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The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProClude Prophylaxis paste-A | Active Comparator | Arginine Bicarbonate prophylaxis paste |
|
| Nupro-M Prophylaxis paste -B | Placebo Comparator | Control prophylaxis paste (Fluoride free - placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arginine/Calcium Carbonate | Device | One time treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hypersensitivity to Touch (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 elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity. | Immediately after product application |
| Air Blast | 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. | Immediately after product application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hamlin, DDS | Contract Dental Evaluations | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contract Dental Evaluations | Langhorne | Pennsylvania | 19047 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ProClude Prophylaxis Paste-A | Arginine Bicarbonate prophy paste (experimental). |
| FG001 | Nupro-M Prophylaxis Paste-B | Control prophy paste (Fluoride free). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProClude Prophylaxis Paste-A | Arginine Bicarbonate prophy paste (experimental). |
| BG001 | Nupro-M Prophylaxis Paste-B | Control prophy paste (Fluoride free). |
| 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 | Hypersensitivity to Touch (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 elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity. | Posted | Mean | Standard Deviation | Units on a scale | Immediately after product application |
|
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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 | ProClude Prophylaxis Paste-A | Arginine Bicarbonate prophy paste (experimental). |
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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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| Nupro - Fluoride Free |
| Device |
Brush twice daily |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Air Blast | 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 | Immediately after product application |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Nupro-M Prophylaxis Paste-B | Control prophy paste (Fluoride free). | 0 | 23 | 0 | 23 |
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