History
# Registration date Revision Id
2 2018-02-12, 1396/11/23 39286
1 2017-07-26, 1396/05/04 24872
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  • Protocol summary

    1. Present study will be conducted in Qom Province, Iran. Participants include elementary school students in two cities of "Kahak" and "Jafariyeh" so that the students in Kahak are considered as the intervention group and those live in "Jafariye" are considered as control group. At baseline, we evaluate current brushing habit of the participants in the both groups of intervention and control by using a checklist that is filled out by parents of the students in first to third grades and completed by the students themselves in other grades. 2. In addition, based on the principals of social marketing, the barriers of proper tooth brushing are asked to design the content of interventions.The educational interventions such as pamphlet, poster, banners, placards, interactive lectures, and distribution of toothbrush and hourglass with study logo, in relation to duration and frequency of daily brushing) is done during one month among the students in Kahak. A traditional educational method (pamphlet) is used in the control city. After the intervention, the checklist is filled out again and the changes in brushing habits is calculated in two groups of intervention and control.
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    مطالعه حاضر در استان قم اجرا خواهد شد. شرکت کنندگان شامل دانش آموزان مقطع ابتدایی دو شهر کهک به عنوان گروه مداخله و جعفریه به عنوان گروه مقایسه می باشند. در مرحله پیش از مداخله، عادات مسواک زدن کنونی تمامی دانش آموزان در هر دو گروه، توسط چک لیستی ارزیابی می شود. قابل ذکر است که چک لیست مذکور در پایه اول تا سوم، توسط والدین دانش آموزان و در سایر پایه ها، توسط خود دانش آموزان تکمیل می گردد. به علاوه بر اساس اصول بازاریابی اجتماعی موانعی که از دید مخاطبین هدف باعث عدم اجرای رفتار مطلوب می شوند بررسی شده تا در طراحی مداخله استفاده شوند. سپس در شهر مداخله(کهک) بسته مداخلات آموزشی (شامل توزیع پمفلت، نصب پوستر، بنر و پلاکارد، برگزاری سخنرانی های تعاملی، ارائه مسواک و ساعت شنی دارای لوگوی مطالعه) در ارتباط با مدت زمان و فراوانی مسواک زدن بر مبنای اصول بازاریابی اجتماعی در مدت زمانی حدود یک ماه ارائه شده و در شهر مقایسه (جعفریه) صرفا یک روش سنتی آموزشی (پخش پمفلت) انجام می پذیرد. پس از انجام مداخله، تکمیل چک لیست مجدداً صورت گرفته و بر اساس آنالیزهای آماری نتایج قبل و بعد از مطالعه با هم مقایسه می شود.
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    The aim of this study was to evaluate the effect of social marketing approach versus the traditional method on promotion of tooth brushing habits in primary school students of Kahak and Jafariyeh, Qom
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    هدف این مطالعه بررسی تأثیر اصول بازاریابی اجتماعی در مقایسه با روش سنتی در دانش‌آموزان ابتدایی دو شهر کهک و جعفریه استان قم در بهبود عادات مسواک‌زدن می‌باشد.
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    This quasi-experimental controlled trial had a parallel design. The study was conducted in the cities of Kahak and Jafariyeh, Qom, Iran. Considering the relatively small number of students in the two cities, sampling was not done and the whole target population entered the census. 1318 students participated in the study and enrolled in February 2017 and followed one and half months.
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    این مطالعه به صورت یک مطالعه نیمه‌تجربی مقایسه‌دار و به صورت موازی طراحی شده است. محل انجام مطالعه دو شهر کهک و جعفریه استان قم در نظر گرفته شد. با توجه به جمعیت نسبتاً کم دانش‌آموزان دو شهر نمونه گیری انجام نشد و سرشماری تمام جامعه هدف انجام شد. 1318 دانش آموز در مطالعه شرکت کردند و مداخله در اسفند ماه سال 1396 اجرا شد و به مدت یک ماه و نیم پیگیری شد.
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    Intervention Group (Kahak) In this city, intervention was done according to the social marketing approach. The SMART model was used to organize different phases of social marketing in the following order [6, 13]: Phase 1: Preliminary planning The main problem, to overcome which this study was designed, was lack of interest in tooth brushing with the proper length and frequency. Therefore, the main objective of the study was to improve tooth-brushing habits as at least two times a day for at least two minutes each time. The main method that was used for project assessment was a self-report checklist before and after