Trial Outcomes & Findings for Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity (NCT NCT01691560)
NCT ID: NCT01691560
Last Updated: 2014-05-29
Results Overview
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
COMPLETED
PHASE2
140 participants
Baseline to 4 weeks post administration of study treatment
2014-05-29
Participant Flow
Participants were recruited at the clinical site.
Out of 152 screened participants, 16 did not meet the study criterion while 2 withdrew consent. Hence, a total of 134 participants were randomized into the study.
Participant milestones
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
34
|
33
|
|
Overall Study
COMPLETED
|
34
|
33
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.4 Years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
33.2 Years
STANDARD_DEVIATION 10.13 • n=7 Participants
|
38.2 Years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
36.2 Years
STANDARD_DEVIATION 9.62 • n=4 Participants
|
35.8 Years
STANDARD_DEVIATION 9.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeks post administration of study treatmentPopulation: Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
|---|---|---|---|---|
|
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
|
-0.36 Score on a scale
Interval -0.53 to -0.2
|
-0.43 Score on a scale
Interval -0.59 to -0.27
|
-0.40 Score on a scale
Interval -0.57 to -0.23
|
-0.45 Score on a scale
Interval -0.62 to -0.28
|
PRIMARY outcome
Timeframe: Baseline to 4 weeks post administration of study treatmentPopulation: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
|---|---|---|---|---|
|
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
|
7.31 grams
Standard Deviation 11.227
|
6.32 grams
Standard Deviation 13.045
|
4.09 grams
Standard Deviation 4.752
|
3.64 grams
Standard Deviation 6.030
|
PRIMARY outcome
Timeframe: Baseline to 8 weeks post administration of study treatmentPopulation: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
|---|---|---|---|---|
|
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
|
-0.55 Score on a scale
Interval -0.78 to -0.33
|
-0.43 Score on a scale
Interval -0.66 to -0.2
|
-0.43 Score on a scale
Interval -0.66 to -0.2
|
-0.92 Score on a scale
Interval -1.15 to -0.68
|
PRIMARY outcome
Timeframe: Baseline to 8 weeks post administration of study treatmentPopulation: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
|---|---|---|---|---|
|
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
|
10.15 grams
Standard Deviation 15.100
|
5.88 grams
Standard Deviation 11.512
|
4.39 grams
Standard Deviation 5.556
|
11.97 grams
Standard Deviation 16.486
|
PRIMARY outcome
Timeframe: Baseline to 4 weeks post administration of study treatmentPopulation: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
|---|---|---|---|---|
|
Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
|
-1.22 Score on a scale
Interval -1.76 to -0.69
|
-1.07 Score on a scale
Interval -1.6 to -0.55
|
-1.35 Score on a scale
Interval -1.89 to -0.81
|
-1.25 Score on a scale
Interval -1.8 to -0.71
|
PRIMARY outcome
Timeframe: Baseline to 8 weeks post administration of study treatmentPopulation: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.
Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=33 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=33 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
|
|---|---|---|---|---|
|
Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
|
-1.76 Score on a scale
Interval -2.35 to -1.17
|
-1.22 Score on a scale
Interval -1.81 to -0.63
|
-1.31 Score on a scale
Interval -1.9 to -0.71
|
-2.06 Score on a scale
Interval -2.67 to -1.46
|
Adverse Events
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Sodium Monofluorophosphate
Sodium Fluoride
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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