Dentine 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 arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory 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
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
DRUG0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Dentifrice containing 1000 ppmF as sodium monofluorophosphate
Dentifrice containing 1100 ppmF as sodium fluoride
Sponsors
BioSci Research
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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
1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. 2. Breast-feeding: Women who are breast-feeding. 3. Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc. 4. Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs. 5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter 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 etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months. 6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 7. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit b) Previous participation in this study. 8. Other: Any subject who in the opinion of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on 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. |
| Change From Baseline in Tactile Sensitivity Pain Response (g) 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. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on 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 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. |
| Change From Baseline in Tactile Sensitivity Pain Response (g) 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. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. |
| Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | Baseline to 4 weeks post administration of study treatment | Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain). |
| Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | Baseline to 8 weeks post administration of study treatment | Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Out of 152 screened participants, 16 did not meet the study criterion while 2 withdrew consent. Hence, a total of 134 participants were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate | 34 |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate | 33 |
| Sodium Monofluorophosphate Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate | 34 |
| Sodium Fluoride Dentifrice containing 1100 ppm fluoride as sodium fluoride | 33 |
| Total | 134 |
Baseline characteristics
| Characteristic | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Sodium Monofluorophosphate | Sodium Fluoride | Total |
|---|---|---|---|---|---|
| Age, Continuous | 35.4 Years STANDARD_DEVIATION 10.45 | 33.2 Years STANDARD_DEVIATION 10.13 | 38.2 Years STANDARD_DEVIATION 8.88 | 36.2 Years STANDARD_DEVIATION 9.62 | 35.8 Years STANDARD_DEVIATION 9.85 |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 27 Participants | 22 Participants | 98 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 7 Participants | 11 Participants | 36 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 | 0 / 34 | 0 / 33 | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 34 | 0 / 33 |
Outcome results
Primary
Change From Baseline in Evaporative Air Sensitivity Pain Response on 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: Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | -0.36 Score on a scale |
| Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | -0.43 Score on a scale |
| Sodium Fluoride | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | -0.40 Score on a scale |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | -0.45 Score on a scale |
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.455395% CI: [-0.14, 0.32]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.568995% CI: [-0.16, 0.3]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.751795% CI: [-0.2, 0.27]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.854995% CI: [-0.21, 0.25]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.668595% CI: [-0.18, 0.29]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.803195% CI: [-0.26, 0.2]ANCOVA
Primary
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale 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 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: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | -0.55 Score on a scale |
| Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | -0.43 Score on a scale |
| Sodium Fluoride | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | -0.43 Score on a scale |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | -0.92 Score on a scale |
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.029295% CI: [0.04, 0.69]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.448495% CI: [-0.44, 0.2]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.453795% CI: [-0.45, 0.2]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.003795% CI: [0.16, 0.81]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.00495% CI: [0.16, 0.81]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.997495% CI: [-0.32, 0.32]ANCOVA
Primary
Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
Time frame: Baseline to 4 weeks post administration of study treatment
Population: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | -1.22 Score on a scale |
| Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | -1.07 Score on a scale |
| Sodium Fluoride | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | -1.35 Score on a scale |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | -1.25 Score on a scale |
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.942195% CI: [-0.74, 0.8]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.691895% CI: [-0.9, 0.6]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.742195% CI: [-0.63, 0.88]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.643395% CI: [-0.58, 0.94]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.80195% CI: [-0.86, 0.67]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.469295% CI: [-0.48, 1.03]ANCOVA
Primary
Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).
Time frame: Baseline to 8 weeks post administration of study treatment
Population: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | -1.76 Score on a scale |
| Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | -1.22 Score on a scale |
| Sodium Fluoride | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | -1.31 Score on a scale |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | -2.06 Score on a scale |
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.479795% CI: [-0.55, 1.16]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.202395% CI: [-1.37, 0.29]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.291795% CI: [-1.29, 0.39]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.050395% CI: [0, 1.69]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.081195% CI: [-0.09, 1.61]ANCOVA
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.832295% CI: [-0.75, 0.93]ANCOVA
Primary
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Time frame: Baseline to 4 weeks post administration of study treatment
Population: ITT population: All randomized participants 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 |
|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | 7.31 grams | Standard Deviation 11.227 |
| Sodium Monofluorophosphate | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | 6.32 grams | Standard Deviation 13.045 |
| Sodium Fluoride | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | 4.09 grams | Standard Deviation 4.752 |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | 3.64 grams | Standard Deviation 6.03 |
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.046795% CI: [0, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.113395% CI: [0, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.257995% CI: [0, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.614995% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.325995% CI: [0, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.572195% CI: [0, 0]Wilcoxon (Mann-Whitney)
Primary
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Time frame: Baseline to 8 weeks post administration of study treatment
Population: ITT population: All randomized participants 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 |
|---|---|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | 10.15 grams | Standard Deviation 15.1 |
| Sodium Monofluorophosphate | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | 5.88 grams | Standard Deviation 11.512 |
| Sodium Fluoride | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | 4.39 grams | Standard Deviation 5.556 |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | 11.97 grams | Standard Deviation 16.486 |
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.886195% CI: [-5, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.064195% CI: [0, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.183195% CI: [0, 5]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.087195% CI: [-10, 0]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.16995% CI: [-10, 0]Wilcoxon (Mann-Whitney)
Comparison: Null hypothesis considered change from baseline to be same for treatments in comparison.p-value: 0.382995% CI: [-5, 0]Wilcoxon (Mann-Whitney)