the intervention and comparison of the checklists. Phase 2: Audience analysis Only the primary school students of the two cities were identified as the target population. To analyze the target population’s beliefs and prioritization of the reasons for irregular or no tooth brushing from the perspective of themselves or their parents, a checklist was provided to all students and its results (Table 1) were used in designing the intervention tools. Phase 3: Channel analysis Since most of the students’ time was spent at home or school, communication channels that were appropriate for these environments like face-to-face training sessions, printed material for use in the school, training through parents, and the effect of parents on their children were considered. Phase 4: Market analysis In this study, one of the supporting factors was the performance of some teachers that considered a day of the week as the “tooth brush day”. On this day, the teachers asked the students to bring their toothbrushes and brush their teeth under the teacher’s supervision. One of the identified competitors was the parents’ low level of oral health knowledge in Iran [14]. Another competitor was the common belief among the students that brushing the teeth once a day is enough [15]. The second part of market analysis was implementation of market mix principles or 4P as the following: 1. Product: The main product was prevention of tooth decay and the real product was tooth brushing two times a day for two minutes each time. 2. Price: The time spent in the class (about 30 minutes), time spent on brushing the teeth and commitment to completing the tooth brushing calendar were among the expenses that the participants met. 3. Place: The place that was considered for the intervention was the students’ schools and houses because they were easily accessible. 4. Promotion: All the tools that were designed to persuade students to brush their teeth are placed in this group. These tools were planned based on the results of the first checklist. Phase 5: Development In this study, a sample of the tools was provided to school managers and health authorities to collect their comments. The intervention tools were approved in all schools and no comments were received. Phase 6: Implementation In this phase, the project was implemented as designed in the previous phases, and interventions were applied in the schools. At the beginning of this phase, a checklist containing questions on tooth-brushing habits was completed by the students to record their status before the intervention. This checklist was completed by the parents of students in grades 1 to 3 and by the students in grades 4-6. After the checklists were collected, the intervention was continued for one and a half months. Phase 7: Evaluation In this study, considering the students’ presence at school, it was possible to convey messages to the target population. On the other hand, due to the availability of teachers, they were requested to cooperate in the assessment of the project and review the main concepts of the project with the students and check the tooth-brushing calendar at least once a week. At the end of this phase, the students completed the tooth-brushing habits checklist for the second time to evaluate the changes following the intervention. Control Group (Jafariyeh) The students in Jafariyeh completed the tooth-brushing habits checklist before the intervention (similar to students in Kahak). After collecting the checklists, since this city was considered as the control group, a traditional intervention, i.e. pamphlet that was exactly similar to the pamphlet distributed in Kahak, was applied. Then, the changes were assessed through completing the checklist for a second time.
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    گروه مداخله (شهر کهک) در این شهر، مداخله در نظر گرفته شده طبق اصول بازاریابی اجتماعی اجرا شد. جهت سازماندهی مراحل بازاریابی اجتماعی در این مطالعه از مدل SMART استفاده شد که مراحل آن به ترتیب ذکر می‌گردد (6, 13): فاز 1. طراحی مقدماتی مشکل اصلی که این مطالعه جهت رفع آن طراحی شد عدم تمایل به مسواک‌زدن با تناوب و مدت‌زمان صحیح بود. لذا اهداف کلی مطالعه بهبود عادات مسواک‌زدن به صورت روزی حداقل دو بار و هر بار حداقل دو دقیقه تعیین شد. روش اصلی که برای ارزیابی پروژه طراحی شد استفاده از چک‌لیست خوداظهار پیش و پس از مداخله و مقایسه این دو چک‌لیست بود. فاز 2. آنالیز مخاطبین در جمعیت شهرهای مورد نظر صرفاً دانش‌آموزان