(1) Tooth decay is one of the most common human infectious diseases, specially in children. (2) This research has been done to prove the importance of varnish fluoride; This study is based on the influence of two kinds of varnish fluoride: Pascal and Preventa in amount of salivary streptococcus mutans bacteria. (3,4) The data are collected by choosing 38 kids of a kindergarten (ranging 4_6) and dividing them into two groups of 19 randomly. Their milk teeth must be free of decay or have initial caries. (5) Initial samples of unstimulated saliva are collected one hour after eating and brushing. Then one group are applied Pascal varnish fluoride and the other one are applied Preventa type. After 24 hours saliva samples of two groups are collected again. (6) The samples will be sent to microbiology laboratory in order to identify and account of bacteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102630521N1
Registration date:2017-06-17, 1396/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
maryam kazemi
Name of organization / entity
jondi shapour university medical of science
Country
Iran (Islamic Republic of)
Phone
+98 61 4326 1182
Email address
kazemi.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz university of medical science, Vice chancellor for research
Expected recruitment start date
2017-04-26, 1396/02/06
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pascal and Preventa fluoride varnishes on Streptococcus mutans count in saliva in children 4-6 years old(in vivo study)
Public title
The effect of Pascal and Preventa fluoride varnishes on Streptococcus mutans count in saliva
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. in clinical examination at the time of the study have caries free primary dentition or initial caries; 2. No history of antibiotics for the past one month; 3.No history of fluoride treatment for the past six month; 4. The children do not have any contraindications to apply fluoride therapy; 5. children 4 to 6 years old.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
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
Ahvaz Jondi shapoor university of medical science, Ethics Committee
Street address
ground floor, Department of Development Research and Technological University of Medical Sciences and Health Services Ahvaz, City University
City
ahvaz
Postal code
6135715794
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.AJUMS.REC.1395.578
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02
ICD-10 code description
dental caries
Primary outcomes
1
Description
streptococcus mutans count
Timepoint
24 hours after application of fluoride varnish
Method of measurement
Colony forming unit
Secondary outcomes
1
Description
do not have
Timepoint
do not have
Method of measurement
do not have
Intervention groups
1
Description
The application of fluoride varnish, Pascal fluoride varnish, 5% Sodium Fluoride, single dose, frequency of use once,A small brush or applicator is then used to apply the
varnish, Inc. Pascal America
Category
Prevention
2
Description
The application of fluoride varnish, Preventa fluoride varnish , 5% Sodium Fluoride, single dose, frequency of once-a,A small brush or applicator is then used to apply the
varnish, the Asian pharmaceutical chemistry medicine in Iran
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, School of Dentistry
Full name of responsible person
Street address
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technological Development Jundishapur University of Medical Science
Full name of responsible person
Mohsen safi
Street address
ground floor, Research and technology development department of Ahvaz University of Medical Sciences, university town
City
Ahvaz
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 and Technological Development Jundishapur University of Medical Science
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
Department of Pediatrics, Faculty of Dentistry, Ahvaz University of Medical Sciences
Full name of responsible person
Dr Leila Basir
Position
Professor of Pediatric Dentistry,Professor and Head of Department
Other areas of specialty/work
Street address
Department of Pediatrics, College of Dentistry, City University
City
Ahvaz
Postal code
Phone
+98 61 3320 5170
Fax
Email
Basir_l@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Razie Meshki
Position
Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Dental College, Ahvaz University of Medical Sciences, Golestan highway, Ahvaz
City
ahvaz
Postal code
Phone
+98 61 3320 5170
Fax
Email
Dr.raziemeshki@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Kazemi
Position
Dental student
Other areas of specialty/work
Street address
School of Dentistry, Ahvaz University of Medical Sciences,Golestan highway, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3320 5170
Fax
Email
maryam.kazemi10@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)