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

Oragenics

Status: Unknown

Conditions: Oral Health

Treatments: Other: Placebo tablet; Other: ProBiora3 mints

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01520974

ORA.2011.PB3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 2 patient groups, including a placebo group

Probiotic tablet

Active Comparator group

Treatment:

Other: ProBiora3 mints

Placebo tablet

Placebo Comparator group

Description:

Comparison tablet without the probiotic bacteria

Treatment:

Other: Placebo tablet