Dentin Sensitivity
Conditions
Brief summary
The aim of this study is to investigate the efficacy of a marketed dentifrice containing 5 percent (%) NovaMin (Calcium Sodium Phosphosilicate) to reduce tooth sensitivity during and post tooth bleaching compared to a marketed dentifrice containing 5% potassium nitrate (KNO3) and a marketed regular fluoride-containing dentifrice.
Detailed description
This is a randomized, examiner blind, single-center, controlled, three arm, parallel group, proof-of-principal study to evaluate tooth sensitivity during and following a course of at-home tooth bleaching in participants with and without clinically confirmed dentine hypersensitivity (DH). The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 90 participants to study treatment (approximately 30 per treatment group).
Interventions
DRUGTest Dentifrice (Sensodyne Repair and Protect Original Mint)
Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.
DRUGPositive Control Dentifrice (Sensodyne Fresh Mint)
Dentifrice containing 5% w/w KNO3 and 1150 ppm fluoride as sodium fluoride.
DRUGReference Dentifrice (Crest Cavity Protection Regular)
Dentifrice containing 1100 ppm fluoride as sodium fluoride.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Up to Day 36 | 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. |
| Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Up to Day 36 | 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. |
| Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Up to Day 36 | 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. |
| LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Upto Day 36 | 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. |
| LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Up to Day 36 | 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. |
| Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Up to Day 36 | 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. |
| Number of Participants With a Tooth Sensitivity-free Day Through the Study | Up to Day 36 | 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. |
| Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity | Up to Day 36 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching | Day 22 up to Day 36 | 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. |
| Mean VAS Score During Tooth Bleaching | Day 15 up to Day 21 | 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. |
| Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score | Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching) | 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. |
| Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching | Day 22 up to Day 36 | 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. |
| Mean LMS Score During Tooth Bleaching | Day 15 up to Day 21 | 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. |
| Mean Bothersomeness NRS Score During Tooth Bleaching | Day 15 up to Day 21 | 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. |
| Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching | Day 15 up to Day 21 | 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. |
| Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching | Day 15 up to Day 21 | 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. |
| Mean VAS Score Post Completion of Tooth Bleaching | Day 22 up to Day 36 | 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. |
| Mean LMS Score Post Completion of Tooth Bleaching | Day 22 up to Day 36 | 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. |
| Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching | Day 22 up to Day 36 | 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. |
Countries
Canada
Participant flow
Recruitment details
This study was conducted at a single center in Canada.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| 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 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Family Emergency | 0 | 1 | 0 |
| Overall Study | Scheduling Issues | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Test Dentifrice (NovaMin Containing Dentifrice) | Positive Control Dentifrice (KNO3 Containing Dentifrice) | Reference Dentifrice (Regular Fluoride Dentifrice) | Total |
|---|---|---|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 14.46 | 48.8 years STANDARD_DEVIATION 13.02 | 50.3 years STANDARD_DEVIATION 9.25 | 48.3 years STANDARD_DEVIATION 12.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 29 Participants | 27 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian and Alaskan Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Black/African American | 12 Participants | 11 Participants | 14 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 16 Participants | 8 Participants | 39 Participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 20 Participants | 64 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 10 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 2 / 31 | 0 / 29 | 2 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 | 0 / 30 |
Outcome results
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.
Time frame: Up to Day 36
Population: mITT population. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 4 | 2.9 score on a scale | Standard Deviation 2.37 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 4 | 3.9 score on a scale | Standard Deviation 2.79 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 14 | 2.6 score on a scale | Standard Deviation 2.16 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 3 | 2.9 score on a scale | Standard Deviation 2.39 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 5 | 3.5 score on a scale | Standard Deviation 2.78 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 10 | 2.6 score on a scale | Standard Deviation 2.17 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 6 | 3.7 score on a scale | Standard Deviation 2.67 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 13 | 2.5 score on a scale | Standard Deviation 2.19 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Screening | 3.5 score on a scale | Standard Deviation 2.85 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 7 | 3.5 score on a scale | Standard Deviation 2.67 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 2 | 3.1 score on a scale | Standard Deviation 2.46 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 9 | 2.7 score on a scale | Standard Deviation 2.27 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline | 3.2 score on a scale | Standard Deviation 2.56 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 12 | 2.5 score on a scale | Standard Deviation 2.22 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 8 | 2.7 score on a scale | Standard Deviation 2.26 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 1 | 3.5 score on a scale | Standard Deviation 2.7 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 7 | 2.6 score on a scale | Standard Deviation 2.29 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 6 | 2.7 score on a scale | Standard Deviation 2.29 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 2 | 3.7 score on a scale | Standard Deviation 2.81 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 1 | 3.3 score on a scale | Standard Deviation 2.49 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 5 | 2.7 score on a scale | Standard Deviation 2.31 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 3 | 3.9 score on a scale | Standard Deviation 2.79 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 11 | 2.6 score on a scale | Standard Deviation 2.17 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 1 | 3.3 score on a scale | Standard Deviation 2.66 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 8 | 2.8 score on a scale | Standard Deviation 2.41 