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Probiotics in Children With Early Childhood Caries

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03998306
Enrollment
40
Registered
2019-06-26
Start date
2019-07-19
Completion date
2020-01-31
Last updated
2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Supplement

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.

Interventions

DIETARY_SUPPLEMENTExperimental: Probiotics

the participants will receive probiotic lozenge before falling asleep for 12 weeks. the participants will receive dietetic and hygienic instructions

OTHERNo intervention

No intervention

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units12 weeksDuring 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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026