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Assessment the efficacy of a Health-Promoting Educational Program Based on the Multi-Theory Model (MTM) on the Oral Health of first and second grade High School Students.

Protocol summary

Study aim
This study was conducted with the aim of investigating the effect of the oral and dental health promotion program on the oral and dental health of first and second high school students and providing an educational model.
Design
Clinical trial with control group, with parallel groups, randomized, on 50 students
Settings and conduct
This study will be conducted in first and second secondary schools for girls and boys in Hamadan city. 50 male and female students will be selected and included in the study by multi-stage cluster sampling method. Educational interventions will be implemented in the form of 10 educational sessions for students for two months.Interventions will be done with the help of educational videos, pamphlets, posters, discussion and exchange of opinions, forming a Telegram group. The follow-up period will be three months.
Participants/Inclusion and exclusion criteria
Entry conditions: age 13 to 18, parents' consent to their child's participation in the study, student's consent to participate in the study, exclusion conditions: having systemic diseases, presence of oral mucosal lesions, having orthodontics, needing any emergency dental treatment
Intervention groups
A training program based on multi theory model. The control group did not receive any intervention
Main outcome variables
indicators of dental plaque, community periodontal disease, dental plaque and calculus

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250128064551N1
Registration date: 2025-04-22, 1404/02/02
Registration timing: prospective

Last update: 2025-04-22, 1404/02/02
Update count: 0
Registration date
2025-04-22, 1404/02/02
Registrant information
Name
Farzaneh Mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 2716
Email address
farzanehmohamadi232@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-10-05, 1404/07/13
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the efficacy of a Health-Promoting Educational Program Based on the Multi-Theory Model (MTM) on the Oral Health of first and second grade High School Students.
Public title
The effect of educational programs on improving oral health of first and second grade High School Students.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being 13-18 years old the student consent to participate in the study Parental consent to their child's participation in the study
Exclusion criteria:
Having systemic diseases Presence of oral mucosal lesions Having orthodontic appliances needing any emergency dental treatment
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study will be a multi-stage cluster. Based on the education division, Hamadan is divided into two educational regions (regions one and two). First, from each educational region, based on the level of access to health services, 3 girls first grad high schools, 3 girls second grade high schools, 3 boysfirst grade high schools, and 3 boys second grade high schools (one school each from the well-off, semi-well-off, and under-well-off regions) will be randomly selected. Then, from the class list, one class from each of the sixth, seventh, eighth or ninth, tenth, and twelfth grades will be selected at simple random from each school. After the initial assessment of plaque levels, periodontal health, oral hygiene status, and completion of the questionnaire, the schools will be randomly assigned to the intervention and control groups. A total of 50 students will be placed in the intervention group and 50 students in the control group.
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
Hamedan
Province
Hamadan
Postal code
6517838636
Approval date
2025-03-16, 1403/12/26
Ethics committee reference number
IR.UMSHA.REC.1403.944

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
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced

Primary outcomes

1

Description
Percentage of people who brushed twice a day with a toothpaste containingfluoride
Timepoint
Before the start of the study, immediately after the end of the intervention, threemonths 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
Based on the results obtained from the descriptive phase, the age group with the most oral and dental problems will be selected for intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rostami Boys' Middle School
Full name of responsible person
Hamidreza Jafari
Street address
Farhangian Town Phase 1-Dhanemouz Street
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۹۹۵۵۳۹۱
Phone
+98 81 3254 3020
Email
farzanehmohamadi232@gmail.com

2

Recruitment center
Name of recruitment center
Persian Gulf Middle School 2
Full name of responsible person
Ali Karami
Street address
Imamzadeh Abdullah Square - Zeinbiyeh Boulevard - Madrasah Alley
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۸۶۶۴۸۸۷
Phone
+98 81 3423 8578
Email
farzanehmohamadi232@gmail.com

3

Recruitment center
Name of recruitment center
Taleghani Girls' Middle School 2
Full name of responsible person
Fariba Torabi
Street address
Mahdieh Street - Behnam Joo Street - Opposite the Martyrs' Pool - School Dead End
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۶۷۳۴۵۶۵
Phone
+98 81 3837 0212
Email
farzanehmohamadi232@gmail.com

4

Recruitment center
Name of recruitment center
Imam Khomeini Girls' Middle School
Full name of responsible person
Bahar Paayaab
Street address
Khizr Neighborhood - Vahdat Street - Saderat Bank Alley
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۳۷۱۳۷۵۶
Phone
+98 81 3275 1155
Email
farzanehmohamadi232@gmail.com

5

Recruitment center
Name of recruitment center
Farshchian Girls' Middle School 2
Full name of responsible person
Parisa Haddadi
Street address
Mohammadieh Boulevard - Opposite Baharestan Boulevard
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۵۹۵۸۵۶۲
Phone
+98 81 3272 7215
Email
farzanehmohamadi232@gmail.com

6

Recruitment center
Name of recruitment center
Takhti Boys' Middle School
Full name of responsible person
Akbar Rahmani
Street address
Shahid Beheshti Town - End of Jihad Street - Next to Ghadir Complex
City
Hamedan
Province
Hamadan
Postal code
6514838487
Phone
+98 81 3262 2284
Email
farzanehmohamadi232@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samaneh Shirahmadi
Street address
Faculty of Dentistry- University of Medical Sciences-Shahid Fahmideh Street pajuhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
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
Farzaneh Mohamadi
Position
Doctoral Student In General Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 30 - Second Floor-Hakim Alley-18 Meters From Laleh -30 Meters From Bani Hashem
City
Hamedan
Province
Hamadan
Postal code
6514737479
Phone
+98 81 3264 2716
Email
farzanehmohamadi232@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farzaneh Mohamadi
Position
Doctoral Student In General Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 30 - Second Floor- Hakim Alley -18 Meters From Laleh-30 Meters From Bani Hashem
City
Hamedan
Province
Hamadan
Postal code
6514737479
Phone
+98 81 3264 2716
Email
farzanehmohamadi232@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farzaneh Mohamadi
Position
Doctoral Student In General Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Second Floor-No. 30- Hakim Alley-18 Meters From Laleh-30 Meters From Bani Hashem
City
Hamedan
Province
Hamadan
Postal code
6514737479
Phone
+98 81 3264 2716
Email
farzanehmohamadi232@gmail.com

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 identifying individuals
When the data will become available and for how long
The access period starts 6 month after the result 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
Farzaneh Mohamadis email
What processes are involved for a request to access data/document
After checking the requester's email by Farzaneh Mohamadi.if conditions are met,the data will be sent to them after 3 days
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