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Screening | 3.9 score on a scale | Standard Deviation 2.86 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline | 3.4 score on a scale | Standard Deviation 2.6 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 2 | 3.3 score on a scale | Standard Deviation 2.57 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 3 | 3.3 score on a scale | Standard Deviation 2.7 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 4 | 3.3 score on a scale | Standard Deviation 2.48 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 5 | 3.5 score on a scale | Standard Deviation 2.62 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 6 | 3.5 score on a scale | Standard Deviation 2.75 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline Period: Day 7 | 3.6 score on a scale | Standard Deviation 2.74 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 1 | 3.2 score on a scale | Standard Deviation 2.59 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 2 | 3.1 score on a scale | Standard Deviation 2.58 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 3 | 3.0 score on a scale | Standard Deviation 2.53 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 4 | 2.9 score on a scale | Standard Deviation 2.56 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 5 | 2.9 score on a scale | Standard Deviation 2.41 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 6 | 2.9 score on a scale | Standard Deviation 2.41 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 7 | 2.7 score on a scale | Standard Deviation 2.4 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 9 | 2.5 score on a scale | Standard Deviation 2.21 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 10 | 2.5 score on a scale | Standard Deviation 2.17 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 11 | 2.5 score on a scale | Standard Deviation 2.24 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 12 | 2.5 score on a scale | Standard Deviation 2.21 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 13 | 2.4 score on a scale | Standard Deviation 2.22 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Post Baseline Period: Day 14 | 2.5 score on a scale | Standard Deviation 2.24 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Bothersomeness Numerical Rating Scale (NRS) Score of Tooth Sensitivity Questionnaire Collected Through the Study | Baseline | 4.1 score on a scale | Standard Deviation 3.3 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
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.
Time frame: Up to Day 36
Population: mITT population. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 14 | 15.2 millimeter | Standard Deviation 20.1 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 5 | 16.5 millimeter | Standard Deviation 21.01 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 5 | 25.9 millimeter | Standard Deviation 28.92 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Screening | 28.1 millimeter | Standard Deviation 30.95 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 6 | 26.2 millimeter | Standard Deviation 26.59 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 7 | 26.1 millimeter | Standard Deviation 27.19 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 13 | 15.1 millimeter | Standard Deviation 19.76 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 4 | 17.5 millimeter | Standard Deviation 21.53 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 11 | 15.3 millimeter | Standard Deviation 20.68 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 3 | 19.8 millimeter | Standard Deviation 23.83 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 2 | 20.8 millimeter | Standard Deviation 23.97 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Baseline | 26.5 millimeter | Standard Deviation 29.76 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 1 | 21.6 millimeter | Standard Deviation 24.47 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 10 | 15.1 millimeter | Standard Deviation 20.52 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 1 | 29.7 millimeter | Standard Deviation 29.82 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 7 | 16.2 millimeter | Standard Deviation 20.66 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 9 | 15.4 millimeter | Standard Deviation 20.53 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 2 | 30.5 millimeter | Standard Deviation 30.83 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 12 | 14.9 millimeter | Standard Deviation 20.3 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 8 | 15.5 millimeter | Standard Deviation 20.59 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 3 | 30.0 millimeter | Standard Deviation 29.04 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 6 | 17.1 millimeter | Standard Deviation 21.16 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 4 | 30.4 millimeter | Standard Deviation 29.13 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 3 | 29.4 millimeter | Standard Deviation 31.34 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 6 | 30.0 millimeter | Standard Deviation 27.68 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 14 | 14.9 millimeter | Standard Deviation 23.81 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Screening | 38.8 millimeter | Standard Deviation 35.79 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Baseline | 34.1 millimeter | Standard Deviation 33.49 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 1 | 33.3 millimeter | Standard Deviation 34.07 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 2 | 30.1 millimeter | Standard Deviation 31.85 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 4 | 30.9 millimeter | Standard Deviation 28.96 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 5 | 31.7 millimeter | Standard Deviation 28.86 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 7 | 28.5 millimeter | Standard Deviation 28.68 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 1 | 25.4 millimeter | Standard Deviation 28.8 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 2 | 23.7 millimeter | Standard Deviation 28.36 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 3 | 22.4 millimeter | Standard Deviation 26.93 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 4 | 21.3 millimeter | Standard Deviation 27.02 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 5 | 20.7 millimeter | Standard Deviation 27.01 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 6 | 20.8 millimeter | Standard Deviation 25.79 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 7 | 19.2 millimeter | Standard Deviation 25.11 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 8 | 18.7 millimeter | Standard Deviation 25.58 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 9 | 16.9 millimeter | Standard Deviation 24.29 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 10 | 16.6 millimeter | Standard Deviation 24.32 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 11 | 16.0 millimeter | Standard Deviation 24.5 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 12 | 15.2 millimeter | Standard Deviation 23.62 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Post Bleaching Period: Day 13 | 14.4 millimeter | Standard Deviation 23.18 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Bleaching Period: Day 1 | 31.6 millimeter | Standard Deviation 35.6 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Baseline | 33.0 millimeter | Standard Deviation 36.02 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Labelled Magnitude Scale (LMS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Intensity | Screening | 32.6 millimeter | Standard Deviation 35.57 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
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.
