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

This study is currently recruiting participants.
Verified May 2012 by Oragenics, Inc.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Oragenics, Inc.
ClinicalTrials.gov Identifier:
NCT01520974
First received: January 25, 2012
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Oral Health
 Other: ProBiora3 mints
Other: Placebo tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: ProBiora3 Oral Care Probiotics Usage

Resource links provided by NLM:

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Further study details as provided by Oragenics, Inc.:

Primary Outcome Measures:
  • Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Breath odor [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Halimeter used to evaluate breath odor

  • Teeth whiteness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Teeth whiteness measured with VITA Toothguide 3D-MASTER


Estimated Enrollment: 48
Study Start Date: January 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Oragenics, Inc.
ClinicalTrials.gov Identifier: NCT01520974     History of Changes
Other Study ID Numbers: ORA.2011.PB3
Study First Received: January 25, 2012
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013