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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Dental Caries, Oral Health

Intervention / Treatment
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* Dietary Supplement: Yogurt containing probiotics
* Dietary Supplement: Placebo yogurt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Group of patients using yogurt containing probiotics during the experimental phase of the study. | Dietary Supplement: Yogurt containing probiotics<br>* patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.<br>* Other names: yogurt containing Bifidobacterium animalis;|
| Placebo Comparator: Control Yogurt<br>Group of patients that will use a placebo yogurt for providing comparison with the experimental group. | Dietary Supplement: Placebo yogurt<br>* Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes<br>* Other names: Yogurt without probiotics;|

What is the study measuring?
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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 |