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| Name | Class |
|---|---|
| BioSci Research | UNKNOWN |
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The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% calcium sodium phosphosilicate/sodium monofluorophosphate | Experimental | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF). |
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| 0% calcium sodium phosphosilicate/sodium monofluorophosphate | Active Comparator | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
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| Sodium monofluorophosphate | Active Comparator | Dentifrice containing 1000 ppmF as sodium monofluorophosphate |
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| Sodium fluoride | Active Comparator | Dentifrice containing 1100 ppmF as sodium fluoride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice | Drug | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. | Baseline to 4 weeks post administration of study treatment |
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. | Baseline to 4 weeks post administration of study treatment |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. | Baseline to 8 weeks post administration of study treatment |
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSci Research America | Las Vegas | Nevada | 89121-5466 | United States |
Out of 152 screened participants, 16 did not meet the study criterion while 2 withdrew consent. Hence, a total of 134 participants were randomized into the study.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate |
| FG001 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice | Drug | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
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| Sodium monofluorophosphate dentifrice | Drug | Dentifrice containing 1000 ppmF as sodium monofluorophosphate |
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| Sodium fluoride dentifrice | Drug | Dentifrice containing 1100 ppmF as sodium fluoride |
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| Baseline to 8 weeks post administration of study treatment |
| Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain). | Baseline to 4 weeks post administration of study treatment |
| Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain). | Baseline to 8 weeks post administration of study treatment |
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
| FG002 | Sodium Monofluorophosphate | Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| FG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
| BG001 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
| BG002 | Sodium Monofluorophosphate | Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| BG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
| BG004 | Total | Total of all reporting groups |
| 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 | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. | Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline to 4 weeks post administration of study treatment |
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| Primary | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | grams | Baseline to 4 weeks post administration of study treatment |
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| Primary | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline to 8 weeks post administration of study treatment |
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| Primary | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | grams | Baseline to 8 weeks post administration of study treatment |
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| Primary | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain). | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline to 4 weeks post administration of study treatment |
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| Primary | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain). | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline to 8 weeks post administration of study treatment |
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Adverse events were collected collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
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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 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate | 0 | 34 | 0 | 34 | ||
| EG001 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate | 0 | 33 | 0 | 33 | ||
| EG002 | Sodium Monofluorophosphate | Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate | 0 | 34 | 0 | 34 | ||
| EG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride | 0 | 33 | 0 | 33 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Male |
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| Null hypothesis considered change from baseline to be same for treatments in comparison. | ANCOVA | From ANCOVA model with treatment and baseline included as covariate. | 0.5689 | Adjusted mean difference | 0.07 | 2-Sided | 95 | -0.16 | 0.30 | Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment. | No | Superiority or Other |
| Null hypothesis considered change from baseline to be same for treatments in comparison. | ANCOVA | From ANCOVA model with treatment and baseline included as covariate. | 0.7517 | Adjusted Mean Difference | 0.04 | 2-Sided | 95 | -0.20 | 0.27 | Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment. | No | Superiority or Other |
| Null hypothesis considered change from baseline to be same for treatments in comparison. | ANCOVA | From ANCOVA model with treatment and baseline included as covariate. | 0.8549 | Adjusted Mean Difference | 0.02 | 2-Sided | 95 | -0.21 | 0.25 | Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment. | No | Superiority or Other |
| Null hypothesis considered change from baseline to be same for treatments in comparison. | ANCOVA | From ANCOVA model with treatment and baseline included as covariate. | 0.6685 | Adjusted mean difference | 0.05 | 2-Sided | 95 | -0.18 | 0.29 | Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment. | No | Superiority or Other |
| Null hypothesis considered change from baseline to be same for treatments in comparison. | ANCOVA | 0.8031 | Adjusted Mean Difference | -0.03 | 2-Sided | 95 | -0.26 | 0.20 | Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment. | No | Superiority or Other |
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
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Dentifrice containing 1100 ppm fluoride as sodium fluoride |
| OG003 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
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Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
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Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate |
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Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
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