Protocol summary

Summary
Aim: comparison of oral hygiene instruction by a dentist or peer-led on oral health knowledge among male elementary students. Research design: male students in the last elementary class in two schools; one of the schools as control school( teaching by dentist) and another school as test school( teaching by peer-led) will be chosen if the volunteers accept to take part in the study. Intervention: teaching by dentist in the control group and by peer-led in the test group Time of intervention: after getting a pre-test, the education will be done in the study groups. Immediately after intervention and one month thereafter, the test will be done again. Outcome(s): It is expected at least similar improvement in oral health knowledge could be seen in the two study groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081517053N7
Registration date: 2017-08-28, 1396/06/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Ferena Sayar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
f_sayar@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
By the researchers
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two models of oral health education on knowledge of male elementary students
Public title
The effect of different oral health education on male elementary students.
Purpose
Prevention
Inclusion/Exclusion criteria
Male students at the last elementary class who agree to enter to the study.
Age
From 12 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Dental Branch
Street address
10th Neyestan St., Pasdaran Ave.
City
Tehran
Postal code
19585175
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,44

Health conditions studied

1

Description of health condition studied
peer-led method
ICD-10 code
Z01.2
ICD-10 code description
dental examination

Primary outcomes

1

Description
Knowledge
Timepoint
Baseline, immediately after education and 1 month later
Method of measurement
Exam marks

Secondary outcomes

empty

Intervention groups

1

Description
Control group: learning by dentist for 20 minutes.
Category
N/A

2

Description
Intervention group: learning by peer-led for 20 minutes.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Dental Branch
Full name of responsible person
Dr. Ferena Sayar
Street address
Periodontics Department, 10th neyestan St., Pasdaran Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Dental Branch
Full name of responsible person
Dr. Arash Azizi
Street address
10th Neyestan St., Pasdaran Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Dental Branch
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
Islamic Azad Unuversity, Dental Branch
Full name of responsible person
Dr. Ferena Sayar
Position
Associate professor/ periodontist
Other areas of specialty/work
Street address
10th Neyestan St., Pasdaran Ave.
City
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Fax
Email
f_sayar@dentaliau.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Dental Branch
Full name of responsible person
Dr. Ferena Sayar
Position
MSc in periodontics
Other areas of specialty/work
Street address
10th Neyestan St, Pasdaran Ave.
City
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Fax
Email
f_sayar@dentaliau.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Dental Branch
Full name of responsible person
Dr.Ferena Sayar
Position
MSc in periodontics
Other areas of specialty/work
Street address
10th Neyestan St., Pasdaran Ave.
City
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Fax
Email
f_sayar@dentaliau.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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