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Probiotic
Probiotic Oral Tablets for Oral Hygiene
N/A
Waitlist Available
Led By Whasun O Chung, PhD
Research Sponsored by Oragenics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
radiation therapy or systemic cancer treatment (chemotherapy)
require antibiotics for dental treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This trial will test if taking a probiotic pill every day for 12 weeks can reduce the amount of harmful bacteria in the mouths of healthy young adults, which could help prevent tooth decay and gum disease.
Who is the study for?
This trial is for dentally healthy young adults with a good general health status. Participants must be willing to use birth control, have measurable levels of certain oral bacteria, and possess at least 20 teeth with minimal fillings. Those undergoing cancer treatment, needing antibiotics for dental work, pregnant or planning pregnancy, or suffering from chronic illnesses like heart disease or diabetes cannot join.
What is being tested?
The study tests if taking ProBiora3 mints daily for twelve weeks can reduce harmful oral bacteria linked to tooth decay and gum disease compared to a placebo tablet in a controlled environment.
What are the potential side effects?
While the trial primarily involves probiotics that are generally considered safe, potential side effects may include digestive discomfort such as bloating or gas due to changes in the balance of oral and gut bacteria.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing or have completed radiation or chemotherapy.
Select...
I need antibiotics before dental work.
Select...
I have a chronic or acute illness like heart disease, diabetes, cancer, hepatitis, or HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque
Secondary study objectives
Breath odor
Teeth whiteness
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Probiotic tabletActive Control1 Intervention
Group II: Placebo tabletPlacebo Group1 Intervention
Comparison tablet without the probiotic bacteria
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Who is running the clinical trial?
Oragenics, Inc.Lead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
University of WashingtonOTHER
1,791 Previous Clinical Trials
1,905,458 Total Patients Enrolled
Whasun O Chung, PhDPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are in good overall health.I am currently undergoing or have completed radiation or chemotherapy.I have at least 20 teeth with few fillings.I need antibiotics before dental work.I have a chronic or acute illness like heart disease, diabetes, cancer, hepatitis, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo tablet
- Group 2: Probiotic tablet
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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