Probiotics in Children With Early Childhood Caries

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

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

Study Overview

• Status: Unknown
• Conditions: Dietary Supplement
• Intervention / Treatment: Other: No intervention; Dietary supplement: Experimental: Probiotics

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, 18 Miodowa Saint
    • Warsaw, Warsaw, 18 Miodowa Saint, Poland, 00-246
      • Recruiting
      • Dorota Olczak-Kowalczyk
      • Contact: Dorota Olczak-Kowalczyk, Ass.Prof.; Phone Number: +48 22 502 20 31; Email: pedodoncja@wum.edu.pl
      • Principal Investigator: Anna Turska-Szybka, Phd, MD
      • Principal Investigator: Dorota Olczak-Kowalczyk, Ass.Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; 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; the participants will receive probiotic lozenge before falling asleep for 12 weeks. the participants will receive dietetic and hygienic instructions
Sham Comparator: CONTROL; no intervention	Other: No intervention; No intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KB/202/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No