Dentine Hypersensitivity
Conditions
Brief summary
Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
Interventions
DRUGStannous fluoride
Test dentifrice containing 0.454% SnF
Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate \[1000 parts per million (ppm) fluoride\]
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
* Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years. * Participants with minimum of 20 natural teeth. * At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria. 1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. 2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1. 3. Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.
Exclusion criteria
* Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. * Any condition which, in the opinion of the investigator, causes dry mouth. * Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. * Participant using of a desensitising dentifrice within 6 weeks of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score | Baseline-Week 8 | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score | Baseline-Week 4 | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation |
| Mean Change From Baseline in Tactile Sensitivity | Baseline-Week 8 | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe 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 participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached. |
| Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | Baseline-Week 4 | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF |
| Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | Baseline - Week 8 | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Participants with a minimum of two non-adjacent sensitive teeth (incisors, canines or pre-molars) with a Schiff Sensitivity Score(following an air blast stimulus) of ≥ 2 and a tactile threshold (Yeaple probe) of ≤ 20 grams (g) force were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Control Dentifrice (0.76% Sodium Monofluorophosphate) Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds. | 57 |
| Test Dentifrice (0.454% Stannous Fluoride) Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds. | 57 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal of Consent | 3 | 2 |
Baseline characteristics
| Characteristic | Control Dentifrice (0.76% Sodium Monofluorophosphate) | Test Dentifrice (0.454% Stannous Fluoride) | Total |
|---|---|---|---|
| Age, Continuous | 43.1 Years STANDARD_DEVIATION 12.27 | 42.2 Years STANDARD_DEVIATION 11.27 | 42.6 Years STANDARD_DEVIATION 11.73 |
| Sex: Female, Male Female | 43 Participants 75.4 | 46 Participants 80.7 | 89 Participants |
| Sex: Female, Male Male | 14 Participants 24.6 | 11 Participants 19.3 | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 60 | 1 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
Mean Change From Baseline in Schiff Sensitivity Score
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
Time frame: Baseline-Week 8
Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Baseline | 2.26 Score on a scale | Standard Deviation 0.379 |
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Week 8 | 2.09 Score on a scale | Standard Deviation 0.628 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Baseline | 2.25 Score on a scale | Standard Deviation 0.355 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Week 8 | 0.78 Score on a scale | Standard Deviation 0.687 |
Comparison: The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatmentsp-value: <0.000195% CI: [-1.53, -1.06]ANCOVA
Secondary
Mean Change From Baseline in Schiff Sensitivity Score
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
Time frame: Baseline-Week 4
Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Baseline | 2.26 Score on a Scale | Standard Deviation 0.379 |
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Week 4 | 2.10 Score on a Scale | Standard Deviation 0.601 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Baseline | 2.25 Score on a Scale | Standard Deviation 0.355 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Schiff Sensitivity Score | Schiff Sensitivity Score at Week 4 | 1.27 Score on a Scale | Standard Deviation 0.598 |
Comparison: The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatmentsp-value: <0.000195% CI: [-1, -0.62]ANCOVA
Secondary
Mean Change From Baseline in Tactile Sensitivity
The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe 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 participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached.
Time frame: Baseline-Week 8
Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Tactile Sensitivity | Tactile Threshold at Baseline (g) | 10.1 Grams | Standard Deviation 0.66 |
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Tactile Sensitivity | Tactile Threshold at Week 8 (g) | 14.6 Grams | Standard Deviation 13.77 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Tactile Sensitivity | Tactile Threshold at Baseline (g) | 10.4 Grams | Standard Deviation 1.43 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Tactile Sensitivity | Tactile Threshold at Week 8 (g) | 41.6 Grams | Standard Deviation 25.85 |
Comparison: The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatmentsp-value: <0.000195% CI: [19.4, 35.1]ANCOVA
Secondary
Mean Change From Baseline in Tactile Sensitivity
The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe 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 participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached.
Time frame: Baseline-Week 4
Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Tactile Sensitivity | Tactile Thresold (g) at Baseline | 10.1 Grams | Standard Deviation 0.66 |
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change From Baseline in Tactile Sensitivity | Tactile Thresold (g) at Week 4 | 15.8 Grams | Standard Deviation 14.78 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Tactile Sensitivity | Tactile Thresold (g) at Baseline | 10.4 Grams | Standard Deviation 1.43 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change From Baseline in Tactile Sensitivity | Tactile Thresold (g) at Week 4 | 24.6 Grams | Standard Deviation 17.53 |
Comparison: The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatmentsp-value: 0.013895% CI: [1.6, 13.4]ANCOVA
Secondary
Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF
Time frame: Baseline-Week 4
Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at Baseline | 58.40 Score on a Scale | Standard Deviation 21.661 |
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at week 4 | 50.32 Score on a Scale | Standard Deviation 23.257 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at Baseline | 58.26 Score on a Scale | Standard Deviation 21.099 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at week 4 | 38.09 Score on a Scale | Standard Deviation 21.612 |
Comparison: The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatmentsp-value: 0.000395% CI: [-18.51, -5.77]ANCOVA
Secondary
Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF
Time frame: Baseline - Week 8
Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at Baseline | 58.40 Score on a Scale | Standard Deviation 21.661 |
| Control Dentrifice (0.76% Sodium Monofluorophosphate) | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at Week 8 | 43.94 Score on a Scale | Standard Deviation 23.996 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at Baseline | 58.26 Score on a Scale | Standard Deviation 21.099 |
| Test Dentrifice (0.454% Stannous Fluoride) | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | VAS Score at Week 8 | 22.17 Score on a Scale | Standard Deviation 22.299 |
Comparison: The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments.p-value: <0.000195% CI: [-29.55, -14.09]ANCOVA