Trial | NCT01520974  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
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.
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 Started
Jan 31
2012
Primary Completion
Aug 31
2012
Anticipated
Last Update
May 02
2012
Estimate

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

Other Placebo tablet

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

  • Other names: placebo

Probiotic tablet Active Comparator

Placebo tablet Placebo Comparator

Comparison tablet without the probiotic bacteria

Criteria 

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
No Results Posted