Effect of an Oral Probiotic Tablet on Oral Bacteria and Clinical Measurements (ProBiora3)
ProBiora3 Oral Care Probiotics Usage
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedMay 2, 2012
May 1, 2012
7 months
January 25, 2012
May 1, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Breath odor
12 weeks
Teeth whiteness
12 weeks
Study Arms (2)
Probiotic tablet
ACTIVE COMPARATORPlacebo tablet
PLACEBO COMPARATORComparison tablet without the probiotic bacteria
Interventions
Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria
Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oragenics, Inc.lead
- University of Washingtoncollaborator
Study Sites (1)
University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 19486429RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Whasun O Chung, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2012
First Posted
January 30, 2012
Study Start
January 1, 2012
Primary Completion
August 1, 2012
Last Updated
May 2, 2012
Record last verified: 2012-05