مقطع ابتدایی به عنوان مخاطبین هدف شناسایی شدند. جهت آنالیز عقاید مخاطبین هدف و اولویت‌بندی دلایل مسواک‌زدن نامرتب یا مسواک‌نزدن دانش‌آموزان از دید والدین یا خود آنها چک‌لیستی در ابتدای مطالعه بین کلیه دانشآموزان توزیع شد و از نتایج آن (جدول 1) در طراحی ابزارهای مداخله استفاده شد. فاز 3. آنالیز کانال‌های ارتباطی در مطالعه حاضر با توجه به اینکه اکثر وقت دانش‌آموزان در مدرسه و خانه می‌گذرد کانال‌های ارتباطی متناسب با این فضاها مانند کلاس آموزشی حضوری و ابزارهای چاپی قابل نصب در مدرسه و همین‌طور آموزش از طریق والدین و تأثیری که والدین بر فرزندان خود می‌گذارند در نظر گرفته شد. فاز 4. تحلیل بازار در این مطالعه از جمله عوامل حمایتگری که شناسایی شدند عملکرد برخی از معلمان مدارس بود که در هفته روزی را به عنوان روز مسواک‌زدن در نظر گرفته بودند و از دانش‌آموزان می‌خواستند که در آن روز مسواک شخصی خود را به مدرسه آورده و با نظارت معلم در مدرسه مسواک بزنند. از طرف دیگر از جمله عوامل رقیب که شناسایی شد ناکافی بودن سطح سواد سلامت دهان والدین در ایران بود (14). همچنین می‌توان به این باور شایع در میان دانش‌آموزان به عنوان عامل رقیب دیگری اشاره کرد که یک بار مسواک‌زدن در روز کافی است (15). بخش دوم آنالیز بازار اجرای اصول آمیزه بازاریابی یا 4P است که به شرح ذیل می باشد: 1. محصول: محصول اصلی جلوگیری از پوسیدگی دندانی و محصول واقعی انجام رفتار مسواک‌زدن به صورت روزی دو بار، هر بار دو دقیقه بود. 2. قیمت: از جمله هزینه‌هایی که شخص در این طرح متحمل می‌شد زمان حضور در کلاس حضوری (حدود نیم ساعت)، زمانی که برای مسواک‌زدن صرف می‌شد و تعهد به پرکردن تقویم گزارش مسواک‌زدن بود. 3. مکان: مکانی که برای اعمال مداخله در نظر گرفته شد مدرسه و منزل دانش‌آموز بود که بیشترین امکان دسترسی را برای دانش‌آموز داشتند. 4. ترویج: تمامی ابزارهایی که جهت تشویق دانش‌آموز به مسواک‌زدن طراحی شدند در این دسته قرار می‌گیرند. این ابزار با توجه به نتایج چک‌لیست اول که به بررسی دلایل عدم تمایل به رفتار مسواک‌زدن پرداخته بود طراحی شدند. فاز 5. تکامل در این مطالعه نمونه‌ای از ابزارها به مدیران و مسئولین بهداشتی مدارس ارائه شد تا نظرات آن‌ها هم در نظر گرفته شود که در تمامی مدارس ابزارهای مداخله مورد تأیید قرار گرفت و نظر تکمیلی ارائه نشد. فاز 6. اجرا در این مرحله پروژه طبق طراحی های قبلی وارد فاز اجرایی شد و مداخلات به طور عملی در سطح مدارس پیاده شد. در ابتدای این مرحله چک لیست ثبت عادات مسواک‌زدن در بین دانش‌آموزان توزیع شد تا وضعیت دانش‌آموزان قبل از مداخله ثبت شود. این چک لیست در کلاس های اول تا سوم توسط والدین و در کلاس های چهارم تا ششم توسط خود دانش‌آموزان تکمیل شد. پس از جمع آوری چک‌لیست‌ها مداخله به مدت یک ماه و نیم ادامه پیدا کرد. فاز 7. ارزیابی در این مطالعه با توجه به حضور دانش‌آموزان در مدرسه، امکان انتقال پیام به مخاطب هدف میسر بود. از طرفی به دلیل در دسترس بودن معلمان از آن‌ها خواسته شد تا جهت ارزیابی روند طرح با مجریان پژوهش همکاری داشته باشند. بدین صورت که هم هفته ای حداقل یک‌بار مفاهیم اصلی طرح را با دانشآموزان مرور کنند و هم تقویم ثبت مسواک‌زدن را هر هفته بررسی کنند. در پایان این مرحله مجدداً چک لیست ثبت عادات مسواک‌زدن بین دانش‌آموزان توزیع شد تا تغییرات حاصل شده طی اجرای مداخله بررسی شود. گروه شاهد (شهر جعفریه) در این شهر همزمان با شهر کهک ابتدا چک لیست ثبت عادات مسواک‌زدن بین دانش‌آموزان توزیع شد. پس از جمع آوری این چک‌لیست با توجه به اینکه این شهر به عنوان مقایسه در نظر گرفته شده بود از یک مداخله سنتی یعنی توزیع پمفلت که دقیقاً همانند پمفلت توزیع شده در شهر کهک بود استفاده شد. سپس تغییرات حاصل شده از طریق تکمیل مجدد چک لیست بررسی گردید.
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    Entry requirements: All primary school students (grade 1 to 6) of Kahak and Jafariyeh in the 2016-2017 academic year Non-entry requirements: Non-cooperation of the students and their parents’ unwillingness
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    شرایط ورود: کلیه دانش‌آموزان مشغول به تحصیل در کلاس‌های اول تا ششم ابتدایی مدارس دو شهر کهک و جعفریه در سال تحصیلی 95-96 شرایط عدم ورود: عدم همکاری دانش‌آموز یا عدم رضایت خود یا والدین
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    Intervention group: All primary school students of Kahak city in the 2016-2017 academic year Control group: All primary school students of Jafariyeh city in the 2016-2017 academic year
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    گروه مداخله: دانش آموزان مقطع ابتدایی شهر کهک در سال تحصیلی 1395-96 گروه کنترل: دانش آموزان مقطع ابتدایی شهر جعفریه در سال تحصیلی 1395-96
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    Duration of tooth brushing Frequency of tooth brushing
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    مدت زمان مسواک زدن تعداد دفعات مسواک زدن
  • General information

