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

Primary Purpose

Dental Caries, Oral Health

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Yogurt containing probiotics
Placebo yogurt
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Graduate Program in Dentistry, Federal University of Pelotas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Control Yogurt

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cariogenic bacteria reduction
The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient

Secondary Outcome Measures

Patient discomfort with the treatment
Patients were interviewed regarding any discomfort on the use of the treatments

Full Information

First Posted
August 2, 2012
Last Updated
September 17, 2013
Sponsor
Federal University of Pelotas
Collaborators
Pontificia Universidade Católica do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT01657539
Brief Title
Effect of Probiotics Containing Yogurts on the Composition of Biofilms in Patients Under Orthodontic Treatment
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
Collaborators
Pontificia Universidade Católica do Rio Grande do Sul

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Oral Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Group of patients using yogurt containing probiotics during the experimental phase of the study.
Arm Title
Control Yogurt
Arm Type
Placebo Comparator
Arm Description
Group of patients that will use a placebo yogurt for providing comparison with the experimental group.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yogurt containing probiotics
Other Intervention Name(s)
yogurt containing Bifidobacterium animalis
Intervention Description
patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo yogurt
Other Intervention Name(s)
Yogurt without probiotics
Intervention Description
Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes
Primary Outcome Measure Information:
Title
Cariogenic bacteria reduction
Description
The amount of cariogenic bacteria (mutans streptococci and lactobacilli) will be evaluated before and after the treatments for each patient
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Patient discomfort with the treatment
Description
Patients were interviewed regarding any discomfort on the use of the treatments
Time Frame
14 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maximiliano S Cenci, PhD
Organizational Affiliation
Graduate Program in Dentistry, Federal University of Pelotas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gabriela S Pinto, MSc
Organizational Affiliation
Graduate Program in Dentistry, Federal University of Pelotas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Program in Dentistry, Federal University of Pelotas
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015560
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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