CariesNCT01700712
Acid Production in Dental Plaque After Exposure to Probiotic Bacteria
A study testing Probiotic Lactobacilli reuteri in people with Caries, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Probiotic Lactobacilli reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Oct 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- moderate to high counts of salivary mutans streptococci (>104 CFU) as estimated with the Dentocult SM chair-side test,
- no visible open caries lesions or periodontal disease,
Who cannot join
- smokers,
- ingestion of probiotic bacteria within the last two months,
- ingestion of antibiotics within the last two months
Trial locations and contacts
1 site in 1 country.
About this study
The increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli on plaque lactic acid (LA) production in vitro and in vivo.
Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM 17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over trial. The concentration of LA in supragingival plaque samples was determined at baseline and after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated with chair-side methods.
- Conditions
- Caries
- Being tested
- Probiotic Lactobacilli reuteri, Placebo
- Keywords
- Caries, probiotic bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Lactobacilli reuteriDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU | Active comparator | 2 tablets a day for 2 weeks Receives: Dietary Supplement: Probiotic Lactobacilli reuteri |
| Sugar pill | Placebo comparator | 2 tablets a day for 2 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acid production in plaque after exposure to probiotic bacteria
Measured: 2 weeks
Secondary outcomes (1)
Acid producton in plaque after in vitro exposure to probiotic bacteria
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startDec 2010
- Primary completionOct 2011
- Study completionOct 2011
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 CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB, Calcin foundation, Denmark
- Responsible party
- Principal investigator, Mette Kirstine Keller, University of Copenhagen
- Investigators
- Mette K Keller, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700712
- Sponsor's protocol ID
- H-2-2010-112
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
Publications
Keller MK, Twetman S. Acid production in dental plaque after exposure to probiotic bacteria. BMC Oral Health. 2012 Oct 24;12:44. doi: 10.1186/1472-6831-12-44.
PubMed 23092239
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid Production in Dental Plaque After Exposure to Probiotic Bacteria
- ClinicalTrials.gov ID
- NCT01700712
- Acronym / sponsor ID
- H-2-2010-112
- Conditions
- Caries
- Keywords
- Caries, probiotic bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- BioGaia AB, Calcin foundation, Denmark
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Oct 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 increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli on plaque lactic acid (LA) production in vitro and in vivo.
Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM 17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over trial. The concentration of LA in supragingival plaque samples was determined at baseline and after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated with chair-side methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU | Active comparator | Dietary Supplement: Probiotic Lactobacilli reuteri2 tablets a day for 2 weeks |
| Sugar pill | Placebo comparator | Dietary Supplement: Placebo2 tablets a day for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate to high counts of salivary mutans streptococci (>104 CFU) as estimated with the Dentocult SM chair-side test,
- no visible open caries lesions or periodontal disease,
Key exclusion criteria (3 listed)
- smokers,
- ingestion of probiotic bacteria within the last two months,
- ingestion of antibiotics within the last two months
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 |
|---|---|---|
| Probiotic Lactobacilli reuteri | Dietary supplement | L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU |
| Placebo | Dietary supplement | Sugar pill |
Primary outcome
Acid production in plaque after exposure to probiotic bacteria
Time frame: 2 weeks
1 secondary outcome
Acid producton in plaque after in vitro exposure to probiotic bacteria
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 23092239Keller MK, Twetman S. Acid production in dental plaque after exposure to probiotic bacteria. BMC Oral Health. 2012 Oct 24;12:44. doi: 10.1186/1472-6831-12-44.
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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.
Mette K Keller, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Lactobacilli reuteri in people with Caries, run by University of Copenhagen at 1 site in Denmark.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Oct 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acid production in plaque after exposure to probiotic bacteria (time frame: 2 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 NCT01700712, 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 4 Oct 2012.