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evaluation of the effect of oral health education through skill-based and knowledge-based methods in 12-year-old students: a randomized controlled trial study

Protocol summary

Study aim
Determination of the effect of oral health education through skill-based and knowledge-based methods in 12-year-old students on self-efficacy: a randomized controlled trial study
Design
A Double-Blind, Parallel-Group, Randomized Controlled Trial with Two Intervention Groups (Knowledge-Based and Skill-Based) Conducted Among 220 Students in Schools. Schools were selected using stratified cluster random sampling, and students were randomly assigned through a lottery method.
Settings and conduct
All interventions and assessments will be conducted on students in schools. Baseline knowledge will be assessed through a valid and reliable questionnaire, hygiene behavior through a checklist, and plaque and decay indices will be evaluated. Interventions will be tailored to each group: in the knowledge-based group, education will be provided through pamphlets, while in the skill-based group, face-to-face and practical training will be delivered by the researcher. Then, after 3 months, the indices and behavioral and knowledge outcomes of the students will be measured for the second time. Both participants (students) and outcome assessors are blinded. Only one intervention (either knowledge-based or skill-based) will be implemented in each school, preventing participants from knowing their group assignment. Outcome assessors are unaware of group assignments and evaluate predetermined outcomes without bias.
Participants/Inclusion and exclusion criteria
Students who are 12 years old, either in the sixth grade or who have reached the age of 12 at the time of the study.
Intervention groups
1- Knowledge-Based (Use of a Uni-Media Educational Approach) 2- Skill-based (Use of a Multi-Media Educational Approach)
Main outcome variables
Dental Caries; Knowledge and Behavior Score Based on the Constructs of the Theory of Planning Behavior Model; Dental Plaque Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240303061155N1
Registration date: 2025-01-09, 1403/10/20
Registration timing: prospective

Last update: 2025-01-09, 1403/10/20
Update count: 0
Registration date
2025-01-09, 1403/10/20
Registrant information
Name
Maryam ّFazli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 043 6943
Email address
drfazli@zums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-02, 1403/11/14
Expected recruitment end date
2025-05-04, 1404/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of oral health education through skill-based and knowledge-based methods in 12-year-old students: a randomized controlled trial study
Public title
Evaluation of the effect of oral health education in students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Students who are 12 years old, either in the sixth grade or who have reached the age of 12 at the time of the study.
Exclusion criteria:
Reluctance to participate in the study Dental prophylaxis in the past month No systemic health issues
Age
From 12 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 220
Randomization (investigator's opinion)
Randomized
Randomization description
A list of all public elementary schools in Zanjan County will be obtained from the local office of the Education Department. Then, three areas of Zanjan County (Area 1, Area 2, and the Rural Area) will be randomly selected. After that, a list of all girls' and boys' schools in each area will be written on paper and collected separately into different containers (Container 1: all girls' schools in Area 1, Container 2: all boys' schools in Area 1, Container 3: all girls' schools in Area 2, Container 4: all boys' schools in Area 2, Container 5: all girls' schools in the Rural Area, and Container 6: all boys' schools in the Rural Area). To avoid contamination, only one intervention (educational or skill-based) will be performed in each school. Two papers will be drawn from each container: the first paper will be assigned to the skill-based group, and the second paper will be assigned to the knowledge-based group. Thus, schools will be selected using a stratified cluster random sampling method, and based on the order in which schools' names are drawn from each container, they will be assigned to either Intervention Group 1 (Skill-Based) or Intervention Group 2 (Knowledge-Based). For example, from Container 1, which includes all girls' schools in Area 1 of Zanjan County, two papers will be randomly selected. The school on the first paper will be assigned to the skill-based group, while the school on the second paper will be assigned to the knowledge-based group. This process will be repeated in the same manner for the other five containers, resulting in the selection of 12 schools. Additionally, students from the selected schools will be randomly chosen through a lottery to participate in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, to prevent contamination and side effects from different interventions, only one intervention (either knowledge-based or skill-based) is applied to each school. This ensures that participants are unable to discern which group (either knowledge-based or skill-based) they belong to, thus blinding at the participant level is fully achieved. Consequently, all students are exposed to similar conditions and do not have any specific knowledge about the type of intervention they received. Additionally, outcome assessors are also fully blinded. Assessors, without knowledge of the group assignment for each student, evaluate only the predetermined outcomes and are free from any bias in assessing the results. To achieve this, all data are provided to the assessors in an anonymous format, with no reference to intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
The skill-based intervention, based on the constructs of the Theory of Planning Behavior, will be conducted in 3 educational sessions lasting 50 to 60 minutes each. These sessions will include lectures and face-to-face teaching, focusing on directly educating individuals about attitudes, subjective norms, and perceived behavioral control to effectively improve oral health behaviors.In the first session, students will learn about their attitudes regarding the process of tooth decay, foods and beverages involved in the decay process, choosing the right toothbrush by comparing different types through touching the bristles of soft, medium, and hard toothbrushes, brushing time and frequency, common mistakes in oral hygiene, and finally, the proper technique for brushing and flossing using a dental kit demonstrated in front of the students, allowing them to repeat the correct method.In the second session, the construct of social norms from the Theory of Planning Behavior will be addressed, involving teachers and parents in encouraging and motivating students to engage in self-care behaviors with consideration of rewards and praise. This session will include general information about the role of oral health in students’ overall health, the differences between deciduous and permanent teeth, and ways to prevent tooth decay. Teachers and parents will be shown the proper brushing and flossing techniques and informed on how they can encourage their children to brush and floss by practicing these techniques alongside them.In the third session, the key points from the first session will be reviewed, and students will be taught how to deal with perceived behavioral control issues, focusing on the obstacles and difficulties they might face in performing self-care behaviors, and how to overcome these barriers.In Intervention Group 2, knowledge-based education will be delivered through a researcher-developed pamphlet, which is commonly used as an effective strategy in health education and promotion programs to provide information on various levels of health problem prevention. The educational section of this program will consist of a 2-hour training session for parents and teachers, and a 2-hour session for students.In these pamphlet-based sessions, designed according to the constructs of the Theory of Planning Behavior, the pamphlet will be given to students, parents, and teachers to read by themselves over a specified period. The pamphlet will start by explaining tooth decay, the associated process, foods that cause decay, the time and frequency of brushing, brushing techniques, and flossing techniques to improve the audience's knowledge and attitudes regarding oral health.Next, to address barriers to oral health, the pamphlet will include an image demonstrating how to select the right toothbrush and common mistakes encountered during brushing. Afterward, questions will be asked to ensure comprehension, such as "How will you brush your teeth tonight?" or "Can you tell me the minimum brushing time per session?"It should be noted that in this group, by involving coaches, teachers, and parents, the social norm construct regarding oral health education can strengthen students' intentions and health behaviors. At the outset of the study, all participants were provided with standardized oral hygiene kits, including Signal-brand toothbrushes and toothpaste (Unilever factory). This ensured consistency in intervention tools and minimized potential confounders related to resource variability. Participants were instructed to use the provided products exclusively throughout the three-month intervention period. Contingency plans were established with school administrators to replenish resources if needed, ensuring no additional financial burden was placed on families or schools.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical School
Street address
Zanjan, Azadi Square, Beginning of Jomhouri Eslami Boulevard, Central Headquarters of Zanjan University of Medical Sciences
City
zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۱۱
Approval date
2024-12-02, 1403/09/12
Ethics committee reference number
IR.ZUMS.REC.1403.274

