n=77 Participants	48.3 years STANDARD_DEVIATION 12.45 • n=387 Participants
Sex: Female, Male Female	21 Participants n=6009 Participants	23 Participants n=42 Participants	20 Participants n=77 Participants	64 Participants n=387 Participants
Sex: Female, Male Male	10 Participants n=6009 Participants	6 Participants n=42 Participants	10 Participants n=77 Participants	26 Participants n=387 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6009 Participants	0 Participants n=42 Participants	3 Participants n=77 Participants	3 Participants n=387 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=6009 Participants	29 Participants n=42 Participants	27 Participants n=77 Participants	87 Participants n=387 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	0 Participants n=387 Participants
Race/Ethnicity, Customized American Indian and Alaskan Native	1 Participants n=6009 Participants	0 Participants n=42 Participants	0 Participants n=77 Participants	1 Participants n=387 Participants
Race/Ethnicity, Customized Asian	3 Participants n=6009 Participants	2 Participants n=42 Participants	7 Participants n=77 Participants	12 Participants n=387 Participants
Race/Ethnicity, Customized Black/African American	12 Participants n=6009 Participants	11 Participants n=42 Participants	14 Participants n=77 Participants	37 Participants n=387 Participants
Race/Ethnicity, Customized Other	0 Participants n=6009 Participants	0 Participants n=42 Participants	1 Participants n=77 Participants	1 Participants n=387 Participants
Race/Ethnicity, Customized White	15 Participants n=6009 Participants	16 Participants n=42 Participants	8 Participants n=77 Participants	39 Participants n=387 Participants

PRIMARY outcome

Timeframe: Up to Day 36

Population: Modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one VAS score for tooth sensitivity recorded during the tooth-bleaching period. Only those participants with data available at the specified time point were analyzed.

The tooth sensitivity questionnaire including the VAS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 millimeter (mm) VAS with scores ranging from 0 mm (No Sensitivity) to 100 mm (Extreme Sensitivity). Participants made a single vertical mark at the point on the scale which represented the degree of overall tooth sensitivity (example twinges, pain and other sensations in their teeth) that they experienced over the last 24 hours. The marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 4	39.7 millimeter Standard Deviation 34.44	39.7 millimeter Standard Deviation 36.03	36.1 millimeter Standard Deviation 34.51
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Screening	36.9 millimeter Standard Deviation 38.73	33.8 millimeter Standard Deviation 37.00	41.6 millimeter Standard Deviation 38.71
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Baseline	36.5 millimeter Standard Deviation 38.54	31.1 millimeter Standard Deviation 35.07	36.9 millimeter Standard Deviation 36.09
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 1	37.1 millimeter Standard Deviation 38.72	34.3 millimeter Standard Deviation 34.24	34.9 millimeter Standard Deviation 35.35
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 2	36.2 millimeter Standard Deviation 35.88	38.0 millimeter Standard Deviation 36.65	35.9 millimeter Standard Deviation 36.41
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 3	35.3 millimeter Standard Deviation 32.54	37.5 millimeter Standard Deviation 35.54	33.9 millimeter Standard Deviation 36.08
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 5	34.9 millimeter Standard Deviation 35.00	33.3 millimeter Standard Deviation 35.66	38.6 millimeter Standard Deviation 34.52
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 6	33.9 millimeter Standard Deviation 34.95	34.0 millimeter Standard Deviation 33.89	37.7 millimeter Standard Deviation 35.04
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Bleaching Period: Day 7	31.9 millimeter Standard Deviation 35.32	34.0 millimeter Standard Deviation 34.91	37.1 millimeter Standard Deviation 34.79
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 1	30.2 millimeter Standard Deviation 35.82	28.3 millimeter Standard Deviation 31.48	30.1 millimeter Standard Deviation 32.43
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 2	29.9 millimeter Standard Deviation 35.77	27.2 millimeter Standard Deviation 32.33	26.9 millimeter Standard Deviation 31.65
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 3	29.5 millimeter Standard Deviation 35.28	23.8 millimeter Standard Deviation 30.72	23.6 millimeter Standard Deviation 30.15
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 4	28.4 millimeter Standard Deviation 33.89	24.9 millimeter Standard Deviation 31.16	23.8 millimeter Standard Deviation 30.21
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 5	28.4 millimeter Standard Deviation 33.64	22.5 millimeter Standard Deviation 30.48	22.4 millimeter Standard Deviation 29.48
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 6	28.3 millimeter Standard Deviation 33.58	22.7 millimeter Standard Deviation 30.66	23.1 millimeter Standard Deviation 29.74
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 7	28.0 millimeter Standard Deviation 33.52	22.1 millimeter Standard Deviation 30.16	21.3 millimeter Standard Deviation 29.32
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 8	27.7 millimeter Standard Deviation 33.41	21.0 millimeter Standard Deviation 28.58	21.8 millimeter Standard Deviation 30.41
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 9	27.9 millimeter Standard Deviation 33.47	22.3 millimeter Standard Deviation 29.77	18.9 millimeter Standard Deviation 28.57
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 10	26.7 millimeter Standard Deviation 32.75	22.4 millimeter Standard Deviation 29.81	17.7 millimeter Standard Deviation 27.96
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 11	26.9 millimeter Standard Deviation 32.39	20.9 millimeter Standard Deviation 29.40	18.1 millimeter Standard Deviation 28.59
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 12	27.6 millimeter Standard Deviation 33.18	19.9 millimeter Standard Deviation 29.09	17.6 millimeter Standard Deviation 28.26
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 13	27.8 millimeter Standard Deviation 33.68	19.3 millimeter Standard Deviation 28.12	17.3 millimeter Standard Deviation 28.21
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study Post Bleaching Period: Day 14	26.9 millimeter Standard Deviation 32.52	20.1 millimeter Standard Deviation 28.38	18.3 millimeter Standard Deviation 28.72

