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Status unknownNCT01520974Updated May 2, 2012

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

An interventional study of ProBiora3 mints and Placebo tablet in Oral Health, sponsored by Oragenics, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-02.

Sponsored by Oragenics, Inc. · Not applicable and Interventional

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Oral Health
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In context

Lead sponsor

Oragenics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Probiotic tablet

    Other: ProBiora3 mints

  • Placebo comparator
    Placebo tablet

    Comparison tablet without the probiotic bacteria

    Other: Placebo tablet

Interventions

  • OtherProBiora3 mints

    Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria

    Also known as: EvoraPlus, EvoraPro

  • OtherPlacebo tablet

    Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria

    Also known as: placebo

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What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. Breath odor

    Halimeter used to evaluate breath odor

    Time frame: 12 weeks

  2. Teeth whiteness

    Teeth whiteness measured with VITA Toothguide 3D-MASTER

    Time frame: 12 weeks

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Study locations

1 of 1 sites recruiting
  • University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center
    Seattle, Washington 98195, United States
    • Mary Bradley · Contact · mb22@uw.edu · 206-359-0749
    • Shelly Prosise · Contact · sprosise@uw.edu · 206-354-4579
    • Philippe Hujoel, DDS, PhD · Sub investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 19486429 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01520974
Lead sponsor
Oragenics, Inc.
Collaborators
University of Washington
Responsible party
Sponsor
First posted
Jan 30, 2012
Start date
Jan 2012
Primary completion
Aug 2012 (estimated)
Last update
May 2, 2012

Study contacts

Marilynn Rothen, RDH, MS
Contact
rothen@uw.edu
206-685-8132
Mary K Hagstrom, CDA
Contact
mkh8@uw.edu
206-685-8132
Whasun O Chung, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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