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A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste containing 0.454% stannous fluoride | Active Comparator | USA marketed toothpaste [test] |
|
| Toothpaste containing 0.76% sodium monofluorophosphate | Other | USA marketed toothpaste [negative control] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Toothpaste | Drug | 0.454% stannous fluoride toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline. | Baseline and immediately after treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSci Research America, Inc. | Las Vegas | Nevada | 89121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27093773 | Derived | Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32. |
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Participants were recruited at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. |
| FG001 | Negative Control | Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. |
| BG001 | Negative Control |
| 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 | Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment administration |
|
Baseline through 5 days post administration of last treatment
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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 | Test | Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute, for 14 days twice daily. The test product is a commercially available product. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Negative Control Toothpaste | Drug | 0.76% sodium monofluorophosphate toothpaste |
|
| Baseline and Day 3 |
| Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline. | Baseline and Day 14 |
| Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline. | Baseline and immediately after treatment administration |
| Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline. | Baseline and Day 3 |
| Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline. | Baseline and Day 14 |
Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
| Test |
Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product. |
| OG001 | Negative Control | Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily. |
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| Secondary | Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline. | ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Day 3 |
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| Secondary | Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline. | ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Day 14 |
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| Secondary | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline. | ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment administration |
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| Secondary | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline. | ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Day 3 |
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| Secondary | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline. | ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and Day 14 |
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| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Negative Control | Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily | 0 | 59 | 0 | 59 |
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.