Trial | NCT01657539  Report issue

Title

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.

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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).
Study Started
Aug 31
2011
Primary Completion
Aug 31
2012
Study Completion
Mar 31
2013
Last Update
Sep 18
2013
Estimate

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 names: 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 names: Yogurt without probiotics

Probiotics Experimental

Group of patients using yogurt containing probiotics during the experimental phase of the study.

Control Yogurt Placebo Comparator

Group of patients that will use a placebo yogurt for providing comparison with the experimental group.

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.
No Results Posted