Time frame: Up to Day 36
Population: mITT Population. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 8 | 17.6 millimeter | Standard Deviation 25.19 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 7 | 28.2 millimeter | Standard Deviation 31.93 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 1 | 29.3 millimeter | Standard Deviation 34.81 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 7 | 18.2 millimeter | Standard Deviation 25.32 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 1 | 23.6 millimeter | Standard Deviation 28.71 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Screening | 28.8 millimeter | Standard Deviation 35.71 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 6 | 19.9 millimeter | Standard Deviation 25.9 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 2 | 22.1 millimeter | Standard Deviation 28.49 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 12 | 17.2 millimeter | Standard Deviation 24.72 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 5 | 18.6 millimeter | Standard Deviation 25.52 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 3 | 20.8 millimeter | Standard Deviation 27.25 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 3 | 33.4 millimeter | Standard Deviation 36.27 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 4 | 19.3 millimeter | Standard Deviation 26.64 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 2 | 31.0 millimeter | Standard Deviation 34.6 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 11 | 17.2 millimeter | Standard Deviation 24.85 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 4 | 31.3 millimeter | Standard Deviation 33.33 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 13 | 17.5 millimeter | Standard Deviation 24.01 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 10 | 17.4 millimeter | Standard Deviation 24.66 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 5 | 28.7 millimeter | Standard Deviation 33.43 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline | 27.4 millimeter | Standard Deviation 34.75 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 9 | 17.8 millimeter | Standard Deviation 25.64 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 6 | 29.2 millimeter | Standard Deviation 31.35 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 14 | 17.6 millimeter | Standard Deviation 24.05 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 9 | 16.1 millimeter | Standard Deviation 21.47 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Screening | 36.4 millimeter | Standard Deviation 38.09 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline | 32.2 millimeter | Standard Deviation 35.28 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 1 | 30.5 millimeter | Standard Deviation 35.7 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 2 | 28.2 millimeter | Standard Deviation 33.82 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 3 | 27.9 millimeter | Standard Deviation 31.99 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 4 | 33.3 millimeter | Standard Deviation 30.62 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 5 | 31.0 millimeter | Standard Deviation 29.59 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 6 | 31.8 millimeter | Standard Deviation 28.97 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 7 | 30.1 millimeter | Standard Deviation 28.26 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 1 | 28.4 millimeter | Standard Deviation 30.35 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 2 | 26.6 millimeter | Standard Deviation 28.98 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 3 | 25.5 millimeter | Standard Deviation 28.77 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 4 | 24.2 millimeter | Standard Deviation 28.34 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 5 | 21.9 millimeter | Standard Deviation 27.04 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 6 | 21.7 millimeter | Standard Deviation 25.24 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 7 | 19.2 millimeter | Standard Deviation 23.23 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 8 | 19.8 millimeter | Standard Deviation 24.09 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 10 | 16.7 millimeter | Standard Deviation 22.2 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 11 | 14.7 millimeter | Standard Deviation 21.38 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 12 | 15.4 millimeter | Standard Deviation 23.36 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 13 | 14.0 millimeter | Standard Deviation 20.98 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 14 | 14.5 millimeter | Standard Deviation 20.97 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 12 | 19.5 millimeter | Standard Deviation 26.89 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 7 | 21.3 millimeter | Standard Deviation 27.7 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 6 | 30.9 millimeter | Standard Deviation 30.74 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Screening | 35.2 millimeter | Standard Deviation 38.67 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 8 | 21.4 millimeter | Standard Deviation 27.9 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 5 | 31.8 millimeter | Standard Deviation 32.17 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 1 | 33.3 millimeter | Standard Deviation 38.06 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 9 | 21.4 millimeter | Standard Deviation 28.09 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 4 | 40.7 millimeter | Standard Deviation 34.32 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 14 | 19.6 millimeter | Standard Deviation 27 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 10 | 20.5 millimeter | Standard Deviation 27.74 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 3 | 37.0 millimeter | Standard Deviation 32.25 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 13 | 19.9 millimeter | Standard Deviation 27.16 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 3 | 25.6 millimeter | Standard Deviation 28.87 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 11 | 20.6 millimeter | Standard Deviation 28 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 4 | 24.0 millimeter | Standard Deviation 28.75 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 2 | 23.9 millimeter | Standard Deviation 29.11 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 2 | 33.0 millimeter | Standard Deviation 34.47 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 5 | 23.9 millimeter | Standard Deviation 28.53 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 1 | 24.6 millimeter | Standard Deviation 29.32 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline | 34.6 millimeter | Standard Deviation 38.33 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Post Baseline Period: Day 6 | 21.2 millimeter | Standard Deviation 27.08 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Description | Baseline Period: Day 7 | 28.3 millimeter | Standard Deviation 31.04 |
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.
