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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic tablet

Group Type ACTIVE_COMPARATOR

ProBiora3 mints

Intervention Type OTHER

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

Placebo tablet

Comparison tablet without the probiotic bacteria

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type OTHER

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

Interventions

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ProBiora3 mints

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

Intervention Type OTHER

Placebo tablet

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

Intervention Type OTHER

Other Intervention Names

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EvoraPlus EvoraPro placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes