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Effect of health educational program on promoting oral health among elementary school students: Developing an educational model

Protocol summary

Study aim
this study aimed to evaluate the effect of oral health promotion program on oral health elementary school students and presenting an educational model.
Design
Clinical trial with control group, with parallel groups, randomized, on 190 students.
Settings and conduct
This study was conducted in girls' schools in Hamadan city.190 female students were selected and included in the study by multi-stage cluster sampling method. Educational interventions were implemented in the form of 10 educational sessions for students and one session for mothers for two months.The interventions were done through the game method and with the help of 7 educational videos, 3 pamphlets, 5 posters, role playing, holding a oral health celebration, and forming a telegram group. The follow-up period was three months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being 11-12 years old, being a girl, parents' consent to their child's participation in the study, student's consent to participate in the study. Exclusion criteria: Having systemic diseases, having Oral Mucosal Lesions, having orthodontics, needing any emergency dental treatment.
Intervention groups
The intervention consisted of an educational program based on the social cognitive theory.The control group did not receive any intervention.
Main outcome variables
knowledge, social cognitive theory constructs, brushing twice a day using fluoride toothpaste and flossing at least once a day and Plaque Index, Community Periodontal Index, Simplified Oral Hygiene Index.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141128020129N2
Registration date: 2022-10-18, 1401/07/26
Registration timing: retrospective

Last update: 2022-10-18, 1401/07/26
Update count: 0
Registration date
2022-10-18, 1401/07/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0511
Email address
s.shirahmadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-08, 1394/12/18
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-03-19, 1395/12/29
Trial completion date
2017-06-20, 1396/03/30
Scientific title
Effect of health educational program on promoting oral health among elementary school students: Developing an educational model
Public title
Effect of health educational program on promoting oral health among elementary school students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being 11-12 years old being a girl student's consent to participate in the study parents' consent to their child's participation in the study
Exclusion criteria:
Having systemic diseases, Having Oral Mucosal Lesions, Having orthodontics, Needing any emergency dental treatment
Age
From 11 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 190
Actual sample size reached: 190
Randomization (investigator's opinion)
Randomized
Randomization description
. In this study, subjects were selected by multistage cluster sampling. The ministry of education classifies Hamadan into two educational regions (region one and region two). First, three girls’ schools were randomly selected (each school in one of the privileged, semi-privileged, and unprivileged areas) from each educational region based on the health care availability rate. Afterward, one fifth-grade class was selected from the list of classes of each school using simple random sampling. In the end, the schools were randomly allocated to intervention and control groups after the primary evaluation of the level of plaque, gum health, oral and dental health status, and completing the questionnaire. In total, while each group of intervention and control was allocated 102 students, seven participants were removed from each group due to incomplete pretest and post-test questionnaires and the parent's lack of cooperation
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
The Ethics Committee of Hamadan University of Medical Sciences
Street address
4th floor, Headquarters of the University of Medical Sciences, Shahid Fahmideh St., PaJuhesh square
City
Hamadan
Province
Hamadan
Postal code
6517838636
Approval date
2016-02-13, 1394/11/24
Ethics committee reference number
IR.UMSHA.REC.1394.473

Health conditions studied

1

Description of health condition studied
Dental Calculus and Debris
ICD-10 code
K03.6
ICD-10 code description
Deposits [accretions] on teeth

2

Description of health condition studied
Periodontal diseases
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Percentage of people who brushed twice a day with a toothpaste containing fluoride
Timepoint
Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention
Method of measurement
Standard questionnaire

2

Description
Use dental floss at least once a day
Timepoint
Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention
Method of measurement
Standard questionnaire

Secondary outcomes

1

Description
The percentage of dental plaque in each person
Timepoint
Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention
Method of measurement
Clinical examination by a dentist

2

Description
Determining the rate of periodontal tissue health of each person
Timepoint
Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention
Method of measurement
Clinical examination by a dentist

3

Description
Determining the rate of dental debris and calculus in each person
Timepoint
Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention
Method of measurement
Clinical examination by a dentist

