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

Phase 2

Completed

• Conditions: Dental Caries; Oral Health
• Interventions: Dietary Supplement: Yogurt containing probiotics; Dietary Supplement: Placebo yogurt

• Registration Number: NCT01657539
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cariogenic bacteria reduction	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

Name	Time	Method
Patient discomfort with the treatment	14 days after intervention	Patients were interviewed regarding any discomfort on the use of the treatments

Trial Locations

Locations (1)

Graduate Program in Dentistry, Federal University of Pelotas; 🇧🇷 Pelotas, RS, Brazil