The effect of two educational interventions on the knowledge and self-reported practice of 10-13-year-old elementary school students towards traumatic dental injuries
Evaluation of the effect of two educational intervention methods (flashcard and application) in relation to traumatic dental injuries on the awareness and self-expression performance of 10-13-year-old elementary school students.
Design
Clinical trial without a control group, with two parallel groups, without blinding, randomized, on 280 participants. Random number table and flipping a coin will be used for randomization.
Settings and conduct
Interventions will be performed on adolescent students in Tehran in three phases: baseline, intervention, and final, which last for three months. A questionnaire will be used for gathering data on outcome changes.
Participants/Inclusion and exclusion criteria
Entry condition: the age of the student is between 10-13 years old, the parents or the student have consented to participate in the study, and the student or his parents have a smartphone with Android operating system.
Exclusion condition: the student does not have the ability to understand the questions in the questionnaire, the parents or the student do not want to participate in the study, and the student does not have access to a smartphone.
Intervention groups
Intervention 1:educational flash cards; Intervention 2: educational application in Android mobile phone.
The educational content of both interventions will be similar to each other on the importance of preventing dental injuries and appropriate action when dental injuries occur which will be prepared with colorful pictures and based on the latest scientific evidence. The interventions will be presented to two groups of participants: an educational flashcard package and an Android application. In both groups, 45 days after receiving the intervention, a reminder will be sent to the students.
Main outcome variables
Knowledge score changes; self-reported practice score changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130617013695N5
Registration date:2022-11-28, 1401/09/07
Registration timing:registered_while_recruiting
Last update:2022-11-28, 1401/09/07
Update count:0
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Samaneh Razeghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
s-razeghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two educational interventions on the knowledge and self-reported practice of 10-13-year-old elementary school students towards traumatic dental injuries
Public title
Effect of education on prevention of traumatic dental injuries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the student was between 11 - 15 years old
The student or his/her parents have satisfied with participating in the study
The student or his/her parents have a cellphone with Android system
Exclusion criteria:
The student does not have the ability to understand the questionnaire questions
Parents or students do not want to participate in the study
The student does not have access to a smartphone
Age
From 10 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
A list of girls' and boys' elementary schools covered by the Tehran University of Medical Sciences in Tehran will be prepared. From this list, two girls' primary schools and two boys' primary schools will be randomly selected as strata. Again, from the fourth to the sixth grades of each primary school, two classes will be defined as a cluster. Allocation of the intervention to these four primary schools will be done randomly and by a coin toss: in two primary schools (one for girls and one for boys) it will be in the form of educational flash cards and in the other two primary schools (one for girls and one for boys) it will be in the form of an educational application.
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
Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences
Street address
School of Dentistry, Tehran University of Medical Sciences, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.030
Health conditions studied
1
Description of health condition studied
Traumatic dental injuries
ICD-10 code
S02.5
ICD-10 code description
Fracture of tooth
Primary outcomes
1
Description
changes in knowledge score gained by questionnaire
Timepoint
Measuring knowledge score at the baseline (before intervention) and three months after intervention
Method of measurement
Based on scores obtained from knowledge questions in the standardized questionnaire for assessing athletes' knowledge about traumatic dental injuries
2
Description
changes in self-reported practice score gained by questionnaire
Timepoint
Measuring self-reported practice score at the baseline (before intervention) and three months after intervention
Method of measurement
Based on scores obtained from self-reported practice questions in the standardized questionnaire for assessing athletes' self-reported practice about traumatic dental injuries
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: a package containing educational flash cards with color pictures regarding the prevention of dental injuries is prepared based on the latest evidence and scientific guidelines. This package has information for students in two parts: 1- Proper management of dental injuries after they occur, including soft tissue damage, crown fracture, tooth loss, dental avulsion, and alveolar bone fracture, and 2- Methods of preventing dental injuries in teenagers, including the use of mouth guard and its types. At baseline and after collecting filled-out questionnaires by participants, the educational flash cards will be distributed among participants in the flash card group. The flash cards will remain with the students. A month and a half after the flash cards distribution, a reminder will be sent again to the athletes as a reminder.
Category
Prevention
2
Description
Intervention group 2: An educational application on prevention of Traumatic Dental Injuries (TDIs) in Android operating system, will be designed based on on the latest evidence and scientific guidelines with similar content to the pamphlet. As same as flash cards, the application provides information for students in two parts: 1- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage, and 2- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance. At baseline, after collecting filled out questionnaire by participants, the link to access the application in Miket, the Iranian application market, will be sent to the students or thier parents via SMS. Students will be asked to contact one of the study researchers if they have problems in installing or using the app. A month and a half after sending the link, a notification designed in the app will be sent to students as a reminder .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Samaneh Razeghi
Street address
North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
s-razeghi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotoohi
Street address
Vice Chancellor for Research and Technology, sixth floor, University Central Building, corner of Quds Str., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8163 3685
Fax
+98 21 8898 9664
Email
pajoheshi-ece@sina.tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Razeghi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Kargar Str.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
s-razeghi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Razeghi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Kargar Str.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
s-razeghi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samaneh Razeghi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Kargar Str.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
s-razeghi@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After making people unrecognizable, the study protocol, information on the main outcomes (Knowledge and practice), informed consent form, and report of the study will be shareable.
When the data will become available and for how long
Initiation of access: from the publication of the manuscript
To whom data/document is available
Researchers in academic and scientific organizations; Education departments; Parents and students
Under which criteria data/document could be used
Access to data and documents would be possible by sending a request email to the main researcher.
From where data/document is obtainable
Sending email to Dr. Samaneh Razeghi (s-razeghi@tums.ac.ir)
What processes are involved for a request to access data/document
Sending email to Dr. Samaneh Razeghi (s-razeghi@tums.ac.ir)