Oral HealthNCT01520974
Effect of an Oral Probiotic Tablet on Oral Bacteria and Clinical Measurements (ProBiora3)
A study testing ProBiora3 mints in people with Oral Health, run by Oragenics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- ProBiora3 mints
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington, Scool of Dentistry, Regional Clinical Dental Research Center
Seattle, Washington, 98195
Mary Bradley, 206-359-0749, mb22@uw.edu
Shelly Prosise, 206-354-4579, sprosise@uw.edu
About this study
Official title: ProBiora3 Oral Care Probiotics Usage
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.
Read the 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.
- Conditions
- Oral Health
- Being tested
- ProBiora3 mints, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProBiora3 mintsOther
Also called EvoraPlus, EvoraPro
Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria
Placebo tabletOther
Also called placebo
Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria
| Study group | Role | What they receive |
|---|---|---|
| Probiotic tablet | Active comparator | Not described Receives: Other: ProBiora3 mints |
| Placebo tablet | Placebo comparator | Comparison tablet without the probiotic bacteria Receives: Other: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque
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.
Measured: 12 weeks
Secondary outcomes (2)
Breath odor
Halimeter used to evaluate breath odor
Measured: 12 weeks
Teeth whiteness
Teeth whiteness measured with VITA Toothguide 3D-MASTER
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oragenics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Whasun O Chung, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520974
- Sponsor's protocol ID
- ORA.2011.PB3
- Status last verified
- May 2012
- First submitted
- 25 Jan 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zahradnik RT, Magnusson I, Walker C, McDonell E, Hillman CH, Hillman JD. Preliminary assessment of safety and effectiveness in humans of ProBiora3, a probiotic mouthwash. J Appl Microbiol. 2009 Aug;107(2):682-90. doi: 10.1111/j.1365-2672.2009.04243.x. Epub 2009 Mar 30.
PubMed 19486429
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProBiora3 Oral Care Probiotics Usage
- ClinicalTrials.gov ID
- NCT01520974
- Acronym / sponsor ID
- ORA.2011.PB3
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Oragenics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Washington
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic tablet | Active comparator | Other: ProBiora3 mints |
| Placebo tablet | Placebo comparator | Other: Placebo tabletComparison tablet without the probiotic bacteria |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProBiora3 mintsAlso: EvoraPlus, EvoraProProbiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria | Other | Probiotic tablet |
| Placebo tabletAlso: placeboMint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria | Other | Placebo tablet |
Primary outcome
Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque
Time frame: 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.
2 secondary outcomes
Breath odor
Time frame: 12 weeks
Teeth whiteness
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
- Results publication: PubMed 19486429Zahradnik RT, Magnusson I, Walker C, McDonell E, Hillman CH, Hillman JD. Preliminary assessment of safety and effectiveness in humans of ProBiora3, a probiotic mouthwash. J Appl Microbiol. 2009 Aug;107(2):682-90. doi: 10.1111/j.1365-2672.2009.04243.x. Epub 2009 Mar 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Whasun O Chung, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProBiora3 mints in people with Oral Health, run by Oragenics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marilynn Rothen, RDH, MS (206-685-8132, rothen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enumeration of S. mutans in saliva and seven periodontal pathogens in subgingival plaque (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01520974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.