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A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Dentifrice containing stannous fluoride |
|
| Arm 2 | Active Comparator | Marketed dentifrice containing Sodium Monofluorophosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous Fluoride | Drug | dentifrice containing stannous fluoride |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 | Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. | Baseline to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
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- Subjects who suffer from tooth sensitivity.
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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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Of 126 participants screened, 9 participants did not meet the study criteria, 3 were lost to follow up and 1 withdrew consent before randomization. Remaining 113 participants were randomized to study treatments.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stannous Fluoride (SnF) Dentifrice | Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water. |
| FG001 | Sodium Monofluorophosphate (NaMFP) Dentifrice | Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate [NaMFP]) for one timed minute, followed by rinsing with 5 mL of water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SnF Dentifrice | Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water. |
| BG001 | NaMFP Dentifrice |
| 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 | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 | Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. | Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Day 14 |
All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.
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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 | SnF Dentifrice | Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water. |
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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 |
dentifrice containing Sodium Monofluorophosphate |
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| Baseline to immediately post treatment administration |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. | Baseline to Day 3 |
| Change From Baseline in Tactile Pain Threshold Score at Day 14 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity | Baseline to Day 14 |
| Change From Baseline in Tactile Pain Threshold Score at Day 3 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. | Baseline to Day 3 |
| Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. | Baseline to immediately post treatment administration |
Participants brushed 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | SnF Dentifrice | Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water. |
| OG001 | NaMFP Dentifrice | Participants brushed 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. |
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| Secondary | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. | ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to immediately post treatment administration |
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| Secondary | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | Response to a constant jet of air applied to hypersensitive teeth is 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. | ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Day 3 |
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| Secondary | Change From Baseline in Tactile Pain Threshold Score at Day 14 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity | ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Force (grams) | Baseline to Day 14 |
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| Secondary | Change From Baseline in Tactile Pain Threshold Score at Day 3 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. | ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Force (grams) | Baseline to Day 3 |
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| Secondary | Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. | ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Force (grams) | Baseline to immediately post treatment administration |
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| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | NaMFP Dentifrice | Participants brushed 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. | 0 | 57 | 0 | 57 |
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 |