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IRCT20131102015238N6 IRCT 2024-08-21 Tehran University of Medical Sciences Evaluation of effectiveness of two intervention packages on the self-care of mothers and its effect on the oral health of toddlers Evaluation of effectiveness of two intervention packages for oral health promotion programs on oral self care of mothers and oral health status of toddlers 2024-08-15 anticipated 396 Complete https://irct.ir/trial/77679 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The comprehensive health centers of southern areas of Tehran city are assigned to three groups by random sampling using random sequence generation software (Excel). Two intervention groups and one control group. In the Excel software page, the left column, the total number of comprehensive centers. It shows the health of southern areas of Tehran. The three groups of the first intervention, the second intervention, and the control group are randomized with the rand command, and in the next column it is determined that we will have 7 control groups, 5 first intervention groups, and 5 second intervention groups, and in the last column, comprehensive health centers are randomly selected in are placed in one of the intervention groups. Each comprehensive health center is assigned a code. Allocation of groups to intervention arms is done by the supervisor, and the examiner, researcher and the person who performs the statistical evaluation are unaware of this randomization, Blinding description: The examiners and the researcher who conducts the statistical evaluation and analysis are blind to the allocation of the groups. Allocating groups to intervention arms is done by the supervisor. When entering information into the data file, groups are entered with numbers. Depending on which intervention group they are in, the participants in this study receive educational packages through health care providers. Before receiving the services and educational packages, a questionnaire and a blind intervention-type examination were conducted in another room, and then the participants went to the health care providers and received the services. The statistical analyzer also receives the information of the health centers in the form of codes or numbers and is unaware of the intervention groups. N/A Oral health status of toddlers. Intervention 1: Intervention group: The first group (mother and child level): they will receive an educational booklet (self-care training to improve oral health and daily examination training for the child). For memorization, consolidation of information and motivation, and also the Back Teach method will be used to ensure the understanding of educational materials. The choice of the method of receiving more materials is the responsibility of the mother. (SMS/common social network/care site) children in this group are simplified by the lip the lift method after being taught by the mother herself. Intervention 2: Intervention group: The second group (community level: change in services): In addition to the first intervention, they will have an additional service of toothbrush and fluoride toothpaste, and this incentive will be renewed if the care continues in the second follow-up. Intervention 3: Control group: The third group (control group): status quo. At the end of the intervention, this group will receive oral health education for children. Yes - There is a plan to make this available What will be shared: After deidentifying individuals and comprehensive health centers, all data can be shared in the programs of Tehran University of Medical Sciences, comprehensive health centers of the whole country and the Ministry of Health, Treatment and Medical Education. When: The data access period starts 6 months after the results are published. To whom: Considering that the result of the work will be published as an article, the above materials will be provided to the journal (most of the international journals currently request the above materials), to be available to the interested parties. All data can be shared in Tehran University of Medical Sciences for those interested. Conditions: Considering that the result of the work will be published as an article, the above materials will be provided to the journal (most of the international journals currently request the above materials), to be available to the interested parties. All the data will be used for all comprehensive health centers in the country to improve the oral health status of toddlers. Where to obtain: Responsible person: Simin Zahra Mohebi Email: smohebi@tums.ac.ir Phone: 02188015960 How to obtain: Correspondent: Simin Z Mohebbi Email: smohebbi@tums.ac.ir Comments:
public Simin Zahra Mohebbi
End of North Kargar Street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5960 smohebbi@tums.ac.ir Tehran University of Medical Sciences scientific Simin ZahraMohebbi
End of North Kargar Street
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5960 smohebbi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iranian children one to two years old who refer to comprehensive health centers in the south of Tehran for routine vaccination and growth monitoring. Mother's minimum literacy Mother's consent to participate in the plan. 1 year 2 years Both Existence of systemic problems Mental disability of the child Lifestyle Lifestyle Lifestyle Intervention group: The first group (mother and child level): they will receive an educational booklet (self-care training to improve oral health and daily examination training for the child). For memorization, consolidation of information and motivation, and also the Back Teach method will be used to ensure the understanding of educational materials. The choice of the method of receiving more materials is the responsibility of the mother. (SMS/common social network/care site) children in this group are simplified by the lip the lift method after being taught by the mother herself. Intervention group: The second group (community level: change in services): In addition to the first intervention, they will have an additional service of toothbrush and fluoride toothpaste, and this incentive will be renewed if the care continues in the second follow-up Control group: The third group (control group): status quo. At the end of the intervention, this group will receive oral health education for children Index (dmft). Timepoint: First visit after 6 months and 12 months follow up. Method of measurement: Visual exam. Plaque Index. Timepoint: First visit after 6 months and 12 months follow up. Method of measurement: Visual exam. Mother's knowledge about child's oral and dental health. Timepoint: Before the intervention and 6 and 12 months after the intervention. Method of measurement: Questionnaire with 22 questions. Mother's attitude about child's oral and dental health. Timepoint: Before the intervention and 6 and 12 months after the intervention. Method of measurement: Questionnaire with 5 questions. Mother's performance about child's oral and dental health. Timepoint: Before the intervention and 6 and 12 months after the intervention. Method of measurement: Questionnaire with 10 questions. Mother's self-reported regarding the oral and dental health of the child and herself. Timepoint: Before the intervention and 6 and 12 months after the intervention. Method of measurement: Questionnaire with 6 questions. Tehran University of Medical Sciences Approved 2023-11-29 Ethics committee of Tehran University of Medical Sciences North Kargar Street Tehran Tehran Iran (Islamic Republic of)