Dentin Sensitivity
Conditions
Brief summary
This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.
Interventions
OTHERExperimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)
1.5% w/w KOX, 0ppm F, pH 7.0
OTHERExperimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)
2.0% w/w KOX, 45ppm F, pH 4.5
OTHERPlacebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
0% w/w KOX 0ppm F, pH 4.5
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Participants will be male or female aged between 18 and 65 years inclusive. * Good general and mental health with, in the opinion of the investigator or medically qualified designee. No clinically significant and relevant abnormalities in medical history or upon oral examination. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. * Self-reported history of dentinal hypersensitivity (DH) lasting more than(\>) six months but not \> 10 years. * Good general oral health, with a minimum of 20 natural teeth. * Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.
Exclusion criteria
* Women who are pregnant or breast-feeding . * Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs. * Currently taking antibiotics or has taken antibiotics within two weeks of Baseline. * Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. * Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts. * 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 xerostomia. * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. * Previous participation in this study. * Recent history (within the last year) of alcohol or other substance abuse. * Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants. * Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments). * Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening. * Teeth bleaching within eight weeks of Screening. * Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening. * Tooth 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 of exposed dentine. * Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the Investigator. * Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening. * Individuals who require antibiotic prophylaxis for dental procedures. * Any participant who, in the judgment of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Baseline and Week 8 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) | Baseline and Week 8 | Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. |
| Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline and Week 4 | Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 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. |
| Change From Baseline in Tactile Threshold at Week 4 and 8 | Baseline, Week 4 and 8 | Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied 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 without the participant reporting 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 greater the tactile threshold, the less sensitive the tooth. |
| Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | Baseline, Week 4 and 8 | Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one center in USA.
Pre-assignment details
Total 265 participants were screened, out of which 221 participants were randomized. 44 participants were not randomized; 43 participants did not meet the study criteria and 1 participant withdraw his consent before getting randomized to any study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks. | 74 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks. | 74 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks. | 73 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other (Not specified) | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Total |
|---|---|---|---|---|
| Age, Continuous | 43.3 Years STANDARD_DEVIATION 12.41 | 44.9 Years STANDARD_DEVIATION 11.99 | 44.4 Years STANDARD_DEVIATION 12.33 | 44.4 Years STANDARD_DEVIATION 12.21 |
| Sex: Female, Male Female | 60 Participants | 60 Participants | 64 Participants | 184 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 9 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 | 0 / 73 |
| other Total, other adverse events | 4 / 74 | 2 / 74 | 5 / 73 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 | 0 / 73 |
Outcome results
Primary
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time frame: Baseline and Week 8
Population: Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. This analysis was conducted on ITT population. Baseline data only includes those participants who have a corresponding post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Schiff score at baseline | 2.51 Score on scale | Standard Deviation 0.408 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Change from baseline in Schiff score at Week 8 | -1.57 Score on scale | Standard Deviation 0.756 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Schiff score at baseline | 2.53 Score on scale | Standard Deviation 0.408 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Change from baseline in Schiff score at Week 8 | -1.72 Score on scale | Standard Deviation 0.764 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Schiff score at baseline | 2.54 Score on scale | Standard Deviation 0.409 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo) | Change from baseline in Schiff score at Week 8 | -0.69 Score on scale | Standard Deviation 0.875 |
Comparison: For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.p-value: <0.000195% CI: [-1.181, -0.584]ANCOVA
Comparison: For the Week 8 comparisons of the two Treatments against the control, Dunnett's multiplicity adjustment is applied.p-value: <0.000195% CI: [-1.333, -0.738]ANCOVA
Secondary
Change From Baseline in Schiff Sensitivity Score at Week 4
Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 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.
