Protocol summary

Study aim
Comparison of the antibacterial effectiveness of thymes and chamomile extract and chlorhexidine on the salivary Streptococcus mutans of preschool childrens with early childhood caries by the quantitative Real Time PCR
Design
In this clinical trial study, there will be 90 preschool children aged 4-6 who will be matched from demographic data. Children are randomly divided into 3 groups of30 person and each participant assigned a code.
Settings and conduct
ّFirst the aims of the study explain to the parents, then written 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, the methods of oral hygiene and brushing explain to all parents and wanted to brush the teeth of their children without toothpaste for 2 days. also it is emphasized that during the study, the children do not use gums containing Xylitol and any type of mouthwashes containing chlorhexidine and fluoride. Upon completion of the two-day period, Which is considered as a washout period, children are randomly divided into 3 groups of 30 person. then from the participant children will take the sample of saliva and transfer to laboratory for determining the amount of Streptococcus mutans.
Participants/Inclusion and exclusion criteria
The inclusion criteria including preschool children aged 4 to 6 years that have at least dmft 4 and 3 dental caries in their mouth.exclusion criteria including preschool children with sysytemic disease , during the past month take antibiotic and topical flouride and have orthodontic appliance, who take gums containing Xylitol and mouthwash or gel containing flouride at least 3 weeks before study, who have soft tissue lesion in their mouth and have active and severe periodontal disease.
Intervention groups
Intervention group 1: thymes extract 5% , 30 minutes and 1 week after first salivary sampling from 4 to 6 year old children, 1 cc gel measured with a syringe and with a cotton swab is applied to all teeth of the child. Intervention group 2: chamomile extract 5% , 30 minutes and 1 week after first salivary sampling from 4 to 6 year old children, 1 cc gel measured with a syringe and with a cotton swab is applied to all teeth of the child. Control group1: cholorhexidine 0.02 % , 30 minutes and 1 week after first salivary sampling from 4 to 6 year old children, 1 cc gel measured with a syringe and with a cotton swab is applied to all teeth of the child.
Main outcome variables
Streptococcus mutans,

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20171020036896N4
Registration date: 2018-03-09, 1396/12/18
Registration timing: retrospective

Last update: 2018-03-09, 1396/12/18
Update count: 0
Registration date
2018-03-09, 1396/12/18
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 antibacterial effectiveness of thymes and chamomile extract and chlorhexidine on the salivary Streptococcus mutans of preschool childrens with early childhood caries by the quantitative Real Time PCR
Public title
The antibacterial effectiveness of thymes and chamomile extract and chlorhexidine and on the salivary Streptococcus mutans
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Preschoolers aged 4 to 6 years having at least dmft 4 having at least 3 dental caries
Exclusion criteria:
Usage of gum containing xyllitol ، any type of mouthwash or gel of fluoride at least 3 weeks before the study Soft soft tissue lesion in the mouth Useing orthodontic appliances Take antibiotics and topical fluoride over the past month Active and severe periodontal disease The presence of systemic disease
Age
From 4 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
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 ( thymes) and 5 and 6 for the third (chamomile). 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 that what materials is used for. 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, kerman,iran
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
ICD-10 code description

Primary outcomes

1

Description
Streptococcus mutans
Timepoint
before application and 30 minutes and 1 week after application of interventions
Method of measurement
quantitative real time PCR

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: thyme extract 5% , 30 minutes and 1 week after first salivary sampling from 4 to 6 year old children, 1 cc gel measured with a syringe and with a cotton swab is applied to all teeth of the child.
Category
Prevention

2

Description
Intervention group2: Chamomile extract 5% , 30 minutes and 1 week after first salivary sampling from 4 to 6 year old children, 1 cc gel measured with a syringe and with a cotton swab is applied to all teeth of the child.
Category
Prevention

3

Description
Control group1: cholorhexidine 0.02 % , 30 minutes and 1 week after first salivary sampling from 4 to 6 year old children, 1 cc gel measured with a syringe and with a cotton swab is applied to all teeth of the child.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Department of Dentistry University of Kerman
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
No.1 Ave,Tahmasebabad Intersection, Research - Vice Chancellor of Kerman University of Medical Science
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
Dr 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
Kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119021
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
Dr 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
+98 34 3245 7931
Fax
Email
Sajadi@kmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the study data do not have any other scientific application.
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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