PRIMARY outcome

Timeframe: Up to Day 36

Population: mITT population. Only those participants with data available at the specified time point were analyzed.

The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the intensity of their tooth sensitivity using the individual 100 mm LMS for intensity. The scale was labelled with descriptive words related to intensity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the intensity of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 13	18.5 millimeter Standard Deviation 25.35	15.1 millimeter Standard Deviation 19.76	14.4 millimeter Standard Deviation 23.18
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Screening	32.6 millimeter Standard Deviation 35.57	28.1 millimeter Standard Deviation 30.95	38.8 millimeter Standard Deviation 35.79
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Baseline	33.0 millimeter Standard Deviation 36.02	26.5 millimeter Standard Deviation 29.76	34.1 millimeter Standard Deviation 33.49
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 1	31.6 millimeter Standard Deviation 35.60	29.7 millimeter Standard Deviation 29.82	33.3 millimeter Standard Deviation 34.07
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 2	33.4 millimeter Standard Deviation 33.14	30.5 millimeter Standard Deviation 30.83	30.1 millimeter Standard Deviation 31.85
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 3	33.3 millimeter Standard Deviation 29.92	30.0 millimeter Standard Deviation 29.04	29.4 millimeter Standard Deviation 31.34
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 4	35.5 millimeter Standard Deviation 30.36	30.4 millimeter Standard Deviation 29.13	30.9 millimeter Standard Deviation 28.96
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 5	29.2 millimeter Standard Deviation 28.48	25.9 millimeter Standard Deviation 28.92	31.7 millimeter Standard Deviation 28.86
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 6	26.6 millimeter Standard Deviation 27.06	26.2 millimeter Standard Deviation 26.59	30.0 millimeter Standard Deviation 27.68
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Bleaching Period: Day 7	26.0 millimeter Standard Deviation 28.62	26.1 millimeter Standard Deviation 27.19	28.5 millimeter Standard Deviation 28.68
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 1	23.7 millimeter Standard Deviation 28.05	21.6 millimeter Standard Deviation 24.47	25.4 millimeter Standard Deviation 28.80
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 2	23.1 millimeter Standard Deviation 28.21	20.8 millimeter Standard Deviation 23.97	23.7 millimeter Standard Deviation 28.36
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 3	23.5 millimeter Standard Deviation 27.19	19.8 millimeter Standard Deviation 23.83	22.4 millimeter Standard Deviation 26.93
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 4	22.0 millimeter Standard Deviation 27.43	17.5 millimeter Standard Deviation 21.53	21.3 millimeter Standard Deviation 27.02
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 5	21.3 millimeter Standard Deviation 25.67	16.5 millimeter Standard Deviation 21.01	20.7 millimeter Standard Deviation 27.01
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 6	20.3 millimeter Standard Deviation 25.72	17.1 millimeter Standard Deviation 21.16	20.8 millimeter Standard Deviation 25.79
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 7	19.4 millimeter Standard Deviation 25.85	16.2 millimeter Standard Deviation 20.66	19.2 millimeter Standard Deviation 25.11
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 8	20.2 millimeter Standard Deviation 25.96	15.5 millimeter Standard Deviation 20.59	18.7 millimeter Standard Deviation 25.58
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 9	19.7 millimeter Standard Deviation 25.99	15.4 millimeter Standard Deviation 20.53	16.9 millimeter Standard Deviation 24.29
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 10	19.3 millimeter Standard Deviation 25.84	15.1 millimeter Standard Deviation 20.52	16.6 millimeter Standard Deviation 24.32
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 11	18.7 millimeter Standard Deviation 25.22	15.3 millimeter Standard Deviation 20.68	16.0 millimeter Standard Deviation 24.50
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 12	18.2 millimeter Standard Deviation 25.13	14.9 millimeter Standard Deviation 20.30	15.2 millimeter Standard Deviation 23.62
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity Post Bleaching Period: Day 14	18.6 millimeter Standard Deviation 25.38	15.2 millimeter Standard Deviation 20.10	14.9 millimeter Standard Deviation 23.81

