Trial Outcomes & Findings for Dose Response of a Tubule Occlusion Agent (NCT NCT01075256)
NCT ID: NCT01075256
Last Updated: 2013-06-03
Results Overview
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
COMPLETED
PHASE4
195 participants
Baseline to Day 15
2013-06-03
Participant Flow
Participants were recruited at the clinical site.
During the first 4 weeks of the study all participants brushed with an acclimatization toothpaste (sodium fluoride \[NaF\] toothpaste containing 1100 parts per million \[ppm\] fluoride \[F\]) for maintaining wash-out period and standardizing the oral conditions.
Participant milestones
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
65
|
|
Overall Study
COMPLETED
|
63
|
66
|
65
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Dose Response of a Tubule Occlusion Agent
Baseline characteristics by cohort
| Measure |
5% Sodium Calcium Phosphosilicate Toothpaste
n=66 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=63 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=66 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
38.30 years
STANDARD_DEVIATION 8.925 • n=99 Participants
|
37.63 years
STANDARD_DEVIATION 8.920 • n=107 Participants
|
36.61 years
STANDARD_DEVIATION 9.885 • n=206 Participants
|
37.51 years
STANDARD_DEVIATION 9.239 • n=7 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
154 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 15Population: Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=63 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=66 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=65 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15
|
-26.1 Units on a scale
Interval -29.4 to -22.72
|
-28.4 Units on a scale
Interval -31.6 to -25.12
|
-26.2 Units on a scale
Interval -29.54 to -22.95
|
PRIMARY outcome
Timeframe: Baseline to Day 15Population: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=63 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=66 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=65 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15
|
-32.8 Units on a scale
Interval -37.55 to -28.0
|
-32.2 Units on a scale
Interval -36.86 to -27.59
|
-32.3 Units on a scale
Interval -37.04 to -27.6
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=63 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=66 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=65 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7
|
-16.4 Units on a scale
Interval -19.8 to -12.93
|
-17.4 Units on a scale
Interval -20.75 to -14.1
|
-16.4 Units on a scale
Interval -19.78 to -13.02
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=63 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=66 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=65 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7
|
-21.5 Units on a scale
Interval -26.14 to -16.81
|
-22.5 Units on a scale
Interval -26.99 to -17.93
|
-21.8 Units on a scale
Interval -26.44 to -17.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 10Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=17 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10
|
-28.7 Units on a scale
Interval -34.9 to -22.43
|
-22.7 Units on a scale
Interval -33.7 to -21.67
|
-28.2 Units on a scale
Interval -34.46 to -21.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 10Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=17 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10
|
-34.7 Units on a scale
Interval -44.24 to -25.09
|
-31.3 Units on a scale
Interval -40.03 to -22.62
|
-34.7 Units on a scale
Interval -44.22 to -25.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 3Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=17 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3
|
-13.5 Units on a scale
Interval -20.08 to -6.87
|
-12.3 Units on a scale
Interval -18.66 to -5.9
|
-11.1 Units on a scale
Interval -17.74 to -4.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 3Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Outcome measures
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=18 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=17 Participants
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3
|
-19.3 Units on a scale
Interval -27.56 to -11.02
|
-16.9 Units on a scale
Interval -24.44 to -9.44
|
-17.6 Units on a scale
Interval -25.79 to -9.4
|
Adverse Events
7.5% Sodium Calcium Phosphosilicate Toothpaste
5% Sodium Calcium Phosphosilicate Toothpaste
Placebo Toothpaste
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7.5% Sodium Calcium Phosphosilicate Toothpaste
n=63 participants at risk
Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
5% Sodium Calcium Phosphosilicate Toothpaste
n=66 participants at risk
Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
|
Placebo Toothpaste
n=66 participants at risk
Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/63 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
3.0%
2/66 • Number of events 2 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Injury, poisoning and procedural complications
Gingival Injury
|
1.6%
1/63 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Injury, poisoning and procedural complications
Mouth Injury
|
0.00%
0/63 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
1.5%
1/66 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/63 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
1.5%
1/66 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
1.6%
1/63 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/63 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
1.5%
1/66 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Infections and infestations
Tonsilitis
|
1.6%
1/63 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Nervous system disorders
Sinus Headache
|
1.6%
1/63 • Number of events 3 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/63 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/66 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
1.5%
1/66 • Number of events 2 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place