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

This study has been completed.
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 17, 2013
Last verified: September 2013

August 2, 2012
September 17, 2013
August 2011
August 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01657539 on ClinicalTrials.gov Archive Site
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
Patient disconfort 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
Not Provided
Not Provided
 
Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment
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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dental Caries
  • Oral Health
  • 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
  • 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
  • Experimental: Probiotics
    Group of patients using yogurt containing probiotics during the experimental phase of the study.
    Intervention: Dietary Supplement: Yogurt containing probiotics
  • Placebo Comparator: Control Yogurt
    Group of patients that will use a placebo yogurt for providing comparison with the experimental group.
    Intervention: Dietary Supplement: Placebo yogurt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2013
August 2012   (final data collection date for primary outcome measure)

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.
Both
14 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01657539
UFPEL-PPGO0013
Not Provided
Maximiliano Sergio Cenci, Federal University of Pelotas
Federal University of Pelotas
School of Medicine, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil
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
Federal University of Pelotas
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP