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Tooth sensitivity reduction after dentifrices use
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nupro C Prophylaxis paste | Placebo Comparator | Fluoride Free |
|
| ProClude Prophylaxis paste | Experimental | Arginine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arginine/Calcium Carbonate | Device | One application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tooth Hypersensitity to Touch Stimuli (Tactile) | 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 | 12 weeks (Final) |
| Tooth Hypersensivity Stimuli to Air | 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. | 12 weeks (Final) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Schiff, DMD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobsen Dental Clinic | San Francisco | California | 94115 | United States |
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Recruitment, screening and enrollment completed at the clinic site
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| ID | Title | Description |
|---|---|---|
| FG000 | Nupro C Prophylaxis Paste | single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study |
| FG001 | ProClude Prophylaxis Paste | single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nupro C Prophylaxis Paste | |
| BG001 | ProClude Prophylaxis Paste | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tooth Hypersensitity to Touch Stimuli (Tactile) | 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 | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (Final) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nupro C Prophylaxis Paste | single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William DeVizio - DMD | Colgate Palmolive | 732-878-7901 | william_devizio@colpal.com |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Mint Prophy paste - Fluoride free |
| Device |
one application |
|
|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Primary | Tooth Hypersensivity Stimuli to Air | 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. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks (Final) |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | ProClude Prophylaxis Paste | single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study | 0 | 44 | 0 | 44 |
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