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The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587950
Recruitment Status : Completed
First Posted : April 30, 2012
Results First Posted : April 28, 2015
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Dentinal Hypersensitivity
Dental Pain
Interventions Drug: Potassium Nitrate
Drug: Placebo
Enrollment 12
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details Prior to efficacy assessment phase of this study, commercially available dental materials were employed to develop a dental stent in 3 participants. The dental stent design created a reservoir capable of holding the test solution at the cervical margin of a study tooth for at least 10 minutes. There was no efficacy data for this development phase.
Arm/Group Title Overall
Hide Arm/Group Description There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
Period Title: Period 1
Started 12
Received 5% KNO3 Solution (5 Minutes) 5
Received 5% KNO3 Solution (2 Minutes) 3
Received Sterile Water (2 Minutes) 2
Received 5% KNO3 Solution (10 Minutes) 4
Received 2.5% KNO3 Solution (2 Minutes) 4
Received 2.5% KNO3 Solution (10 Minutes) 3
Received Sterile Water (10 Minutes) 5
Received 2.5% KNO3 Solution (5 Minutes) 5
Received Sterile Water (5 Minutes) 5
Completed 12
Not Completed 0
Period Title: Washout 1
Started 12
Completed 12
Not Completed 0
Period Title: Period 2
Started 12
Received Sterile Water (2 Minutes) 8
Received 5% KNO3 Solution (10 Minutes) 4
Received 2.5% KNO3 Solution (5 Minutes) 2
Received 2.5% KNO3 Solution (10 Minutes) 6
Received 5% KNO3 Solution (2 Minutes) 6
Received Sterile Water (5 Minutes) 2
Received 2.5% KNO3 Solution (2 Minutes) 4
Received Sterile Water (10 Minutes) 2
Received 5% KNO3 Solution (5 Minutes) 2
Completed 12
Not Completed 0
Period Title: Washout 2
Started 12
Completed 12
Not Completed 0
Period Title: Period 3
Started 12
Received 2.5% KNO3 Solution (2 Minutes) 4
Received Sterile Water (10 Minutes) 5
Received Sterile Water (2 Minutes) 2
Received 5% KNO3 Solution (10 Minutes) 4
Received Sterile Water (5 Minutes) 5
Received 5% KNO3 Solution (5 Minutes) 5
Received 5% KNO3 Solution (2 Minutes) 3
Received 2.5% KNO3 Solution (10 Minutes) 3
Received 2.5% KNO3 Solution (5 Minutes) 5
Completed 12
Not Completed 0
Arm/Group Title Overall
Hide Arm/Group Description All randomized participants received all study treatments during this cross over study design.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
39.0  (13.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
9
  75.0%
Male
3
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Hide Description Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.
Time Frame Baseline, immediately post administration of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.
Arm/Group Title 2.5% KNO3 Solution (2 Minutes) 5% KNO3 Solution (2 Minutes) Sterile Water (2 Minutes) 2.5% KNO3 Solution (5 Minutes) 5% KNO3 Solution (5 Minutes) Sterile Water (5 Minutes) 2.5% KNO3 Solution (10 Minutes) 5% KNO3 Solution (10 Minutes) Sterile Water (10 Minutes)
Hide Arm/Group Description:
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
Overall Number of Participants Analyzed 8 10 10 7 10 10 7 10 10
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-13.48
(-24.59 to -2.38)
-12.49
(-22.34 to -2.64)
-8.59
(-18.74 to 1.55)
-14.14
(-26.13 to -2.15)
-17.51
(-27.40 to -7.62)
-11.12
(-20.88 to -1.36)
-8.38
(-20.14 to 3.37)
-17.34
(-27.15 to -7.53)
-14.62
(-24.44 to -4.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (2 Minutes), 5% KNO3 Solution (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8918
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-15.50 to 13.52
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (2 Minutes), Sterile Water (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5183
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.89
Confidence Interval (2-Sided) 95%
-19.91 to 10.14
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (2 Minutes), Sterile Water (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5718
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.89
Confidence Interval (2-Sided) 95%
-17.59 to 9.80
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (5 Minutes), 5% KNO3 Solution (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6591
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.37
Confidence Interval (2-Sided) 95%
-11.82 to 18.56
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (5 Minutes), Sterile Water (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6921
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -3.02
Confidence Interval (2-Sided) 95%
-18.17 to 12.13
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (5 Minutes), Sterile Water (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3513
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.39
Confidence Interval (2-Sided) 95%
-19.98 to 7.20
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (10 Minutes), 5% KNO3 Solution (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2346
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 8.96
Confidence Interval (2-Sided) 95%
-5.96 to 23.88
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (10 Minutes), Sterile Water (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4138
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.24
Confidence Interval (2-Sided) 95%
-8.92 to 21.39
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (10 Minutes), Sterile Water (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6931
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -2.72
Confidence Interval (2-Sided) 95%
-16.44 to 10.99
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
2.Primary Outcome
Title Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Hide Description Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.
Time Frame Baseline, 10 minutes post administration of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.
