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

Oral Health Clinical Trial

Official title:

ProBiora3 Oral Care Probiotics Usage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01520974
• Other study ID #: ORA.2011.PB3
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2012
• Last updated: May 1, 2012
• Start date: January 2012

Study information

• Verified date: May 2012
• Source: Oragenics, Inc.
• Contact: Marilynn Rothen, RDH, MS
• Phone: 206-685-8132
• Email: rothen[@]uw.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Oral Health

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Oragenics, Inc.	University of Washington

Country where clinical trial is conducted

United States, 

References & 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Breath odor	Halimeter used to evaluate breath odor	12 weeks	No
Secondary	Teeth whiteness	Teeth whiteness measured with VITA Toothguide 3D-MASTER	12 weeks	No