Time frame: Up to Day 36
Population: mITT population. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 8 | 14.8 millimeter | Standard Deviation 20.17 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 14 | 15.2 millimeter | Standard Deviation 20.07 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 3 | 23.2 millimeter | Standard Deviation 22.58 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 10 | 14.4 millimeter | Standard Deviation 19.85 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 2 | 23.5 millimeter | Standard Deviation 24.45 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 12 | 14.1 millimeter | Standard Deviation 19.71 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 9 | 13.9 millimeter | Standard Deviation 19.28 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 1 | 19.7 millimeter | Standard Deviation 22.14 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 13 | 13.9 millimeter | Standard Deviation 19.34 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 7 | 21.7 millimeter | Standard Deviation 21.87 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 4 | 15.1 millimeter | Standard Deviation 20.13 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Baseline | 18.0 millimeter | Standard Deviation 21.55 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 3 | 17.1 millimeter | Standard Deviation 21.53 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Screening | 18.8 millimeter | Standard Deviation 21.55 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 5 | 15.8 millimeter | Standard Deviation 21.35 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 2 | 16.8 millimeter | Standard Deviation 20.8 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 6 | 23.5 millimeter | Standard Deviation 21.55 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 6 | 15.4 millimeter | Standard Deviation 20.35 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 11 | 14.6 millimeter | Standard Deviation 20.08 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 5 | 20.0 millimeter | Standard Deviation 21.96 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 7 | 15.1 millimeter | Standard Deviation 20.42 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 1 | 18.5 millimeter | Standard Deviation 20.71 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 4 | 23.9 millimeter | Standard Deviation 22.94 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 9 | 13.9 millimeter | Standard Deviation 19.3 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 10 | 13.6 millimeter | Standard Deviation 19.38 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Baseline | 23.0 millimeter | Standard Deviation 22.19 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 4 | 18.9 millimeter | Standard Deviation 20.89 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 5 | 17.7 millimeter | Standard Deviation 20.6 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 6 | 18.9 millimeter | Standard Deviation 21.52 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 7 | 18.4 millimeter | Standard Deviation 21.48 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 8 | 16.9 millimeter | Standard Deviation 19.92 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 11 | 13.7 millimeter | Standard Deviation 19.92 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 12 | 13.1 millimeter | Standard Deviation 19.29 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 13 | 13.0 millimeter | Standard Deviation 19.08 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 14 | 13.4 millimeter | Standard Deviation 18.7 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 1 | 21.7 millimeter | Standard Deviation 21.33 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 2 | 20.7 millimeter | Standard Deviation 21.66 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 3 | 22.4 millimeter | Standard Deviation 23.66 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 4 | 26.0 millimeter | Standard Deviation 22.18 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 5 | 26.7 millimeter | Standard Deviation 23.24 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Screening | 26.4 millimeter | Standard Deviation 25.3 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 6 | 28.7 millimeter | Standard Deviation 24.22 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 7 | 28.2 millimeter | Standard Deviation 25.51 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 1 | 24.5 millimeter | Standard Deviation 24.16 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 2 | 22.2 millimeter | Standard Deviation 23.45 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 3 | 20.7 millimeter | Standard Deviation 21.64 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 3 | 31.2 millimeter | Standard Deviation 25.29 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 7 | 19.1 millimeter | Standard Deviation 23.14 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 13 | 17.5 millimeter | Standard Deviation 22.04 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 4 | 29.7 millimeter | Standard Deviation 25 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 6 | 20.5 millimeter | Standard Deviation 24.08 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 2 | 22.3 millimeter | Standard Deviation 24.65 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 5 | 27.0 millimeter | Standard Deviation 25.43 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 5 | 22.4 millimeter | Standard Deviation 24.41 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 4 | 22.4 millimeter | Standard Deviation 24.71 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 1 | 23.8 millimeter | Standard Deviation 25.35 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 10 | 17.7 millimeter | Standard Deviation 22.47 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 6 | 25.9 millimeter | Standard Deviation 24.33 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Screening | 24.4 millimeter | Standard Deviation 26.28 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 14 | 17.4 millimeter | Standard Deviation 21.8 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Baseline | 24.6 millimeter | Standard Deviation 26.76 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 12 | 17.5 millimeter | Standard Deviation 22.53 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 3 | 23.5 millimeter | Standard Deviation 24.8 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 1 | 23.6 millimeter | Standard Deviation 25.56 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 11 | 17.6 millimeter | Standard Deviation 22.05 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 9 | 18.3 millimeter | Standard Deviation 22.41 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 2 | 26.6 millimeter | Standard Deviation 25.74 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Post Bleaching Period: Day 8 | 18.4 millimeter | Standard Deviation 22.51 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Duration | Bleaching Period: Day 7 | 24.5 millimeter | Standard Deviation 24.89 |
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.