Intervention groups

1

Description
Intervention group: The education program in this study included one education session for mothers and 10 education sessions for students. In the education session for mothers, tips were presented about the importance of oral health and its role in the general health, and the goals and implementation of the intervention program.Interventions in students were done through the game method and with the help of 7 educational videos, 3 pamphlets, 5 posters, role playing, holding a health and oral health celebration and forming a telegram group.Students were trained in the following areas: familiarizing students with tooth structure and periodontal structure, knowledge of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. In order to remind students to practice oral and dental hygiene behaviors, daily brushing and flossing records were provided to the students. In order to investigate the oral hygiene behaviors of the students at home, the researcher checked the forms of the students once a week in each class. A group called "Oral Health" was created on Telegram and family members of students, teachers and administrators of each school, professor of social dentistry and health education joined this group. The educational videos that were played in the classes in every session, educational materials related to oral health were uploaded in the group and the questions of the members were answered about issues related to oral health. Students were asked to take pictures of themselves while brushing and flossing and post them in the group. The educational intervention ended with the celebration of oral health in each school. The parents of the students participated in the celebration held in the school. In this ceremony, students performed their shows for parents, principal and school teacher.
Category
Prevention

2

Description
Control group: They received routine programs and training at school.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Malek Mohammadi Primary School
Full name of responsible person
kobra Sharifian
Street address
Shahidan Samari Alley, Ayatollah Kashani Blvd
City
Hamadan
Province
Hamadan
Postal code
6010738448
Phone
+98 81 3252 2548
Email
prm@medu.ir

2

Recruitment center
Name of recruitment center
Shahid Oshtad Primary School
Full name of responsible person
Fahima Mohammadi Ezzati
Street address
Azadi St., Dr. Chamran Town
City
Hamadan
Province
Hamadan
Postal code
6010738448
Phone
+98 81 3835 5227
Email
prm@medu.ir

3

Recruitment center
Name of recruitment center
Haj Mohammad Javad Alavi1 Primary School
Full name of responsible person
Mehrangiz Eskandari
Street address
Madani town
City
Hamadan
Province
Hamadan
Postal code
6513817433
Phone
+98 81 3429 6837
Email
prm@medu.ir

4

Recruitment center
Name of recruitment center
Shahid Sabrian Ranjbar Primary School
Full name of responsible person
Masoume Ebrahimi Hajir
Street address
Hakim St., Ostadan
City
Hamadan
Province
Hamadan
Postal code
6513817433
Phone
+98 81 3822 1277
Email
prm@medu.ir

5

Recruitment center
Name of recruitment center
Simai Baharan 2 Primary School
Full name of responsible person
Zahra Zabarjadi
Street address
Number 608, West Azad Street, Jihad Street
City
Hamadan
Province
Hamadan
Postal code
6513817433
Phone
+98 81 3821 0322
Email
prm@medu.ir

6

Recruitment center
Name of recruitment center
Sadegh Dahihi 2 Primary School
Full name of responsible person
Aqdas Herati
Street address
Koi Kosar, Hesar Road Ali Abad
City
Hamadan
Province
Hamadan
Postal code
6513817433
Phone
+98 81 3422 4216
Email
prm@medu.ir

7

Recruitment center
Name of recruitment center
Shahid Ahmed Karmi Primary School
Full name of responsible person
Azize Malmir
Street address
18 meters away from Sadeghieh, Dr. Chamran Blvd.,
City
Hamadan
Province
Hamadan
Postal code
6513817433
Phone
+98 81 3823 9300
Email
prm@medu.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Public Health School, University of Medical Science, Shahid Fahmide Ave., Pajuhesh Squer
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 4058
Email
s.shirahmadi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Samane Shirahmadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Community Oral Health, School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St., PaJuhesh square
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1059
Fax
Email
s.shirahmadi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samane Shirahmadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Community Oral Health, School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St., PaJuhesh square
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1059
Fax
Email
s.shirahmadi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samane shirahmadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Community Oral Health, School of Dentistry, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1059
Fax
Email
s.shirahmadi@umsha.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
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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who intend to use the study data for review articles and meta-analysis
From where data/document is obtainable
Samane Shirahmadi emails
What processes are involved for a request to access data/document
After checking the requester's email by Samane Shirahamdi, if the conditions are met, the data will be sent to them 3 days later.
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