Arm/Group Title 2.5% KNO3 Solution (2 Minutes) 5% KNO3 Solution (2 Minutes) Sterile Water (2 Minutes) 2.5% KNO3 Solution (5 Minutes) 5% KNO3 Solution (5 Minutes) Sterile Water (5 Minutes) 2.5% KNO3 Solution (10 Minutes) 5% KNO3 Solution (10 Minutes) Sterile Water (10 Minutes)
Hide Arm/Group Description:
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
Overall Number of Participants Analyzed 8 10 10 7 10 10 7 10 10
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-20.23
(-31.58 to -8.88)
-13.84
(-23.92 to -3.76)
-9.01
(-19.39 to 1.38)
-22.67
(-34.92 to -10.42)
-12.80
(-22.92 to -2.67)
-11.55
(-21.55 to -1.55)
-9.80
(-21.83 to 2.23)
-20.81
(-30.88 to -10.74)
-15.25
(-25.31 to -5.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (2 Minutes), 5% KNO3 Solution (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3867
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.39
Confidence Interval (2-Sided) 95%
-21.04 to 8.26
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (2 Minutes), Sterile Water (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1448
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -11.22
Confidence Interval (2-Sided) 95%
-26.41 to 3.96
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (2 Minutes), Sterile Water (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4874
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.83
Confidence Interval (2-Sided) 95%
-18.66 to 8.99
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (5 Minutes), 5% KNO3 Solution (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2038
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -9.87
Confidence Interval (2-Sided) 95%
-25.23 to 5.49
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (5 Minutes), Sterile Water (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1518
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -11.12
Confidence Interval (2-Sided) 95%
-26.43 to 4.19
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (5 Minutes), Sterile Water (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8567
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-14.98 to 12.49
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (10 Minutes), 5% KNO3 Solution (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1493
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 11.01
Confidence Interval (2-Sided) 95%
-4.06 to 26.08
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (10 Minutes), Sterile Water (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4798
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 5.45
Confidence Interval (2-Sided) 95%
-9.86 to 20.76
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (10 Minutes), Sterile Water (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4255
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -5.56
Confidence Interval (2-Sided) 95%
-19.42 to 8.29
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
3.Primary Outcome
Title Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Hide Description Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.
Time Frame Baseline, 20 minutes post administration of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.
Arm/Group Title 2.5% KNO3 Solution (2 Minutes) 5% KNO3 Solution (2 Minutes) Sterile Water (2 Minutes) 2.5% KNO3 Solution (5 Minutes) 5% KNO3 Solution (5 Minutes) Sterile Water (5 Minutes) 2.5% KNO3 Solution (10 Minutes) 5% KNO3 Solution (10 Minutes) Sterile Water (10 Minutes)
Hide Arm/Group Description:
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
Overall Number of Participants Analyzed 8 10 10 7 10 10 7 10 10
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-22.54
(-33.96 to -11.12)
-20.58
(-30.88 to -10.29)
-16.22
(-26.78 to -5.67)
-22.25
(-34.52 to -9.98)
-16.57
(-26.88 to -6.26)
-18.23
(-28.46 to -8.00)
-12.21
(-24.38 to -0.05)
-19.97
(-30.33 to -9.61)
-18.90
(-29.21 to -8.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (2 Minutes), 5% KNO3 Solution (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7769
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.96
Confidence Interval 95%
-15.71 to 11.80
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (2 Minutes), Sterile Water (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3811
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -6.32
Confidence Interval (2-Sided) 95%
-20.64 to 8.00
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (2 Minutes), Sterile Water (2 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5044
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -4.36
Confidence Interval 95%
-17.35 to 8.63
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (5 Minutes), 5% KNO3 Solution (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4374
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -5.68
Confidence Interval (2-Sided) 95%
-20.20 to 8.84
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (5 Minutes), Sterile Water (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5796
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Slope
Estimated Value -4.02
Confidence Interval (2-Sided) 95%
-18.46 to 10.41
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (5 Minutes), Sterile Water (5 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7994
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
-11.32 to 14.64
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (10 Minutes), 5% KNO3 Solution (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2784
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.75
Confidence Interval (2-Sided) 95%
-6.42 to 21.93
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 2.5% KNO3 Solution (10 Minutes), Sterile Water (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3581
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 6.68
Confidence Interval (2-Sided) 95%
-7.75 to 21.12
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 5% KNO3 Solution (10 Minutes), Sterile Water (10 Minutes)
Comments Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8703
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with factors for treatment group, application site, period and random effect for subject
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-14.11 to 11.97
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.
Time Frame All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall
Hide Arm/Group Description All participants received all study treatments during this cross over study design.
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%)
Total   0/12 (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
Affected / at Risk (%)
Total   0/12 (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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01587950     History of Changes
Other Study ID Numbers: Z3770631
First Submitted: November 17, 2011
First Posted: April 30, 2012
Results First Submitted: March 21, 2013
Results First Posted: April 28, 2015
Last Update Posted: April 28, 2015