L. rhamnosus and L.ruteri and Bifid bacterium infantis on salivary Lactobacillus and Streptococcus mutans. Design: double-blind randomized placebo-controlled trial with two parallel groups. The inclusion criteria: 3-6 years old children; have no systemic diseases and with good oral health; Any product containing probiotics and xylitol are not used within 4 weeks ago; had not receive systemic antibiotics and topical fluoride treatment for 4 weeks ago. The exclusion criteria: consume of probiotics, xylitol and systemic antibiotic medication or topical fluoride treatment during the study. Intervention: randomly 26 children will receive placebo drops (control group) and 26 children will receive probiotic drops (experimental group). The parents were asked to give children 5 drops every night before go to bed and refrain children from brushing and eating/drinking for at least one hours after for 2 weeks. Saliva sampling: Before and after the intervention at 7:30 to 8:30 a.m. unstimulated saliva will be collected in a sterile container. No tooth brushing or other tooth-cleaning methods and eating/drinking were allowed before sampling. Immediately samples will be sent to the laboratory for culture and colonies counted. Study Outcome: change level of salivary Lactobacillus and Streptococcus mutan
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120320202N1
Registration date:2015-07-14, 1394/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-14, 1394/04/23
Registrant information
Name
Leila Talebian
Name of organization / entity
Isfahan Universiy of Medical Sciences, School of Dental Medicine
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2891
Email address
leila.talebian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-02-04, 1393/11/15
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of probiotics drops on salivary Streptococcus mutans and lactobacilli in children 3 to 6 years old
Public title
Evaluation the effect of probiotics drops on saliva bacteria causing caries in children 3 to 6 years old
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: 3-6 years old children ; no systemic diseases; with good oral health; Any product containing probiotics and xylitol are not used within 4 weeks ago and had not receive systemic antibiotics and topical fluoride treatment for 4 weeks ago.The exclusion criteria: consume of probiotics, xylitol and systemic antibiotic medication or topical fluoride treatment
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar jerib St., Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
393875
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
k02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
The number of Lactobacilli in saliva
Timepoint
The start of the study, day the fourteenth
Method of measurement
Microbial culture
2
Description
The number of Streptococcus mutans in saliva
Timepoint
The start of the study, day the fourteenth
Method of measurement
Microbial culture
Secondary outcomes
empty
Intervention groups
1
Description
pedilac placebo drop ,2 weeks,every night,befor sleep,5 drops
Category
Placebo
2
Description
pedilac probiotic drop ,2 weeks,every night,befor sleep,5 drops
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Leila Talebian
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjarib St., Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahdi Nematbakhsh
Street address
hezarjarib st, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Isfahan 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
Isfahan Dental Medical School
Full name of responsible person
Dr Maryam Tehrani
Position
Professor in the Department of Pediatric Dentistry; Professional Doctor of Pediatric Dentistry
Other areas of specialty/work
Street address
Hezar jerib St., Isfahan
City
Isfahan
Postal code
36687080
Phone
+98 31 3972 2891
Fax
+98 31 3668 7080
Email
leila.talebiani@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Dental Medical School
Full name of responsible person
Leila.talebian
Position
General Dentist; Assistant Professor of Pediatric Dentistry