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

NCT01657539 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-09-18

No results posted yet for this study

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. 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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo yogurt

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

Sponsors & Collaborators

  • Pontificia Universidade Católica do Rio Grande do Sul

    collaborator OTHER

  • Federal University of Pelotas

    lead OTHER

Principal Investigators

  • Maximiliano S Cenci, PhD · Graduate Program in Dentistry, Federal University of Pelotas

  • Gabriela S Pinto, MSc · Graduate Program in Dentistry, Federal University of Pelotas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2013-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01657539 on ClinicalTrials.gov