Children are randomly divided into three groups of 30. Saliva samples are collected from three groups before the intervention and 24 hours after the intervention. In this study, participants and microbial analyzers and data analyzers are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children without caries or primary caries within the age group of 4-6 years
exclusion criteria: Children with a specific systemic disease or those who have had fluoride therapy in the last 6 months.
Intervention groups
Group I are treated with 5% chitosan varnish and group II received 3% chitosan varnish and group III (control) was treated with sodium fluoride varnish
Main outcome variables
The effect of chitosan varnish on plaque mutant streptococcus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190925044878N1
Registration date:2020-12-22, 1399/10/02
Registration timing:registered_while_recruiting
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Leila Basir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 9516
Email address
basir-l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Chitosan and Fluoride Varnish on Mutans Streptococcus levels in Saliva: a randomized clinical trial
Public title
Effect of Chitosan and Fluoride Varnish
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children must be aged 4-6 years old.
At the time of clinical examination, the teeth must be free of caries or have primary caries.
Participants must have no history of taking antibiotics in the last month.
Exclusion criteria:
Children with a specific systemic disease
Participants who have had fluoride therapy in the last 6 months.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is simple, the unit of randomization is individual, and the tool of randomization is the table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, data analyzer, and microbial analyzer were doubled blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan boulvard
City
ahvaz
Province
Khouzestan
Postal code
61355-393
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.AJUMS.REC.1396.592
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 in saliva
Timepoint
before intervention and 24h after intervention
Method of measurement
sterile tubes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 30 children for whom chitosan 5% varnish will be used.
Category
Other
2
Description
Intervention group 2: 30 children for whom Chitosan 3% varnish will be used.
Category
Other
3
Description
Control group: 30 children for whom the standard Sodium Flouride varnish will be used.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of dentistry, Ahvaz jundishapur university of medical science
Full name of responsible person
Leila Basir
Street address
school of dentistry, Ahvaz Jundishapur university of medical science, Golestan boulvard
City
Ahvaz
Province
Khouzestan
Postal code
61355-393
Phone
+98 61 3373 8426
Email
basir_l@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Basir
Street address
school of dentistry, Ahvaz Jundishapur university of medical science, Golestan boulvard
City
ahvaz
Province
Khouzestan
Postal code
61355-393
Phone
+98 61 3373 8426
Email
basir_l@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Basir
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mihan street - Chamran avenue - Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61355-393
Phone
+98 61 3373 8426
Fax
Email
Basir-l@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Basir
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mihan street - Chamran avenue - Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61355-393
Phone
+98 61 3373 8426
Fax
Email
Basir-l@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Basir
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mihan street - Chamran avenue - Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
61355-393
Phone
+98 61 3373 8426
Fax
Email
Basir-l@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available