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The objective of this clinical study is to assess the efficacy of a dentifrice containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste, GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over a seven (7) day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush |
|
| Group II | Active Comparator | Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush |
|
| Group III | Placebo Comparator | Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate SNF | Drug | toothpaste |
| |
| Sensodyne Extra Whitening |
| Measure | Description | Time Frame |
|---|---|---|
| Tactile dentin hypersensitivity | Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA) | Baseline, 1-Day, 3-Days and 7-Days |
| Air blast dentin hypersensitivity | Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale. | Baseline, 1-Day, 3-Days and 7-Days |
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Inclusion Criteria:
Sign an Informed Consent Form;
Male or female 18 to 70 years of age, inclusive;
Be in good general health as determined by the study investigators;
Available for the seven (7) days duration of the study;
Must present two (2) sensitive teeth which must meet ALL of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farid Ayad, DMD, MSD | Mesa Dental Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa Dental Centre | Costa Mesa | California | 92627 | United States |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002487 | Centers for Disease Control and Prevention, U.S. |
| ID | Term |
|---|---|
| D014492 | United States Public Health Service |
| D014483 | United States Dept. of Health and Human Services |
| D037041 | United States Government Agencies |
| D035082 | Federal Government |
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| Drug |
toothpaste |
|
| Colgate Fluoride (CDC) | Drug | toothpaste |
|
| D006076 | Government |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |