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Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.454% stannous fluoride dentifrice | Experimental | Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water. |
|
| 0.76% sodium monofluorophosphate dentifrice | Active Comparator | Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride | Drug | Test dentifrice containing 0.454% SnF |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation | Baseline-Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation |
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Inclusion Criteria:
Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
Participants with minimum of 20 natural teeth.
At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26437498 | Derived | Parkinson CR, Jeffery P, Milleman JL, Milleman KR, Mason S. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial. Am J Dent. 2015 Aug;28(4):190-6. |
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Participants with a minimum of two non-adjacent sensitive teeth (incisors, canines or pre-molars) with a Schiff Sensitivity Score(following an air blast stimulus) of ≥ 2 and a tactile threshold (Yeaple probe) of ≤ 20 grams (g) force were enrolled in this study.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Dentifrice (0.76% Sodium Monofluorophosphate) | Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds . |
| FG001 | Test Dentifrice (0.454% Stannous Fluoride) | Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Dentifrice (0.76% Sodium Monofluorophosphate) | Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Schiff Sensitivity Score | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Posted | Mean | Standard Deviation | Score on a scale | Baseline-Week 8 |
|
All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Dentifrice (0.76% Sodium Monofluorophosphate) | Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014002 | Tin Fluorides |
| C012980 | fluorophosphate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium monofluorophosphate |
| Drug |
Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride] |
|
| Baseline-Week 4 |
| Mean Change From Baseline in Tactile Sensitivity | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached. | Baseline-Week 8 |
| Mean Change From Baseline in Tactile Sensitivity | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached. | Baseline-Week 4 |
| Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF | Baseline-Week 4 |
| Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF | Baseline - Week 8 |
| BG001 | Test Dentifrice (0.454% Stannous Fluoride) | Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) |
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds. |
| OG001 | Test Dentrifice (0.454% Stannous Fluoride) | Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds. |
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| Secondary | Mean Change From Baseline in Schiff Sensitivity Score | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Posted | Mean | Standard Deviation | Score on a Scale | Baseline-Week 4 |
|
|
|
|
| Secondary | Mean Change From Baseline in Tactile Sensitivity | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached. | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Posted | Mean | Standard Deviation | Grams | Baseline-Week 8 |
|
|
|
|
| Secondary | Mean Change From Baseline in Tactile Sensitivity | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached. | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Posted | Mean | Standard Deviation | Grams | Baseline-Week 4 |
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| Secondary | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Posted | Mean | Standard Deviation | Score on a Scale | Baseline-Week 4 |
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| Secondary | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Posted | Mean | Standard Deviation | Score on a Scale | Baseline - Week 8 |
|
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|
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | Test Dentifrice (0.454% Stannous Fluoride) | Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds. | 0 | 59 | 1 | 59 |
| Mouth Injury | General disorders | Systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D017971 |
| Tin Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |