Trial Outcomes & Findings for Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity (NCT NCT02542943)
NCT ID: NCT02542943
Last Updated: 2017-03-06
Results Overview
The examiner assessed 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.
COMPLETED
NA
240 participants
Baseline, Week 8
2017-03-06
Participant Flow
A total of 262 participants were screened, out of which 240 participants were randomized and 238 completed the study.
Participant milestones
| Measure |
Experimental Oral Rinse 1
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate \[KOX\], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
80
|
81
|
|
Overall Study
COMPLETED
|
78
|
79
|
81
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental Oral Rinse 1
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate \[KOX\], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Experimental Oral Rinse1
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=80 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.8 Years
STANDARD_DEVIATION 10.45 • n=99 Participants
|
35.0 Years
STANDARD_DEVIATION 8.41 • n=107 Participants
|
36.5 Years
STANDARD_DEVIATION 10.07 • n=206 Participants
|
35.4 Years
STANDARD_DEVIATION 9.67 • n=7 Participants
|
|
Gender
Female
|
51 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
160 Participants
n=7 Participants
|
|
Gender
Male
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 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.
The examiner assessed 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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
At Baseline
|
2.54 score on a scale
Standard Deviation 0.420
|
2.56 score on a scale
Standard Deviation 0.416
|
2.55 score on a scale
Standard Deviation 0.415
|
|
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
|
-0.86 score on a scale
Standard Deviation 0.772
|
-0.66 score on a scale
Standard Deviation 0.803
|
-0.73 score on a scale
Standard Deviation 0.779
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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.
The examiner assessed 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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
At Baseline
|
2.54 score on a scale
Standard Deviation 0.420
|
2.56 score on a scale
Standard Deviation 0.416
|
—
|
|
Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
Change from Baseline at Week 8
|
-0.86 score on a scale
Standard Deviation 0.772
|
-0.66 score on a scale
Standard Deviation 0.803
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: 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.
The examiner assessed 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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
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 0.420
|
2.56 score on a scale
Standard Deviation 0.416
|
2.55 score on a scale
Standard Deviation 0.415
|
|
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
|
-0.63 score on a scale
Standard Deviation 0.701
|
-0.56 score on a scale
Standard Deviation 0.670
|
-0.57 score on a scale
Standard Deviation 0.732
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: 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.
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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
At Baseline
|
10.00 g
Full Range 0.000 • Interval 10.0 to 10.0
|
10.00 g
Full Range 0.000 • Interval 10.0 to 10.0
|
10.00 g
Full Range 0.000 • Interval 10.0 to 10.0
|
|
Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Change from Baseline at Week 4
|
5.00 g
Full Range 16.371 • Interval 0.0 to 80.0
|
0.00 g
Full Range 14.692 • Interval 0.0 to 70.0
|
5.00 g
Full Range 13.219 • Interval 0.0 to 55.0
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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.
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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8
Change from Baseline at Week 8
|
7.50 g
Interval 0.0 to 80.0
|
5.00 g
Interval 0.0 to 80.0
|
5.00 g
Interval 0.0 to 80.0
|
|
Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8
At Baseline
|
10.00 g
Interval 10.0 to 10.0
|
10.00 g
Interval 10.0 to 10.0
|
10.00 g
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: 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.
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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
At Baseline
|
6.22 score on a scale
Standard Deviation 1.515
|
6.32 score on a scale
Standard Deviation 1.209
|
6.19 score on a scale
Standard Deviation 1.422
|
|
Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
Change from Baseline at Week 4
|
-1.60 score on a scale
Standard Deviation 1.476
|
-1.29 score on a scale
Standard Deviation 1.669
|
-1.45 score on a scale
Standard Deviation 1.505
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: 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.
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.
Outcome measures
| Measure |
Experimental Oral Rinse1
n=78 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=79 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 Participants
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
At Baseline
|
6.22 score on a scale
Standard Deviation 1.515
|
6.32 score on a scale
Standard Deviation 1.209
|
6.19 score on a scale
Standard Deviation 1.422
|
|
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
|
-2.25 score on a scale
Standard Deviation 1.781
|
-2.07 score on a scale
Standard Deviation 1.820
|
-2.15 score on a scale
Standard Deviation 1.865
|
Adverse Events
Experimental Oral Rinse 1
Experimental Oral Rinse 2
Placebo Oral Rinse
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Oral Rinse 1
n=79 participants at risk
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Experimental Oral Rinse 2
n=80 participants at risk
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
Placebo Oral Rinse
n=81 participants at risk
Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
SENSITIVITY OF TEETH
|
6.3%
5/79
|
8.8%
7/80
|
9.9%
8/81
|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
3.8%
3/79
|
2.5%
2/80
|
0.00%
0/81
|
|
Gastrointestinal disorders
DENTAL DISCOMFORT
|
1.3%
1/79
|
0.00%
0/80
|
1.2%
1/81
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.3%
1/79
|
0.00%
0/80
|
1.2%
1/81
|
|
Gastrointestinal disorders
CHAPPED LIPS
|
0.00%
0/79
|
0.00%
0/80
|
1.2%
1/81
|
|
Gastrointestinal disorders
LEUKOPLAKIA ORAL
|
0.00%
0/79
|
1.2%
1/80
|
0.00%
0/81
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/79
|
2.5%
2/80
|
0.00%
0/81
|
|
Infections and infestations
BRONCHITIS
|
1.3%
1/79
|
0.00%
0/80
|
0.00%
0/81
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/79
|
1.2%
1/80
|
1.2%
1/81
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
0.00%
0/79
|
1.2%
1/80
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.3%
1/79
|
0.00%
0/80
|
0.00%
0/81
|
Additional Information
GSK Response Center
GlaxoSmithKline
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