Clinical Trial Protocol Iranian Registry of Clinical Trials

04 Oct 2021

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

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

1 This checklist was completed by the parents of students Recruitment complete in grades 1 to 3 and by the students in grades 4-6. After Funding source the checklists were collected, the intervention was Funding of Tehran University of Medical Sciences for continued for one and a half months. Phase 7: Evaluation thesis and research projects In this study, considering the students’ presence at school, it was possible to convey messages to the target Expected recruitment start date population. On the other hand, due to the availability of 2017-02-25, 1395/12/07 teachers, they were requested to cooperate in the Expected recruitment end date assessment of the project and review the main concepts 2017-02-28, 1395/12/10 of the project with the students and check the tooth- Actual recruitment start date brushing calendar at least once a week. At the end of empty this phase, the students completed the tooth-brushing Actual recruitment end date habits checklist for the second time to evaluate the empty changes following the intervention. Control Group Trial completion date (Jafariyeh) The students in Jafariyeh completed the tooth- empty brushing habits checklist before the intervention (similar to students in Kahak). After collecting the checklists, Scientific title since this city was considered as the control group, a The effect of two types of intervention (based on the traditional intervention, i.e. pamphlet that was exactly principles of social marketing and traditional education) similar to the pamphlet distributed in Kahak, was on increase in self-reported frequency and duration of applied. Then, the changes were assessed through tooth brushing of elementary school students: A completing the checklist for a second time. controlled quasi-experimental study Participants/Inclusion and exclusion criteria Entry requirements: All primary school students (grade 1 Public title to 6) of Kahak and Jafariyeh in the 2016-2017 academic The application of social marketing to promote good year Non-entry requirements: Non-cooperation of the habits of brushing (at least twice a day, each time at students and their parents’ unwillingness least two minutes) Intervention groups Purpose Intervention group: All primary school students of Kahak Prevention city in the 2016-2017 academic year Control group: All Inclusion/Exclusion criteria primary school students of Jafariyeh city in the Inclusion criteria: 2016-2017 academic year Students enrolled in grades of one to six in elementary Main outcome variables schools of Kahak and Jafariye cities in the academic year Duration of tooth brushing Frequency of tooth brushing 2016-2017 Exclusion criteria: non-compliance or lack of consent of the student or General information parents Age Reason for update No age limit Acronym Gender IRCT registration information Both IRCT registration number: IRCT2016123131675N1 Registration date: 2017-07-26, 1396/05/04 Phase Registration timing: retrospective N/A Groups that have been masked No information Last update: 2018-03-05, 1396/12/14 Sample size Update count: 1 Target sample size: 1720 Registration date Randomization (investigator's opinion) 2017-07-26, 1396/05/04 Not randomized Registrant information Randomization description Name Blinding (investigator's opinion) AliAsghar Habibi Not blinded Name of organization / entity Blinding description Tehran University of Medical Sciences Placebo Country Not used Iran (Islamic Republic of) Assignment Phone Parallel +98 21 8801 4039 Other design features Email address [email protected] Secondary Ids

Recruitment status empty

2 Ethics committees 1 Description 1 Intervention in intervention city (Kahak city): The use of social marketing principles such as use of adware, Ethics committee masterclass, distributed toothbrushes, timers, brochures, Name of ethics committee etc. based on the assessed needs of students with using Tehran University of Medical Sciences Ethics of SMART (Social marketing assessment and response Committee tool) model in order to promote good habits of brushing Street address (at least twice a day and each time at least two minutes) room No. 604, sixth floor, the Central Organization of Category Tehran University of Medical Sciences, St. Qods, Prevention Keshavarz Blvd, Tehran City 2 Tehran Province Description Tehran Intervention in the control city (Jafariye city): The use of Postal code traditional methods such as distributing pamphlets to 1417653761 increase the frequency and duration of brushing Approval date Category 2016-10-25, 1395/08/04 Prevention Ethics committee reference number IR.TUMS.VCR.REC.1395.852 Recruitment centers

Health conditions studied 1 Recruitment center 1 Name of recruitment center Motahhari2 school of Kahak city Description of health condition studied Full name of responsible person Oral health advice and education (tooth brushing habit) Mr Esmaeily ICD-10 code Street address Z72.9, Z71 Zeynabieh St. ICD-10 code description City Problem related to lifestyle, unspecified---Other specified Kahak counselling Province Ghoum Primary outcomes Postal code 3735114640 Phone 1 +98 25 3422 3424 Description Email Frequency of tooth brushing [email protected] Timepoint Before and one month after intervention 2 Method of measurement Recruitment center Answering checklist (self-reported) Name of recruitment center Motahhari1 school of Kahak city 2 Full name of responsible person Mr Abarghooyi Description Street address Duration of tooth brushing Zeynabieh St. Timepoint City Before and one month after intervention Kahak Method of measurement Province Answering checklist (self-reported) Ghoum Postal code Secondary outcomes 3735114641 Phone empty +98 25 3422 7676 Email Intervention groups [email protected]

