Trial Outcomes & Findings for Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity (NCT NCT01115452)
NCT ID: NCT01115452
Last Updated: 2015-01-26
Results Overview
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.
COMPLETED
PHASE2
32 participants
Baseline and immediately after treatment on Day 5
2015-01-26
Participant Flow
Participants were recruited at the clinical site
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.
Participant milestones
| Measure |
5% or 2.5% Potassium Nitrate Solution or Water
Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
|
|---|---|
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Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Overall Study
n=32 Participants
|
|---|---|
|
Age, Continuous
|
36.5 Years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediately after treatment on Day 5Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
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.
|
|---|---|---|---|
|
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
|
-24.36 units on a scale
Interval -31.56 to -17.16
|
-24.04 units on a scale
Interval -31.24 to -16.84
|
—
|
SECONDARY outcome
Timeframe: Baseline and immediately after treatment on Day 1Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-8.18 units on a scale
Interval -15.35 to -1.02
|
-8.20 units on a scale
Interval -15.37 to -1.04
|
-12.08 units on a scale
Interval -19.31 to -4.86
|
SECONDARY outcome
Timeframe: Baseline and 10 mins post treatment on Day 1Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-13.38 units on a scale
Interval -20.55 to -6.22
|
-12.47 units on a scale
Interval -19.63 to -5.31
|
-12.48 units on a scale
Interval -19.71 to -5.26
|
SECONDARY outcome
Timeframe: Baseline and 20 mins post treatment on Day 1Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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.
|
-17.42 units on a scale
Interval -24.58 to -10.25
|
-21.64 units on a scale
Interval -28.8 to -14.47
|
-16.15 units on a scale
Interval -23.37 to -8.92
|
SECONDARY outcome
Timeframe: Baseline and immediately after treatment on Day 2Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS
|
-11.66 units on a scale
Interval -19.03 to -4.29
|
-10.31 units on a scale
Interval -17.67 to -2.94
|
-12.32 units on a scale
Interval -19.76 to -4.89
|
SECONDARY outcome
Timeframe: Baseline and 10 mins post treatment on Day 2Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-18.09 units on a scale
Interval -25.46 to -10.72
|
-16.14 units on a scale
Interval -23.51 to -8.77
|
-18.52 units on a scale
Interval -25.96 to -11.09
|
SECONDARY outcome
Timeframe: Baseline and 20 mins post treatment on Day 2Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-20.39 units on a scale
Interval -27.76 to -13.02
|
-16.81 units on a scale
Interval -24.17 to -9.44
|
-18.69 units on a scale
Interval -26.12 to -11.25
|
SECONDARY outcome
Timeframe: Baseline and immediately after treatment on Day 3Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-16.66 units on a scale
Interval -24.48 to -8.84
|
-14.58 units on a scale
Interval -22.4 to -6.76
|
-14.90 units on a scale
Interval -22.79 to -7.0
|
SECONDARY outcome
Timeframe: Baseline and 10 mins post treatment on Day 3Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-23.29 units on a scale
Interval -31.12 to -15.47
|
-20.71 units on a scale
Interval -28.53 to -12.89
|
-21.20 units on a scale
Interval -29.09 to -13.3
|
SECONDARY outcome
Timeframe: Baseline and 20 mins post treatment on Day 3Population: 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.
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-24.86 units on a scale
Interval -32.68 to -17.04
|
-22.71 units on a scale
Interval -30.53 to -14.89
|
-25.46 units on a scale
Interval -33.36 to -17.57
|
SECONDARY outcome
Timeframe: Baseline and immediately after treatment on Day 4Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS
|
-21.89 units on a scale
Interval -29.26 to -14.52
|
-18.52 units on a scale
Interval -25.89 to -11.15
|
-22.63 units on a scale
Interval -30.08 to -15.19
|
SECONDARY outcome
Timeframe: Baseline and 10 mins post treatment on Day 4Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-21.09 units on a scale
Interval -28.46 to -13.72
|
-24.32 units on a scale
Interval -31.69 to -16.95
|
-22.13 units on a scale
Interval -29.58 to -14.69
|
SECONDARY outcome
Timeframe: Baseline and 20 mins post treatment on Day 4Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-27.92 units on a scale
Interval -35.3 to -20.55
|
-22.78 units on a scale
Interval -30.15 to -15.41
|
-27.53 units on a scale
Interval -34.98 to -20.09
|
SECONDARY outcome
Timeframe: Baseline and immediately after treatment on Day 5Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-24.36 units on a scale
Interval -31.56 to -17.16
|
-24.04 units on a scale
Interval -31.24 to -16.84
|
-25.48 units on a scale
Interval -32.75 to -18.21
|
SECONDARY outcome
Timeframe: Baseline and 10 mins post treatment on Day 5Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-27.83 units on a scale
Interval -35.03 to -20.63
|
-26.47 units on a scale
Interval -33.67 to -19.27
|
-28.88 units on a scale
Interval -36.15 to -21.61
|
SECONDARY outcome
Timeframe: Baseline and 20 mins post treatment on Day 5Population: 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
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.
Outcome measures
| Measure |
5% Potassium Nitrate Solution
n=30 Participants
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.
|
2.5% Potassium Nitrate Solution
n=30 Participants
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
|
Water
n=30 Participants
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.
|
|---|---|---|---|
|
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
|
-30.93 units on a scale
Interval -38.13 to -23.73
|
-30.20 units on a scale
Interval -37.4 to -23.01
|
-30.78 units on a scale
Interval -38.05 to -23.51
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER