Probiotics in Children With Early Childhood Caries

Not Applicable

• Conditions: Dietary Supplement

• Registration Number: NCT03998306
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Study Start: 2019-07-19
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units	12 weeks	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

Trial Locations

Locations (1)

Dorota Olczak-Kowalczyk; 🇵🇱 Warsaw, Warsaw, 18 Miodowa Saint, Poland