Time frame: Upto Day 36
Population: mITT population. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 11 | 13.9 millimeter | Standard Deviation 20.2 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 6 | 23.4 millimeter | Standard Deviation 24.18 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 2 | 24.1 millimeter | Standard Deviation 27.44 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 2 | 17.0 millimeter | Standard Deviation 21.21 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 8 | 14.5 millimeter | Standard Deviation 20.21 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Screening | 20.7 millimeter | Standard Deviation 25.13 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 3 | 15.5 millimeter | Standard Deviation 20.91 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 1 | 22.6 millimeter | Standard Deviation 24.42 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 12 | 13.8 millimeter | Standard Deviation 19.94 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 4 | 15.5 millimeter | Standard Deviation 20.71 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 4 | 23.7 millimeter | Standard Deviation 25.87 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline | 19.4 millimeter | Standard Deviation 24.84 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 5 | 14.4 millimeter | Standard Deviation 19.76 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 10 | 14.4 millimeter | Standard Deviation 19.86 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 13 | 13.5 millimeter | Standard Deviation 19.82 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 6 | 14.7 millimeter | Standard Deviation 19.94 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 3 | 23.8 millimeter | Standard Deviation 25.83 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 5 | 21.5 millimeter | Standard Deviation 25.25 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 7 | 14.2 millimeter | Standard Deviation 19.91 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 9 | 14.7 millimeter | Standard Deviation 20.41 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 7 | 22.6 millimeter | Standard Deviation 24.72 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 14 | 14.2 millimeter | Standard Deviation 20.11 |
| Test Dentifrice (NovaMin Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 1 | 18.0 millimeter | Standard Deviation 21.53 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 2 | 19.8 millimeter | Standard Deviation 22.66 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 1 | 20.5 millimeter | Standard Deviation 25.84 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 7 | 15.4 millimeter | Standard Deviation 22.57 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 3 | 21.9 millimeter | Standard Deviation 24.65 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 9 | 13.8 millimeter | Standard Deviation 20.75 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 10 | 13.3 millimeter | Standard Deviation 20.37 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 4 | 22.8 millimeter | Standard Deviation 22.54 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 11 | 12.6 millimeter | Standard Deviation 20.29 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 12 | 11.7 millimeter | Standard Deviation 19.02 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 14 | 12.4 millimeter | Standard Deviation 20.07 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 13 | 11.9 millimeter | Standard Deviation 19.31 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 5 | 23.6 millimeter | Standard Deviation 22.85 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 1 | 19.9 millimeter | Standard Deviation 22.93 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 2 | 20.7 millimeter | Standard Deviation 26.21 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 3 | 19.4 millimeter | Standard Deviation 25.28 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Screening | 21.9 millimeter | Standard Deviation 22.88 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 4 | 18.3 millimeter | Standard Deviation 24.7 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 5 | 16.8 millimeter | Standard Deviation 24.32 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline | 20.9 millimeter | Standard Deviation 22.56 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 6 | 17.9 millimeter | Standard Deviation 24.36 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 8 | 17.9 millimeter | Standard Deviation 23.64 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 6 | 24.1 millimeter | Standard Deviation 24.53 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 7 | 24.6 millimeter | Standard Deviation 26.02 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 6 | 22.4 millimeter | Standard Deviation 23.49 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 3 | 22.8 millimeter | Standard Deviation 21.55 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 12 | 15.9 millimeter | Standard Deviation 22.73 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 1 | 22.2 millimeter | Standard Deviation 24.5 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline | 21.0 millimeter | Standard Deviation 23.95 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 2 | 22.3 millimeter | Standard Deviation 23.68 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 4 | 25.0 millimeter | Standard Deviation 22.96 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 5 | 22.9 millimeter | Standard Deviation 23.81 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 1 | 20.5 millimeter | Standard Deviation 25.43 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 2 | 19.3 millimeter | Standard Deviation 24.72 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 3 | 21.7 millimeter | Standard Deviation 25.21 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 4 | 19.6 millimeter | Standard Deviation 24.34 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 5 | 18.6 millimeter | Standard Deviation 23.8 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 6 | 19.1 millimeter | Standard Deviation 24.64 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Screening | 19.9 millimeter | Standard Deviation 22.37 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Baseline Period: Day 7 | 21.5 millimeter | Standard Deviation 24.76 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 7 | 17.5 millimeter | Standard Deviation 23.71 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 8 | 17.5 millimeter | Standard Deviation 23.27 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 9 | 17.0 millimeter | Standard Deviation 23.13 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 10 | 15.9 millimeter | Standard Deviation 22.53 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 11 | 16.1 millimeter | Standard Deviation 22.58 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 13 | 16.2 millimeter | Standard Deviation 22.77 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | LMS Scores of the Tooth Sensitivity Questionnaire Collected Through the Study: Tolerability | Post Baseline Period: Day 14 | 16.0 millimeter | Standard Deviation 22.67 |
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.
Time frame: Up to Day 36
Population: mITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity | 0 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity | 0 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants Who Use Analgesics to Alleviate Tooth Sensitivity | 0 Participants |
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.
