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

ProBiora3 Oral Care Probiotics Usage

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.

Study Overview

• Status: Unknown
• Conditions: Oral Health
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilynn Rothen, RDH, MS; Phone Number: 206-685-8132; Email: rothen@uw.edu
• Study Contact Backup: Name: Mary K Hagstrom, CDA; Phone Number: 206-685-8132; Email: mkh8@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center
      • Contact: Mary Bradley; Phone Number: 206-359-0749; Email: mb22@uw.edu
      • Contact: Shelly Prosise; Phone Number: 206-354-4579; Email: sprosise@uw.edu
      • Sub-Investigator: Philippe Hujoel, DDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath odor	Halimeter used to evaluate breath odor	12 weeks
Teeth whiteness	Teeth whiteness measured with VITA Toothguide 3D-MASTER	12 weeks

Collaborators and Investigators

• Sponsor: Oragenics, Inc.
• Collaborators: University of Washington
• Investigators: Principal Investigator: Whasun O Chung, PhD, University of Washington

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 2, 2012
• Last Update Submitted That Met QC Criteria: May 1, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: ORA.2011.PB3