NCT01657539

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Federal University of Pelotas · Academic / Other
• Sex: All
• Age: 14 Years – 30 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dental Caries
• Oral Health

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Placebo yogurt	Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-08-01
• Completion: 2013-03-01
• First posted: 2012-08-06
• Last updated: 2013-09-18

Locations

1 site across 1 country: Brazil