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).

Study Overview

• Status: Completed
• Conditions: Dental Caries; Oral Health
• Intervention / Treatment: Dietary supplement: Yogurt containing probiotics; Dietary supplement: Placebo yogurt

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015560
      • Graduate Program in Dentistry, Federal University of Pelotas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; Group of patients using yogurt containing probiotics during the experimental phase of the study.	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
Placebo Comparator: Control Yogurt; Group of patients that will use a placebo yogurt for providing comparison with the experimental group.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cariogenic bacteria reduction	The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient discomfort with the treatment	Patients were interviewed regarding any discomfort on the use of the treatments	14 days after intervention

Collaborators and Investigators

• Sponsor: Federal University of Pelotas
• Collaborators: Pontificia Universidade Católica do Rio Grande do Sul
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: UFPEL-PPGO0013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No