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

F

Federal University of Pelotas

Status and phase

Completed
Phase 3
Phase 2

Conditions

Dental Caries
Oral Health

Treatments

Dietary Supplement: Placebo yogurt
Dietary Supplement: Yogurt containing probiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT01657539
UFPEL-PPGO0013

Details and patient eligibility

About

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).

Enrollment

30 patients

Sex

All

Ages

14 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Probiotics
Experimental group
Description:
Group of patients using yogurt containing probiotics during the experimental phase of the study.
Treatment:
Dietary Supplement: Yogurt containing probiotics
Control Yogurt
Placebo Comparator group
Description:
Group of patients that will use a placebo yogurt for providing comparison with the experimental group.
Treatment:
Dietary Supplement: Placebo yogurt

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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