Trial Outcomes & Findings for Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction (NCT NCT01040169)
NCT ID: NCT01040169
Last Updated: 2013-12-10
Results Overview
Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity
COMPLETED
NA
79 participants
12 weeks (Final)
2013-12-10
Participant Flow
Recruitment, screening and enrollment completed at the clinic site
Participant milestones
| Measure |
Nupro C Prophylaxis Paste
single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
|
ProClude Prophylaxis Paste
single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
44
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
| Measure |
Nupro C Prophylaxis Paste
single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
|
ProClude Prophylaxis Paste
single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
8
|
Baseline Characteristics
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Baseline characteristics by cohort
| Measure |
Nupro C Prophylaxis Paste
n=35 Participants
|
ProClude Prophylaxis Paste
n=44 Participants
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
78.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1.0 Participants
n=5 Participants
|
|
Age Continuous
|
37.34 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
35.55 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
36.34 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
44 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (Final)Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity
Outcome measures
| Measure |
Nupro C Prophylaxis Paste
n=35 Participants
|
ProClude Prophylaxis Paste
n=44 Participants
|
|---|---|---|
|
Tooth Hypersensitity to Touch Stimuli (Tactile)
|
10.83 Units on a scale
Standard Deviation 1.89
|
10.63 Units on a scale
Standard Deviation 2.11
|
PRIMARY outcome
Timeframe: 12 weeks (Final)Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.
Outcome measures
| Measure |
Nupro C Prophylaxis Paste
n=35 Participants
|
ProClude Prophylaxis Paste
n=44 Participants
|
|---|---|---|
|
Tooth Hypersensivity Stimuli to Air
|
2.69 Units on a scale
Standard Deviation 0.32
|
2.73 Units on a scale
Standard Deviation 0.36
|
Adverse Events
Nupro C Prophylaxis Paste
ProClude Prophylaxis Paste
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
- Publication restrictions are in place
Restriction type: GT60