The purpose of this clinical trial study is to evaluate the role of the two oral hygiene methods(conventional method vs. educational film) on oral health promotion among students, as one of the important goal groups in society.
Design
In this randomized clinical trial study,120 Students in the last elementary class in one of the schools in Tehran with inclusion criteria will participate and the classes will be randomly selected into the tests or control groups.
Settings and conduct
A questionnaire with 6 multiple choice questions will be answered by the students; the score will be assumed as the "pretest" score. Three weeks after intervention, the questionnaire will be answered again and the score will be recorded as "post test" score.
Participants/Inclusion and exclusion criteria
Boy students at the 6th elementary class who are volunteer to participate to the study.
Intervention groups
Test Group 1:Animation Film Group
Test Group 2: Dentist with Artificial Model Group
Control Group: Without Intervention
Main outcome variables
Knowledge change about oral hygiene.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140318017053N8
Registration date:2018-01-27, 1396/11/07
Registration timing:retrospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
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
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2017-11-29, 1396/09/08
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2017-11-29, 1396/09/08
Trial completion date
empty
Scientific title
Effect of two Oral Hygiene Learning Methods on Knowledge among the Last Elementary Class Students.
Public title
Effect of two Oral Hygiene Methods on Knowledge of Students at Elementary School.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Male Students
6th elementary class
Exclusion criteria:
Discontent to participate
Age
From 11 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Each class will be selected for one of the study groups by a sealed pocket,.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
It is the first time in Iran we are going to use of animation film to promote oral hygiene knowledge among elementary students.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University
Street address
9th Neyestan St., Pasdaran Ave., Dental School, Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-11-12, 1396/08/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,33
Health conditions studied
1
Description of health condition studied
Knowledge about Oral Hygiene
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in Knowledge.
Timepoint
Base line and 3 weeks after the interventions.
Method of measurement
Score of the questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Test group 1: Educational Film Group.
Category
N/A
2
Description
Test group 2: Dentist with Artificial Model Group.
Category
N/A
3
Description
Control group: Without Intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Islamic Azad Medical Sciences
Full name of responsible person
Ferena Sayar
Street address
9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Email
f_sayar@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferena Sayar
Street address
9th Neyestan, Pasdaran Ave, Islamic Azad Dental School
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2274 6248
Email
f_sayar@dentaliau.ac.ir
Grant name
vice chancellor for research, Islamic Azad Dental School.
Grant code / Reference number
2279608130002
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Ferena Sayar
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Periodontics
Street address
9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2274 6248
Email
f_sayar@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferena Sayar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Periodontics
Street address
9th Neyestan, Pasdaran Ave., Islamic Azad Dental School, Periodontics Department
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2274 6248
Email
f_sayar@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferena Sayar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Periodontics
Street address
9th Neyeatan, Pasdaran Ave., Islamic Azad Dental School, Periodontics Department
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2274 6248
Email
f_sayar@dentaliau.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
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