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This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | toothpaste brushing 2/day for 2 minutes |
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| Group II | Experimental | toothpaste brushing 2/day for 2 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannous fluoride toothpaste | Drug | product containing 0.45% stannous fluoride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole mouth scores of dental plaque | Measuring the dental plaque using the Turesky Modification of Quigley-Hein.Subjects presenting with whole mouth scores for dental plaque of 1.5 or more [Turesky Modification of plaque will be enrolled. Quigley-Hein.](streamdown:incomplete-link) | baseline, 2 week & 4 week |
| Measurement of total bacterial counts on tongue | Scrapings from the surface of the tongue. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis | baseline, 2 week & 4 week |
| Measurement of total bacterial counts on cheek | Scrapings from the surface of the cheek mucosa. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis | baseline, 2 week & 4 week |
| Measurement of gingivitis | Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis [Loe-Silness] will be enrolled. | baseline, 2 week & 4 week |
| Measurement of total bacterial counts in saliva | Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis | baseline, 2 week & 4 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M U International Oral Science Research, Ltd. | Bangkok | Bangkok | 10250 | Thailand |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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blinded
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| Colgate Dental Cream | Drug | product containing 0.76% sodium monofluorophosphate |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |