The purpose of this study is to examine the effect of cheese containing lactobacillus casei LAFTI-L26 consumption on the salivary levels of mutans streptococci and Lactobacilli and to compare with conventional cheese. A total of 60 healthy subjects (18-37 years old), signed informed consent, are randomized into following groups. Subjects will be asked not to consume cheese for 1 week in any way, then, they are assigned to consume 50 gram cheese containing either probiotic L.casei or a control cheese with no added lactobacilli, twice daily for 2 weeks. Before and after consumption of each variety of cheeses, salivary samples are collected and the levels of salivary streptococcus mutans and lactobacilli will be determined by the microbiological laboratory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009144745N1
Registration date:2010-11-02, 1389/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-02, 1389/08/11
Registrant information
Name
Najme Akhlaghi
Name of organization / entity
Dental Faculty of Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33 1273 5636
Email address
sh_mortazavi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Isfahan University of Medial Sciences
Expected recruitment start date
2010-05-29, 1389/03/08
Expected recruitment end date
2010-10-12, 1389/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic cheese containing Lactobacillus casei LAFTI-L26 on salivary mutans streptococci and lactobacilli
Public title
Effect of probiotic cheese containing Lactobacillus casei on the oral microbial flora
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age18-37 years old, no history of systemic antibiotic or topical fluoride treatments, regular Xylitol chewing gum or dairy probiotics within 4 weeks prior to the study, good oral health, no untreated active caries lesions or signs of either gingivitis or periodontal disease, signing the informed consent
Exclusion criteria: smoking, pregnancy, presence of any systemic diseases
Age
From 18 years old to 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized, double – blind, controlled trial with two parallel groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Dental faculty, Isfahan University of Medical Sciense, Hezar jarib Ave, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2010-05-29, 1389/03/08
Ethics committee reference number
39178
Health conditions studied
1
Description of health condition studied
colony forming units of salivary streptococcus mutans and lactobacilli
ICD-10 code
A49.1
ICD-10 code description
Streptococcal infection, unspecified
Primary outcomes
1
Description
streptococcus mutans colony count
Timepoint
at the baseline/after 1 week/after 2 weeks
Method of measurement
cfu/ml (colony forming unit in mililiter of saliva)
2
Description
lactobacilli colony count
Timepoint
at the baseline/after 1 week/after 2 weeks
Method of measurement
cfu/ml (colony forming unit in mililiter of saliva)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: not to intake cheese in any way for 1 week then consume 50 grams probiotic cheese twice daily at breakfast and dinner for 2 weeks
Category
Prevention
2
Description
(control group)not to intake cheese in any way for 1week then consume50 gram conventional cheese twice daily at breakfast and dinner for 2 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department of Dental Faculty of Isfahan University of Medical Sciences
Full name of responsible person
Dr Najme Akhlaghi, Resident of Pediatric Dentistry
Street address
Pediatric Department of Dental Faculty of Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Faculty of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mahnaz Sheikhi
Street address
Dental Faculty of Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan
City
Isfahan
Grant name
10/12
Grant code / Reference number
39178
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Faculty of 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
Dental Faculty of Isfahan University of Medical Sciences
Full name of responsible person
Najme Akhlaghi
Position
Assistant of Pediatric Dentistry Deprtment
Other areas of specialty/work
Street address
Dental Faculty of Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2891
Fax
+98 33 1273 5636
Email
najme.a20082yahoo.com,akhlaghi@dnt.mui.ac.ir
Web page address
dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Isfahan University of Medical Sciences
Full name of responsible person
Shiva Mortazavi
Position
Assistant Professor of Pediatric Dentistry Deprtment
Other areas of specialty/work
Street address
Dental Faculty of Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 311792283940
Fax
00983312735636- 00983116687080
Email
najme.a20082yahoo.com,akhlaghi@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Isfahan University of Medical Sciences
Full name of responsible person
Najme Akhlaghi
Position
Residentof Pediatric Dentistry Deprtment
Other areas of specialty/work
Street address
Dental Faculty of Isfahan University of Medical Sciences, Hezar jarib Ave, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2891
Fax
+98 33 1273 5636
Email
najme.a20082yahoo.com,akhlaghi@dnt.mui.ac.ir
Web page address
www.dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)