PRIMARY outcome

Timeframe: Up to Day 36

Population: mITT population. Only those participants with data available at the specified time point were analyzed.

The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a Yes response completed the remainder of the questionnaire and rated the duration of their tooth sensitivity using the individual 100 mm LMS for duration. The scale was labelled with descriptive words related to duration and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the duration of sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 6	20.5 millimeter Standard Deviation 24.08	15.4 millimeter Standard Deviation 20.35	18.9 millimeter Standard Deviation 21.52
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 8	18.4 millimeter Standard Deviation 22.51	14.8 millimeter Standard Deviation 20.17	16.9 millimeter Standard Deviation 19.92
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 10	17.7 millimeter Standard Deviation 22.47	14.4 millimeter Standard Deviation 19.85	13.6 millimeter Standard Deviation 19.38
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 11	17.6 millimeter Standard Deviation 22.05	14.6 millimeter Standard Deviation 20.08	13.7 millimeter Standard Deviation 19.92
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Screening	24.4 millimeter Standard Deviation 26.28	18.8 millimeter Standard Deviation 21.55	26.4 millimeter Standard Deviation 25.30
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Baseline	24.6 millimeter Standard Deviation 26.76	18.0 millimeter Standard Deviation 21.55	23.0 millimeter Standard Deviation 22.19
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 1	23.6 millimeter Standard Deviation 25.56	19.7 millimeter Standard Deviation 22.14	21.7 millimeter Standard Deviation 21.33
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 2	26.6 millimeter Standard Deviation 25.74	23.5 millimeter Standard Deviation 24.45	20.7 millimeter Standard Deviation 21.66
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 3	31.2 millimeter Standard Deviation 25.29	23.2 millimeter Standard Deviation 22.58	22.4 millimeter Standard Deviation 23.66
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 4	29.7 millimeter Standard Deviation 25.00	23.9 millimeter Standard Deviation 22.94	26.0 millimeter Standard Deviation 22.18
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 5	27.0 millimeter Standard Deviation 25.43	20.0 millimeter Standard Deviation 21.96	26.7 millimeter Standard Deviation 23.24
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 6	25.9 millimeter Standard Deviation 24.33	23.5 millimeter Standard Deviation 21.55	28.7 millimeter Standard Deviation 24.22
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Bleaching Period: Day 7	24.5 millimeter Standard Deviation 24.89	21.7 millimeter Standard Deviation 21.87	28.2 millimeter Standard Deviation 25.51
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 1	23.8 millimeter Standard Deviation 25.35	18.5 millimeter Standard Deviation 20.71	24.5 millimeter Standard Deviation 24.16
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 2	22.3 millimeter Standard Deviation 24.65	16.8 millimeter Standard Deviation 20.80	22.2 millimeter Standard Deviation 23.45
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 3	23.5 millimeter Standard Deviation 24.80	17.1 millimeter Standard Deviation 21.53	20.7 millimeter Standard Deviation 21.64
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 4	22.4 millimeter Standard Deviation 24.71	15.1 millimeter Standard Deviation 20.13	18.9 millimeter Standard Deviation 20.89
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 5	22.4 millimeter Standard Deviation 24.41	15.8 millimeter Standard Deviation 21.35	17.7 millimeter Standard Deviation 20.60
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 7	19.1 millimeter Standard Deviation 23.14	15.1 millimeter Standard Deviation 20.42	18.4 millimeter Standard Deviation 21.48
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 9	18.3 millimeter Standard Deviation 22.41	13.9 millimeter Standard Deviation 19.28	13.9 millimeter Standard Deviation 19.30
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 12	17.5 millimeter Standard Deviation 22.53	14.1 millimeter Standard Deviation 19.71	13.1 millimeter Standard Deviation 19.29
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 13	17.5 millimeter Standard Deviation 22.04	13.9 millimeter Standard Deviation 19.34	13.0 millimeter Standard Deviation 19.08
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration Post Bleaching Period: Day 14	17.4 millimeter Standard Deviation 21.80	15.2 millimeter Standard Deviation 20.07	13.4 millimeter Standard Deviation 18.70

