Caries DentalisNCT01738958
Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF
A study testing L. retueri in people with Caries Dentalis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Dentalis
- What is being tested?
- L. retueri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Mar 2014
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- two sites with white spot lesions in anterior teeth
Who cannot join
- antibiotic treatment within 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. However, it is not known whether probiotic bacteria can affect the increased porosity in young permanent teeth in children and adolescents with many cavities.
It can be difficult to measure the increased porosity of the enamel by tooth decay, but this can be done using quantitative laser fluorescence (QLF). The method is based on visible light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and green color tones and the dominant color of the enamel is green. Increased porosity of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the mineral can be quantified by means of a corresponding software.
The purpose of this study is to investigate the effect of a daily supplement of probiotic lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis is that the mineral content will not differ from baseline in either the test group or the placebo group.
- Conditions
- Caries Dentalis
- Being tested
- L. retueri, Placebo
- Keywords
- Probiotic bacteria, Caries dentalis, QLF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. retueriBiological
two tablets a day for 6 weeks
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Probiotic lactobacilli | Active comparator | L. reuteri, two times a day for 6 weeks Receives: Biological: L. retueri |
| Placebo | Placebo comparator | Placebo tablets, two times a day for 6 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in enamel porosity
Change in enamel porosity assed by QLF
Measured: Baseine and 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 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries DentalisStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Kirstine Keller, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738958
- Sponsor's protocol ID
- H-4-2012-096
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF
- ClinicalTrials.gov ID
- NCT01738958
- Acronym / sponsor ID
- H-4-2012-096
- Conditions
- Caries Dentalis
- Keywords
- Probiotic bacteria, Caries dentalis, QLF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Nov 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.
Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. However, it is not known whether probiotic bacteria can affect the increased porosity in young permanent teeth in children and adolescents with many cavities.
It can be difficult to measure the increased porosity of the enamel by tooth decay, but this can be done using quantitative laser fluorescence (QLF). The method is based on visible light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and green color tones and the dominant color of the enamel is green. Increased porosity of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the mineral can be quantified by means of a corresponding software.
The purpose of this study is to investigate the effect of a daily supplement of probiotic lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis is that the mineral content will not differ from baseline in either the test group or the placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic lactobacilli | Active comparator | Biological: L. retueriL. reuteri, two times a day for 6 weeks |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo tablets, two times a day for 6 weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- two sites with white spot lesions in anterior teeth
Key exclusion criteria (1 listed)
- antibiotic treatment within 2 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 |
|---|---|---|
| L. retueritwo tablets a day for 6 weeks | Biological | Probiotic lactobacilli |
| Placebo | Biological | Placebo |
Primary outcome
Change in enamel porosity
Time frame: Baseine and 12 weeks
Change in enamel porosity assed by QLF
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 3 Dec 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. retueri in people with Caries Dentalis, 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 1 inclusion and 1 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 3 Dec 2014. 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?
Change in enamel porosity (time frame: Baseine and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.