Probiotics in Children With Early Childhood Caries

Study Overview
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Brief Summary
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The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans

Detailed Description
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Streptococcus salivarius is one of the commensal bacteria of the mouth and the main component of biofilm. Research indicates that some microorganisms present in plaque, which until recently were considered not to cause caries, including Streptococcus salivarius, present in the supragingival microbiome, can also cause tooth decay.

Official Title
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Influence of the Probiotic Streptococcus Salivarius K12 on Dental Health in Children With Early Childhood Caries

Conditions
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Dietary Supplement

Intervention / Treatment
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* Dietary Supplement: Experimental: Probiotics
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally healthy children aged 3-6; recognized caries of early childhood, dmf> 1, lack of active caries and inflammation of the mouth CFU> 105 / ml Streptococcus mutans a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research. Exclusion Criteria: chronic diseases and chronically taken medicines in the past, planned change of residence during the year, age below 3 and above 6 years, healthy teeth, dmf = 0, CFU <105 / ml Streptococcus mutans Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations no toothpaste with fluoride using xylitol lack of written consent of parents / legal guardians for participation in research.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>A half of the participants will be randomly allocated to the probiotics group. They will receive probiotic lozenge before falling asleep for12 weeks. They will receive hygienic and dietetic instructions. examination will be conducted before study and after 12 weeks. | Dietary Supplement: Experimental: Probiotics<br>* the participants will receive probiotic lozenge before falling asleep for 12 weeks. the participants will receive dietetic and hygienic instructions<br>|
| Sham Comparator: CONTROL<br>no intervention | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units | During control test saliva will be applied to the medium for identification and detailed quantification of Streptococcus mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva. colony forming unit CFU in intervention and control groups. Bacterial tests will be used to assess this outcome measure. We expect decrement of amount of cariogenic bacteria in intervention group | 12 weeks |