Dentine Hypersensitivity
Conditions
Brief summary
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.
Interventions
DRUGStannous Fluoride
dentifice
dentifrice
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who suffer from tooth sensitivity Inclusion Criteria: \- none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | Baseline to 8 weeks post administration of study treatment | Response to a constant jet of air applied to hypersensitive teeth is 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 | Baseline to 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | Baseline to 8 weeks post administration of study treatment | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | Baseline to 4 weeks post administration of study treatment | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Of 122 participants screened, 2 participants did not meet the study criteria, and 2 withdrew consent before randomization. 118 participants were randomized to study treatments.
Participants by arm
| Arm | Count |
|---|---|
| SnF Dentifrice Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. | 60 |
| NaMFP Dentifrice Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water. | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | SnF Dentifrice | NaMFP Dentifrice | Total |
|---|---|---|---|
| Age, Continuous | 36.9 Years STANDARD_DEVIATION 10.9 | 35.5 Years STANDARD_DEVIATION 10.6 | 36.2 Years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 46 Participants | 37 Participants | 83 Participants |
| Sex: Female, Male Male | 14 Participants | 21 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 60 | 0 / 58 |
| serious Total, serious adverse events | 0 / 60 | 1 / 58 |
Outcome results
Primary
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
Response to a constant jet of air applied to hypersensitive teeth is 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Time frame: Baseline to 8 weeks post administration of study treatment
Population: Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | -0.9 Score on a scale | Standard Deviation 0.68 |
| NaMFP Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | -0.5 Score on a scale | Standard Deviation 0.44 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: <0.000195% CI: [-0.6, -0.2]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated
Time frame: Baseline to 4 weeks post administration of study treatment
Population: ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | 11.2 grams | Standard Deviation 15.95 |
| NaMFP Dentifrice | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | 1.5 grams | Standard Deviation 3.86 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: <0.000195% CI: [5.4, 13.9]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.
Time frame: Baseline to 8 weeks post administration of study treatment
Population: ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | 21.3 grams | Standard Deviation 21.8 |
| NaMFP Dentifrice | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | 4.2 grams | Standard Deviation 6.18 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: <0.000195% CI: [11.1, 22.8]ANCOVA
Secondary
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Time frame: Baseline to 4 weeks post administration of study treatment
Population: ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 | -0.7 Score on a scale | Standard Deviation 0.58 |
| NaMFP Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 | -0.2 Score on a scale | Standard Deviation 0.43 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: <0.000195% CI: [-0.6, -0.3]ANCOVA