Trial Outcomes & Findings for Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity (NCT NCT02773758)
NCT ID: NCT02773758
Last Updated: 2017-09-29
Results Overview
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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.
COMPLETED
PHASE4
143 participants
Baseline, Day 14
2017-09-29
Participant Flow
Participants were recruited at a single center in Canada.
A total of 143 participants were enrolled in the study. Out of which 141 participants were randomized.
Participant milestones
| Measure |
Stannous Fluoride Dentifrice
Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \[ppm\] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
|
Sodium Monofluorophosphate Dentifrice
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
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|---|---|---|
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Overall Study
STARTED
|
71
|
70
|
|
Overall Study
COMPLETED
|
71
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
Baseline characteristics by cohort
| Measure |
Stannous Fluoride Dentifrice
n=72 Participants
Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \[ppm\] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
|
Sodium Monofluorophosphate Dentifrice
n=69 Participants
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
|
Total
n=141 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 10.27 • n=93 Participants
|
48.0 Years
STANDARD_DEVIATION 10.58 • n=4 Participants
|
47.9 Years
STANDARD_DEVIATION 10.39 • n=27 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14Population: Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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 |
Stannous Fluoride Dentifrice
n=71 Participants
Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
|
Sodium Monofluorophosphate Dentifrice
n=70 Participants
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
|
|---|---|---|
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Change From Baseline in Schiff Sensitivity Score at Day 14
At Baseline
|
2.70 score on a scale
Standard Deviation 0.427
|
2.74 score on a scale
Standard Deviation 0.423
|
|
Change From Baseline in Schiff Sensitivity Score at Day 14
Change From Baseline at Day 14
|
-1.38 score on a scale
Standard Deviation 0.843
|
-0.10 score on a scale
Standard Deviation 0.405
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 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 |
Stannous Fluoride Dentifrice
n=71 Participants
Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
|
Sodium Monofluorophosphate Dentifrice
n=70 Participants
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
|
|---|---|---|
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Change From Baseline in Schiff Sensitivity Score at Day 7
At Baseline
|
2.70 score on a scale
Standard Deviation 0.427
|
2.74 score on a scale
Standard Deviation 0.423
|
|
Change From Baseline in Schiff Sensitivity Score at Day 7
Change from baseline at Week 7
|
-0.74 score on a scale
Standard Deviation 0.446
|
-0.04 score on a scale
Standard Deviation 0.374
|
SECONDARY outcome
Timeframe: Baseline, Day 7 and Day 14Population: Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.
A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.
Outcome measures
| Measure |
Stannous Fluoride Dentifrice
n=71 Participants
Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
|
Sodium Monofluorophosphate Dentifrice
n=70 Participants
Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
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|---|---|---|
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Change From Baseline in Tactile Threshold at Day 7 and Day 14
At Baseline
|
11.83 gram (g)
Standard Deviation 3.189
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11.50 gram (g)
Standard Deviation 2.992
|
|
Change From Baseline in Tactile Threshold at Day 7 and Day 14
Change from Baseline at Day 7
|
5.92 gram (g)
Standard Deviation 6.113
|
0.86 gram (g)
Standard Deviation 3.898
|
|
Change From Baseline in Tactile Threshold at Day 7 and Day 14
Change from Baseline at Day 14
|
15.21 gram (g)
Standard Deviation 11.663
|
0.86 gram (g)
Standard Deviation 3.708
|
Adverse Events
Stannous Fluoride Dentifrice
Sodium Monofluorophosphate Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stannous Fluoride Dentifrice
n=72 participants at risk
Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
|
Sodium Monofluorophosphate Dentifrice
n=69 participants at risk
Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
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|---|---|---|
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General disorders
Pyrexia
|
1.4%
1/72 • From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
|
0.00%
0/69 • From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
|
|
Infections and infestations
Influenza
|
1.4%
1/72 • From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
|
0.00%
0/69 • From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
|
|
Nervous system disorders
Headache
|
1.4%
1/72 • From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
|
0.00%
0/69 • From start of screening to 5 days following last administration of the study product (up to 39 days)
Safety population included 72 participants in treatment arm "stannous fluoride dentifrice" \& 69 participants in treatment arm "sodium monofluorophosphate dentifrice".
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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