A Clinical Study Assessing the Effects of a Marketed Dent... | NCT06608368

NCT06608368

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Dentifrice	Experimental	Participants will dose the toothbrush provided with a strip of test dentifrice containing 5% weight by weight (w/w) NovaMin (Calcium Sodium Phosphosilicate) and 1040 parts per million (ppm) fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.	Drug: Test Dentifrice (Sensodyne Repair and Protect Original Mint)
Positive Control Dentifrice	Active Comparator	Participants will dose 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 will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.	Drug: Positive Control Dentifrice (Sensodyne Fresh Mint)
Reference Dentifrice	Active Comparator	Participants will dose the toothbrush provided with a strip of reference dentifrice containing 1100 ppm fluoride as sodium fluoride on each brushing occasion and will brush for one timed minute twice daily (morning and evening) for up to 5 weeks. Participants will use the dentifrice for 2 weeks pre tooth bleaching, 1 week during tooth bleaching and 2 weeks post tooth bleaching application. At Week 3, participants will perform the first application of tooth bleaching as per the instructions provided and continue the application once daily for up to 7 days.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test Dentifrice (Sensodyne Repair and Protect Original Mint)	Drug	Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study	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.	Up to Day 36
Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity	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.	Up to Day 36
LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration	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.

Secondary Outcomes

Measure	Description	Time Frame
Mean VAS Score During Tooth Bleaching	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 that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.
Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.
Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition confirmed to be causing xerostomia), or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
Participant who wishes and is able to undergo at-home peroxide tooth bleaching.
Participant with generally good oral health that fulfil all of the following:
1. Having no lesions of the teeth or oral cavity that could interfere with the study evaluations.
2. At least a total of 11 of the facial surfaces of maxillary and mandibular anterior 6 teeth (tooth numbers 6-11 and 22-27) suitable for peroxide whitening and gradable for VITA Bleachedguide evaluation with no significant defects, calculus, restorations, crowns or veneers that could impact tooth bleaching performance or study evaluations as judged by the clinical examiner.
3. A minimum of 16 natural teeth.

Exclusion Criteria:

Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 60 days prior to study entry and/or during study participation.
Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
Participant who is pregnant or intending to become pregnant over the duration of the study or who is breastfeeding.
Participant with known or suspected intolerance or hypersensitivity to the study materials [including the peroxide whitening gel] (or closely related compounds) or any of their stated ingredients.
Participant who, in the opinion of the investigator or medically qualified designee, has a condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements or who should not participate in the study for other reasons.
Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
Participant with a recent history (within the last year) of alcohol or other substance abuse.
Participant with gross periodontal disease or who has had treatment for periodontal disease (including surgery) within 12 months of Screening or who has had scaling or root planning within 3 months of Screening.
Participant who has had a tooth bleaching procedure (either professionally dispensed or at home) within 12 months of Screening.
Participant with a fixed or removable partial prosthesis, multiple dental implants or orthodontic braces/bands or fixed retainer or togue/lip piercing which, in the opinion of the investigator, could impact study outcomes.
During the period from screening till 2 weeks post completion of tooth bleaching, participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
Participant who has previously been enrolled in this study.
Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
Participant who is taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
Participant who has had dental prophylaxis within 4 weeks of Screening or who requires antibiotic prophylaxis for dental procedures.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
All Sum Research		Mississauga	Ontario	L5N 6J2	Canada

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 27, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Safety population included all randomized participants who received at least one dose of the study product.

Arm/Group Information

ID	Title	Description
BG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00031 BG00129 BG00230 BG00390

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.0± 14.46 BG00148.8± 13.02 BG00250.3± 9.25 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00021 BG00123 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian and Alaskan Native

Title	Measurements
	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study

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.

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.

Posted

Mean

Standard Deviation

millimeter

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00031 OG00127 OG00230

Title

Denominators

Categories

Screening

- ParticipantsOG00031
- ParticipantsOG00127
- ParticipantsOG00230

Title	Measurements

Primary

Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity

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.

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

Posted

Mean

Standard Deviation

millimeter

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Primary

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration

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.

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

Posted

Mean

Standard Deviation

millimeter

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Primary

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability

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.

