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

Not Applicable

• Conditions: Oral Health
• Interventions: Other: ProBiora3 mints; Other: Placebo tablet

• Registration Number: NCT01520974
• Lead Sponsor: Oragenics, Inc.

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-30
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-02
• Primary Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic tablet	ProBiora3 mints	-
Placebo tablet	Placebo tablet	Comparison tablet without the probiotic bacteria

Primary Outcome Measures

Name	Time	Method
Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Breath odor	12 weeks	Halimeter used to evaluate breath odor
Teeth whiteness	12 weeks	Teeth whiteness measured with VITA Toothguide 3D-MASTER

Trial Locations

Locations (1)

University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center; 🇺🇸 Seattle, Washington, United States