    3
    N/A
    Students enrolled in grades of one to six in elementary schools of Kahak and Jafariye cities in the academic year 2016-2017
    تعداد دانش آموزان مشغول به تحصیل در کلاس های اول تا ششم ابتدایی مدارس دو شهر کهک و جعفریه در سال تحصیلی 95-96.
    non-compliance or lack of consent of the student or parents
    عدم همکاری دانش آموز یا عدم رضایت خود دانش آموز یا والدین وی
  • Recruitment centers

    #1
    Name of recruitment center - English: Motahhari2 school of Kahak city
    Name of recruitment center - Persian: مدرسه مطهری 2 شهر کهک
    Full name of responsible person - English: Mr Esmaeily
    Full name of responsible person - Persian: آقای اسماعیلی
    Street address - English:
    Street address - Persian:
    City - English: Kahak
    City - Persian: کهک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
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    Web page address:
    Name of recruitment center - English: Motahhari2 school of Kahak city
    Name of recruitment center - Persian: مدرسه مطهری 2 شهر کهک
    Full name of responsible person - English: Mr Esmaeily
    Full name of responsible person - Persian: آقای اسماعیلی
    Street address - English: Zeynabieh St.
    Street address - Persian: زینبیه
    City - English: Kahak
    City - Persian: کهک
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3735114640
    Phone: +98 25 3422 3424
    Fax:
    Email: name@domian.com
    Web page address:
    #2
    Name of recruitment center - English: Motahhari1 school of Kahak city
    Name of recruitment center - Persian: مدرسه مطهری 1 شهر کهک
    Full name of responsible person - English: Mr Abarghooyi
    Full name of responsible person - Persian: آقای ابرقویی
    Street address - English:
    Street address - Persian:
    City - English: Kahak
    City - Persian: کهک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Motahhari1 school of Kahak city
    Name of recruitment center - Persian: مدرسه مطهری 1 شهر کهک
    Full name of responsible person - English: Mr Abarghooyi
    Full name of responsible person - Persian: آقای ابرقویی
    Street address - English: Zeynabieh St.
    Street address - Persian: زینبیه
    City - English: Kahak
    City - Persian: کهک
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3735114641
    Phone: +98 25 3422 7676
    Fax:
    Email: name@domian.com
    Web page address:
    #3
    Name of recruitment center - English: Fatemiyeh school of Kahak city
    Name of recruitment center - Persian: مدرسه فاطمیه شهر کهک
    Full name of responsible person - English: Mrs Moosayi
    Full name of responsible person - Persian: خانم موسایی
    Street address - English:
    Street address - Persian:
    City - English: Kahak
    City - Persian: کهک
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Fatemiyeh school of Kahak city
    Name of recruitment center - Persian: مدرسه فاطمیه شهر کهک
    Full name of responsible person - English: Mrs Moosayi
    Full name of responsible person - Persian: خانم موسایی
    Street address - English: Hazrat Abalfazl Blvd.
    Street address - Persian: بلوار حضرت ابوالفضل (ع)
    City - English: Kahak
    City - Persian: کهک
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3735114159
    Phone: +98 25 3422 5464
    Fax:
    Email: name@domian.com
    Web page address:
    #4
    Name of recruitment center - English: Ansarolhossein1 school of Jafariyeh
    Name of recruitment center - Persian: مدرسه انصارالحسین1 شهر جعفریه
    Full name of responsible person - English: Mr Moosavi
    Full name of responsible person - Persian: آقای موسوی
    Street address - English:
    Street address - Persian:
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
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    Name of recruitment center - English: Ansarolhossein1 school of Jafariyeh
    Name of recruitment center - Persian: مدرسه انصارالحسین1 شهر جعفریه
    Full name of responsible person - English: Mr Moosavi
    Full name of responsible person - Persian: آقای موسوی
    Street address - English: Imam Ali St.
    Street address - Persian: امام علی(ع)
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3744118884
    Phone: +98 25 3627 3223
    Fax:
    Email: name@domian.com
    Web page address:
    #5
    Name of recruitment center - English: Ansarolhosein2 school of Jafariyeh
    Name of recruitment center - Persian: مدرسه انصارالحسین2 شهر جعفریه
    Full name of responsible person - English: Mr Jokar
    Full name of responsible person - Persian: آقای جوکار
    Street address - English:
    Street address - Persian:
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province:
    Country: Iran (Islamic Republic of)
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    Name of recruitment center - English: Ansarolhosein2 school of Jafariyeh
    Name of recruitment center - Persian: مدرسه انصارالحسین2 شهر جعفریه
    Full name of responsible person - English: Mr Jokar
    Full name of responsible person - Persian: آقای جوکار
    Street address - English: Farhang St.
    Street address - Persian: فرهنگ
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3744118875
