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IRCT20240303061155N1 IRCT 2025-01-09 Zanjan University of Medical Sciences Evaluation of the effect of oral health education in students 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 2025-02-02 anticipated 220 Complete https://irct.ir/trial/80912 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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 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. N/A 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. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All participant data can be shared after de-identification. When: The access period starts 6 months after the results are published. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: There are no special conditions. Where to obtain: 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 How to obtain: Data requests are usually answered after two working weeks. Comments:
public Maryam ّFazli
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
zanjan Iran (Islamic Republic of) 4513956111 +98 912 043 6943 drfazli@zums.ac.ir Zanjan University of Medical Sciences scientific Maryam ّFazli
Mahdavi blv. Zanjan University of Medical School-Dentistry Faculty
zanjan Iran (Islamic Republic of) 4513956111 +98 912 043 6943 drfazli@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) 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. 12 years 12 years Both Reluctance to participate in the study Dental prophylaxis in the past month No systemic health issues Prevention Prevention 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. 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. 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. 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. 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. 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. 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. 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). 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). 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. 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). 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. Unilever Iran Factory Zanjan University of Medical Sciences Zanjan University of Medical Sciences Unilever Iran Factory Zanjan University of Medical Sciences Approved 2024-12-02 Ethics committee of Zanjan University of Medical School Zanjan, Azadi Square, Beginning of Jomhouri Eslami Boulevard, Central Headquarters of Zanjan University of Medical Sciences zanjan Zanjan Iran (Islamic Republic of)