Dentin Sensitivity
Conditions
Brief summary
This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
Interventions
Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5
Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5
OTHERPlacebo Oral Rinse
Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5
DRUGFluoride toothpaste
Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Sponsors
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
Yes
Inclusion criteria
* Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon 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) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response). * 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
* Participants 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 * Scaling or root planning 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 |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | Baseline, Week 8 | The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | Baseline, Week 4 | The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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 in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Baseline, Week 4 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as \>80g. For analysis purposes values recorded as \>80g were treated as 90g values. |
| Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8 | Baseline, Week 8 | The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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 in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Baseline, Week 4 | Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity. |
| Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | Baseline, Week 8 | Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity. |
| Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | Baseline, Week 8 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as \>80g. For analysis purposes values recorded as \>80g were treated as 90g values. |
Countries
United States
Participant flow
Pre-assignment details
A total of 283 participants were screened, out of which 240 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Oral Rinse 1 Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks. | 79 |
| Experimental Oral Rinse 2 Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks. | 80 |
| Placebo Oral Rinse Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks. | 81 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
| Overall Study | Physician Decision | 3 | 1 | 0 |
| Overall Study | Withdrawal of Consent | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Experimental Oral Rinse 1 | Experimental Oral Rinse 2 | Placebo Oral Rinse | Total |
|---|---|---|---|---|
| Age, Continuous | 40.5 Years STANDARD_DEVIATION 9 | 40.0 Years STANDARD_DEVIATION 9.81 | 40.5 Years STANDARD_DEVIATION 8.71 | 40.3 Years STANDARD_DEVIATION 9.15 |
| Sex: Female, Male Female | 67 Participants | 72 Participants | 70 Participants | 209 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 11 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 79 | 8 / 80 | 2 / 81 |
| serious Total, serious adverse events | 0 / 79 | 0 / 80 | 0 / 81 |
Outcome results
Primary
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Time frame: Baseline, Week 8
Population: Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | At Baseline | 2.53 score on a scale | Standard Deviation 0.422 |
| Experimental Oral Rinse 1 | Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | Change from Baseline at Week 8 | -1.19 score on a scale | Standard Deviation 1.097 |
| Experimental Oral Rinse 2 | Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | At Baseline | 2.55 score on a scale | Standard Deviation 0.415 |
| Experimental Oral Rinse 2 | Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | Change from Baseline at Week 8 | -1.29 score on a scale | Standard Deviation 0.961 |
| Placebo Oral Rinse | Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | At Baseline | 2.55 score on a scale | Standard Deviation 0.416 |
| Placebo Oral Rinse | Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8 | Change from Baseline at Week 8 | -1.28 score on a scale | Standard Deviation 1.031 |
p-value: 0.82995% CI: [-0.289, 0.461]ANCOVA
p-value: 0.999395% CI: [-0.372, 0.362]ANCOVA
Secondary
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Time frame: Baseline, Week 4
Population: ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 2.54 score on a scale | Standard Deviation 0.42 |
| Experimental Oral Rinse 1 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | -0.71 score on a scale | Standard Deviation 0.864 |
| Experimental Oral Rinse 2 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 2.54 score on a scale | Standard Deviation 0.417 |
| Experimental Oral Rinse 2 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | -0.83 score on a scale | Standard Deviation 0.738 |
| Placebo Oral Rinse | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 2.54 score on a scale | Standard Deviation 0.417 |
| Placebo Oral Rinse | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | -0.85 score on a scale | Standard Deviation 0.825 |
p-value: 0.282595% CI: [-0.116, 0.396]ANCOVA
p-value: 0.844895% CI: [-0.229, 0.28]ANCOVA
p-value: 0.378495% CI: [-0.141, 0.371]ANCOVA
Secondary
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth 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.