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

Posted

Mean

Standard Deviation

millimeter

Upto Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Primary

LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description

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.

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

Posted

Mean

Standard Deviation

millimeter

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Primary

Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study

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.

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

Posted

Mean

Standard Deviation

score on a scale

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001

Primary

Number of Participants With a Tooth Sensitivity-free Day Through the Study

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.

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

Posted

Count of Participants

Participants

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Primary

Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity

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.

mITT population.

Posted

Count of Participants

Participants

Up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Secondary

Mean VAS Score During Tooth Bleaching

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 that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 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.

mITT population.

Posted

Least Squares Mean

Standard Error

millimeter

Day 15 up to Day 21

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Secondary

Mean LMS Score During Tooth Bleaching

The tooth sensitivity questionnaire including the LMS 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 the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 mm LMS. Each individual scale was labelled with descriptive words related to the intensity, duration, tolerability, quality of tooth sensitivity and ranged from 0 mm to 100 mm where lower scores indicated better outcome (no pain). Participants marked each 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.

mITT population.

Posted

Least Squares Mean

Standard Error

millimeter

Day 15 up to Day 21

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Secondary

Mean Bothersomeness NRS Score During Tooth Bleaching

The tooth sensitivity questionnaire 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 were 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.

mITT population.

Posted

Least Squares Mean

Standard Error

score on a scale

Day 15 up to Day 21

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	Positive Control Dentifrice (KNO3 Containing Dentifrice)

Secondary

Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching

The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days during tooth bleaching where participants reported no tooth sensitivity in the tooth sensitivity questionnaire were reported.

mITT population.

Posted

Geometric Least Squares Mean

95% Confidence Interval

percentage of days

Day 15 up to Day 21

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Secondary

Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching

The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days (derived for each participant) during tooth bleaching where participants reported the use of analgesics to relieve tooth sensitivity/pain in the tooth sensitivity questionnaire were reported.

mITT population.

Posted

Mean

Full Range

percentage of days

Day 15 up to Day 21

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Secondary

Mean VAS Score Post Completion of Tooth Bleaching

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 that they felt tooth sensitivity completed the remainder of the questionnaire and rated their overall tooth sensitivity using a 100 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.

mITT population.

Posted

Least Squares Mean

Standard Error

millimeter

Day 22 up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Secondary

Mean LMS Score Post Completion of Tooth Bleaching

mITT population.

Posted

Least Squares Mean

Standard Error

millimeter

Day 22 up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.

Secondary

Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching

mITT population.

Posted

Least Squares Mean

Standard Error

score on a scale

Day 22 up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	Positive Control Dentifrice (KNO3 Containing Dentifrice)

Secondary

Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching

The tooth sensitivity questionnaire was used to describe the overall tooth sensitivity experienced by the participant during the previous 24 hours. Percentage of days post completion of tooth bleaching where participants reported no tooth sensitivity in the tooth sensitivity questionnaire were reported.

mITT population.

Posted

Geometric Least Squares Mean

95% Confidence Interval

percentage of days

Day 22 up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Secondary

Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching

mITT population.

Posted

Mean

Full Range

percentage of days

Day 22 up to Day 36

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Secondary

Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score

Tooth shade (color) of the facial surfaces of the anterior 6 maxillary and mandibular teeth were assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. VITA Bleachedguide 3D-MASTER uses a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleachedguide. Lower scores indicated an improvement.

mITT population.

Posted

Least Squares Mean

Standard Error

score on a scale

Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching)

ID	Title	Description
OG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Test Dentifrice (NovaMin Containing Dentifrice)	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.	31	31	2	31
EG001	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.	29	29	0	29
EG002	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.	30	30	2	30

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	Nervous system disorders		Systematic Assessment		EG0001 affected31 at risk EG0010 affected29 at risk EG0022 affected30 at risk
Gingival Inflammation	Gastrointestinal disorders		Systematic Assessment		EG0001 affected31 at risk EG0010 affected29 at risk EG0020 affected30 at risk

ID	Term
D003807	Dentin Sensitivity

ID	Term
C546060	hydrated silica gel-based toothpaste

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.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases