Dentine Hypersensitivity
Conditions
Brief summary
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.
Interventions
DRUGStannous Fluoride
dentifrice containing stannous fluoride
dentifrice containing Sodium Monofluorophosphate
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 | Baseline to Day 14 | 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | Baseline to immediately post treatment administration | 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | Baseline to Day 3 | 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
| Change From Baseline in Tactile Pain Threshold Score at Day 14 | Baseline to Day 14 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity |
| Change From Baseline in Tactile Pain Threshold Score at Day 3 | Baseline to Day 3 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. |
| Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | Baseline to immediately post treatment administration | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Of 126 participants screened, 9 participants did not meet the study criteria, 3 were lost to follow up and 1 withdrew consent before randomization. Remaining 113 participants were randomized to study treatments.
Participants by arm
| Arm | Count |
|---|---|
| SnF Dentifrice Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water. | 56 |
| NaMFP Dentifrice Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water. | 57 |
| Total | 113 |
Baseline characteristics
| Characteristic | SnF Dentifrice | NaMFP Dentifrice | Total |
|---|---|---|---|
| Age, Continuous | 38.1 Years STANDARD_DEVIATION 10.7 | 34.8 Years STANDARD_DEVIATION 9.86 | 36.5 Years STANDARD_DEVIATION 10.37 |
| Sex: Female, Male Female | 37 Participants | 42 Participants | 79 Participants |
| Sex: Female, Male Male | 19 Participants | 15 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 56 | 0 / 57 |
| serious Total, serious adverse events | 0 / 56 | 0 / 57 |
Outcome results
Primary
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.
Time frame: Baseline to Day 14
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 | -1.20 Score on a scale | Standard Deviation 0.7 |
| NaMFP Dentifrice | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 | -0.37 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: [-1.03, -0.63]ANCOVA
Secondary
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3
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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.
Time frame: Baseline to Day 3
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | -0.70 Score on a scale | Standard Deviation 0.6 |
| NaMFP Dentifrice | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | -0.25 Score on a scale | Standard Deviation 0.39 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: <0.000195% CI: [-0.63, -0.28]ANCOVA
Secondary
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.
Time frame: Baseline to immediately post treatment administration
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | -0.40 Score on a scale | Standard Deviation 0.46 |
| NaMFP Dentifrice | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | -0.14 Score on a scale | Standard Deviation 0.35 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: 0.000695% CI: [-0.41, -0.12]ANCOVA
Secondary
Change From Baseline in Tactile Pain Threshold Score at Day 14
The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity
Time frame: Baseline to Day 14
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Change From Baseline in Tactile Pain Threshold Score at Day 14 | 22.9 Force (grams) | Standard Deviation 21.14 |
| NaMFP Dentifrice | Change From Baseline in Tactile Pain Threshold Score at Day 14 | 3.5 Force (grams) | Standard Deviation 5.67 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: <0.000195% CI: [13.7, 25.15]ANCOVA
Secondary
Change From Baseline in Tactile Pain Threshold Score at Day 3
The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.
Time frame: Baseline to Day 3
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Change From Baseline in Tactile Pain Threshold Score at Day 3 | 9.8 Force (grams) | Standard Deviation 15.52 |
| NaMFP Dentifrice | Change From Baseline in Tactile Pain Threshold Score at Day 3 | 3.0 Force (grams) | Standard Deviation 4.9 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: 0.002195% CI: [2.54, 11.13]ANCOVA
Secondary
Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment
The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.
Time frame: Baseline to immediately post treatment administration
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SnF Dentifrice | Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | 5.8 Force (grams) | Standard Deviation 10.17 |
| NaMFP Dentifrice | Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | 1.9 Force (grams) | Standard Deviation 3.24 |
Comparison: Null hypothesis considered change from baseline to be same for both treatments.p-value: 0.00795% CI: [1.08, 6.65]ANCOVA