Protocol summary

Study aim
Determination the antibacterial effect of metanolic green tea، Teucrium Polium plant and chlorhexidine gel 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, 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, how to observe oral hygiene and brushing explain to all parents and wanted brush without toothpaste to their children for 2 days.During study, don't 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 people. After taking saliva sample , transfer samples to laboratory for determining Streptococcus mutans.
Participants/Inclusion and exclusion criteria
The inclusion 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 Teucrium Polium plant
Main outcome variables
Streptococcus mutans

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171020036896N5
Registration date: 2018-04-04, 1397/01/15
Registration timing: prospective

Last update: 2018-04-04, 1397/01/15
Update count: 0
Registration date
2018-04-04, 1397/01/15
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
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the antibacterial effect of metanolic green tea extract , Teucrium Polium plant and chlorhexidine gel on the salivary streptococcus mutans ُin preschool children with early childhood caries by the PCR
Public title
the antibacterial effect of metanolic green tea extract , Teucrium Polium plant and chlorhexidine gel on the salivary streptococcus mutans ُin preschool children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Preschool children aged 4 to 6 years
Exclusion criteria:
Usage of gum containing xyllitolSoft tissue lesion in the mouthUse orthodontic appliancesThe presence of systemic diseaseTake antibiotics and topical fluoride over the past monthPresense 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
  • 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 (Teucrium Polium) 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
Ethics committee of Kerman University of Medical Sciences
Street address
Vice-Chancellor for Research, Kerman University of Medical Sciences, Tahmasbabad cross, Jahad Street,Kerman
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-04-03, 1397/01/14
Ethics committee reference number
IR.KMU.REC.1395.681

Health conditions studied

1

Description of health condition studied
Streptococcus mutans
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

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

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Green tea methanolic extract 20%, 1 cc gel with a graded syringe is measured and with a cotton swab is applied to the teeth of the child.
Category
Prevention

2

Description
Intervention group: Teucrium Polium plant 20%, 1 cc gel with a graded syringe is measured and with a cotton swab is applied to the teeth of the child.
Category
Prevention

3

Description
Control group: Chlorhexidine 0.2%,1 cc gel with a graded syringe is measured and with a cotton swab is applied to the teeth of the child.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Department of Dental school of Kerman University of Medical Sciences
Full name of responsible person
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 of pediatric department, Faculty of 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
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
Email
sajadi@kmu.ac.ir

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
Department of pediatrics,Faculty of Dentistry,Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
Sajadi@kmu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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