Trial Outcomes & Findings for Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity (NCT NCT01827670)
NCT ID: NCT01827670
Last Updated: 2015-01-26
Results Overview
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
COMPLETED
PHASE3
119 participants
Baseline-Week 8
2015-01-26
Participant Flow
Participants were recruited at the clinical site.
Participants with a minimum of two non-adjacent sensitive teeth (incisors, canines or pre-molars) with a Schiff Sensitivity Score(following an air blast stimulus) of ≥ 2 and a tactile threshold (Yeaple probe) of ≤ 20 grams (g) force were enrolled in this study.
Participant milestones
| Measure |
Control Dentifrice (0.76% Sodium Monofluorophosphate)
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
|
Test Dentifrice (0.454% Stannous Fluoride)
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
57
|
56
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Control Dentifrice (0.76% Sodium Monofluorophosphate)
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
|
Test Dentifrice (0.454% Stannous Fluoride)
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
|
|---|---|---|
|
Overall Study
Withdrawal of Consent
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Control Dentifrice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentifrice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 12.27 • n=93 Participants
|
42.2 Years
STANDARD_DEVIATION 11.27 • n=4 Participants
|
42.6 Years
STANDARD_DEVIATION 11.73 • n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
75.4 • n=93 Participants
|
46 Participants
80.7 • n=4 Participants
|
89 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
24.6 • n=93 Participants
|
11 Participants
19.3 • n=4 Participants
|
25 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline-Week 8Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
Outcome measures
| Measure |
Control Dentrifice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentrifice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
Mean Change From Baseline in Schiff Sensitivity Score
Schiff Sensitivity Score at Baseline
|
2.26 Score on a scale
Standard Deviation 0.379
|
2.25 Score on a scale
Standard Deviation 0.355
|
|
Mean Change From Baseline in Schiff Sensitivity Score
Schiff Sensitivity Score at Week 8
|
2.09 Score on a scale
Standard Deviation 0.628
|
0.78 Score on a scale
Standard Deviation 0.687
|
SECONDARY outcome
Timeframe: Baseline-Week 4Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
Outcome measures
| Measure |
Control Dentrifice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentrifice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
Mean Change From Baseline in Schiff Sensitivity Score
Schiff Sensitivity Score at Baseline
|
2.26 Score on a Scale
Standard Deviation 0.379
|
2.25 Score on a Scale
Standard Deviation 0.355
|
|
Mean Change From Baseline in Schiff Sensitivity Score
Schiff Sensitivity Score at Week 4
|
2.10 Score on a Scale
Standard Deviation 0.601
|
1.27 Score on a Scale
Standard Deviation 0.598
|
SECONDARY outcome
Timeframe: Baseline-Week 8Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.
Outcome measures
| Measure |
Control Dentrifice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentrifice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
Mean Change From Baseline in Tactile Sensitivity
Tactile Threshold at Baseline (g)
|
10.1 Grams
Standard Deviation 0.66
|
10.4 Grams
Standard Deviation 1.43
|
|
Mean Change From Baseline in Tactile Sensitivity
Tactile Threshold at Week 8 (g)
|
14.6 Grams
Standard Deviation 13.77
|
41.6 Grams
Standard Deviation 25.85
|
SECONDARY outcome
Timeframe: Baseline-Week 4Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.
Outcome measures
| Measure |
Control Dentrifice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentrifice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
Mean Change From Baseline in Tactile Sensitivity
Tactile Thresold (g) at Baseline
|
10.1 Grams
Standard Deviation 0.66
|
10.4 Grams
Standard Deviation 1.43
|
|
Mean Change From Baseline in Tactile Sensitivity
Tactile Thresold (g) at Week 4
|
15.8 Grams
Standard Deviation 14.78
|
24.6 Grams
Standard Deviation 17.53
|
SECONDARY outcome
Timeframe: Baseline-Week 4Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF
Outcome measures
| Measure |
Control Dentrifice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentrifice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
VAS Score at Baseline
|
58.40 Score on a Scale
Standard Deviation 21.661
|
58.26 Score on a Scale
Standard Deviation 21.099
|
|
Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
VAS Score at week 4
|
50.32 Score on a Scale
Standard Deviation 23.257
|
38.09 Score on a Scale
Standard Deviation 21.612
|
SECONDARY outcome
Timeframe: Baseline - Week 8Population: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2
The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF
Outcome measures
| Measure |
Control Dentrifice (0.76% Sodium Monofluorophosphate)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
|
Test Dentrifice (0.454% Stannous Fluoride)
n=57 Participants
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
VAS Score at Baseline
|
58.40 Score on a Scale
Standard Deviation 21.661
|
58.26 Score on a Scale
Standard Deviation 21.099
|
|
Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
VAS Score at Week 8
|
43.94 Score on a Scale
Standard Deviation 23.996
|
22.17 Score on a Scale
Standard Deviation 22.299
|
Adverse Events
Control Dentifrice (0.76% Sodium Monofluorophosphate)
Test Dentifrice (0.454% Stannous Fluoride)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Dentifrice (0.76% Sodium Monofluorophosphate)
n=60 participants at risk
Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice \[0.76% weight for weight (w/w) Sodium Monofluorophosphate\] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
|
Test Dentifrice (0.454% Stannous Fluoride)
n=59 participants at risk
Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
|
|---|---|---|
|
General disorders
Dysgeusia
|
0.00%
0/60 • All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
|
1.7%
1/59 • Number of events 1 • All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
|
|
General disorders
Mouth Injury
|
1.7%
1/60 • Number of events 1 • All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
|
0.00%
0/59 • All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.7%
1/60 • Number of events 1 • All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
|
0.00%
0/59 • All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56)
|
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