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An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% KNO3 solution | Experimental | Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. |
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| 2.5% KNO3 solution | Experimental | Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. |
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| Sterile Water | Placebo Comparator | Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Potassium nitrate | Drug | 5% potassium nitrate solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. |
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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 |
Participants with at least three non-adjacent sensitive teeth were included in the study. Each participant received three treatments during each of the five days treatment. Treatments were randomly assigned to each of the three individual sensitive tooth.
Participants were recruited at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | 5% or 2.5% Potassium Nitrate Solution or Water | Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| 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 | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment on Day 5 |
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Baseline through 5 days post administration of last 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 | Overall Study |
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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 |
|---|---|
| C023844 | potassium nitrate |
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| 2.5% Potassium nitrate | Drug | 2.5% potassium nitrate solution |
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| Sterile water | Other | Sterile water |
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| Baseline and immediately after treatment on Day 1 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 1 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS. | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 1 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 2 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 2 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 2 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 3 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 3 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 3 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 4 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 4 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 4 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 5 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 5 |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 5 |
| 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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| OG000 | 5% Potassium Nitrate Solution | Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment. |
| OG001 | 2.5% Potassium Nitrate Solution | Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment on Day 1 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 10 mins post treatment on Day 1 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS. | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 20 mins post treatment on Day 1 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment on Day 2 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 10 mins post treatment on Day 2 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 20 mins post treatment on Day 2 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment on Day 3 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 10 mins post treatment on Day 3 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 20 mins post treatment on Day 3 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment on Day 4 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 10 mins post treatment on Day 4 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 20 mins post treatment on Day 4 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and immediately after treatment on Day 5 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 10 mins post treatment on Day 5 |
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| Secondary | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 20 mins post treatment on Day 5 |
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| 0 |
| 32 |
| 0 |
| 32 |
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.
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.3582 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 3.90 | 2-Sided | 95 | -4.45 | 12.25 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.3600 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 3.88 | 2-Sided | 95 | -4.46 | 12.22 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.8314 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -0.90 | 2-Sided | 95 | -9.25 | 7.45 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.9978 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.01 | 2-Sided | 95 | -8.33 | 8.35 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.7646 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -1.27 | 2-Sided | 95 | -9.62 | 7.08 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.1957 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -5.49 | 95 | -13.83 | 2.85 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.8767 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.66 | 95 | -7.75 | 9.08 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.6367 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 2.01 | 95 | -6.39 | 10.42 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.9200 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.43 | 2-Sided | 95 | -7.99 | 8.85 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.5766 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 2.38 | 95 | -6.02 | 10.78 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.6896 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -1.70 | 2-Sided | 95 | -10.12 | 6.71 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.6591 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjustes mean difference | 1.88 | 2-Sided | 95 | -6.52 | 10.28 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.6888 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -1.76 | 2-Sided | 95 | -10.46 | 6.93 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.9428 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.32 | 2-Sided | 95 | -8.37 | 9.00 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.6340 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -2.10 | 2-Sided | 95 | -10.80 | 6.60 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | 0.9127 | Adjusted mean difference | 0.48 | 2-Sided | 95 | -8.20 | 9.16 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.8912 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.60 | 2-Sided | 95 | -8.10 | 9.30 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.5321 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 2.75 | 2-Sided | 95 | -5.93 | 11.43 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.8573 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.74 | 2-Sided | 95 | -7.42 | 8.91 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.3193 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 4.12 | 2-Sided | 95 | -4.03 | 12.27 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.8008 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 1.04 | 2-Sided | 95 | -7.42 | 9.21 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.5969 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -2.18 | 2-Sided | 95 | -10.33 | 5.97 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.9248 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -0.39 | 2-Sided | 95 | -8.56 | 7.77 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.2508 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 4.75 | 2-Sided | 95 | -3.40 | 12.90 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.7208 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 1.44 | 2-Sided | 95 | -6.52 | 9.41 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.7949 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 1.05 | 2-Sided | 95 | -6.93 | 9.03 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.5507 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 2.41 | 2-Sided | 95 | -5.56 | 10.37 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |
| Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.9705 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | -0.15 | 2-Sided | 95 | -8.13 | 7.83 | Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution. | No | Superiority or Other |
| Null hypothesis is no difference between treatments. | ANCOVA | Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor. | 0.8867 | No adjustment for multiple comparisons were made as the primary comparison was pre-defined. | Adjusted mean difference | 0.57 | 2-Sided | 95 | -7.39 | 8.54 | Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution. | No | Superiority or Other |