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Effect of Probiotic on Oral Health of Children

NCT ID: NCT03919838

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-19

Study Completion Date

2019-12-31

Brief Summary

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The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria Streptococcus mutans, compared to the control group in which the placebo will be administered? The main end point will be to reduce the titre of cariogenic bacteria.

Detailed Description

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Probiotic bacteria are used in the prevention and treatment of gastrointestinal diseases and infections, including the treatment of oral diseases. Probiotic bacteria can be found in saliva, plaque and adhering directly to the mucous membrane. They compete with cariogenic bacteria and pathogens of periodontal disease. Increased interest in probiotics means that attempts are being made to find new solutions regarding the methods of their administration. The use of probiotic bacteria brings beneficial health effects. Lactobacillus salivarius is a strain isolated from human milk. It is inactive (heat treatment) and therefore does not produce metabolites that can promote the formation of carious lesions in the mouth by lowering the mouth potential of hydrogen.

Conditions

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Oral Disease

Keywords

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probiotic oral health children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Probiotics

Participants will receive two lozenges containing probiotic bacteria and cranberry.

Group Type ACTIVE_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

A half of the participants will be randomly allocated to the probiotics group. They will receive two probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.

Placebo - No probiotics

Participants will receive a control two lozenges containing no probiotic bacteria.

Group Type PLACEBO_COMPARATOR

Placebo - No probiotics

Intervention Type DIETARY_SUPPLEMENT

A half of the participants will be randomly allocated to the placebo group. They will receive two no probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.

Interventions

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Probiotics

A half of the participants will be randomly allocated to the probiotics group. They will receive two probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo - No probiotics

A half of the participants will be randomly allocated to the placebo group. They will receive two no probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* generally healthy children aged 3-6;
* recognized caries of early childhood, dmf\> 1,
* lack of active caries and inflammation of the mouth
* colony forming unit 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,
* colony forming unit 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NutroPharma

UNKNOWN

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dorota Olczak-Kowalczyk

Warsaw, Warsaw, 18 Miodowa Saint, Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Dorota Olczak-Kowalczyk, Ass.Prof.

Role: primary

Other Identifiers

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KB/232/2016

Identifier Type: -

Identifier Source: org_study_id