Time frame: Baseline and Week 4
Population: Intent-to-treat (ITT) population (N=218), defined as 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 |
|---|---|---|---|---|
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Schiff Sensitivity Score at Week 4 | Shiff score at baseline | 2.52 Score on scale | Standard Deviation 0.409 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Schiff Sensitivity Score at Week 4 | Change from baseline in Schiff score at Week 4 | -1.04 Score on scale | Standard Deviation 0.814 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Schiff Sensitivity Score at Week 4 | Shiff score at baseline | 2.53 Score on scale | Standard Deviation 0.408 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Schiff Sensitivity Score at Week 4 | Change from baseline in Schiff score at Week 4 | -1.18 Score on scale | Standard Deviation 0.846 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Schiff Sensitivity Score at Week 4 | Shiff score at baseline | 2.54 Score on scale | Standard Deviation 0.411 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Schiff Sensitivity Score at Week 4 | Change from baseline in Schiff score at Week 4 | -0.50 Score on scale | Standard Deviation 0.761 |
Secondary
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time frame: Baseline and Week 8
Population: Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Data shown for Treatment 1\& 2 only for this endpoint. Baseline data only includes those participants who have a corresponding post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) | Schiff score at Baseline | 2.51 Score on a scale | Standard Deviation 0.408 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) | Change from baseline in Schiff score at Week 8 | -1.57 Score on a scale | Standard Deviation 0.756 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) | Schiff score at Baseline | 2.53 Score on a scale | Standard Deviation 0.408 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2) | Change from baseline in Schiff score at Week 8 | -1.72 Score on a scale | Standard Deviation 0.764 |
p-value: 0.247895% CI: [-0.107, 0.413]ANCOVA
Secondary
Change From Baseline in Tactile Threshold at Week 4 and 8
Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied 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 without the participant reporting 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 greater the tactile threshold, the less sensitive the tooth.
Time frame: Baseline, Week 4 and 8
Population: Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.~Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Tactile threshold at baseline for Week 4 | 10.14 grams | Standard Deviation 0.816 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Change at Week 4 | 37.91 grams | Standard Deviation 26.276 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Tactile threshold at baseline for Week 8 | 10.14 grams | Standard Deviation 0.822 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Change at Week 8 | 53.56 grams | Standard Deviation 21.024 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Change at Week 8 | 57.91 grams | Standard Deviation 25.062 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Tactile threshold at baseline for Week 4 | 10.14 grams | Standard Deviation 0.816 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Tactile threshold at baseline for Week 8 | 10.14 grams | Standard Deviation 0.816 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Change at Week 4 | 47.16 grams | Standard Deviation 26.133 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Change at Week 8 | 17.39 grams | Standard Deviation 28.743 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Change at Week 4 | 15.29 grams | Standard Deviation 23.558 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Tactile threshold at baseline for Week 8 | 10.00 grams | Standard Deviation 0 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Tactile Threshold at Week 4 and 8 | Tactile threshold at baseline for Week 4 | 10.00 grams | Standard Deviation 0 |
Secondary
Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain).
Time frame: Baseline, Week 4 and 8
Population: Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.~Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at baseline for Week 4 | 6.56 Score on a scale | Standard Deviation 1.969 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at Week 4 | -2.05 Score on a scale | Standard Deviation 1.805 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at baseline for Week 8 | 6.55 Score on a scale | Standard Deviation 1.982 |
| Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at Week 8 | -3.13 Score on a scale | Standard Deviation 2.012 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at Week 8 | -3.34 Score on a scale | Standard Deviation 1.756 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at baseline for Week 4 | 6.55 Score on a scale | Standard Deviation 1.952 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at baseline for Week 8 | 6.55 Score on a scale | Standard Deviation 1.952 |
| Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at Week 4 | -2.09 Score on a scale | Standard Deviation 1.675 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at Week 8 | -2.27 Score on a scale | Standard Deviation 2.105 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at Week 4 | -1.46 Score on a scale | Standard Deviation 1.862 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at baseline for Week 8 | 6.64 Score on a scale | Standard Deviation 1.749 |
| Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) | Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8 | VRS at baseline for Week 4 | 6.60 Score on a scale | Standard Deviation 1.777 |