Health conditions studied

1

Description of health condition studied
Design, implementation, and evaluation of the effect of oral health education through skill-based and knowledge-based methods in 12-year-old students: a randomized controlled trial study
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knowledge and Behavior Score Based on the Constructs of the Theory of Planning Behavior Model
Timepoint
before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Through a Valid and Reliable Questionnaire

Secondary outcomes

1

Description
The Attitude Construct of the Theory of Planning Behavior
Timepoint
Measurement before the start of the intervention and 3 months after the start of the intervention
Method of measurement
In this study, attitude refers to the students’ belief regarding the positive or negative impact of adhering to or neglecting proper oral self-care behaviors. This is assessed based on their responses to the relevant questions in the questionnaire.

2

Description
The Subjective Norms Construct of the Theory of Planning Behavior
Timepoint
Measurement before the start of the intervention and 3 months after the start of the intervention
Method of measurement
In this study, subjective norms refer to the students' perceptions of the opinions of parents, peers, teachers, principals, and other significant individuals regarding adherence to proper oral self-care behaviors. These perceptions are assessed based on the students' responses to the relevant questions in the questionnaire.

3

Description
The Perceived Behavioral Control Construct of the Theory of Planning Behavior
Timepoint
Measurement before the start of the intervention and 3 months after the start of the intervention
Method of measurement
In this study, perceived behavioral control refers to the individual's perceived difficulty or ease and their perceived ability to perform proper oral self-care behaviors. This is assessed based on their responses to the relevant questions in the questionnaire.

