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| Name | Class |
|---|---|
| University of Washington | OTHER |
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The purpose of this study is to determine if an oral probiotic tablet taken once a day for twelve weeks can decrease the numbers of bacteria that are associated with tooth decay and gum disease in a dentally healthy, young adult population.
There are over 500 types of bacteria in the mouth. Most of these bacteria do not cause disease. However, some mouth bacteria can cause tooth decay and gum disease. The purpose of a probiotic tablet for the mouth is to put known healthy bacteria in the mouth. This study will compare the effect of the probiotic tablet on the levels of harmful or disease causing bacteria in the mouth to a placebo tablet that does not contain any probiotic bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic tablet | Active Comparator |
| |
| Placebo tablet | Placebo Comparator | Comparison tablet without the probiotic bacteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProBiora3 mints | Other | Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque | Quantitative RT-PCR analyses for S. mutans in saliva, and A. actinomycetemcomitans, P. intermedia, T. forsythia, F. nucleatum, C. rectus, and E. corrodens in subgingival dental plaque. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Breath odor | Halimeter used to evaluate breath odor | 12 weeks |
| Teeth whiteness | Teeth whiteness measured with VITA Toothguide 3D-MASTER |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marilynn Rothen, RDH, MS | Contact | 206-685-8132 | rothen@uw.edu | |
| Mary K Hagstrom, CDA | Contact | 206-685-8132 | mkh8@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Whasun O Chung, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center | Recruiting | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19486429 | Result | Zahradnik RT, Magnusson I, Walker C, McDonell E, Hillman CH, Hillman JD. Preliminary assessment of safety and effectiveness in humans of ProBiora3, a probiotic mouthwash. J Appl Microbiol. 2009 Aug;107(2):682-90. doi: 10.1111/j.1365-2672.2009.04243.x. Epub 2009 Mar 30. |
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| Placebo tablet | Other | Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria |
|
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| 12 weeks |