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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 arms, parallel design 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 and 1500ppmF as sodium monofluorophosphate |
|
| 0% calcium sodium phosphosilicate/sodium monofluorophosphate | Active Comparator | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
|
| Sodium monofluorophosphate | Active Comparator | Dentifrice containing 1000 ppmF as sodium monofluorophosphate |
|
| Sodium fluoride | Active Comparator | Dentifrice containing 1100 ppmF as sodium fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice | Drug | Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. | Baseline and 4 weeks post administration of study treatment |
| Mean Change From Baseline in Schiff Sensitivity Score 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. | Baseline and 8 weeks post administration of study treatment |
| Median Change From Baseline in Tactile Sensitivity at Week 4 | Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | Baseline and 4 weeks post administration of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. |
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Inclusion Criteria:
Exclusion Criteria:
Specific Dentition Exclusions for Test teeth
Use of a sensitivity dentifrice within 8 weeks of screening
Individuals who require antibiotic prophylaxis for dental procedures
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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 |
Participants aged 18 and 55 years of age (inclusive), in good general health, with preexisting self-reported and clinically diagnosed tooth sensitivity were enrolled in this 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 1500ppm 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 | No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate |
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| Sodium monofluorophosphate dentifrice | Drug | Sodium monofluorophospate dentifrice (1000 ppm F) |
|
| Sodium Fluoride dentifrice | Drug | Dentifrice containing 1100ppm F as sodium fluoride |
|
| Median Change From Baseline in Tactile Sensitivity at Week 8 |
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. |
| Baseline and 8 weeks post administration of study treatment |
| Mean Change From Baseline in Visual Rating Scale Score at Week 4 | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain". | Baseline and 4 weeks post administration of study treatment |
| Mean Change From Baseline in Visual Rating Scale Score at Week 8 | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain". | Baseline and 8 weeks post administration of study treatment |
| Baseline and 4 weeks post administration of study treatment |
| Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. | Baseline and 8 weeks post administration of study treatment |
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm 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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ITT population consisted of all subjects who were randomized, administered at least one study treatment and provided at least one post-baseline assessment of efficacy. The data of 1 subject in 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate group who was lost to follow up was included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate |
| BG001 | 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm 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 |
| |||||||||||||||
| 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 | Mean Change From Baseline in Schiff Sensitivity Score 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 4 weeks post administration of study treatment |
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| Primary | Mean Change From Baseline in Schiff Sensitivity Score 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline and 8 weeks post administration of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Median Change From Baseline in Tactile Sensitivity at Week 4 | Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Median | Full Range | grams | Baseline and 4 weeks post administration of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Median Change From Baseline in Tactile Sensitivity at Week 8 | Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Median | Full Range | grams | Baseline and 8 weeks post administration of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain". | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 4 weeks post administration of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain". | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 8 weeks post administration of study treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 4 weeks post administration of study treatment |
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| Secondary | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 8 weeks post administration of study 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 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate | 0 | 35 | 5 | 35 | ||
| EG001 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate | 0 | 34 | 3 | 34 | ||
| EG002 | Sodium Monofluorophosphate | Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate | 0 | 35 | 2 | 35 | ||
| EG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride | 0 | 36 | 2 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Arthralgia | Immune system disorders |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Pain in Jaw | General disorders | Systematic Assessment |
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| Oral Herpes | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infections | Infections and infestations | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Sinus Headache | Nervous system disorders | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| Male |
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| Week 4 |
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| Mean change from baseline at Week 4 |
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| Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons | ANCOVA | 0.0002 | Mean change difference | -0.48 | 2-Sided | 95 | -0.73 | -0.23 | Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment | No | Superiority or Other |
| Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons | ANCOVA | 0.0002 | Mean change difference | -0.49 | 2-Sided | 95 | -0.74 | -0.24 | Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment | No | Superiority or Other |
| Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons | ANCOVA | 0.0028 | Mean change difference | 0.38 | 2-Sided | 95 | 0.13 | 0.63 | Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment | No | Superiority or Other |
| Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons | ANCOVA | 0.0022 | Mean change difference | 0.39 | 2-Sided | 95 | 0.14 | 0.63 | Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment | No | Superiority or Other |
| Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons | ANCOVA | 0.9606 | Mean change difference | -0.01 | 2-Sided | 95 | -0.25 | 0.24 | Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment | No | Superiority or Other |
| Sodium Monofluorophosphate |
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| OG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
|
|
| Sodium Monofluorophosphate |
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| OG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
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|
| Sodium Monofluorophosphate |
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| OG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
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Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
|
|
Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
|
|
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| OG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
|
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate |
| OG003 | Sodium Fluoride | Dentifrice containing 1100 ppm fluoride as sodium fluoride |
|
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