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

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ClinicalTrials.gov Identifier: NCT01657539
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : September 18, 2013
Sponsor:
Collaborator:
Pontificia Universidade Católica do Rio Grande do Sul
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Brief 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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient discomfort with the treatment [ Time Frame: 14 days after intervention ]
    Patients were interviewed regarding any discomfort on the use of the treatments



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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657539


Locations
Brazil
Graduate Program in Dentistry, Federal University of Pelotas
Pelotas, RS, Brazil, 96015560
Sponsors and Collaborators
Federal University of Pelotas
Pontificia Universidade Católica do Rio Grande do Sul
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

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
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

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