Dentinal Hypersensitivity
Conditions
Brief summary
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
Detailed description
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.
Interventions
Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate
DRUG0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate
Sodium monofluorophospate dentifrice (1000 ppm F)
Dentifrice containing 1100ppm F as sodium fluoride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study. * Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.
Exclusion criteria
* Specific Dentition Exclusions for Test teeth 1. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening. 2. Tooth with exposed dentin but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentin. 3. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator * Use of a sensitivity dentifrice within 8 weeks of screening * Individuals who require antibiotic prophylaxis for dental procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline and 8 weeks post administration of study treatment | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain. |
| Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline and 8 weeks post administration of study treatment | Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. |
| Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline and 4 weeks post administration of study treatment | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain. |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline and 4 weeks post administration of study treatment | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline and 8 weeks post administration of study treatment | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. |
| Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline and 4 weeks post administration of study treatment | Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline and 8 weeks post administration of study treatment | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. |
| Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline and 4 weeks post administration of study treatment | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site
Pre-assignment details
Participants aged 18 and 55 years of age (inclusive), in good general health, with preexisting self-reported and clinically diagnosed tooth sensitivity were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate | 32 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate | 34 |
| Sodium Monofluorophosphate Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate | 35 |
| Sodium Fluoride Dentifrice containing 1100 ppm fluoride as sodium fluoride | 36 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawl of Consent | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Sodium Monofluorophosphate | Sodium Fluoride | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.9 Years STANDARD_DEVIATION 10.08 | 39.6 Years STANDARD_DEVIATION 9.72 | 38.3 Years STANDARD_DEVIATION 8.73 | 42.7 Years STANDARD_DEVIATION 9.1 | 39.5 Years STANDARD_DEVIATION 9.55 |
| Sex: Female, Male Female | 28 Participants | 32 Participants | 28 Participants | 30 Participants | 118 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 7 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 35 | 3 / 34 | 2 / 35 | 2 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 | 0 / 35 | 0 / 36 |
Outcome results
Primary
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Time frame: Baseline and 4 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline | 2.39 Score on a scale | Standard Deviation 0.396 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Mean change from baseline at Week 4 | -0.56 Score on a scale | Standard Deviation 0.759 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Week 4 | 1.83 Score on a scale | Standard Deviation 0.779 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline | 2.41 Score on a scale | Standard Deviation 0.435 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Mean change from baseline at Week 4 | -0.47 Score on a scale | Standard Deviation 0.563 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Week 4 | 1.94 Score on a scale | Standard Deviation 0.547 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Week 4 | 2.31 Score on a scale | Standard Deviation 0.516 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline | 2.40 Score on a scale | Standard Deviation 0.417 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Mean change from baseline at Week 4 | -0.09 Score on a scale | Standard Deviation 0.445 |
| Sodium Fluoride | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline | 2.38 Score on a scale | Standard Deviation 0.403 |
| Sodium Fluoride | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Mean change from baseline at Week 4 | -0.07 Score on a scale | Standard Deviation 0.341 |
| Sodium Fluoride | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Week 4 | 2.31 Score on a scale | Standard Deviation 0.401 |
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.432195% CI: [-0.35, 0.15]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.000295% CI: [-0.73, -0.23]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.000295% CI: [-0.74, -0.24]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.002895% CI: [0.13, 0.63]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisonsp-value: 0.002295% CI: [0.14, 0.63]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.960695% CI: [-0.25, 0.24]ANCOVA
Primary
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Time frame: Baseline and 8 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Mean change from baseline at Week 8 | -0.81 Score on a Scale | Standard Deviation 0.972 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline | 2.40 Score on a Scale | Standard Deviation 0.396 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Week 8 | 1.60 Score on a Scale | Standard Deviation 0.987 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Week 8 | 1.56 Score on a Scale | Standard Deviation 0.894 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline | 2.41 Score on a Scale | Standard Deviation 0.435 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Mean change from baseline at Week 8 | -0.85 Score on a Scale | Standard Deviation 0.901 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Mean change from baseline at Week 8 | 0.01 Score on a Scale | Standard Deviation 0.353 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline | 2.40 Score on a Scale | Standard Deviation 0.417 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Week 8 | 2.41 Score on a Scale | Standard Deviation 0.462 |
| Sodium Fluoride | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Week 8 | 2.44 Score on a Scale | Standard Deviation 0.427 |
| Sodium Fluoride | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline | 2.38 Score on a Scale | Standard Deviation 0.403 |
| Sodium Fluoride | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Mean change from baseline at Week 8 | 0.07 Score on a Scale | Standard Deviation 0.45 |
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.80395% CI: [-0.3, 0.38]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: <0.000195% CI: [-1.16, -0.48]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: <0.000195% CI: [-1.2, -0.53]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: <0.000195% CI: [0.53, 1.19]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: <0.000195% CI: [0.58, 1.23]ANCOVA
Comparison: Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisonsp-value: 0.787295% CI: [-0.37, 0.28]ANCOVA
Primary
Mean Change From Baseline in Visual Rating Scale Score at Week 4
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain.
Time frame: Baseline and 4 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Week 4 | 5.45 Score on a scale | Standard Deviation 2.212 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Mean change from baseline at Week 4 | -1.20 Score on a scale | Standard Deviation 1.727 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline | 6.66 Score on a scale | Standard Deviation 1.886 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline | 6.69 Score on a scale | Standard Deviation 1.723 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Mean change from baseline at Week 4 | -0.97 Score on a scale | Standard Deviation 2.371 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Week 4 | 5.72 Score on a scale | Standard Deviation 1.776 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Week 4 | 5.39 Score on a scale | Standard Deviation 1.702 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline | 6.41 Score on a scale | Standard Deviation 1.776 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Mean change from baseline at Week 4 | -1.03 Score on a scale | Standard Deviation 1.356 |
| Sodium Fluoride | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline | 6.92 Score on a scale | Standard Deviation 1.783 |
| Sodium Fluoride | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Mean change from baseline at Week 4 | -0.54 Score on a scale | Standard Deviation 1.742 |
| Sodium Fluoride | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Week 4 | 6.38 Score on a scale | Standard Deviation 1.814 |
p-value: 0.555595% CI: [-1.03, 0.56]ANCOVA
p-value: 0.876995% CI: [-0.86, 0.73]ANCOVA
p-value: 0.056295% CI: [-1.55, 0.02]ANCOVA
p-value: 0.656295% CI: [-0.95, 0.6]ANCOVA
p-value: 0.178895% CI: [-0.24, 1.3]ANCOVA
p-value: 0.073495% CI: [-1.47, 0.07]ANCOVA
Primary
Mean Change From Baseline in Visual Rating Scale Score at Week 8
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain.
Time frame: Baseline and 8 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline | 6.71 Score on a scale | Standard Deviation 1.892 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Mean change from baseline at Week 8 | -2.06 Score on a scale | Standard Deviation 2.205 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Week 8 | 4.65 Score on a scale | Standard Deviation 2.55 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline | 6.69 Score on a scale | Standard Deviation 1.723 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Mean change from baseline at Week 8 | -2.24 Score on a scale | Standard Deviation 2.287 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Week 8 | 4.46 Score on a scale | Standard Deviation 2.076 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Week 8 | 5.70 Score on a scale | Standard Deviation 1.914 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline | 6.41 Score on a scale | Standard Deviation 1.776 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Mean change from baseline at Week 8 | -0.71 Score on a scale | Standard Deviation 1.559 |
| Sodium Fluoride | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline | 6.92 Score on a scale | Standard Deviation 1.783 |
| Sodium Fluoride | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Mean change from baseline at Week 8 | -0.86 Score on a scale | Standard Deviation 1.673 |
| Sodium Fluoride | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Week 8 | 6.07 Score on a scale | Standard Deviation 2.046 |
p-value: 0.672795% CI: [-0.71, 1.1]ANCOVA
p-value: 0.007295% CI: [-2.14, -0.34]ANCOVA
p-value: 0.005695% CI: [-2.16, -0.38]ANCOVA
p-value: 0.001695% CI: [0.56, 2.31]ANCOVA
p-value: 0.001195% CI: [0.59, 2.33]ANCOVA
p-value: 0.941395% CI: [-0.9, 0.84]ANCOVA
Primary
Median Change From Baseline in Tactile Sensitivity at Week 4
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Time frame: Baseline and 4 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline | 10.00 grams |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Median change from baseline at Week 4 | 0.00 grams |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Week 4 | 10.00 grams |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline | 10.00 grams |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Median change from baseline at Week 4 | 0.00 grams |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Week 4 | 10.00 grams |
| Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Week 4 | 10.00 grams |
| Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline | 10.00 grams |
| Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 4 | Median change from baseline at Week 4 | 0.00 grams |
| Sodium Fluoride | Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline | 10.00 grams |
| Sodium Fluoride | Median Change From Baseline in Tactile Sensitivity at Week 4 | Median change from baseline at Week 4 | 0.00 grams |
| Sodium Fluoride | Median Change From Baseline in Tactile Sensitivity at Week 4 | Week 4 | 10.00 grams |
p-value: 0.964295% CI: [0, 0]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.001695% CI: [0, 5]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.0195% CI: [0, 5]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.00295% CI: [0, 0]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.012295% CI: [0, 0]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.713895% CI: [0, 0]Hodges-Lehmann Wilcoxon non-parametric
Primary
Median Change From Baseline in Tactile Sensitivity at Week 8
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Time frame: Baseline and 8 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline | 10.00 grams |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Week 8 | 15.00 grams |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Median change from baseline at Week 8 | 5.00 grams |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Week 8 | 15.00 grams |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline | 10.00 grams |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Median change from baseline at Week 8 | 5.00 grams |
| Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Week 8 | 10.00 grams |
| Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline | 10.00 grams |
| Sodium Monofluorophosphate | Median Change From Baseline in Tactile Sensitivity at Week 8 | Median change from baseline at Week 8 | 0.00 grams |
| Sodium Fluoride | Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline | 10.00 grams |
| Sodium Fluoride | Median Change From Baseline in Tactile Sensitivity at Week 8 | Median change from baseline at Week 8 | 0.00 grams |
| Sodium Fluoride | Median Change From Baseline in Tactile Sensitivity at Week 8 | Week 8 | 10.00 grams |
p-value: 0.000195% CI: [0, 15]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.000395% CI: [0, 15]Hodges-Lehmann Wilcoxon non-parametric
p-value: <0.000195% CI: [-10, 0]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.983495% CI: [-5, 5]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.000295% CI: [-10, 0]Hodges-Lehmann Wilcoxon non-parametric
p-value: 0.289495% CI: [0, 0]Hodges-Lehmann Wilcoxon non-parametric
Secondary
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.
Time frame: Baseline and 8 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline | 134.33 Score on a scale | Standard Deviation 33.778 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Change from baseline at Week 8 | -6.43 Score on a scale | Standard Deviation 28.693 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Change from baseline at Week 8 | -7.97 Score on a scale | Standard Deviation 31.324 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline | 132.55 Score on a scale | Standard Deviation 35.646 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline | 120.09 Score on a scale | Standard Deviation 44.614 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Change from baseline at Week 8 | -3.88 Score on a scale | Standard Deviation 22.222 |
| Sodium Fluoride | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline | 133.89 Score on a scale | Standard Deviation 33.638 |
| Sodium Fluoride | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Change from baseline at Week 8 | -10.86 Score on a scale | Standard Deviation 33.669 |
Secondary
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.
Time frame: Baseline and 4 weeks post administration of study treatment
Population: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline | 136.53 Score on a scale | Standard Deviation 34.194 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Mean change from baseline at Week 4 | -3.91 Score on a scale | Standard Deviation 21.85 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Mean change from baseline at Week 4 | -4.39 Score on a scale | Standard Deviation 27.155 |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline | 132.55 Score on a scale | Standard Deviation 35.646 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline | 121.09 Score on a scale | Standard Deviation 44.467 |
| Sodium Monofluorophosphate | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Mean change from baseline at Week 4 | -3.80 Score on a scale | Standard Deviation 24.874 |
| Sodium Fluoride | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline | 133.89 Score on a scale | Standard Deviation 33.638 |
| Sodium Fluoride | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Mean change from baseline at Week 4 | -7.50 Score on a scale | Standard Deviation 28.905 |