Trial Outcomes & Findings for Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity (NCT NCT02861664)
NCT ID: NCT02861664
Last Updated: 2018-08-10
Results Overview
The examiner assessed 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
COMPLETED
NA
135 participants
At Baseline and Week 8
2018-08-10
Participant Flow
All participants were recruited at a single center in China.
A total of 273 participants were screened, out of which 135 participants were randomized to the study. 138 participants were not randomized because out of these, 135 participants did not meet the study criteria and 3 participants withdrew consent.
Participant milestones
| Measure |
Test Dentifrice: Stannous Fluoride (SnF2)
Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million \[ppm\] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
|
Overall Study
COMPLETED
|
67
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test Dentifrice: Stannous Fluoride (SnF2)
Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million \[ppm\] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
|---|---|---|
|
Overall Study
Withdrawal of Consent
|
0
|
1
|
Baseline Characteristics
This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
Baseline characteristics by cohort
| Measure |
Test Dentifrice: Stannous Fluoride (SnF2)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride SMFP to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 8.21 • n=99 Participants
|
41.9 years
STANDARD_DEVIATION 8.83 • n=107 Participants
|
41.0 years
STANDARD_DEVIATION 8.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
67 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Schiff Sensitivity Score at Baseline
|
2.26 score on a scale
STANDARD_DEVIATION 0.393 • n=99 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
|
2.23 score on a scale
STANDARD_DEVIATION 0.352 • n=107 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
|
2.25 score on a scale
STANDARD_DEVIATION 0.372 • n=206 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
|
|
Tactile Threshold at Baseline
|
11.1 gram (g)
STANDARD_DEVIATION 2.10 • n=99 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
|
10.9 gram (g)
STANDARD_DEVIATION 2.29 • n=107 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
|
11.0 gram (g)
STANDARD_DEVIATION 2.19 • n=206 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
|
PRIMARY outcome
Timeframe: At Baseline and 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 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Outcome measures
| Measure |
Test Dentifrice: Stannous Fluoride (SnF2)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride SMFP to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score at Week 8
|
-0.94 score on a scale
Standard Deviation 0.526
|
-0.33 score on a scale
Standard Deviation 0.699
|
SECONDARY outcome
Timeframe: At Baseline and 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. Number of participants analyzed is number of participants from ITT population evaluated at Week 4.
The examiner assessed 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Outcome measures
| Measure |
Test Dentifrice: Stannous Fluoride (SnF2)
n=66 Participants
Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride SMFP to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score at Week 4
|
-0.63 score on a scale
Standard Deviation 0.570
|
-0.10 score on a scale
Standard Deviation 0.512
|
SECONDARY outcome
Timeframe: At Baseline, Week 4 and 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. Number of participants analyzed is the number of participants from ITT population evaluated at specific time point for each treatment arm respectively.
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.
Outcome measures
| Measure |
Test Dentifrice: Stannous Fluoride (SnF2)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
n=67 Participants
Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride SMFP to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
|
|---|---|---|
|
Change From Baseline in Tactile Threshold at Week 4 and 8
Change from baseline at Week 4
|
4.8 g
Standard Deviation 8.57
|
4.9 g
Standard Deviation 12.31
|
|
Change From Baseline in Tactile Threshold at Week 4 and 8
Change from baseline at Week 8
|
10.4 g
Standard Deviation 14.87
|
8.4 g
Standard Deviation 16.73
|
Adverse Events
Test Dentifrice: Stannous Fluoride (SnF2)
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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