Dentinal Hypersensitivity, Dental Pain
Conditions
Keywords
dentinal sensitivity, potassium nitrate, dental pain
Brief summary
A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.
Interventions
250 μL of Potassium nitrate solution (either 5% or 2.5%)
DRUGPlacebo
Sterile Water
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. * Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid. * Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. 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 visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS.
Exclusion criteria
* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients. * Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) dentifrice in the opinion of the investigator. b) 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 aetiologies other than erosion, abrasion or recession of exposed dentine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, immediately post administration of treatment | 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. |
| 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 | Baseline, 10 minutes post administration of treatment | 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. |
| 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 | Baseline, 20 minutes post administration of treatment | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall All randomized participants received all study treatments during this cross over study design. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 39.0 Years STANDARD_DEVIATION 13.65 |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 2.5% KNO3 Solution (2 Minutes) | 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 | -20.23 Units on a scale |
| 5% KNO3 Solution (2 Minutes) | 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 | -13.84 Units on a scale |
| Sterile Water (2 Minutes) | 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 | -9.01 Units on a scale |
| 2.5% KNO3 Solution (5 Minutes) | 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 | -22.67 Units on a scale |
| 5% KNO3 Solution (5 Minutes) | 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 | -12.80 Units on a scale |
| Sterile Water (5 Minutes) | 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 | -11.55 Units on a scale |
| 2.5% KNO3 Solution (10 Minutes) | 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 | -9.80 Units on a scale |
| 5% KNO3 Solution (10 Minutes) | 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 | -20.81 Units on a scale |
| Sterile Water (10 Minutes) | 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 | -15.25 Units on a scale |
Comparison: 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.p-value: 0.386795% CI: [-21.04, 8.26]ANCOVA
Comparison: 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.p-value: 0.144895% CI: [-26.41, 3.96]ANCOVA
Comparison: 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.p-value: 0.487495% CI: [-18.66, 8.99]ANCOVA
Comparison: 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.p-value: 0.203895% CI: [-25.23, 5.49]ANCOVA
Comparison: 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.p-value: 0.151895% CI: [-26.43, 4.19]ANCOVA
Comparison: 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.p-value: 0.856795% CI: [-14.98, 12.49]ANCOVA
Comparison: 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.p-value: 0.149395% CI: [-4.06, 26.08]ANCOVA
Comparison: 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.p-value: 0.479895% CI: [-9.86, 20.76]ANCOVA
Comparison: 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.p-value: 0.425595% CI: [-19.42, 8.29]ANCOVA
Primary
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
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 2.5% KNO3 Solution (2 Minutes) | 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 | -22.54 Units on a scale |
| 5% KNO3 Solution (2 Minutes) | 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 | -20.58 Units on a scale |
| Sterile Water (2 Minutes) | 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 | -16.22 Units on a scale |
| 2.5% KNO3 Solution (5 Minutes) | 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 | -22.25 Units on a scale |
| 5% KNO3 Solution (5 Minutes) | 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 | -16.57 Units on a scale |
| Sterile Water (5 Minutes) | 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 | -18.23 Units on a scale |
| 2.5% KNO3 Solution (10 Minutes) | 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 | -12.21 Units on a scale |
| 5% KNO3 Solution (10 Minutes) | 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 | -19.97 Units on a scale |
| Sterile Water (10 Minutes) | 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 | -18.90 Units on a scale |
Comparison: 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.p-value: 0.776995% CI: [-15.71, 11.8]ANCOVA
Comparison: 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.p-value: 0.381195% CI: [-20.64, 8]ANCOVA
Comparison: 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.p-value: 0.504495% CI: [-17.35, 8.63]ANCOVA
Comparison: 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.p-value: 0.437495% CI: [-20.2, 8.84]ANCOVA
Comparison: 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.p-value: 0.579695% CI: [-18.46, 10.41]ANCOVA
Comparison: 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 0.05p-value: 0.799495% CI: [-11.32, 14.64]ANCOVA
Comparison: 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.p-value: 0.278495% CI: [-6.42, 21.93]ANCOVA
Comparison: 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.p-value: 0.358195% CI: [-7.75, 21.12]ANCOVA
Comparison: 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.p-value: 0.870395% CI: [-14.11, 11.97]ANCOVA
Primary
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
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| 2.5% KNO3 Solution (2 Minutes) | 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 | -13.48 Units on a scale |
| 5% KNO3 Solution (2 Minutes) | 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 | -12.49 Units on a scale |
| Sterile Water (2 Minutes) | 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 | -8.59 Units on a scale |
| 2.5% KNO3 Solution (5 Minutes) | 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 | -14.14 Units on a scale |
| 5% KNO3 Solution (5 Minutes) | 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 | -17.51 Units on a scale |
| Sterile Water (5 Minutes) | 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 | -11.12 Units on a scale |
| 2.5% KNO3 Solution (10 Minutes) | 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 | -8.38 Units on a scale |
| 5% KNO3 Solution (10 Minutes) | 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 | -17.34 Units on a scale |
| Sterile Water (10 Minutes) | 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 | -14.62 Units on a scale |
Comparison: 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.p-value: 0.891895% CI: [-15.5, 13.52]ANCOVA
Comparison: 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.p-value: 0.518395% CI: [-19.91, 10.14]ANCOVA
Comparison: 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.p-value: 0.571895% CI: [-17.59, 9.8]ANCOVA
Comparison: 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.p-value: 0.659195% CI: [-11.82, 18.56]ANCOVA
Comparison: 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.p-value: 0.692195% CI: [-18.17, 12.13]ANCOVA
Comparison: 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.p-value: 0.351395% CI: [-19.98, 7.2]ANCOVA
Comparison: 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.p-value: 0.234695% CI: [-5.96, 23.88]ANCOVA
Comparison: 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.p-value: 0.413895% CI: [-8.92, 21.39]ANCOVA
Comparison: 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.p-value: 0.693195% CI: [-16.44, 10.99]ANCOVA