PRIMARY outcome

Timeframe: Upto Day 36

Population: mITT population. Only those participants with data available at the specified time point were analyzed.

The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for tolerability. The scale was labelled with descriptive words related to tolerability and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of the tolerability of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Screening	19.9 millimeter Standard Deviation 22.37	20.7 millimeter Standard Deviation 25.13	21.9 millimeter Standard Deviation 22.88
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline	21.0 millimeter Standard Deviation 23.95	19.4 millimeter Standard Deviation 24.84	20.9 millimeter Standard Deviation 22.56
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 1	22.2 millimeter Standard Deviation 24.50	22.6 millimeter Standard Deviation 24.42	19.9 millimeter Standard Deviation 22.93
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 2	22.3 millimeter Standard Deviation 23.68	24.1 millimeter Standard Deviation 27.44	19.8 millimeter Standard Deviation 22.66
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 3	22.8 millimeter Standard Deviation 21.55	23.8 millimeter Standard Deviation 25.83	21.9 millimeter Standard Deviation 24.65
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 4	25.0 millimeter Standard Deviation 22.96	23.7 millimeter Standard Deviation 25.87	22.8 millimeter Standard Deviation 22.54
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 3	21.7 millimeter Standard Deviation 25.21	15.5 millimeter Standard Deviation 20.91	19.4 millimeter Standard Deviation 25.28
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 4	19.6 millimeter Standard Deviation 24.34	15.5 millimeter Standard Deviation 20.71	18.3 millimeter Standard Deviation 24.70
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 10	15.9 millimeter Standard Deviation 22.53	14.4 millimeter Standard Deviation 19.86	13.3 millimeter Standard Deviation 20.37
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 12	15.9 millimeter Standard Deviation 22.73	13.8 millimeter Standard Deviation 19.94	11.7 millimeter Standard Deviation 19.02
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 5	22.9 millimeter Standard Deviation 23.81	21.5 millimeter Standard Deviation 25.25	23.6 millimeter Standard Deviation 22.85
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 6	22.4 millimeter Standard Deviation 23.49	23.4 millimeter Standard Deviation 24.18	24.1 millimeter Standard Deviation 24.53
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Baseline Period: Day 7	21.5 millimeter Standard Deviation 24.76	22.6 millimeter Standard Deviation 24.72	24.6 millimeter Standard Deviation 26.02
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 1	20.5 millimeter Standard Deviation 25.43	18.0 millimeter Standard Deviation 21.53	20.5 millimeter Standard Deviation 25.84
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 2	19.3 millimeter Standard Deviation 24.72	17.0 millimeter Standard Deviation 21.21	20.7 millimeter Standard Deviation 26.21
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 5	18.6 millimeter Standard Deviation 23.80	14.4 millimeter Standard Deviation 19.76	16.8 millimeter Standard Deviation 24.32
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 6	19.1 millimeter Standard Deviation 24.64	14.7 millimeter Standard Deviation 19.94	17.9 millimeter Standard Deviation 24.36
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 7	17.5 millimeter Standard Deviation 23.71	14.2 millimeter Standard Deviation 19.91	15.4 millimeter Standard Deviation 22.57
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 8	17.5 millimeter Standard Deviation 23.27	14.5 millimeter Standard Deviation 20.21	17.9 millimeter Standard Deviation 23.64
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 9	17.0 millimeter Standard Deviation 23.13	14.7 millimeter Standard Deviation 20.41	13.8 millimeter Standard Deviation 20.75
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 11	16.1 millimeter Standard Deviation 22.58	13.9 millimeter Standard Deviation 20.20	12.6 millimeter Standard Deviation 20.29
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 13	16.2 millimeter Standard Deviation 22.77	13.5 millimeter Standard Deviation 19.82	11.9 millimeter Standard Deviation 19.31
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability Post Baseline Period: Day 14	16.0 millimeter Standard Deviation 22.67	14.2 millimeter Standard Deviation 20.11	12.4 millimeter Standard Deviation 20.07

PRIMARY outcome

Timeframe: Up to Day 36

Population: mITT Population. Only those participants with data available at the specified time point were analyzed.

The tooth sensitivity questionnaire including the LMS was used to describe the overall tooth sensitivity experienced by the participants. Participants indicated whether they felt tooth sensitivity during the previous 24 hours using a Yes/No response. Participants with a 'Yes' response completed the remainder of the questionnaire and rated the tolerability of their tooth sensitivity using the individual 100 mm LMS for description. The scale was labelled with descriptive words related to the quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked the scale to indicate the best description of their sensitivity and the marked-off line segment was measured in 'mm'. Lower scores indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Screening	35.2 millimeter Standard Deviation 38.67	28.8 millimeter Standard Deviation 35.71	36.4 millimeter Standard Deviation 38.09
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline	34.6 millimeter Standard Deviation 38.33	27.4 millimeter Standard Deviation 34.75	32.2 millimeter Standard Deviation 35.28
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 1	33.3 millimeter Standard Deviation 38.06	29.3 millimeter Standard Deviation 34.81	30.5 millimeter Standard Deviation 35.70
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 2	33.0 millimeter Standard Deviation 34.47	31.0 millimeter Standard Deviation 34.60	28.2 millimeter Standard Deviation 33.82
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 3	37.0 millimeter Standard Deviation 32.25	33.4 millimeter Standard Deviation 36.27	27.9 millimeter Standard Deviation 31.99
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 4	40.7 millimeter Standard Deviation 34.32	31.3 millimeter Standard Deviation 33.33	33.3 millimeter Standard Deviation 30.62
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 5	31.8 millimeter Standard Deviation 32.17	28.7 millimeter Standard Deviation 33.43	31.0 millimeter Standard Deviation 29.59
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 6	30.9 millimeter Standard Deviation 30.74	29.2 millimeter Standard Deviation 31.35	31.8 millimeter Standard Deviation 28.97
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Baseline Period: Day 7	28.3 millimeter Standard Deviation 31.04	28.2 millimeter Standard Deviation 31.93	30.1 millimeter Standard Deviation 28.26
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 1	24.6 millimeter Standard Deviation 29.32	23.6 millimeter Standard Deviation 28.71	28.4 millimeter Standard Deviation 30.35
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 2	23.9 millimeter Standard Deviation 29.11	22.1 millimeter Standard Deviation 28.49	26.6 millimeter Standard Deviation 28.98
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 3	25.6 millimeter Standard Deviation 28.87	20.8 millimeter Standard Deviation 27.25	25.5 millimeter Standard Deviation 28.77
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 4	24.0 millimeter Standard Deviation 28.75	19.3 millimeter Standard Deviation 26.64	24.2 millimeter Standard Deviation 28.34
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 5	23.9 millimeter Standard Deviation 28.53	18.6 millimeter Standard Deviation 25.52	21.9 millimeter Standard Deviation 27.04
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 6	21.2 millimeter Standard Deviation 27.08	19.9 millimeter Standard Deviation 25.90	21.7 millimeter Standard Deviation 25.24
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 7	21.3 millimeter Standard Deviation 27.70	18.2 millimeter Standard Deviation 25.32	19.2 millimeter Standard Deviation 23.23
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 8	21.4 millimeter Standard Deviation 27.90	17.6 millimeter Standard Deviation 25.19	19.8 millimeter Standard Deviation 24.09
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 9	21.4 millimeter Standard Deviation 28.09	17.8 millimeter Standard Deviation 25.64	16.1 millimeter Standard Deviation 21.47
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 10	20.5 millimeter Standard Deviation 27.74	17.4 millimeter Standard Deviation 24.66	16.7 millimeter Standard Deviation 22.20
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 11	20.6 millimeter Standard Deviation 28.00	17.2 millimeter Standard Deviation 24.85	14.7 millimeter Standard Deviation 21.38
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 12	19.5 millimeter Standard Deviation 26.89	17.2 millimeter Standard Deviation 24.72	15.4 millimeter Standard Deviation 23.36
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 13	19.9 millimeter Standard Deviation 27.16	17.5 millimeter Standard Deviation 24.01	14.0 millimeter Standard Deviation 20.98
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description Post Baseline Period: Day 14	19.6 millimeter Standard Deviation 27.00	17.6 millimeter Standard Deviation 24.05	14.5 millimeter Standard Deviation 20.97

