Recruiting

ProBiora3

Sponsor:

Oragenics, Inc.

Code:

NCT01520974

Conditions

Oral Health

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

ProBiora3 mints

Placebo tablet

Study Details

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.

Conditions

Oral Health

Study ID

NCT01520974

Start date

Jan, 2012

Status verified date

May, 2012

Primary completion date

Aug, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

active comparator: Probiotic tablet

placebo comparator: Placebo tablet

Comparison tablet without the probiotic bacteria

Interventions

ProBiora3 mints

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

Placebo tablet

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

Primary outcome measure

  • Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Marilynn Rothen, RDH, MS

206-685-8132rothen@uw.edu

Mary K Hagstrom, CDA

206-685-8132mkh8@uw.edu

Locations

University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Mary Bradley

206-359-0749mb22@uw.edu

Shelly Prosise

206-354-4579sprosise@uw.edu

More Information

Sponsor

Oragenics, Inc.

Last update posted

May 2, 2012

Last verified

May, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oragenics, Inc. on 2012-05-02.