Time frame: Up to Day 36
Population: mITT population. Only those participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 8 | 17 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 6 | 10 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 1 | 12 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 7 | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 7 | 11 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 3 | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 6 | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 1 | 12 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 12 | 17 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 5 | 17 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 2 | 14 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 2 | 14 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 4 | 15 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 14 | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 11 | 17 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 3 | 12 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Baseline | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 10 | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 4 | 12 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Screening | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 9 | 16 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 5 | 12 Participants |
| Test Dentifrice (NovaMin Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 13 | 16 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 9 | 14 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 3 | 11 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Screening | 12 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Baseline | 12 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 1 | 10 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 2 | 13 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 3 | 13 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 4 | 9 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 5 | 9 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 6 | 8 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 7 | 8 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 1 | 10 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 2 | 11 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 4 | 12 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 5 | 12 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 6 | 11 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 7 | 11 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 8 | 11 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 10 | 14 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 11 | 15 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 12 | 15 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 13 | 15 Participants |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 14 | 14 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 12 | 17 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 7 | 15 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 5 | 12 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Baseline | 15 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 8 | 16 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 4 | 10 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 2 | 14 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 9 | 16 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 3 | 10 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 14 | 17 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 10 | 17 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 2 | 13 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 13 | 17 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 3 | 14 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 11 | 16 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 4 | 15 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 1 | 14 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 1 | 12 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 5 | 15 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 7 | 13 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Screening | 15 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Post Bleaching Period: Day 6 | 16 Participants |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Number of Participants With a Tooth Sensitivity-free Day Through the Study | Bleaching Period: Day 6 | 11 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 10 | 22.4 millimeter | Standard Deviation 29.81 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Screening | 33.8 millimeter | Standard Deviation 37 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Baseline | 31.1 millimeter | Standard Deviation 35.07 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 1 | 34.3 millimeter | Standard Deviation 34.24 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 2 | 38.0 millimeter | Standard Deviation 36.65 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 3 | 37.5 millimeter | Standard Deviation 35.54 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 4 | 39.7 millimeter | Standard Deviation 36.03 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 5 | 33.3 millimeter | Standard Deviation 35.66 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 6 | 34.0 millimeter | Standard Deviation 33.89 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 7 | 34.0 millimeter | Standard Deviation 34.91 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 1 | 28.3 millimeter | Standard Deviation 31.48 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 2 | 27.2 millimeter | Standard Deviation 32.33 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 3 | 23.8 millimeter | Standard Deviation 30.72 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 4 | 24.9 millimeter | Standard Deviation 31.16 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 5 | 22.5 millimeter | Standard Deviation 30.48 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 6 | 22.7 millimeter | Standard Deviation 30.66 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 7 | 22.1 millimeter | Standard Deviation 30.16 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 8 | 21.0 millimeter | Standard Deviation 28.58 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 9 | 22.3 millimeter | Standard Deviation 29.77 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 11 | 20.9 millimeter | Standard Deviation 29.4 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 12 | 19.9 millimeter | Standard Deviation 29.09 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 13 | 19.3 millimeter | Standard Deviation 28.12 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 14 | 20.1 millimeter | Standard Deviation 28.38 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 10 | 17.7 millimeter | Standard Deviation 27.96 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 7 | 21.3 millimeter | Standard Deviation 29.32 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Screening | 41.6 millimeter | Standard Deviation 38.71 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 7 | 37.1 millimeter | Standard Deviation 34.79 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 4 | 23.8 millimeter | Standard Deviation 30.21 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Baseline | 36.9 millimeter | Standard Deviation 36.09 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 2 | 26.9 millimeter | Standard Deviation 31.65 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 14 | 18.3 millimeter | Standard Deviation 28.72 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 1 | 34.9 millimeter | Standard Deviation 35.35 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 1 | 30.1 millimeter | Standard Deviation 32.43 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 8 | 21.8 millimeter | Standard Deviation 30.41 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 2 | 35.9 millimeter | Standard Deviation 36.41 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 5 | 22.4 millimeter | Standard Deviation 29.48 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 11 | 18.1 millimeter | Standard Deviation 28.59 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 3 | 33.9 millimeter | Standard Deviation 36.08 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 12 | 17.6 millimeter | Standard Deviation 28.26 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 13 | 17.3 millimeter | Standard Deviation 28.21 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 4 | 36.1 millimeter | Standard Deviation 34.51 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 6 | 23.1 millimeter | Standard Deviation 29.74 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 9 | 18.9 millimeter | Standard Deviation 28.57 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 5 | 38.6 millimeter | Standard Deviation 34.52 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Post Bleaching Period: Day 3 | 23.6 millimeter | Standard Deviation 30.15 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 6 | 37.7 millimeter | Standard Deviation 35.04 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Screening | 36.9 millimeter | Standard Deviation 38.73 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Baseline | 36.5 millimeter | Standard Deviation 38.54 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | 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 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Visual Analogue Scale (VAS) Scores of the Tooth Sensitivity Questionnaire Collected Through the Study | Bleaching Period: Day 5 | 34.9 millimeter | Standard Deviation 35 |
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.