    Phone: +98 25 3627 5433
    Fax:
    Email: name@domian.com
    Web page address:
    #6
    Name of recruitment center - English: Bahonar school of Kahak city
    Name of recruitment center - Persian: مدرسه باهنر شهر جعفریه
    Full name of responsible person - English: Mr Rahnama
    Full name of responsible person - Persian: آقای رهنما
    Street address - English:
    Street address - Persian:
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Bahonar school of Kahak city
    Name of recruitment center - Persian: مدرسه باهنر شهر جعفریه
    Full name of responsible person - English: Mr Rahnama
    Full name of responsible person - Persian: آقای رهنما
    Street address - English: Khamenei Blvd.
    Street address - Persian: بلوار آیت اله خامنه ای
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3744118864
    Phone: +98 25 3627 4312
    Fax:
    Email: name@domian.com
    Web page address:
    #7
    Name of recruitment center - English: Jahad school of Jafariyeh
    Name of recruitment center - Persian: مدرسه جهاد شهر جعفریه
    Full name of responsible person - English: Mrs Jafari
    Full name of responsible person - Persian: خانم جعفری
    Street address - English:
    Street address - Persian:
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Jahad school of Jafariyeh
    Name of recruitment center - Persian: مدرسه جهاد شهر جعفریه
    Full name of responsible person - English: Mrs Jafari
    Full name of responsible person - Persian: خانم جعفری
    Street address - English: Imam ALi St.
    Street address - Persian: امام علی(ع)
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3744118891
    Phone: +98 25 3627 7679
    Fax:
    Email: name@domian.com
    Web page address:
    #8
    Name of recruitment center - English: Bagher Rabbani school of Jafariyeh
    Name of recruitment center - Persian: مدرسه باقر ربانی شهر جعفریه
    Full name of responsible person - English: Mrs Karimi
    Full name of responsible person - Persian: خانم کریمی
    Street address - English:
    Street address - Persian:
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Bagher Rabbani school of Jafariyeh
    Name of recruitment center - Persian: مدرسه باقر ربانی شهر جعفریه
    Full name of responsible person - English: Mrs Karimi
    Full name of responsible person - Persian: خانم کریمی
    Street address - English: Moradi St.
    Street address - Persian: مرادی
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3744118721
    Phone: +98 25 3627 4563
    Fax:
    Email: name@domian.com
    Web page address:
    #9
    Name of recruitment center - English: Kowsar school of Jafariyeh
    Name of recruitment center - Persian: مدرسه کوثر شهر جعفریه
    Full name of responsible person - English: Mrs Mirzayi
    Full name of responsible person - Persian: خانم میرزایی
    Street address - English:
    Street address - Persian:
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Kowsar school of Jafariyeh
    Name of recruitment center - Persian: مدرسه کوثر شهر جعفریه
    Full name of responsible person - English: Mrs Mirzayi
    Full name of responsible person - Persian: خانم میرزایی
    Street address - English: Hakim St.
    Street address - Persian: حکیم
    City - English: Jafariyeh
    City - Persian: جعفریه
    Province: Ghoum
    Country: Iran (Islamic Republic of)
    Postal code: 3744118731
    Phone: +98 25 3627 4456
    Fax:
    Email: name@domian.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Younesian
    Full name of responsible person - Persian: دکتر یونسیان
    Street address - English: room No. 605, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran
    Street address - Persian: امیرآباد شمالی، بعد از انرژی اتمی، دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Younesian
    Full name of responsible person - Persian: دکتر یونسیان
    Street address - English: room No. 605, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran
    Street address - Persian: امیرآباد شمالی، بعد از انرژی اتمی، دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417713541
    Phone: +98 21 8893 3766
    Fax:
    Email: tumspr@tums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Dentistry School of Teharan University of Medical Sciences
    Name of organization / entity - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Mahdia Gholami
    Full name of responsible person - Persian: دکتر مهدیا غلامی
    Position - English: Member of science committee of oral health and social dentistry department
    Position - Persian: عضو هیات علمی گروه سلامت دهان و دندانپزشکی اجتماعی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, after Energy-Atomi, North AmirAbad
    Street address - Persian: امیرآباد شمالی-بالاتر از انرژی اتمی-دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8801 5960
    Mobile: +98 912 547 2534
    Fax:
    Email: m_gholami@sina.tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Dentistry School of Teharan University of Medical Sciences
    Name of organization / entity - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Mahdia Gholami
    Full name of responsible person - Persian: دکتر مهدیا غلامی
