Dentine Hypersensitivity
Conditions
Keywords
potassium nitrate, tooth sensitivity, dentin sensitivity
Brief summary
An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.
Interventions
5% potassium nitrate solution
DRUG2.5% Potassium nitrate
2.5% potassium nitrate solution
OTHERSterile water
Sterile water
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth * Three teeth that can be isolated that meet all of the following criteria at the screening visit: * Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3 mm recession at the facial surface midpoint * Teeth must be visually stain and calculus free * Teeth having a gingival index score of less than or equal to 2 * Teeth with a clinical mobility less than or equal to 1 * Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS
Exclusion criteria
* Chronic disease or other condition that is associated with intermittent episodes of constant daily pain, such as arthritis, low back pain, etc. * An condition or medication that causes xerostomia as determined by investigator * Sensitive teeth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator * Teeth with exposed dentine but with deep, defective or facial restorations * Teeth used as abutments for fixed or removable partial dentures * Teeth with full crowns, orthodontic bands, extensive caries or cracked enamel * Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. * Dental prophylaxis within 3 weeks of the screening visit * Tongue or lip piercing or presence of dental implants * Subjects not using the same brand of toothpaste for at least 4 months prior to the screening visit * Subjects who have used desensitizing toothpaste during the 4 weeks before Treatment Visit 1 * Taking daily dose of medication which may interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquillizers, mood-altering drugs or anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and immediately after treatment on Day 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 10 mins post treatment on Day 1 | 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. |
| 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. | Baseline and 20 mins post treatment on Day 1 | 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. |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS | Baseline and immediately after treatment on Day 2 | 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. |
| 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 | Baseline and 10 mins post treatment on Day 2 | 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. |
| 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 | Baseline and 20 mins post treatment on Day 2 | 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. |
| 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 | Baseline and immediately after treatment on Day 3 | 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. |
| 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 | Baseline and 10 mins post treatment on Day 3 | 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. |
| 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 | Baseline and immediately after treatment on Day 1 | 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. |
| Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS | Baseline and immediately after treatment on Day 4 | 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. |
| 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 | Baseline and 10 mins post treatment on Day 4 | 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. |
| 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 | Baseline and 20 mins post treatment on Day 4 | 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. |
| 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 | Baseline and immediately after treatment on Day 5 | 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. |
| 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 | Baseline and 10 mins post treatment on Day 5 | 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. |
| 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 | Baseline and 20 mins post treatment on Day 5 | 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. |
| 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 | Baseline and 20 mins post treatment on Day 3 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 36.5 Years STANDARD_DEVIATION 11.63 |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and immediately after treatment on Day 5
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -24.04 units on a scale |
Comparison: Null hypothesis was no difference between treatments.p-value: 0.934795% CI: [-8.14, 7.5]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 20 mins post treatment on Day 4
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -22.78 units on a scale |
| Water | 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 | -27.53 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.205995% CI: [-13.14, 2.86]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.924895% CI: [-8.56, 7.77]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.250895% CI: [-3.4, 12.9]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 10 mins post treatment on Day 1
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -12.47 units on a scale |
| Water | 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 | -12.48 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.826595% CI: [-9.13, 7.3]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.831495% CI: [-9.25, 7.45]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.997895% CI: [-8.33, 8.35]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 10 mins post treatment on Day 2
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -16.14 units on a scale |
| Water | 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 | -18.52 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.641795% CI: [-10.22, 6.32]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.9295% CI: [-7.99, 8.85]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.576695% CI: [-6.02, 10.78]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 10 mins post treatment on Day 3
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -20.71 units on a scale |
| Water | 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 | -21.20 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.550495% CI: [-11.1, 5.95]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.63495% CI: [-10.8, 6.6]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.912795% CI: [-8.2, 9.16]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 10 mins post treatment on Day 4
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -24.32 units on a scale |
| Water | 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 | -22.13 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.426495% CI: [-4.77, 11.23]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.800895% CI: [-7.42, 9.21]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.596995% CI: [-10.33, 5.97]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 10 mins post treatment on Day 5
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -26.47 units on a scale |
| Water | 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 | -28.88 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.731895% CI: [-9.18, 6.46]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.794995% CI: [-6.93, 9.03]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.550795% CI: [-5.56, 10.37]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 20 mins post treatment on Day 1
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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. | -21.64 units on a scale |
| Water | 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. | -16.15 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.312295% CI: [-4, 12.44]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.764695% CI: [-9.62, 7.08]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.195795% CI: [-13.83, 2.85]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 20 mins post treatment on Day 2
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -16.81 units on a scale |
| Water | 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 | -18.69 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.39395% CI: [-11.65, 4.68]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.689695% CI: [-10.12, 6.71]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.659195% CI: [-6.52, 10.28]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 20 mins post treatment on Day 3
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -22.71 units on a scale |
| Water | 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 | -25.46 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.619295% CI: [-10.67, 6.38]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.891295% CI: [-8.1, 9.3]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.532195% CI: [-5.93, 11.43]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and 20 mins post treatment on Day 5
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -30.20 units on a scale |
| Water | 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 | -30.78 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.854995% CI: [-8.54, 7.1]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.970595% CI: [-8.13, 7.83]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.886795% CI: [-7.39, 8.54]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and immediately after treatment on Day 2
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS | -10.31 units on a scale |
| Water | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS | -12.32 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.747295% CI: [-9.62, 6.92]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.876795% CI: [-7.75, 9.08]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.636795% CI: [-6.39, 10.42]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and immediately after treatment on Day 4
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS | -18.52 units on a scale |
| Water | Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS | -22.63 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.405595% CI: [-11.37, 4.63]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.857395% CI: [-7.42, 8.91]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.319395% CI: [-4.03, 12.27]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and immediately after treatment on Day 1
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -8.20 units on a scale |
| Water | 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 | -12.08 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.996395% CI: [-8.2, 8.24]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.358295% CI: [-4.45, 12.25]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.3695% CI: [-4.46, 12.22]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and immediately after treatment on Day 3
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -14.58 units on a scale |
| Water | 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 | -14.90 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.630195% CI: [-10.6, 6.45]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.688895% CI: [-10.46, 6.93]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.942895% CI: [-8.37, 9]ANCOVA
Secondary
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
Time frame: Baseline and immediately after treatment on Day 5
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 5% Potassium Nitrate Solution | 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 |
| 2.5% Potassium Nitrate Solution | 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 | -24.04 units on a scale |
| Water | 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 | -25.48 units on a scale |
Comparison: Null hypothesis is no difference between treatments.p-value: 0.782295% CI: [-6.86, 9.1]ANCOVA
Comparison: Null hypothesis is no difference between treatments.p-value: 0.720895% CI: [-6.52, 9.41]ANCOVA