Time frame: Day 15 (Pre-bleaching) up to Day 22 (Post-bleaching)
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score | -3.3043 score on a scale | Standard Error 0.2877 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score | -3.6640 score on a scale | Standard Error 0.3099 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Change From Pre to Post-tooth Bleaching in Mean VITA Shade Score | -3.2813 score on a scale | Standard Error 0.2927 |
p-value: 0.398495% CI: [-1.2026, 0.4831]ANCOVA
p-value: 0.373495% CI: [-1.2332, 0.4678]ANCOVA
p-value: 0.955595% CI: [-0.8382, 0.7923]ANCOVA
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.
Time frame: Day 15 up to Day 21
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean Bothersomeness NRS Score During Tooth Bleaching | 3.9603 score on a scale | Standard Error 0.2408 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean Bothersomeness NRS Score During Tooth Bleaching | 3.3288 score on a scale | Standard Error 0.2581 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean Bothersomeness NRS Score During Tooth Bleaching | 3.9735 score on a scale | Standard Error 0.2456 |
p-value: 0.075695% CI: [-1.3296, 0.06658]Mixed Model with Repeated Measures
p-value: 0.076195% CI: [-1.3586, 0.06924]Mixed Model with Repeated Measures
p-value: 0.969895% CI: [-0.7031, 0.6767]Mixed Model with Repeated Measures
Secondary
Mean Bothersomeness NRS Score Post Completion of 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.
Time frame: Day 22 up to Day 36
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching | 2.9902 score on a scale | Standard Error 0.3059 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching | 2.7262 score on a scale | Standard Error 0.3278 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean Bothersomeness NRS Score Post Completion of Tooth Bleaching | 3.2306 score on a scale | Standard Error 0.3114 |
p-value: 0.555195% CI: [-1.15, 0.6221]Mixed Model with Repeated Measures
p-value: 0.271495% CI: [-1.4104, 0.4016]Mixed Model with Repeated Measures
p-value: 0.586495% CI: [-1.116, 0.6351]Mixed Model with Repeated Measures
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.
Time frame: Day 15 up to Day 21
Population: mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Duration | 25.2392 millimeter | Standard Error 2.2168 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Intensity | 31.4069 millimeter | Standard Error 2.2894 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Tolerability | 23.3203 millimeter | Standard Error 2.0242 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Description | 33.2256 millimeter | Standard Error 2.7497 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Duration | 22.5202 millimeter | Standard Error 2.3259 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Description | 28.3419 millimeter | Standard Error 2.9352 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Tolerability | 21.4742 millimeter | Standard Error 2.1743 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Intensity | 26.6679 millimeter | Standard Error 2.4227 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Tolerability | 23.5177 millimeter | Standard Error 2.0578 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Intensity | 31.1071 millimeter | Standard Error 2.2738 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Duration | 26.2188 millimeter | Standard Error 2.2087 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score During Tooth Bleaching | LMS Description | 32.3172 millimeter | Standard Error 2.7867 |
Comparison: LMS Intensityp-value: 0.16595% CI: [-11.4672, 1.9891]Mixed Model with Repeated Measures
Comparison: LMS Intensityp-value: 0.185595% CI: [-11.0516, 2.1732]Mixed Model with Repeated Measures
Comparison: LMS Intensityp-value: 0.926195% CI: [-6.1107, 6.7104]Mixed Model with Repeated Measures
Comparison: LMS Durationp-value: 0.403995% CI: [-9.1643, 3.7265]Mixed Model with Repeated Measures
Comparison: LMS Durationp-value: 0.250595% CI: [-10.0548, 2.6577]Mixed Model with Repeated Measures
Comparison: LMS Durationp-value: 0.757795% CI: [-7.2744, 5.3151]Mixed Model with Repeated Measures
Comparison: LMS Tolerabilityp-value: 0.536795% CI: [-7.7642, 4.072]Mixed Model with Repeated Measures
Comparison: LMS Tolerabilityp-value: 0.496395% CI: [-7.9916, 3.9047]Mixed Model with Repeated Measures
Comparison: LMS Tolerabilityp-value: 0.945795% CI: [-5.9429, 5.5481]Mixed Model with Repeated Measures
Comparison: LMS Descriptionp-value: 0.228195% CI: [-12.8837, 3.1163]Mixed Model with Repeated Measures
Comparison: LMS Descriptionp-value: 0.32995% CI: [-12.0283, 4.0775]Mixed Model with Repeated Measures
Comparison: LMS Descriptionp-value: 0.817895% CI: [-6.9076, 8.7243]Mixed Model with Repeated Measures
Secondary
Mean LMS Score Post Completion of 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.
Time frame: Day 22 up to Day 36
Population: mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Intensity | 17.8845 millimeter | Standard Error 3.2466 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Duration | 17.4989 millimeter | Standard Error 2.6791 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Tolerability | 14.7900 millimeter | Standard Error 2.55 |
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Description | 20.7559 millimeter | Standard Error 3.1888 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Description | 18.2722 millimeter | Standard Error 3.4002 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Intensity | 16.9250 millimeter | Standard Error 3.4264 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Tolerability | 15.4884 millimeter | Standard Error 2.7406 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Duration | 15.0944 millimeter | Standard Error 2.7983 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Description | 21.2502 millimeter | Standard Error 3.2253 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Duration | 19.2415 millimeter | Standard Error 2.6559 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Tolerability | 18.7096 millimeter | Standard Error 2.5932 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean LMS Score Post Completion of Tooth Bleaching | LMS Intensity | 20.5072 millimeter | Standard Error 3.2181 |
Comparison: LMS Tolerabilityp-value: 0.852795% CI: [-6.7589, 8.1556]Mixed Model with Repeated Measures
Comparison: LMS Intensityp-value: 0.841795% CI: [-10.4856, 8.5665]Mixed Model with Repeated Measures
Comparison: LMS Intensityp-value: 0.448795% CI: [-12.942, 5.7777]Mixed Model with Repeated Measures
Comparison: LMS Intensityp-value: 0.56795% CI: [-11.697, 6.4517]Mixed Model with Repeated Measures
Comparison: LMS Durationp-value: 0.539595% CI: [-10.1672, 5.3583]Mixed Model with Repeated Measures
Comparison: LMS Durationp-value: 0.284395% CI: [-11.8005, 3.5062]Mixed Model with Repeated Measures
Comparison: LMS Durationp-value: 0.648895% CI: [-9.3255, 5.8401]Mixed Model with Repeated Measures
Comparison: LMS Tolerabilityp-value: 0.39595% CI: [-10.7149, 4.2726]Mixed Model with Repeated Measures
Comparison: LMS Tolerabilityp-value: 0.284795% CI: [-11.1588, 3.3198]Mixed Model with Repeated Measures
Comparison: LMS Descriptionp-value: 0.595495% CI: [-11.7512, 6.7839]Mixed Model with Repeated Measures
Comparison: LMS Descriptionp-value: 0.527195% CI: [-12.3044, 6.3485]Mixed Model with Repeated Measures
Comparison: LMS Descriptionp-value: 0.913895% CI: [-9.5478, 8.5593]Mixed Model with Repeated Measures
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.
Time frame: Day 15 up to Day 21
Population: mITT population.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching | 17.0 percentage of days |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching | 19.0 percentage of days |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean Percentage of Tooth Sensitivity-free Days During Tooth Bleaching | 17.7 percentage of days |
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.
Time frame: Day 22 up to Day 36
Population: mITT population.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching | 32.4 percentage of days |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching | 41.3 percentage of days |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean Percentage of Tooth Sensitivity-free Days Post Completion of Tooth Bleaching | 41.0 percentage of 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.
Time frame: Day 15 up to Day 21
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean VAS Score During Tooth Bleaching | 39.0423 millimeter | Standard Error 2.7961 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean VAS Score During Tooth Bleaching | 32.8316 millimeter | Standard Error 2.9787 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean VAS Score During Tooth Bleaching | 35.7939 millimeter | Standard Error 2.8196 |
p-value: 0.133295% CI: [-14.3568, 1.9353]Mixed Model with Repeated Measures
p-value: 0.472295% CI: [-11.1207, 5.196]Mixed Model with Repeated Measures
p-value: 0.415595% CI: [-4.6456, 11.1425]Mixed Model with Repeated Measures
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.
Time frame: Day 22 up to Day 36
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Mean VAS Score Post Completion of Tooth Bleaching | 25.0948 millimeter | Standard Error 4.0687 |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Mean VAS Score Post Completion of Tooth Bleaching | 19.0720 millimeter | Standard Error 4.3244 |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Mean VAS Score Post Completion of Tooth Bleaching | 28.4576 millimeter | Standard Error 4.0951 |
p-value: 0.314295% CI: [-17.8534, 5.8078]Mixed Model with Repeated Measures
p-value: 0.118995% CI: [-21.2335, 2.4624]Mixed Model with Repeated Measures
p-value: 0.561295% CI: [-14.8264, 8.1009]Mixed Model with Repeated Measures
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.
Time frame: Day 15 up to Day 21
Population: mITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching | 0 percentage of days |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching | 0 percentage of days |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity During Tooth Bleaching | 0 percentage of days |
Secondary
Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity 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 (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.
Time frame: Day 22 up to Day 36
Population: mITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Dentifrice (NovaMin Containing Dentifrice) | Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching | 0 percentage of days |
| Positive Control Dentifrice (KNO3 Containing Dentifrice) | Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching | 0 percentage of days |
| Reference Dentifrice (Regular Fluoride Dentifrice) | Percentage of Days Analgesics Were Used to Alleviate Tooth Sensitivity Post Completion of Tooth Bleaching | 0 percentage of days |