4

Description
The Behavioral Intention Construct of the Theory of Planning Behavior
Timepoint
Measurement before the start of the intervention and 3 months after the start of the intervention
Method of measurement
In this study, behavioral intention refers to the individual's intention (or willingness) to adhere to proper oral self-care behaviors. This is assessed based on their responses to the relevant questions in the questionnaire

5

Description
Use of Dental Floss
Timepoint
before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Check list (Yes/No)

6

Description
Use of Tooth brush
Timepoint
before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Check list (Yes/No)

7

Description
The number of times using teeth brush
Timepoint
before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Check list

8

Description
Dental Caries
Timepoint
Measurement before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Clinical Examination through the assessment of the DMFT (the ratio of the number of restored teeth after the intervention to the number of decayed teeth before and after the intervention)

9

Description
Dental Plaque Index
Timepoint
Measurement before the start of the intervention and 3 months after the start of the intervention
Method of measurement
Specialized examinations using a periodontal probe and registration in the examination form

Intervention groups

1

Description
Intervention group: Skill-based (Use of a Multi-Media Educational Approach) - The skill-based intervention, based on the constructs of the Theory of Planning Behavior, will be conducted in 3 educational sessions lasting 50 to 60 minutes each. These sessions will include lectures and face-to-face teaching, focusing on directly educating individuals about attitudes, subjective norms, and perceived behavioral control to effectively improve oral health behaviors.In the first session, students will learn about their attitudes regarding the process of tooth decay, foods and beverages involved in the decay process, choosing the right toothbrush by comparing different types through touching the bristles of soft, medium, and hard toothbrushes, brushing time and frequency, common mistakes in oral hygiene, and finally, the proper technique for brushing and flossing using a dental kit demonstrated in front of the students, allowing them to repeat the correct method.In the second session, the construct of social norms from the Theory of Planning Behavior will be addressed, involving teachers and parents in encouraging and motivating students to engage in self-care behaviors with consideration of rewards and praise. This session will include general information about the role of oral health in students’ overall health, the differences between deciduous and permanent teeth, and ways to prevent tooth decay. Teachers and parents will be shown the proper brushing and flossing techniques and informed on how they can encourage their children to brush and floss by practicing these techniques alongside them.In the third session, the key points from the first session will be reviewed, and students will be taught how to deal with perceived behavioral control issues, focusing on the obstacles and difficulties they might face in performing self-care behaviors, and how to overcome these barriers.
Category
Prevention

2

Description
Intervention group: Knowledge-Based (Use of a Uni-Media Educational Approach) - In Intervention Group 2, knowledge-based education will be delivered through a researcher-developed pamphlet, which is commonly used as an effective strategy in health education and promotion programs to provide information on various levels of health problem prevention. The educational section of this program will consist of a 2-hour training session for parents and teachers, and a 2-hour session for students.In these pamphlet-based sessions, designed according to the constructs of the Theory of Planning Behavior, the pamphlet will be given to students, parents, and teachers to read by themselves over a specified period. The pamphlet will start by explaining tooth decay, the associated process, foods that cause decay, the time and frequency of brushing, brushing techniques, and flossing techniques to improve the audience's knowledge and attitudes regarding oral health.Next, to address barriers to oral health, the pamphlet will include an image demonstrating how to select the right toothbrush and common mistakes encountered during brushing. Afterward, questions will be asked to ensure comprehension, such as "How will you brush your teeth tonight?" or "Can you tell me the minimum brushing time per session?"It should be noted that in this group, by involving coaches, teachers, and parents, the social norm construct regarding oral health education can strengthen students' intentions and health behaviors.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected Primary Schools of Zanjan County
Full name of responsible person
Maryam Fazli
Street address
Mahdavi Blv.Faculty of Dentistry, Department of Oral Health and Social Dentistry
City
zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 912 043 6943
Email
drfazli@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Azin nourian
Street address
Mahdavi St., Dentistry Department, Zanjan Univeristy of Medical Science
City
zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3314 8100
Email
azin.nourian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
25
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

2

Sponsor
Name of organization / entity
Unilever Iran Factory
Full name of responsible person
Reza Safari
Street address
Qazvin, Alborz Industrial City, Sohrevardi Boulevard, Abu Reyhan Birooni Street
City
qazvin
Province
Qazvin
Postal code
3531944893
Phone
+98 28 3381 6000
Email
info@unilever.ir
Web page address
https://unilever.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Unilever Iran Factory
Proportion provided by this source
20
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
Industry

3

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Maryam ّFazli
Street address
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
City
zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 912 043 6943
Email
drfazli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
55
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam ّFazli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Community oral health
Street address
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
City
zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 912 043 6943
Email
drfazli@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam ّFazli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Community oral health
Street address
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
City
zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 912 043 6943
Email
drfazli@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam ّFazli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Community oral health
Street address
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
City
zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 912 043 6943
Email
drfazli@zums.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 participant data can be shared after de-identification.
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
There are no special conditions.
From where data/document is obtainable
To receive the data and documents, send an email to Dr.Maryam Fazli Or contact the research office of Zanjan School of Dentistry. Dr.Maryam Fazli's email: drfazli@zums.ac.ir Zanjan Faculty of Dentistry research office phone number: +98-24-33148215
What processes are involved for a request to access data/document
Data requests are usually answered after two working weeks.
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