Time frame: Baseline, Week 8
Population: ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8 | At Baseline | 2.53 score on a scale | Standard Deviation 0.422 |
| Experimental Oral Rinse 1 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8 | Change from Baseline at Week 8 | -1.19 score on a scale | Standard Deviation 1.097 |
| Experimental Oral Rinse 2 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8 | At Baseline | 2.55 score on a scale | Standard Deviation 0.415 |
| Experimental Oral Rinse 2 | Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8 | Change from Baseline at Week 8 | -1.29 score on a scale | Standard Deviation 0.961 |
p-value: 0.589295% CI: [-0.242, 0.424]ANCOVA
Secondary
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as \>80g. For analysis purposes values recorded as \>80g were treated as 90g values.
Time frame: Baseline, Week 8
Population: ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | At Baseline | 10.00 g | Full Range 1.187 |
| Experimental Oral Rinse 1 | Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | Change from Baseline at Week 8 | 40.00 g | Full Range 30.932 |
| Experimental Oral Rinse 2 | Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | At Baseline | 10.00 g | Full Range 1.737 |
| Experimental Oral Rinse 2 | Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | Change from Baseline at Week 8 | 40.00 g | Full Range 30.754 |
| Placebo Oral Rinse | Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | At Baseline | 10.00 g | Full Range 1.971 |
| Placebo Oral Rinse | Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8 | Change from Baseline at Week 8 | 40.00 g | Full Range 32.873 |
p-value: 0.778995% CI: [-5, 0]Wilcoxon rank sum test
p-value: 0.721495% CI: [-5, 0]Wilcoxon rank sum test
p-value: 0.89695% CI: [-5, 5]Wilcoxon rank sum test
Secondary
Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. 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. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as \>80g. For analysis purposes values recorded as \>80g were treated as 90g values.
Time frame: Baseline, Week 4
Population: ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 10.00 g |
| Experimental Oral Rinse 1 | Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | 15.00 g |
| Experimental Oral Rinse 2 | Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 10.00 g |
| Experimental Oral Rinse 2 | Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | 10.00 g |
| Placebo Oral Rinse | Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 10.00 g |
| Placebo Oral Rinse | Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | 5.00 g |
p-value: 0.168895% CI: [-10, 0]Wilcoxon rank sum test
p-value: 0.43895% CI: [-5, 0]Wilcoxon rank sum test
p-value: 0.569395% CI: [-5, 0]Wilcoxon rank sum test
Secondary
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity.
Time frame: Baseline, Week 4
Population: ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 6.88 score on a scale | Standard Deviation 1.67 |
| Experimental Oral Rinse 1 | Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | -1.57 score on a scale | Standard Deviation 1.699 |
| Experimental Oral Rinse 2 | Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 6.96 score on a scale | Standard Deviation 1.472 |
| Experimental Oral Rinse 2 | Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | -1.84 score on a scale | Standard Deviation 1.698 |
| Placebo Oral Rinse | Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | At Baseline | 6.72 score on a scale | Standard Deviation 1.692 |
| Placebo Oral Rinse | Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4 | Change from Baseline at Week 4 | -1.97 score on a scale | Standard Deviation 1.819 |
p-value: 0.097895% CI: [-0.084, 0.987]ANCOVA
p-value: 0.460795% CI: [-0.333, 0.732]ANCOVA
p-value: 0.354295% CI: [-0.283, 0.787]ANCOVA
Secondary
Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity.
Time frame: Baseline, Week 8
Population: ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Oral Rinse 1 | Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | At Baseline | 6.92 score on a scale | Standard Deviation 1.626 |
| Experimental Oral Rinse 1 | Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | Change from Baseline at Week 8 | -2.63 score on a scale | Standard Deviation 2.257 |
| Experimental Oral Rinse 2 | Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | At Baseline | 6.92 score on a scale | Standard Deviation 1.471 |
| Experimental Oral Rinse 2 | Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | Change from Baseline at Week 8 | -2.73 score on a scale | Standard Deviation 2.096 |
| Placebo Oral Rinse | Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | At Baseline | 6.72 score on a scale | Standard Deviation 1.703 |
| Placebo Oral Rinse | Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8 | Change from Baseline at Week 8 | -2.54 score on a scale | Standard Deviation 2.325 |
p-value: 0.947495% CI: [-0.665, 0.711]ANCOVA
p-value: 0.798795% CI: [-0.76, 0.586]ANCOVA
p-value: 0.752595% CI: [-0.578, 0.798]ANCOVA