Determination of teeth health by decreasing Mutans streptococcus in saliva
Design
Randomized cross- over double-blinded clinical trial
Settings and conduct
30 healthy children ages 8 to 12 from two round-the-clock centers in Kerman, as volunteers, enter this study with informed consent.
Stage One: The volunteers are asked to take no probiotic product for a week. Then non-stimulated saliva are taken for one minute from them at specific time before breakfast. The saliva samples are sent to the laboratory for checking the count of streptococcus. Then, the volunteers are divided into two groups randomly. In the second phase, the intervention group mouthwash solution of 1 gram sachet Kidi-Lact in 50 cc water and control group mouthwash placebo daily for 2 weeks for 1 minute, then non-stimulated saliva samples from the subjects will take .In the third stage, people in the study have a regular diet for one month, then again, people do not use any probiotic product for a week and their non-stimulated saliva samples are collected. In the fourth stage, the subjects in the two groups use a 1 gram of Kidi-Lact or placebo solution daily for 2 weeks, in such a way that Kidi Lact is given to the group that consumed the placebo in the previous step and vice versa. After two weeks, a sample of unstimulated saliva is collected and sent to the laboratory
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 8-12 years old; Physical and mental health; Daily brushing habit; Exclusion criteria: uncooperative patient; Use of Antibiotic one month prior to research; Use of mouthwash, fluoride gel and gum containing Xylitol one month prior to research; Having untreated decayed teeth
Intervention groups
Intervention group: participant who receive probiotic product( Kidi-Lact)
Control group: participant who receive placebo
Main outcome variables
Mutans streptococcus count in saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161007030193N2
Registration date:2018-05-12, 1397/02/22
Registration timing:retrospective
Last update:2018-05-12, 1397/02/22
Update count:0
Registration date
2018-05-12, 1397/02/22
Registrant information
Name
Iman Parisay
Name of organization / entity
Mashhad University of Medical Sciences-Mashhad Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 6977
Email address
parisayi@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-03-17, 1396/12/26
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-03-17, 1396/12/26
Trial completion date
empty
Scientific title
The effect of Kidi Lact on salivary streptococcus mutans in 8-12 years old children
Public title
The effect of Kidi Lact on salivary streptococcus mutans in 8-12 years old children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Physical and mental health
Daily brushing habit
8-12 year old children
Exclusion criteria:
Uncooperative patient
Use of Antibiotic one month prior to research
Use of mouthwash,fluoride gel and gum containing Xylitol one month prior to research
Having untreated decayed teeth
Age
From 8 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the participants divided into two groups by simple randomization method by use of random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study all participant will receive Kidi-Lact and placebo in similar packages ,so they are blinds in the study .The operator who gets the samples and the person who evaluates the samples for microbial assess are blind too,because they have no idea about the group to which the person or the sample belongs.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad Dental Faculty, Vakil Abbad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91735
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.mums.sd.REC.1394.265
Health conditions studied
1
Description of health condition studied
Saliva Streptococcus mutans count
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Saliva streptococcus mutans
Timepoint
base line,14,37,51 day
Method of measurement
counting streptococcus mutans in culture media under microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Kidi Lact probiotic solution is mouth washed for 1 minute daily for 2 weeks
Category
Prevention
2
Description
Control group: placebo solution is mouth washed for 1 minute daily for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ashiyaneh ali charity
Full name of responsible person
Dr. Hamid reza Poureslami
Street address
No.16, Hojaj Blvd., Ashiyaneh ali charity
City
Kerman
Province
Kerman
Postal code
7618759666
Phone
+98 34 3261 7952
Fax
+98 34 3247 6644
Email
ashiyaneh_ali@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 1882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Iman Parisay
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental Faculty, Vakil Abbad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735
Phone
+98 51 3608 6977
Fax
+98 51 3882 9500
Email
parisayi@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Iman Parisay
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental Faculty, Vakil Abbad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735
Phone
+98 51 3608 6977
Fax
+98 51 3882 9500
Email
parisayi@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Iman Parisay
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental Faculty, Vakil Abbad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735
Phone
+98 51 3608 6977
Fax
+98 51 3882 9500
Email
parisayi@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data are available among corresponding author
When the data will become available and for how long
After publication of the article
To whom data/document is available
Every one who needs for scientific aims such as researchers who work on systematic review projects
Under which criteria data/document could be used
For research aims by formal request
From where data/document is obtainable
Contact with corresponding author by e-mail address
What processes are involved for a request to access data/document
After discussion the authors decide to accept or reject the request