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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT01657539
First received: August 2, 2012
Last updated: September 2, 2012
Last verified: September 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Dental Caries
Oral Health
 Dietary Supplement: Yogurt containing probiotics
Dietary Supplement: Placebo yogurt
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Pelotas:

Primary Outcome Measures:
  • Cariogenic bacteria reduction [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient


Secondary Outcome Measures:
  • Patient discomfort with the treatment [ Time Frame: 14 days after intervention ] [ Designated as safety issue: Yes ]
    Patients were interviewed regarding any discomfort on the use of the treatments


Enrollment: 30
Study Start Date: August 2011
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
Group of patients using yogurt containing probiotics during the experimental phase of the study.
 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.
Other Name: yogurt containing Bifidobacterium animalis
Placebo Comparator: Control Yogurt
Group of patients that will use a placebo yogurt for providing comparison with the experimental group.
 Dietary Supplement: Placebo yogurt
Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes
Other Name: Yogurt without probiotics

  Eligibility

Ages Eligible for Study:   14 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657539

Locations
Brazil
Graduate Program in Dentistry, Federal University of Pelotas
Pelotas, RS, Brazil, 96015560
Sponsors and Collaborators
Federal University of Pelotas
School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil
Investigators
Study Chair: Maximiliano S Cenci, PhD Graduate Program in Dentistry, Federal University of Pelotas
Principal Investigator: Gabriela S Pinto, MSc Graduate Program in Dentistry, Federal University of Pelotas
  More Information

No publications provided

Responsible Party: Maximiliano Sergio Cenci, Coordinator of Clinical Trial, Graduate of Program of Dentistry, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT01657539     History of Changes
Other Study ID Numbers: UFPEL-PPGO0013
Study First Received: August 2, 2012
Last Updated: September 2, 2012
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 21, 2013