Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | dentifice |
| |
| Sodium Monofluorophosphate |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | 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. | Baseline to 8 weeks post administration of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a 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. |
Not provided
Inclusion Criteria:
Inclusion Criteria:
- none
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Of 122 participants screened, 2 participants did not meet the study criteria, and 2 withdrew consent before randomization. 118 participants were randomized to study treatments.
Participants were recruited at the clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stannous Fluoride (SnF) Dentifrice | Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water. |
| FG001 | Sodium Monofluorophosphate (NaMFP) Dentifrice | Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SnF Dentifrice | Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. |
| BG001 | NaMFP Dentifrice |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | 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. | 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. Missing values were not imputed. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 8 weeks post administration of study treatment |
|
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.
Not provided
Not provided
| 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 whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Herpes | Infections and infestations |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014002 | Tin Fluorides |
| C012980 | fluorophosphate |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
dentifrice |
|
| Baseline to 4 weeks post administration of study treatment |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. | Baseline to 8 weeks post administration of study treatment |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure 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 subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated | Baseline to 4 weeks post administration of study treatment |
Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| SnF Dentifrice |
Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. |
| OG001 | NaMFP Dentifrice | Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. |
|
|
|
| Secondary | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a 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. | 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. Missing values were not imputed. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 4 weeks post administration of study treatment |
|
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. | 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. Missing values were not imputed. | Posted | Mean | Standard Deviation | grams | Baseline to 8 weeks post administration of study treatment |
|
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure 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 subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated | 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. Missing values were not imputed. | Posted | Mean | Standard Deviation | grams | Baseline to 4 weeks post administration of study treatment |
|
|
|
|
| 0 |
| 60 |
| 1 |
| 60 |
| EG001 | NaMFP Dentifrice | Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. | 1 | 58 | 0 | 58 |
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 |