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

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ClinicalTrials.gov Identifier: NCT01520974
Recruitment Status : Unknown
Verified May 2012 by Oragenics, Inc..
Recruitment status was:  Recruiting
First Posted : January 30, 2012
Last Update Posted : May 2, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Oral Health Other: ProBiora3 mints Other: Placebo tablet

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: ProBiora3 Oral Care Probiotics Usage
Study Start Date : January 2012
Estimated Primary Completion Date : August 2012
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Probiotic tablet Other: ProBiora3 mints
Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria
Other Names:
  • EvoraPlus
  • EvoraPro
Placebo Comparator: Placebo tablet
Comparison tablet without the probiotic bacteria
Other: Placebo tablet
Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria
Other Name: placebo


Outcome Measures

Primary Outcome Measures :
  1. Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque [ Time Frame: 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 Outcome Measures :
  1. Breath odor [ Time Frame: 12 weeks ]
    Halimeter used to evaluate breath odor

  2. Teeth whiteness [ Time Frame: 12 weeks ]
    Teeth whiteness measured with VITA Toothguide 3D-MASTER


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520974


Contacts
Contact: Marilynn Rothen, RDH, MS 206-685-8132 rothen@uw.edu
Contact: Mary K Hagstrom, CDA 206-685-8132 mkh8@uw.edu

Locations
United States, Washington
University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center Recruiting
Seattle, Washington, United States, 98195
Contact: Mary Bradley    206-359-0749    mb22@uw.edu   
Contact: Shelly Prosise    206-354-4579    sprosise@uw.edu   
Sub-Investigator: Philippe Hujoel, DDS, PhD         
Sponsors and Collaborators
Oragenics, Inc.
University of Washington
Investigators
Principal Investigator: Whasun O Chung, PhD University of Washington