Dentine Sensitivity
Conditions
Brief summary
An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.
Detailed description
A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.
Interventions
5% w/w calcium sodium phosphosilicate
OTHERSodium fluoride
1426 ppm fluoride as sodium fluoride
1426 ppm fluoride as sodium monofluorophosphate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* subjects in good general health with no clinically significant/ relevant abnormalities of oral examination * pre-existing self reported and clinically diagnosed tooth sensitivity * at screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment * at baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
Exclusion criteria
* subjects with a known or suspected intolerance or hypersensitivity to study products * presence of chronic debilitating disease which could affect study outcomes * any condition which is causing dry mouth * use of an oral care product indicated for the relief of dentine hypersensitivity * participation in a DH treatment study in the 8 weeks prior to screening * taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth * require antibiotic prophylaxis for dental procedures * dental prophylaxis within 4 weeks of screening * treatment of periodontal disease within 12 months of screening+C60 * scaling or root planing within 3 months of screening * tooth bleaching within 8 weeks of screening * active caries or periodontitis * partial dentures, orthodontic appliances or dental implants which could affect study outcomes * Pregnant and breast-feeding females * Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; 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 or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | At Baseline and Week 8 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | At Baseline and Week 4 | Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. |
| Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Baseline, Week 4 and Week 8 | Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. |
| Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Baseline, Week 4 and Week 8 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at one center (three sites) in United Kingdom.
Pre-assignment details
A total of 731 participants were screened, out of which 304 participants were randomized. 427 participants were not randomized because 377 did not met the study criteria, 1 had adverse event, 3 were lost to follow up and 1 due to protocol violation, 5 withdrew consent and 40 participants were not randomized because of other reasons (not specified).
Participants by arm
| Arm | Count |
|---|---|
| Test Dentifrice Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium fluoride. | 150 |
| Comparator Dentifrice Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate. | 154 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Other (Not specified) | 1 | 5 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal of Consent | 1 | 0 |
Baseline characteristics
| Characteristic | Test Dentifrice | Comparator Dentifrice | Total |
|---|---|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 10.33 | 42.5 years STANDARD_DEVIATION 9.43 | 41.9 years STANDARD_DEVIATION 9.89 |
| Sex: Female, Male Female | 122 Participants | 131 Participants | 253 Participants |
| Sex: Female, Male Male | 28 Participants | 23 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 154 |
| other Total, other adverse events | 51 / 150 | 59 / 154 |
| serious Total, serious adverse events | 0 / 150 | 0 / 154 |
Outcome results
Primary
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time frame: At Baseline and Week 8
Population: Analysis for this outcome was performed on per protocol (PP) population which is defined as all participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | At Baseline | 53.05 score on a scale | Standard Deviation 20.873 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | At Week 8 | 31.62 score on a scale | Standard Deviation 24.194 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | Change from baseline at Week 8 | -21.50 score on a scale | Standard Deviation 22.231 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | At Baseline | 55.89 score on a scale | Standard Deviation 21.334 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | At Week 8 | 30.51 score on a scale | Standard Deviation 23.96 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 | Change from baseline at Week 8 | -25.16 score on a scale | Standard Deviation 22.322 |
Comparison: Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.p-value: 0.267895% CI: [-2.06, 7.4]ANCOVA
Secondary
Change From Baseline in Tactile Threshold at Week 4 and Week 8
Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time frame: At Baseline, Week 4 and Week 8
Population: Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Week 4 | 25.45 gram (g) | Standard Deviation 20.573 |
| Test Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Week 8 | 32.88 gram (g) | Standard Deviation 25.392 |
| Test Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Change from baseline at Week 4 | 12.72 gram (g) | Standard Deviation 20.181 |
| Test Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Change from baseline at Week 8 | 20.10 gram (g) | Standard Deviation 25.041 |
| Test Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Baseline | 12.79 gram (g) | Standard Deviation 3.419 |
| Comparator Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Change from baseline at Week 8 | 21.42 gram (g) | Standard Deviation 24.45 |
| Comparator Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Baseline | 12.18 gram (g) | Standard Deviation 2.982 |
| Comparator Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Week 4 | 23.61 gram (g) | Standard Deviation 18.616 |
| Comparator Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | Change from baseline at Week 4 | 11.42 gram (g) | Standard Deviation 18.099 |
| Comparator Dentifrice | Change From Baseline in Tactile Threshold at Week 4 and Week 8 | At Week 8 | 33.58 gram (g) | Standard Deviation 24.84 |
Secondary
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time frame: At Baseline, Week 4 and Week 8
Population: Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Week 4 | 2.13 score on a scale | Standard Deviation 0.771 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Week 8 | 1.65 score on a scale | Standard Deviation 0.99 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Change from baseline at Week 4 | -0.59 score on a scale | Standard Deviation 0.689 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Change from baseline at Week 8 | -1.08 score on a scale | Standard Deviation 0.922 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Baseline | 2.72 score on a scale | Standard Deviation 0.393 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Change from baseline at Week 8 | -1.09 score on a scale | Standard Deviation 0.937 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Baseline | 2.68 score on a scale | Standard Deviation 0.4 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Week 4 | 2.11 score on a scale | Standard Deviation 0.832 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | Change from baseline at Week 4 | -0.57 score on a scale | Standard Deviation 0.745 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 | At Week 8 | 1.58 score on a scale | Standard Deviation 1.002 |
Secondary
Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.
Time frame: At Baseline and Week 4
Population: Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | At Week 4 | 40.71 score on a scale | Standard Deviation 22.828 |
| Test Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | Change from baseline at Week 4 | -12.12 score on a scale | Standard Deviation 18.438 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | At Week 4 | 40.60 score on a scale | Standard Deviation 23.09 |
| Comparator Dentifrice | Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 | Change from baseline at Week 4 | -15.24 score on a scale | Standard Deviation 19.895 |