Back to resultsEffect of Probiotic on Oral Health of Children
Primary Purpose
Oral Disease
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotics
Placebo - No probiotics
Sponsored by
About this trial
This is an interventional prevention trial for Oral Disease focused on measuring probiotic, oral health, children
Eligibility Criteria
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.
Sites / Locations
- Dorota Olczak-KowalczykRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotics
Placebo - No probiotics
Arm Description
Participants will receive two lozenges containing probiotic bacteria and cranberry.
Participants will receive a control two lozenges containing no probiotic bacteria.
Outcomes
Primary Outcome Measures
Changing the titre of the carcinogenic bacteria Streptococcus mutans
During control tests saliva will be applied to the medium for identification and detailed quantification of S. 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03919838
First Posted
April 15, 2019
Last Updated
October 30, 2019
Sponsor
Medical University of Warsaw
Collaborators
NutroPharma
1. Study Identification
Unique Protocol Identification Number
NCT03919838
Brief Title
Effect of Probiotic on Oral Health of Children
Official Title
Effect of Probiotic Lactobacillus Salivarius and Cranberry on Oral Health of Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
NutroPharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Disease
Keywords
probiotic, oral health, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
Participants will receive two lozenges containing probiotic bacteria and cranberry.
Arm Title
Placebo - No probiotics
Arm Type
Placebo Comparator
Arm Description
Participants will receive a control two lozenges containing no probiotic bacteria.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
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
Intervention Name(s)
Placebo - No probiotics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changing the titre of the carcinogenic bacteria Streptococcus mutans
Description
During control tests saliva will be applied to the medium for identification and detailed quantification of S. 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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Dorota Olczak-Kowalczyk
City
Warsaw
State/Province
Warsaw, 18 Miodowa Saint
ZIP/Postal Code
00-246
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorota Olczak-Kowalczyk, Ass.Prof.
Phone
+48 22 502 20 31
Email
pedodoncja@wum.edu.pl
First Name & Middle Initial & Last Name & Degree
Anna Turska-Szybka, Phd, MD
First Name & Middle Initial & Last Name & Degree
Dorota Olczak-Kowalczyk, Ass.Prof.
12. IPD Sharing Statement
Learn more about this trial
Effect of Probiotic on Oral Health of Children
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