    Position - English: Member of science committee of oral health and social dentistry department
    Position - Persian: عضو هیات علمی گروه سلامت دهان و دندانپزشکی اجتماعی
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, after Energy-Atomi, North AmirAbad
    Street address - Persian: امیرآباد شمالی-بالاتر از انرژی اتمی-دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955934
    Phone: +98 21 8801 5960
    Mobile: +98 912 547 2534
    Fax:
    Email: m_gholami@sina.tums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Dentistry School of Teharan University of Medical Sciences
    Name of organization / entity - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Mahdia Gholami
    Full name of responsible person - Persian: دکتر مهدیا غلامی
    Position - English: PhD of oral health and social dentistry
    Position - Persian: PhD سلامت دهان و دندانپزشکی اجتماعی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, after Energy-Atomi, North AmirAbad
    Street address - Persian: امیرآباد شمالی-بالاتر از انرژی اتمی-دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8801 5960
    Mobile: +98 912 547 2534
    Fax:
    Email: m_gholami@sina.tums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Dentistry School of Teharan University of Medical Sciences
    Name of organization / entity - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Dr. Mahdia Gholami
    Full name of responsible person - Persian: دکتر مهدیا غلامی
    Position - English: PhD of oral health and social dentistry
    Position - Persian: PhD سلامت دهان و دندانپزشکی اجتماعی
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Dentistry, after Energy-Atomi, North AmirAbad
    Street address - Persian: امیرآباد شمالی-بالاتر از انرژی اتمی-دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439955934
    Phone: +98 21 8801 5960
    Mobile: +98 912 547 2534
    Fax:
    Email: m_gholami@sina.tums.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Dentistry faculty of Teharan University of Medical Sciences
    Name of organization / entity - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: AliAsghar Habibi
    Full name of responsible person - Persian: علی اصغر حبیبی
    Position - English: Dentistry student
    Position - Persian: دانشجوی دندانپزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kooy-e-Daneshgah, North AmirAbad
    Street address - Persian: امیرآباد شمالی کوی دانشگاه
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439957181
    Phone:
    Mobile: +98 919 663 4589
    Fax:
    Email: dreamstar890@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Dentistry faculty of Teharan University of Medical Sciences
    Name of organization / entity - Persian: دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: AliAsghar Habibi
    Full name of responsible person - Persian: علی اصغر حبیبی
    Position - English: Dentistry student
    Position - Persian: دانشجوی دندانپزشکی
    Latest degree: med_doctor
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kooy-e-Daneshgah, North AmirAbad
    Street address - Persian: امیرآباد شمالی کوی دانشگاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1439957181
    Phone: +98 25 3423 4155
    Mobile: +98 919 663 4589
    Fax:
    Email: dreamstar890@gmail.com
    Web page address:
  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    The total potential data can be shared after unidentifying people
    empty
    کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
    empty
    The start of access to data is 3 months after publishing the results
    empty
    شروع دوره دسترسی 3 ماه پس از چاپ نتایج
    empty
    Study data will be available to all individuals, including academic and industry researchers
    empty
    داده های مطالعه برای تمام افراد اعم از محققین دانشگاهی و مشغول در صنعت قابل دسترس خواهد بود
    empty
    Access to data will be available for oral health promotion programs and any statistical analysis will be allowed.
    empty
    دسترسی به داده ها به منظور اجرای برنامه های ارتقای سلامت دهان و دندان قابل دسترس خواهند بود و هر گونه آنالیز آماری مجاز خواهد بود
    empty
    1. Dr Mahdia Gholami, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran Call Phone: +982188015960 Email: m_gholami@sina.tums.ac.ir 2. Dr. Ahmadreza Shamshiri- Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran Call Phone: +982188015960 Email: ar_shamshiri@yahoo.com
    empty
    1. دکتر مهدیا غلامی- عضو هیأت علمی گروه سلامت دهان و دندانپزشکی اجتماعی دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران تلفن تماس: 02188015960 ایمیل:m_gholami@sina.tums.ac.ir 2. دکتر احمدرضا شمشیری- عضو هیأت علمی گروه سلامت دهان و دندانپزشکی اجتماعی دانشکده دندانپزشکی دانشگاه علوم پزشکی تهران تلفن تماس: 02188015960 ایمیل: ar_shamshiri@yahoo.com
    empty
    The requester must send the application to the persons mentioned in previous section to receive the study data. It is expected to receive information within a week.
    empty
    درخواست کننده میبایست با ارسال ایمیل به افراد ذکر شده درخواست خود را مبنی بر دریافت داده های مطالعه مطرح نمایند. انتظار میرود طی حدود یک هفته اطلاعات ارسال شود.

