Probiotics in Children With Early Childhood Caries

NCT03998306 | Unknown

• 1 other identifier: KB/202/2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotics

EXPERIMENTAL

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

CONTROL

SHAM COMPARATOR

no intervention

Other: No intervention

Interventions

Experimental: Probiotics DIETARY_SUPPLEMENT

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

Probiotics

No intervention OTHER

No intervention

CONTROL

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Dorota Olczak-Kowalczyk

Warsaw, Warsaw, 18 Miodowa Saint, 00-246, Poland

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: June 26, 2019
• Study Start: July 19, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 31, 2019

Record last verified: 2019-04

Locations

PL (1)