3 3 Name of recruitment center Bahonar school of Kahak city Recruitment center Full name of responsible person Name of recruitment center Mr Rahnama Fatemiyeh school of Kahak city Street address Full name of responsible person Khamenei Blvd. Mrs Moosayi City Street address Jafariyeh Hazrat Abalfazl Blvd. Province City Ghoum Kahak Postal code Province 3744118864 Ghoum Phone Postal code +98 25 3627 4312 3735114159 Email Phone [email protected] +98 25 3422 5464 Email [email protected] 7 Recruitment center 4 Name of recruitment center Jahad school of Jafariyeh Recruitment center Full name of responsible person Name of recruitment center Mrs Jafari Ansarolhossein1 school of Jafariyeh Street address Full name of responsible person Imam ALi St. Mr Moosavi City Street address Jafariyeh Imam Ali St. Province City Ghoum Jafariyeh Postal code Province 3744118891 Ghoum Phone Postal code +98 25 3627 7679 3744118884 Email Phone [email protected] +98 25 3627 3223 Email [email protected] 8 Recruitment center 5 Name of recruitment center Bagher Rabbani school of Jafariyeh Recruitment center Full name of responsible person Name of recruitment center Mrs Karimi Ansarolhosein2 school of Jafariyeh Street address Full name of responsible person Moradi St. Mr Jokar City Street address Jafariyeh Farhang St. Province City Ghoum Jafariyeh Postal code Province 3744118721 Ghoum Phone Postal code +98 25 3627 4563 3744118875 Email Phone [email protected] +98 25 3627 5433 Email 9 [email protected] Recruitment center Name of recruitment center 6 Kowsar school of Jafariyeh Recruitment center Full name of responsible person

4 Mrs Mirzayi Dentistry School of Teharan University of Medical Street address Sciences Hakim St. Full name of responsible person City Dr. Mahdia Gholami Jafariyeh Position Province Member of science committee of oral health and Ghoum social dentistry department Postal code Latest degree 3744118731 Ph.D. Phone Other areas of specialty/work +98 25 3627 4456 Street address Email School of Dentistry, after Energy-Atomi, North [email protected] AmirAbad City Sponsors / Funding sources Tehran Province Tehran 1 Postal code 1439955934 Sponsor Phone Name of organization / entity +98 21 8801 5960 Vice chancellor for research, Tehran University of Fax Medical Sciences Email Full name of responsible person [email protected] Dr. Younesian Web page address Street address room No. 605, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Person responsible for scientific Keshavarz Blvd, Tehran inquiries City Tehran Contact Province Name of organization / entity Tehran Dentistry School of Teharan University of Medical Postal code Sciences 1417713541 Full name of responsible person Phone Dr. Mahdia Gholami +98 21 8893 3766 Position Email PhD of oral health and social dentistry [email protected] Latest degree Grant name Ph.D. Grant code / Reference number Other areas of specialty/work Is the source of funding the same sponsor Street address organization/entity? School of Dentistry, after Energy-Atomi, North Yes AmirAbad Title of funding source City Vice chancellor for research, Tehran University of Medical Tehran Sciences Province Proportion provided by this source Tehran 100 Postal code Public or private sector 1439955934 Public Phone Domestic or foreign origin +98 21 8801 5960 Domestic Fax Category of foreign source of funding Email empty [email protected] Country of origin Web page address Type of organization providing the funding Academic Person responsible for updating data Person responsible for general inquiries Contact Name of organization / entity Contact Dentistry faculty of Teharan University of Medical Name of organization / entity Sciences

5 Full name of responsible person Yes - There is a plan to make this available AliAsghar Habibi Analytic Code Position Yes - There is a plan to make this available Dentistry student Data Dictionary Latest degree Yes - There is a plan to make this available Medical doctor Title and more details about the data/document Other areas of specialty/work The total potential data can be shared after unidentifying Street address people Kooy-e-Daneshgah, North AmirAbad When the data will become available and for how City long Tehran The start of access to data is 3 months after publishing Province the results Tehran To whom data/document is available Postal code Study data will be available to all individuals, including 1439957181 academic and industry researchers Phone Under which criteria data/document could be used +98 25 3423 4155 Access to data will be available for oral health promotion Fax programs and any statistical analysis will be allowed. Email From where data/document is obtainable [email protected] 1. Dr Mahdia Gholami, Department of Community Oral Web page address Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran Call Phone: +982188015960 Sharing plan Email: [email protected] 2. Dr. Ahmadreza Shamshiri- Department of Community Oral Health, Deidentified Individual Participant Data Set (IPD) School of Dentistry, Tehran University of Medical Yes - There is a plan to make this available Sciences, Tehran, Iran Call Phone: +982188015960 Study Protocol Email: [email protected] Yes - There is a plan to make this available What processes are involved for a request to access Statistical Analysis Plan data/document Yes - There is a plan to make this available The requester must send the application to the persons Informed Consent Form mentioned in previous section to receive the study data. Yes - There is a plan to make this available It is expected to receive information within a week. Clinical Study Report Comments

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