Protocol summary

Study aim
The aim of this study was to evaluate the effect of social marketing approach versus the traditional method on promotion of tooth brushing habits in primary school students of Kahak and Jafariyeh, Qom
Design
This quasi-experimental controlled trial had a parallel design. The study was conducted in the cities of Kahak and Jafariyeh, Qom, Iran. Considering the relatively small number of students in the two cities, sampling was not done and the whole target population entered the census. 1318 students participated in the study and enrolled in February 2017 and followed one and half months.
Settings and conduct
Intervention Group (Kahak) In this city, intervention was done according to the social marketing approach. The SMART model was used to organize different phases of social marketing in the following order [6, 13]: Phase 1: Preliminary planning The main problem, to overcome which this study was designed, was lack of interest in tooth brushing with the proper length and frequency. Therefore, the main objective of the study was to improve tooth-brushing habits as at least two times a day for at least two minutes each time. The main method that was used for project assessment was a self-report checklist before and after the intervention and comparison of the checklists. Phase 2: Audience analysis Only the primary school students of the two cities were identified as the target population. To analyze the target population’s beliefs and prioritization of the reasons for irregular or no tooth brushing from the perspective of themselves or their parents, a checklist was provided to all students and its results (Table 1) were used in designing the intervention tools. Phase 3: Channel analysis Since most of the students’ time was spent at home or school, communication channels that were appropriate for these environments like face-to-face training sessions, printed material for use in the school, training through parents, and the effect of parents on their children were considered. Phase 4: Market analysis In this study, one of the supporting factors was the performance of some teachers that considered a day of the week as the “tooth brush day”. On this day, the teachers asked the students to bring their toothbrushes and brush their teeth under the teacher’s supervision. One of the identified competitors was the parents’ low level of oral health knowledge in Iran [14]. Another competitor was the common belief among the students that brushing the teeth once a day is enough [15]. The second part of market analysis was implementation of market mix principles or 4P as the following: 1. Product: The main product was prevention of tooth decay and the real product was tooth brushing two times a day for two minutes each time. 2. Price: The time spent in the class (about 30 minutes), time spent on brushing the teeth and commitment to completing the tooth brushing calendar were among the expenses that the participants met. 3. Place: The place that was considered for the intervention was the students’ schools and houses because they were easily accessible. 4. Promotion: All the tools that were designed to persuade students to brush their teeth are placed in this group. These tools were planned based on the results of the first checklist. Phase 5: Development In this study, a sample of the tools was provided to school managers and health authorities to collect their comments. The intervention tools were approved in all schools and no comments were received. Phase 6: Implementation In this phase, the project was implemented as designed in the previous phases, and interventions were applied in the schools. At the beginning of this phase, a checklist containing questions on tooth-brushing habits was completed by the students to record their status before the intervention. This checklist was completed by the parents of students in grades 1 to 3 and by the students in grades 4-6. After the checklists were collected, the intervention was continued for one and a half months. Phase 7: Evaluation In this study, considering the students’ presence at school, it was possible to convey messages to the target population. On the other hand, due to the availability of teachers, they were requested to cooperate in the assessment of the project and review the main concepts of the project with the students and check the tooth-brushing calendar at least once a week. At the end of this phase, the students completed the tooth-brushing habits checklist for the second time to evaluate the changes following the intervention. Control Group (Jafariyeh) The students in Jafariyeh completed the tooth-brushing habits checklist before the intervention (similar to students in Kahak). After collecting the checklists, since this city was considered as the control group, a traditional intervention, i.e. pamphlet that was exactly similar to the pamphlet distributed in Kahak, was applied. Then, the changes were assessed through completing the checklist for a second time.
Participants/Inclusion and exclusion criteria
Entry requirements: All primary school students (grade 1 to 6) of Kahak and Jafariyeh in the 2016-2017 academic year Non-entry requirements: Non-cooperation of the students and their parents’ unwillingness
Intervention groups
Intervention group: All primary school students of Kahak city in the 2016-2017 academic year Control group: All primary school students of Jafariyeh city in the 2016-2017 academic year
Main outcome variables
Duration of tooth brushing Frequency of tooth brushing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2016123131675N1
Registration date: 2017-07-26, 1396/05/04
Registration timing: retrospective

Last update: 2018-03-05, 1396/12/14
Update count: 1
Registration date
2017-07-26, 1396/05/04
Registrant information
Name
AliAsghar Habibi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 4039
Email address
dreamstar890@gmail.com
Recruitment status
Recruitment complete
Funding source
Funding of Tehran University of Medical Sciences for thesis and research projects
Expected recruitment start date
2017-02-25, 1395/12/07
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two types of intervention (based on the principles of social marketing and traditional education) on increase in self-reported frequency and duration of tooth brushing of elementary school students: A controlled quasi-experimental study
Public title
The application of social marketing to promote good habits of brushing (at least twice a day, each time at least two minutes)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Students enrolled in grades of one to six in elementary schools of Kahak and Jafariye cities in the academic year 2016-2017
Exclusion criteria:
non-compliance or lack of consent of the student or parents
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1720
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Tehran University of Medical Sciences Ethics Committee
Street address
room No. 604, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR.TUMS.VCR.REC.1395.852

Health conditions studied

1

Description of health condition studied
Oral health advice and education (tooth brushing habit)
ICD-10 code
Z72.9, Z71
ICD-10 code description
Problem related to lifestyle, unspecified---Other specified counselling

