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A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterile water | Placebo Comparator | Participants to receive 250 microlitres (μL) of sterile water. |
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| Potassium nitrate 5% solution | Experimental | Participants to receive 250 μL of potassium nitrate 5% solution. |
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| Potassium nitrate 2.5% solution | Experimental | Participants to receive 250 μL of potassium nitrate 2.5% solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Nitrate | Drug | 250 μL of Potassium nitrate solution (either 5% or 2.5%) |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment. | Baseline, immediately post administration of treatment |
| Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment. | Baseline, 10 minutes post administration of treatment |
| Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment. | Baseline, 20 minutes post administration of treatment |
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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 |
|---|---|---|---|---|---|---|
| University Park Research Center (UPRC) | Fort Wayne | Indiana | 46825 | United States |
Prior to efficacy assessment phase of this study, commercially available dental materials were employed to develop a dental stent in 3 participants. The dental stent design created a reservoir capable of holding the test solution at the cervical margin of a study tooth for at least 10 minutes. There was no efficacy data for this development phase.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
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| Period 1 |
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| Washout 1 |
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| Period 2 |
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| Washout 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All randomized participants received all study treatments during this cross over study design. |
| 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 Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment. | Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline, immediately post administration of treatment |
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All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of 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 | Overall | All participants received all study treatments during this cross over study design. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C023844 | potassium nitrate |
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| Placebo | Drug | Sterile Water |
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| Received 2.5% KNO3 Solution (5 Minutes) |
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| Received 2.5% KNO3 Solution (10 Minutes) |
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| Received 5% KNO3 Solution (2 Minutes) |
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| Received Sterile Water (5 Minutes) |
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| Received 2.5% KNO3 Solution (2 Minutes) |
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| Received Sterile Water (10 Minutes) |
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| Received 5% KNO3 Solution (5 Minutes) |
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| COMPLETED |
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| NOT COMPLETED |
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| Received Sterile Water (2 Minutes) |
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| Received 5% KNO3 Solution (10 Minutes) |
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| Received Sterile Water (5 Minutes) |
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| Received 5% KNO3 Solution (5 Minutes) |
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| Received 5% KNO3 Solution (2 Minutes) |
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| Received 2.5% KNO3 Solution (10 Minutes) |
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| Received 2.5% KNO3 Solution (5 Minutes) |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period. |
| OG001 | 5% KNO3 Solution (2 Minutes) | Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period. |
| OG002 | Sterile Water (2 Minutes) | Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period. |
| OG003 | 2.5% KNO3 Solution (5 Minutes) | Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period. |
| OG004 | 5% KNO3 Solution (5 Minutes) | Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period. |
| OG005 | Sterile Water (5 Minutes) | Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period. |
| OG006 | 2.5% KNO3 Solution (10 Minutes) | Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period. |
| OG007 | 5% KNO3 Solution (10 Minutes) | Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period. |
| OG008 | Sterile Water (10 Minutes) | Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period. |
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| Primary | Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment. | ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline, 10 minutes post administration of treatment |
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| Primary | Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment. | ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline, 20 minutes post administration of treatment |
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| 0 |
| 12 |
| 0 |
| 12 |
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.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.1448 | Adjusted Mean Difference | -11.22 | 2-Sided | 95 | -26.41 | 3.96 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.4874 | Adjusted Mean Difference | -4.83 | 2-Sided | 95 | -18.66 | 8.99 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.2038 | Adjusted Mean Difference | -9.87 | 2-Sided | 95 | -25.23 | 5.49 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.1518 | Adjusted Mean Difference | -11.12 | 2-Sided | 95 | -26.43 | 4.19 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.8567 | Adjusted Mean Difference | -1.25 | 2-Sided | 95 | -14.98 | 12.49 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.1493 | Adjusted Mean Difference | 11.01 | 2-Sided | 95 | -4.06 | 26.08 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.4798 | Adjusted Mean Difference | 5.45 | 2-Sided | 95 | -9.86 | 20.76 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.4255 | Adjusted Mean Difference | -5.56 | 2-Sided | 95 | -19.42 | 8.29 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.3811 | Adjusted Mean Difference | -6.32 | 2-Sided | 95 | -20.64 | 8.00 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.5044 | Adjusted Mean Difference | -4.36 | 95 | -17.35 | 8.63 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject. | 0.4374 | Adjusted Mean Difference | -5.68 | 2-Sided | 95 | -20.20 | 8.84 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.5796 | Slope | -4.02 | 2-Sided | 95 | -18.46 | 10.41 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05 | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.7994 | Adjusted Mean Difference | 1.66 | 2-Sided | 95 | -11.32 | 14.64 | Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.2784 | Adjusted Mean Difference | 7.75 | 2-Sided | 95 | -6.42 | 21.93 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.3581 | Adjusted Mean Difference | 6.68 | 2-Sided | 95 | -7.75 | 21.12 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05. | ANCOVA | ANCOVA with factors for treatment group, application site, period and random effect for subject | 0.8703 | Adjusted Mean Difference | -1.07 | 2-Sided | 95 | -14.11 | 11.97 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |