Probiotics in Children With Early Childhood Caries

Medical University of Warsaw

Status: Unknown

Conditions: Dietary Supplement

Treatments: Other: No intervention; Dietary Supplement: Experimental: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03998306

KB/202/2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Experimental: Probiotics

CONTROL

Sham Comparator group

Description:

no intervention

Treatment:

Other: No intervention