Primary outcomes

1

Description
Frequency of tooth brushing
Timepoint
Before and one month after intervention
Method of measurement
Answering checklist (self-reported)

2

Description
Duration of tooth brushing
Timepoint
Before and one month after intervention
Method of measurement
Answering checklist (self-reported)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention in intervention city (Kahak city): The use of social marketing principles such as use of adware, masterclass, distributed toothbrushes, timers, brochures, etc. based on the assessed needs of students with using of SMART (Social marketing assessment and response tool) model in order to promote good habits of brushing (at least twice a day and each time at least two minutes)
Category
Prevention

2

Description
Intervention in the control city (Jafariye city): The use of traditional methods such as distributing pamphlets to increase the frequency and duration of brushing
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari2 school of Kahak city
Full name of responsible person
Mr Esmaeily
Street address
Zeynabieh St.
City
Kahak
Province
Ghoum
Postal code
3735114640
Phone
+98 25 3422 3424
Email
name@domian.com

2

Recruitment center
Name of recruitment center
Motahhari1 school of Kahak city
Full name of responsible person
Mr Abarghooyi
Street address
Zeynabieh St.
City
Kahak
Province
Ghoum
Postal code
3735114641
Phone
+98 25 3422 7676
Email
name@domian.com

3

Recruitment center
Name of recruitment center
Fatemiyeh school of Kahak city
Full name of responsible person
Mrs Moosayi
Street address
Hazrat Abalfazl Blvd.
City
Kahak
Province
Ghoum
Postal code
3735114159
Phone
+98 25 3422 5464
Email
name@domian.com

4

Recruitment center
Name of recruitment center
Ansarolhossein1 school of Jafariyeh
Full name of responsible person
Mr Moosavi
Street address
Imam Ali St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118884
Phone
+98 25 3627 3223
Email
name@domian.com

5

Recruitment center
Name of recruitment center
Ansarolhosein2 school of Jafariyeh
Full name of responsible person
Mr Jokar
Street address
Farhang St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118875
Phone
+98 25 3627 5433
Email
name@domian.com

6

Recruitment center
Name of recruitment center
Bahonar school of Kahak city
Full name of responsible person
Mr Rahnama
Street address
Khamenei Blvd.
City
Jafariyeh
Province
Ghoum
Postal code
3744118864
Phone
+98 25 3627 4312
Email
name@domian.com

7

Recruitment center
Name of recruitment center
Jahad school of Jafariyeh
Full name of responsible person
Mrs Jafari
Street address
Imam ALi St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118891
Phone
+98 25 3627 7679
Email
name@domian.com

8

Recruitment center
Name of recruitment center
Bagher Rabbani school of Jafariyeh
Full name of responsible person
Mrs Karimi
Street address
Moradi St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118721
Phone
+98 25 3627 4563
Email
name@domian.com

9

Recruitment center
Name of recruitment center
Kowsar school of Jafariyeh
Full name of responsible person
Mrs Mirzayi
Street address
Hakim St.
City
Jafariyeh
Province
Ghoum
Postal code
3744118731
Phone
+98 25 3627 4456
Email
name@domian.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Younesian
Street address
room No. 605, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417713541
Phone
+98 21 8893 3766
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Dentistry School of Teharan University of Medical Sciences
Full name of responsible person
Dr. Mahdia Gholami
Position
Member of science committee of oral health and social dentistry department
Latest degree
Ph.D.
Other areas of specialty/work
Street address
School of Dentistry, after Energy-Atomi, North AmirAbad
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
Email
m_gholami@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry School of Teharan University of Medical Sciences
Full name of responsible person
Dr. Mahdia Gholami
Position
PhD of oral health and social dentistry
Latest degree
Ph.D.
Other areas of specialty/work
Street address
School of Dentistry, after Energy-Atomi, North AmirAbad
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5960
Fax
Email
m_gholami@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dentistry faculty of Teharan University of Medical Sciences
Full name of responsible person
AliAsghar Habibi
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Kooy-e-Daneshgah, North AmirAbad
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 25 3423 4155
Fax
Email
dreamstar890@gmail.com
Web page address

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
The total potential data can be shared after unidentifying people
When the data will become available and for how long
The start of access to data is 3 months after publishing the results
To whom data/document is available
Study data will be available to all individuals, including academic and industry researchers
Under which criteria data/document could be used
Access to data will be available for oral health promotion programs and any statistical analysis will be allowed.
From where data/document is obtainable
1. Dr Mahdia Gholami, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran Call Phone: +982188015960 Email: m_gholami@sina.tums.ac.ir 2. Dr. Ahmadreza Shamshiri- Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran Call Phone: +982188015960 Email: ar_shamshiri@yahoo.com
What processes are involved for a request to access data/document
The requester must send the application to the persons mentioned in previous section to receive the study data. It is expected to receive information within a week.
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