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Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

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ClinicalTrials.gov Identifier: NCT01115452
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dentine Hypersensitivity
Interventions Drug: 5% Potassium nitrate
Drug: 2.5% Potassium nitrate
Other: Sterile water
Enrollment 32
Recruitment Details Participants were recruited at the clinical site
Pre-assignment Details 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.
Arm/Group Title 5% or 2.5% Potassium Nitrate Solution or Water
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Overall Study
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
36.5  (11.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
27
  84.4%
Male
5
  15.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and immediately after treatment on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-24.36
(-31.56 to -17.16)
-24.04
(-31.24 to -16.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis was no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9347
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-8.14 to 7.50
Estimation Comments 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.
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and immediately after treatment on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.18
(-15.35 to -1.02)
-8.20
(-15.37 to -1.04)
-12.08
(-19.31 to -4.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9963
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method ANCOVA
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-8.20 to 8.24
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3582
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.90
Confidence Interval (2-Sided) 95%
-4.45 to 12.25
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3600
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.88
Confidence Interval (2-Sided) 95%
-4.46 to 12.22
Estimation Comments 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.
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 10 mins post treatment on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-13.38
(-20.55 to -6.22)
-12.47
(-19.63 to -5.31)
-12.48
(-19.71 to -5.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8265
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-9.13 to 7.30
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8314
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-9.25 to 7.45
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9978
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-8.33 to 8.35
Estimation Comments 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.
4.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline and 20 mins post treatment on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-17.42
(-24.58 to -10.25)
-21.64
(-28.80 to -14.47)
-16.15
(-23.37 to -8.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3122
Comments [Not Specified]
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.22
Confidence Interval (2-Sided) 95%
-4.00 to 12.44
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7646
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-9.62 to 7.08
Estimation Comments 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.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1957
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.49
Confidence Interval 95%
-13.83 to 2.85
Estimation Comments 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.
5.Secondary Outcome
Title Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS
Hide Description 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.
Time Frame Baseline and immediately after treatment on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-11.66
(-19.03 to -4.29)
-10.31
(-17.67 to -2.94)
-12.32
(-19.76 to -4.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7472
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-9.62 to 6.92
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8767
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.66
Confidence Interval 95%
-7.75 to 9.08
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6367
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.01
Confidence Interval 95%
-6.39 to 10.42
Estimation Comments 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.
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 10 mins post treatment on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-18.09
(-25.46 to -10.72)
-16.14
(-23.51 to -8.77)
-18.52
(-25.96 to -11.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6417
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.95
Confidence Interval (2-Sided) 95%
-10.22 to 6.32
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9200
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
-7.99 to 8.85
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5766
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.38
Confidence Interval 95%
-6.02 to 10.78
Estimation Comments 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.
7.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 20 mins post treatment on Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-20.39
(-27.76 to -13.02)
-16.81
(-24.17 to -9.44)
-18.69
(-26.12 to -11.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3930
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.58
Confidence Interval (2-Sided) 95%
-11.65 to 4.68
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6896
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-10.12 to 6.71
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6591
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjustes mean difference
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
-6.52 to 10.28
Estimation Comments 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.
8.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and immediately after treatment on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-16.66
(-24.48 to -8.84)
-14.58
(-22.40 to -6.76)
-14.90
(-22.79 to -7.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6301
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.08
Confidence Interval 95%
-10.60 to 6.45
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6888
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.76
Confidence Interval (2-Sided) 95%
-10.46 to 6.93
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9428
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
-8.37 to 9.00
Estimation Comments 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.
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 10 mins post treatment on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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..
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-23.29
(-31.12 to -15.47)
-20.71
(-28.53 to -12.89)
-21.20
(-29.09 to -13.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5504
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.58
Confidence Interval (2-Sided) 95%
-11.10 to 5.95
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6340
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-10.80 to 6.60
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9127
Comments [Not Specified]
Method ANCOVA
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
-8.20 to 9.16
Estimation Comments 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.
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 20 mins post treatment on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-24.86
(-32.68 to -17.04)
-22.71
(-30.53 to -14.89)
-25.46
(-33.36 to -17.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6192
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.15
Confidence Interval (2-Sided) 95%
-10.67 to 6.38
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8912
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
-8.10 to 9.30
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5321
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.75
Confidence Interval (2-Sided) 95%
-5.93 to 11.43
Estimation Comments 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
11.Secondary Outcome
Title Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS
Hide Description 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.
Time Frame Baseline and immediately after treatment on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-21.89
(-29.26 to -14.52)
-18.52
(-25.89 to -11.15)
-22.63
(-30.08 to -15.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4055
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.37
Confidence Interval (2-Sided) 95%
-11.37 to 4.63
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8573
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
-7.42 to 8.91
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3193
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.12
Confidence Interval (2-Sided) 95%
-4.03 to 12.27
Estimation Comments 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.
12.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 10 mins post treatment on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-21.09
(-28.46 to -13.72)
-24.32
(-31.69 to -16.95)
-22.13
(-29.58 to -14.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4264
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.23
Confidence Interval 95%
-4.77 to 11.23
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8008
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
-7.42 to 9.21
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5969
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.18
Confidence Interval (2-Sided) 95%
-10.33 to 5.97
Estimation Comments 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.
13.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 20 mins post treatment on Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-27.92
(-35.30 to -20.55)
-22.78
(-30.15 to -15.41)
-27.53
(-34.98 to -20.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2059
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.14
Confidence Interval (2-Sided) 95%
-13.14 to 2.86
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9248
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-8.56 to 7.77
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2508
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 4.75
Confidence Interval (2-Sided) 95%
-3.40 to 12.90
Estimation Comments 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.
14.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and immediately after treatment on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-24.36
(-31.56 to -17.16)
-24.04
(-31.24 to -16.84)
-25.48
(-32.75 to -18.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7822
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
-6.86 to 9.10
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7208
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
-6.52 to 9.41
Estimation Comments 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.
15.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 10 mins post treatment on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
Hide Arm/Group Description:
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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-27.83
(-35.03 to -20.63)
-26.47
(-33.67 to -19.27)
-28.88
(-36.15 to -21.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7318
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-9.18 to 6.46
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7949
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
-6.93 to 9.03
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5507
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.41
Confidence Interval (2-Sided) 95%
-5.56 to 10.37
Estimation Comments 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.
16.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and 20 mins post treatment on Day 5
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Hide Analysis Population Description
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
Arm/Group Title 5% Potassium Nitrate Solution 2.5% Potassium Nitrate Solution Water
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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.
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.
Investigator applied the participants with sterile water 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.
Overall Number of Participants Analyzed 30 30 30
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-30.93
(-38.13 to -23.73)
-30.20
(-37.40 to -23.01)
-30.78
(-38.05 to -23.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, 2.5% Potassium Nitrate Solution
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8549
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-8.54 to 7.10
Estimation Comments Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9705
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-8.13 to 7.83
Estimation Comments Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 2.5% Potassium Nitrate Solution, Water
Comments Null hypothesis is no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8867
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANCOVA
Comments Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
-7.39 to 8.54
Estimation Comments 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.
Time Frame Baseline through 5 days post administration of last treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%)
Total   0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01115452     History of Changes
Other Study ID Numbers: Z3770633
First Submitted: April 30, 2010
First Posted: May 4, 2010
Results First Submitted: March 21, 2013
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015