Dental CariesPhase 2/3NCT01657539
Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment
A Phase 2/3 study testing Yogurt containing probiotics in people with Dental Caries and Oral Health, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp. lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Oral Health
- What is being tested?
- Yogurt containing probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Mar 2013
- Phase
- Phase 2/3
- 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 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- excellent oral health
- patients under bimaxillary orthodontic treatment
Who cannot join
- any chronic disease
- antibiotics and/or antimicrobial use in the previous 3 weeks
- topic fluoride or chlorhexidine use in the previous 3 weeks
- presence of cavitated or active carious lesions
- patients with intolerance to lactose.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Graduate Program in Dentistry, Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015560
About this study
Official title: Effects of Yogurt Containing Bifidobacterium Animalis Ssp. Lactis dn- 1173010 Probiotics in the Composition of Biofilms and Saliva of Orthodontic Patients: a Crossover, Double-blind, Randomized and Placebo Controlled Clinical Trial.
Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp. lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4 weeks, respectively. Experimental samples of saliva and biofilm will be collected from each participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values before and after the treatment will be compared with Wilcoxon's test (p<0.05).
- Conditions
- Dental Caries, Oral Health
- Being tested
- Yogurt containing probiotics, Placebo yogurt
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt containing probioticsDietary supplement
Also called yogurt containing Bifidobacterium animalis
patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.
Placebo yogurtDietary supplement
Also called Yogurt without probiotics
Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Group of patients using yogurt containing probiotics during the experimental phase of the study. Receives: Dietary Supplement: Yogurt containing probiotics |
| Control Yogurt | Placebo comparator | Group of patients that will use a placebo yogurt for providing comparison with the experimental group. Receives: Dietary Supplement: Placebo yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cariogenic bacteria reduction
The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient
Measured: 14 days
Secondary outcomes (1)
Patient discomfort with the treatment
Patients were interviewed regarding any discomfort on the use of the treatments
Measured: 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidade Católica do Rio Grande do Sul
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Maximiliano S Cenci, PhD, Study chair, Graduate Program in Dentistry, Federal University of PelotasGabriela S Pinto, MSc, Principal investigator, Graduate Program in Dentistry, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657539
- Sponsor's protocol ID
- UFPEL-PPGO0013
- Status last verified
- Sep 2013
- First submitted
- 2 Aug 2012
- Last updated
- 18 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yogurt Containing Bifidobacterium Animalis Ssp. Lactis dn- 1173010 Probiotics in the Composition of Biofilms and Saliva of Orthodontic Patients: a Crossover, Double-blind, Randomized and Placebo Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01657539
- Acronym / sponsor ID
- UFPEL-PPGO0013
- Conditions
- Dental Caries, Oral Health
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Collaborators
- Pontificia Universidade Católica do Rio Grande do Sul
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Aug 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.
Aim: To assess in vivo if the intake of yogurt containing Bifidobacterium animalis ssp. lactis DN- 1173010 probiotic for a period of 2 weeks affects the salivary levels or biofilms of mutans streptococci and the lactobacilli of patients undergoing orthodontic treatment. Methods: A crossover, double-blind, randomized and placebo controlled clinical trial will be performed with 26 volunteers during 4 periods. During periods 2 and 4 (2 weeks each) the volunteers will have a daily ingestion of yogurt containing probiotic or of control yogurt which did not contain probiotic. Periods 1 and 3 were run-in and wash-out periods of 1 and 4 weeks, respectively. Experimental samples of saliva and biofilm will be collected from each participant at the end of each phase. Mutans streptococci, lactobacilli, total aciduric microorganisms, Candida spp. and total cultivable microorganisms will be counted. The values before and after the treatment will be compared with Wilcoxon's test (p<0.05).
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 |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Yogurt containing probioticsGroup of patients using yogurt containing probiotics during the experimental phase of the study. |
| Control Yogurt | Placebo comparator | Dietary Supplement: Placebo yogurtGroup of patients that will use a placebo yogurt for providing comparison with the experimental group. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- excellent oral health
- patients under bimaxillary orthodontic treatment
Key exclusion criteria (5 listed)
- any chronic disease
- antibiotics and/or antimicrobial use in the previous 3 weeks
- topic fluoride or chlorhexidine use in the previous 3 weeks
- presence of cavitated or active carious lesions
- patients with intolerance to lactose.
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 |
|---|---|---|
| Yogurt containing probioticsAlso: yogurt containing Bifidobacterium animalispatients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes. | Dietary supplement | Probiotics |
| Placebo yogurtAlso: Yogurt without probioticsPatients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes | Dietary supplement | Control Yogurt |
Primary outcome
Cariogenic bacteria reduction
Time frame: 14 days
The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient
1 secondary outcome
Patient discomfort with the treatment
Time frame: 14 days after intervention
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 18 Sep 2013.
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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.
Maximiliano S Cenci, PhD study chair
Graduate Program in Dentistry, Federal University of Pelotas
Gabriela S Pinto, MSc principal investigator
Graduate Program in Dentistry, Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Yogurt containing probiotics in people with Dental Caries and Oral Health, run by Federal University of Pelotas at 1 site in Brazil.
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 5 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 18 Sep 2013. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cariogenic bacteria reduction (time frame: 14 days). 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 18 Sep 2013.