Probiotics in Children With Early Childhood Caries

Dietary Supplement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998306
• Other study ID #: KB/202/2017
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: January 2020

Study information

• Verified date: April 2019
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Supplement

Intervention

Dietary Supplement:
• Experimental: Probiotics
the participants will receive probiotic lozenge before falling asleep for 12 weeks. the participants will receive dietetic and hygienic instructions

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Poland	Dorota Olczak-Kowalczyk	Warsaw	Warsaw, 18 Miodowa Saint

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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