PRIMARY outcome

Timeframe: Up to Day 36

Population: mITT population. Only those participants with data available at the specified time point were analyzed.

The tooth sensitivity questionnaire including Bothersomeness NRS was used to describe the overall tooth sensitivity experienced by the participant. Participants indicated whether they felt tooth sensitivity during the previous 24 hours. Participants who indicated they felt tooth sensitivity completed the remainder of the questionnaire and rated how bothered they had been by any tooth sensitivity (example twinges, pain, ache or other sensations in teeth) using the Bothersomeness NRS scale. The scale ranged from 1 (Not bothered at all) to 10 (Extremely bothered). Lower scores indicated an improvement in sensitivity.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 2	4.3 score on a scale Standard Deviation 3.27	3.7 score on a scale Standard Deviation 2.81	3.3 score on a scale Standard Deviation 2.57
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 3	4.3 score on a scale Standard Deviation 3.03	3.9 score on a scale Standard Deviation 2.79	3.3 score on a scale Standard Deviation 2.70
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 4	4.5 score on a scale Standard Deviation 3.07	3.9 score on a scale Standard Deviation 2.79	3.3 score on a scale Standard Deviation 2.48
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 5	4.2 score on a scale Standard Deviation 3.15	3.5 score on a scale Standard Deviation 2.78	3.5 score on a scale Standard Deviation 2.62
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Screening	4.1 score on a scale Standard Deviation 3.28	3.5 score on a scale Standard Deviation 2.85	3.9 score on a scale Standard Deviation 2.86
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline	4.1 score on a scale Standard Deviation 3.30	3.2 score on a scale Standard Deviation 2.56	3.4 score on a scale Standard Deviation 2.60
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 1	4.1 score on a scale Standard Deviation 3.23	3.5 score on a scale Standard Deviation 2.70	3.3 score on a scale Standard Deviation 2.66
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 6	4.0 score on a scale Standard Deviation 3.13	3.7 score on a scale Standard Deviation 2.67	3.5 score on a scale Standard Deviation 2.75
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Baseline Period: Day 7	3.9 score on a scale Standard Deviation 3.13	3.5 score on a scale Standard Deviation 2.67	3.6 score on a scale Standard Deviation 2.74
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 1	3.6 score on a scale Standard Deviation 3.11	3.3 score on a scale Standard Deviation 2.49	3.2 score on a scale Standard Deviation 2.59
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 2	3.6 score on a scale Standard Deviation 3.12	3.1 score on a scale Standard Deviation 2.46	3.1 score on a scale Standard Deviation 2.58
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 3	3.7 score on a scale Standard Deviation 3.11	2.9 score on a scale Standard Deviation 2.39	3.0 score on a scale Standard Deviation 2.53
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 4	3.5 score on a scale Standard Deviation 2.97	2.9 score on a scale Standard Deviation 2.37	2.9 score on a scale Standard Deviation 2.56
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 5	3.5 score on a scale Standard Deviation 2.98	2.7 score on a scale Standard Deviation 2.31	2.9 score on a scale Standard Deviation 2.41
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 6	3.4 score on a scale Standard Deviation 2.95	2.7 score on a scale Standard Deviation 2.29	2.9 score on a scale Standard Deviation 2.41
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 8	3.4 score on a scale Standard Deviation 2.92	2.7 score on a scale Standard Deviation 2.26	2.8 score on a scale Standard Deviation 2.41
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 11	3.3 score on a scale Standard Deviation 2.84	2.6 score on a scale Standard Deviation 2.17	2.5 score on a scale Standard Deviation 2.24
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 13	3.3 score on a scale Standard Deviation 2.81	2.5 score on a scale Standard Deviation 2.19	2.4 score on a scale Standard Deviation 2.22
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 14	3.2 score on a scale Standard Deviation 2.75	2.6 score on a scale Standard Deviation 2.16	2.5 score on a scale Standard Deviation 2.24
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 7	3.4 score on a scale Standard Deviation 2.97	2.6 score on a scale Standard Deviation 2.29	2.7 score on a scale Standard Deviation 2.40
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 9	3.4 score on a scale Standard Deviation 2.88	2.7 score on a scale Standard Deviation 2.27	2.5 score on a scale Standard Deviation 2.21
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 10	3.3 score on a scale Standard Deviation 2.87	2.6 score on a scale Standard Deviation 2.17	2.5 score on a scale Standard Deviation 2.17
Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study Post Baseline Period: Day 12	3.3 score on a scale Standard Deviation 2.88	2.5 score on a scale Standard Deviation 2.22	2.5 score on a scale Standard Deviation 2.21

