Protocol summary

Study aim
Determination the effect of metanolic green tea، green coffee extract and chlorhexidine on Streptococcus mutans in preschool children with early childhood caries by the PCR
Design
In this clinical trial study, there will be 90 children aged 4-6 who will be matched for demographic data. Children are randomly divided into 3 groups of 30 people and assigned a code to each participants. --------------------------------------------------------------------------------
Settings and conduct
ّFirst explain aims to parents, thenwritten informed consent is taken. A questionnaire including the demographic data of the child (age, sex, history of drug use, history of systemic disease, etc.) is also completed.Then, how to observe oral hygiene and brushing explain to all parents and wanted brush without toothpaste to their children for 2 days.During study, dont use gums containing Xylitol and any type of mouthwashes containing chlorhexidine and flouride. Upon completion of the two-day period, Which is considered as a washout period, children are randomly divided into 3 groups of 30 people. After taking saliva sample,too determining Streptococcus mutans, transfer samples to labrator
Participants/Inclusion and exclusion criteria
The entering criteria including children without any sysytemic disease and during the past month dont take antibiotic and topical flouride and dont have any orthodontic appliance. dont take gums containing Xylitol and any mouthmoush or gel containing flouride at least 3 weeks before study, dont have any soft tissue lesion in their mouth and do not have active and severe periodontal disease.
Intervention groups
Chlorhexidine, Green Tea and Green Coffee
Main outcome variables
Streptococcus mutans

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20171020036896N3
Registration date: 2018-03-04, 1396/12/13
Registration timing: retrospective

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32119023
Email address
sajadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of metanolic green tea، green coffee extract and chlorhexidine and on the salivary Streptococcus mutans ُin preschool children with early childhood caries by the PCR
Public title
The effect of Green tea, Chlorhexidine and green coffee extract on salivary Streptococcus mutans
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Preschoolers aged 4 to 6 years
Exclusion criteria:
Usage of gum containing xyllitol Soft tissue lesion in the mouth Use orthodontic appliances The presence of systemic disease Take antibiotics and topical fluoride over the past month Presense of active and severe periodontal disease
Age
From 4 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization or unrestricted method will be used and randomization unit is Individual .we will use from Roll of a die from the methods of simple randomization because there are 3 groups in this study that actually the tool of randomization is dice. So the numbers 1 and 2 are for the first group (chlorhexidine) 3 and 4 for the second group (green coffee) and 5 and 6 for the third (green tea). The next step Allocation concealment will be done, In such a way that the allocated group is not known before the assignment of the individual. To achieve this goal, a non-transparent, sealed, random sequence envelope is used . In this way, the statistical specialist will provide 90 envelopes and each of the randomly generated links will be recorded on a card and the cards are arranged in the envelopes . In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the envelops are enclosed and placed in the box, respectively. At the time of the implementation of the study, according to the order of entry of eligible participants, one of the envelopes is opened respectively and will determine the group assigned to that participant. In this study, the assistant of Pediatric Dentistry examines the participants in terms of inclusion and exclusion criteria. Randomization methods are done by an statistical specialist and performance of the study is done by a trained dental student.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because all the materials are in the same consistency gel, in a uniform shape and color, considering the informed consent, participants are unaware of material. Outcome evaluator, who performs PCR, is also unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethic Committee of kerman University of Medical Sciencess
Street address
Vice-Chancellor for Research, Building of Kerman University of Medical Sciences, Tahmasbabad cross, Jahad Street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.KMU.REC.1395.553

Health conditions studied

1

Description of health condition studied
Streptococcus mutans
ICD-10 code
k02
ICD-10 code description
پوسیدگی دندانی

Primary outcomes

1

Description
Streptococcus mutans
Timepoint
30 minutes and 1 week later application of interventions
Method of measurement
PCR

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Green tea methanolic extract 20%, for 30 minutes and 1 week after saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.
Category
Prevention

2

Description
Intervention group: Green coffee 10% , for 30 minutes and 1 week after saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.
Category
Prevention

3

Description
Control group: Chlorhexidine 0.2% , 30 minutes and 1 week after saliva taking from 4 to 6 year old children, 1 cc gel with a syringe and a cotton swab is applied to all teeth of the child.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
دانشکده دندانپزشکی کرمان بخش تخصصی کودکان
Full name of responsible person
Dr Fatemeh sadat Sajadi
Street address
Pediatric department, School of Dentistry,Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
Sajadi@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Tahmasebabad Crossing, Deputy of Research and Technology University
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
60
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
Kerman University of Medical Sciences
Full name of responsible person
Dr Hamidreza Poureslami
Position
Professor, Faculty of dentistry for children, part of Kerman,
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa street, Kerman
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
Email
poureslami@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, School of Dentistry, Shafa street, Kerman
City
کرمان
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
Email
sajadi@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh sadat Sajadi
Position
Associate Professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Street, Faculty of Dentistry, Department of pediatrics
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
Fax
Email
Sajadi@kmu.ac.ir
Web page address

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
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
After this study, data and statistical analysis data are available to all.
When the data will become available and for how long
After completing the research plan for 5 years of information dissemination
To whom data/document is available
All Researchers and Faculty Members
Under which criteria data/document could be used
In order to conduct new researches
From where data/document is obtainable
Department of Research and Technology Faculty
What processes are involved for a request to access data/document
Submitting a request to the person responsible for collecting documentation of research projects at the Department of Research and and technology Faculty
Comments
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