Trial Outcomes & Findings for A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli. (NCT NCT02651467)
NCT ID: NCT02651467
Last Updated: 2018-08-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2018-08-27
Participant Flow
Participants were recruited from one center in USA.
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.
Participant milestones
| Measure |
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 20millilitre (mL) 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% weight by weight \[w/w\] KOX, 0 parts per million \[ppm\], 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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
73
|
|
Overall Study
COMPLETED
|
73
|
74
|
69
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
Reasons for withdrawal
| Measure |
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 20millilitre (mL) 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% weight by weight \[w/w\] KOX, 0 parts per million \[ppm\], 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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Other (Not specified)
|
1
|
0
|
2
|
Baseline Characteristics
A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.
Baseline characteristics by cohort
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 Participants
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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 Participants
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.
|
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
n=73 Participants
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.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.3 Years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
44.9 Years
STANDARD_DEVIATION 11.99 • n=7 Participants
|
44.4 Years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 12.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 Participants
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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 Participants
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.
|
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
n=70 Participants
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.
|
|---|---|---|---|
|
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
|
2.53 Score on scale
Standard Deviation 0.408
|
2.54 Score on scale
Standard Deviation 0.409
|
|
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
|
-1.72 Score on scale
Standard Deviation 0.764
|
-0.69 Score on scale
Standard Deviation 0.875
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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.
Outcome measures
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 Participants
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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
2.53 Score on a scale
Standard Deviation 0.408
|
—
|
|
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
|
-1.72 Score on a scale
Standard Deviation 0.764
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: 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.
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.
Outcome measures
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 Participants
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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 Participants
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.
|
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
n=70 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score at Week 4
Shiff score at baseline
|
2.52 Score on scale
Standard Deviation 0.409
|
2.53 Score on scale
Standard Deviation 0.408
|
2.54 Score on scale
Standard Deviation 0.411
|
|
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
|
-1.18 Score on scale
Standard Deviation 0.846
|
-0.50 Score on scale
Standard Deviation 0.761
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 8Population: 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.
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.
Outcome measures
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 Participants
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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 Participants
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.
|
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
n=70 Participants
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.
|
|---|---|---|---|
|
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
|
10.14 grams
Standard Deviation 0.816
|
10.00 grams
Standard Deviation 0.000
|
|
Change From Baseline in Tactile Threshold at Week 4 and 8
Change at Week 4
|
37.91 grams
Standard Deviation 26.276
|
47.16 grams
Standard Deviation 26.133
|
15.29 grams
Standard Deviation 23.558
|
|
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
|
10.14 grams
Standard Deviation 0.816
|
10.00 grams
Standard Deviation 0.000
|
|
Change From Baseline in Tactile Threshold at Week 4 and 8
Change at Week 8
|
53.56 grams
Standard Deviation 21.024
|
57.91 grams
Standard Deviation 25.062
|
17.39 grams
Standard Deviation 28.743
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 8Population: 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.
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").
Outcome measures
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 Participants
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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 Participants
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.
|
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
n=70 Participants
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.
|
|---|---|---|---|
|
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
|
6.55 Score on a scale
Standard Deviation 1.952
|
6.60 Score on a scale
Standard Deviation 1.777
|
|
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
|
-2.09 Score on a scale
Standard Deviation 1.675
|
-1.46 Score on a scale
Standard Deviation 1.862
|
|
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
|
6.55 Score on a scale
Standard Deviation 1.952
|
6.64 Score on a scale
Standard Deviation 1.749
|
|
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
|
-3.34 Score on a scale
Standard Deviation 1.756
|
-2.27 Score on a scale
Standard Deviation 2.105
|
Adverse Events
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)
n=74 participants at risk
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 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (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.
|
Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)
n=74 participants at risk
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 (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.
|
Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
n=73 participants at risk
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 (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.
|
|---|---|---|---|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/73
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
1.4%
1/74
|
0.00%
0/74
|
2.7%
2/73
|
|
Gastrointestinal disorders
OEDEMA MOUTH
|
0.00%
0/74
|
1.4%
1/74
|
0.00%
0/73
|
|
Gastrointestinal disorders
SENSITIVITY OF TEETH
|
0.00%
0/74
|
0.00%
0/74
|
1.4%
1/73
|
|
Gastrointestinal disorders
LIP ULCERATION
|
1.4%
1/74
|
0.00%
0/74
|
0.00%
0/73
|
|
Injury, poisoning and procedural complications
BURN ORAL CAVITY
|
1.4%
1/74
|
1.4%
1/74
|
0.00%
0/73
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
0.00%
0/74
|
0.00%
0/74
|
1.4%
1/73
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/74
|
0.00%
0/74
|
1.4%
1/73
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER