Effect of an Oral Probiotic Tablet on Oral Bacteria and Clinical Measurements (ProBiora3)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ProBiora3 Oral Care Probiotics Usage

Conditions
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Oral Health

Intervention / Treatment
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* Other: ProBiora3 mints
* Other: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic tablet<br> | Other: ProBiora3 mints<br>* Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria<br>* Other names: EvoraPro;|
| Placebo Comparator: Placebo tablet<br>Comparison tablet without the probiotic bacteria | Other: Placebo tablet<br>* Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath odor | Halimeter used to evaluate breath odor | 12 weeks | 
| Teeth whiteness | Teeth whiteness measured with VITA Toothguide 3D-MASTER | 12 weeks |