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Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment

NCT ID: NCT01657539

Last Updated: 2013-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Dental Caries Oral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics

Group of patients using yogurt containing probiotics during the experimental phase of the study.

Group Type EXPERIMENTAL

Yogurt containing probiotics

Intervention Type DIETARY_SUPPLEMENT

patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.

Control Yogurt

Group of patients that will use a placebo yogurt for providing comparison with the experimental group.

Group Type PLACEBO_COMPARATOR

Placebo yogurt

Intervention Type DIETARY_SUPPLEMENT

Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes

Interventions

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Yogurt containing probiotics

patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.

Intervention Type DIETARY_SUPPLEMENT

Placebo yogurt

Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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yogurt containing Bifidobacterium animalis Yogurt without probiotics

Eligibility Criteria

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Inclusion Criteria

* excellent oral health
* patients under bimaxillary orthodontic treatment

Exclusion Criteria

* 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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role collaborator

Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Maximiliano Sergio Cenci

Coordinator of Clinical Trial, Graduate of Program of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maximiliano S Cenci, PhD

Role: STUDY_CHAIR

Graduate Program in Dentistry, Federal University of Pelotas

Gabriela S Pinto, MSc

Role: PRINCIPAL_INVESTIGATOR

Graduate Program in Dentistry, Federal University of Pelotas

Locations

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Graduate Program in Dentistry, Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UFPEL-PPGO0013

Identifier Type: -

Identifier Source: org_study_id