Oral Health
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERProBiora3 mints
Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria
OTHERPlacebo tablet
Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria
Sponsors
University of Washington
Oragenics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* minimum of 20 teeth, with only a few fillings * good general health * willing to use an appropriate method of birth control during the study * measurable levels of Streptococcus mutans and one or more of the selected periodontal pathogens
Exclusion criteria
* chronic or acute illness such as heart disease, diabetes, cancer, hepatitis (liver disease) or HIV positive * radiation therapy or systemic cancer treatment (chemotherapy) * require antibiotics for dental treatment * pregnant or planning to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breath odor | 12 weeks | Halimeter used to evaluate breath odor |
| Teeth whiteness | 12 weeks | Teeth whiteness measured with VITA Toothguide 3D-MASTER |
Countries
United States
Contacts
Primary ContactMarilynn Rothen, RDH, MS
Backup ContactMary K Hagstrom, CDA
Outcome results
None listed