The aim of this study is to examine whether or not short-term consumption of yogurt containing bifidobacteria will affect the salivary levels of mutans streptococci and lactobacilli in children. This is a double-blind, randomized, preventive and without placebo study. The study group contains 50 healthy iranian children aged 6-12 years who will follow over 4 periods, during periods 2 and 4 (2 weeks each), they will ingest 200 g yogurt containing Bifidobacterium once daily or a control yogurt without viable bacteria. Periods 1 and 3 will be washout periods. Regular xylitol chewing gum consumers and subjects with systemic antibiotic or topical fluoride treatments within 4 weeks will not be included.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201308871N1
Registration date:2012-02-26, 1390/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-26, 1390/12/07
Registrant information
Name
Nasim Seyfi
Name of organization / entity
Dental school, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1654 1350
Email address
seyfin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Consumption of Probiotic Yoghurt on the Children’s Salivary Cariogenic Microflora
Public title
Effect of Consumption of Probiotic Yoghurt on the teeth caries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy children aged 6-12 years; Not using xylitol chewing gum and probiotic yoghurt. Exclusion criteria: Children with systemic diseases; subjects with systemic antibiotic or topical fluoride treatments within 4 weeks.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
7th floor, central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
90-5915
Health conditions studied
1
Description of health condition studied
Caries
ICD-10 code
K02
ICD-10 code description
dental caries
Primary outcomes
1
Description
mutans streptococci
Timepoint
before, after 2, 4 & 6 weeks
Method of measurement
The counts of salivary mutans streptococci
2
Description
lactobacilli
Timepoint
before, after 2, 4 & 6 weeks
Method of measurement
The counts of salivary lactobacilli
Secondary outcomes
empty
Intervention groups
1
Description
Consumption of probiotic yogurt for study group. Daily intake is 200gr.
Category
Prevention
2
Description
Consumption of usual yogurt for control group. Daily intake is 200gr.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Nasim Seyfi
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental School, GhomAbad St. Ghasroldasht St.
City
Shiraz
Postal code
Phone
+98 71 1626 3193
Fax
Email
nasimseyfi@gmail.com , seyfin@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Nasim Seyfi
Position
Resident
Other areas of specialty/work
Street address
Dental School, Ghomabad St. Ghasroldasht St.
City
Shiraz
Postal code
Phone
+98 71 1626 3193
Fax
Email
seyfin@sums.ac.ir , nasimseyfi@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)