PRIMARY outcome

Timeframe: Up to Day 36

Population: mITT population. Only those participants with data available at the specified time point were analyzed.

Participants indicated whether they felt tooth sensitivity during the previous 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'No' response were reported.

Outcome measures

Outcome measures
Measure	Reference Dentifrice (Regular Fluoride Dentifrice) n=30 Participants Participants dosed the toothbrush provided with a strip of Reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Test Dentifrice (NovaMin Containing Dentifrice) n=31 Participants Participants dosed the toothbrush provided with a strip of Test dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.	Positive Control Dentifrice (KNO3 Containing Dentifrice) n=27 Participants Participants dosed the toothbrush provided with a strip of Positive Control dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride on each brushing occasion and brushed their teeth for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants used the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants performed the first application of tooth bleaching as per the instructions provided and continued the application once daily for up to 7 days.
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 10	17 Participants	16 Participants	14 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 6	11 Participants	10 Participants	8 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 11	16 Participants	17 Participants	15 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 12	17 Participants	17 Participants	15 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 13	17 Participants	16 Participants	15 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 14	17 Participants	16 Participants	14 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 7	13 Participants	11 Participants	8 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 1	14 Participants	12 Participants	10 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 2	14 Participants	14 Participants	11 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 4	15 Participants	15 Participants	12 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 5	15 Participants	17 Participants	12 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 9	16 Participants	16 Participants	14 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Screening	15 Participants	16 Participants	12 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Baseline	15 Participants	16 Participants	12 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 2	13 Participants	14 Participants	13 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 3	14 Participants	16 Participants	11 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 6	16 Participants	16 Participants	11 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 7	15 Participants	16 Participants	11 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Post Bleaching Period: Day 8	16 Participants	17 Participants	11 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 3	10 Participants	12 Participants	13 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 4	10 Participants	12 Participants	9 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 5	12 Participants	12 Participants	9 Participants
Number of Participants With a Tooth Sensitivity-free Day Through the Study Bleaching Period: Day 1	12 Participants	12 Participants	10 Participants

PRIMARY outcome

Timeframe: Up to Day 36

Population: mITT population.

Participants indicated whether they used any pain killing medications to relieve tooth sensitivity/pain in the last 24 hours as a Yes/No response in the tooth sensitivity questionnaire. Number of participants with 'Yes' response were to be reported.