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IRCT20160822029476N2 IRCT 2023-06-02 Esfahan University of Medical Sciences Effectiveness of a tooth brushing package on the tooth brushing improvement among children Effectiveness of a tooth brushing educational package on the improvement of tooth brushing and gingival health of 4-6 years children: an RCT 2023-09-11 anticipated 90 Complete https://irct.ir/trial/70313 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: After gaining ethical approvals from the Ethics Committee and signed inform consents from the parents, children will be examined to record plaque index and gingival index by one examiner (NA). The examiner will be trained by an oral public health expert and calibrated by examining 10 children before the study.Plaque index will be recorded using the Quigley-Hein index that scores the level of plaque accumulation from 0-6. The gingival index will be recorded using the (Loe Silness and Loe Gingival Index which scores the gums health from 0-3 based on the Ramford Teeth (No (55و51و65و75و71و85)). All the examinations will be performed using disposable mirrors and blunted scalers on the kindergarten chairs and using Head Light. Also, to evaluate the changes in the motivation, capability and opportunities of the parents, the checklist of COM-B self-assessment will be used. This checklist has 6 questions in 3 domains and the scoring system is based on VAS. In addition, the checklist of the oral health behavior including the time and frequency of tooth brushing, using tooth paste and duration of tooth bushing will be completed by the parents and the children, separately. Statistical Analysis: The data will be fed into SPSS 26 and using descriptive and analytical tests including Paired T-test, ANOVA, q-squared or their equivalent non-parametric tests will be analyzed, Randomization description: From the proposed list of kindergartens, three will be selected randomly. Then based on the "lucky ball" randomization method, random allocation of the selected kindergartens into the three groups of Intervention I, Intervention II or control groups will be performed, Blinding description: Participated children are not contaminated with other groups. Their teachers are not involved in the educations and not aware of the content of the interventions. The groups will be introduced to the data analyzer by English articles including A,B ,C and is not aware of the interventions contents. N/A oral health status. Intervention 1: Intervention group I: In the main intervention group (Group I), The behavior changes will be conducted based on the principles of COM-B; for capability improvement, a short educational video will be prepared including the explanations about the process of dental caries, the role of dental plaque, and the ways parents could utilized to remove the dental plaque mechanically. In addition, the proper use of tooth brush and tooth paste will be educated by demonstrating on two 5 and 6 children. During the demonstration, two recommended methods of tooth brushing in this age group (horizontal and roll technique) will be educated. Also, the important role and responsibility of the parents regarding the necessity of direct or supervised tooth brushing will be emphasized. The validity of the prepared videos, regarding the attractiveness, relevancy and content, will be affirmed during an expert panel evaluation including experts from the Health Education, Dental public Health and dental Pediatric departments. To improve the “opportunity” domain among parents, in a virtual group encompassing parents of the selected children, parents were encouraged to ask their questions about the methods of the tooth brushing or any comments related to the video. Also, they were asked to record and share a short film of their child’s brushing and allow the PIs (principle Investigators) to help them find their practical pitfalls. In the third domain of the model, to give children and parents relative Motivations, a 2-miutes animation was sent to the parents. This motivative animation was developed by the OIs in a recent work (oral health promoting schools) and include two singing children (a boy and a girl) who speaks about the importance and method of tooth brushing and flossing. The duration of the animation is exactly as the recommended duration of brushing and was validated in our previous works. Parents were asked to motivate their children in the time of brushing by showing them this animation. This animation is accessible through https://t.me/OHPS. Intervention 2: Intervention group2: In this group just the prepared educational video will be demonstrated. Intervention 3: Control group: no education will be provided. Yes - There is a plan to make this available What will be shared: Data will be available upon the request from corresponding author. When: Six months after the article publication To whom: Academic researchers Conditions: For systematic analysis Where to obtain: Contacting the corresponding author How to obtain: Email and CV Comments:
public Dr. Bahareh Tahani
Hezarjarib st, Isfahan University of Medical Sciences
Iafahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5594 tahani@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Bahareh Tahani
Hezarjarib st, Isfahan University of Medical Sciences
Iafahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5594 tahani@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 5-6 preschool children that are systematically healthy in private kindergarten of the Isfahan city. . Their parents should be alive. Mother education should be diploma or higher. The selection of kindergartens was in accordance to the Rehabilitation Organization located in the regions with moderate to high SES 5 years 6 years Both Children with untreated inter-proximal dental caries, having space retainer or having oral breathing patterns K02 Dental caries Behavior Behavior N/A Intervention group I: In the main intervention group (Group I), The behavior changes will be conducted based on the principles of COM-B; for capability improvement, a short educational video will be prepared including the explanations about the process of dental caries, the role of dental plaque, and the ways parents could utilized to remove the dental plaque mechanically. In addition, the proper use of tooth brush and tooth paste will be educated by demonstrating on two 5 and 6 children. During the demonstration, two recommended methods of tooth brushing in this age group (horizontal and roll technique) will be educated. Also, the important role and responsibility of the parents regarding the necessity of direct or supervised tooth brushing will be emphasized. The validity of the prepared videos, regarding the attractiveness, relevancy and content, will be affirmed during an expert panel evaluation including experts from the Health Education, Dental public Health and dental Pediatric departments. To improve the “opportunity” domain among parents, in a virtual group encompassing parents of the selected children, parents were encouraged to ask their questions about the methods of the tooth brushing or any comments related to the video. Also, they were asked to record and share a short film of their child’s brushing and allow the PIs (principle Investigators) to help them find their practical pitfalls. In the third domain of the model, to give children and parents relative Motivations, a 2-miutes animation was sent to the parents. This motivative animation was developed by the OIs in a recent work (oral health promoting schools) and include two singing children (a boy and a girl) who speaks about the importance and method of tooth brushing and flossing. The duration of the animation is exactly as the recommended duration of brushing and was validated in our previous works. Parents were asked to motivate their children in the time of brushing by showing them this animation. This animation is accessible through https://t.me/OHPS. Intervention group2: In this group just the prepared educational video will be demonstrated Control group: no education will be provided. Dental plaque index. Timepoint: 1 month. Method of measurement: Teeth examination and record in information data sheet. COM-B scores of parents( Capability , Opportunity , Motivation Questionnaire). Timepoint: 1 month. Method of measurement: 6-questions COM-B questionnaire (with questions in domains of Capability, Opportunity, Motivation) with Visual Analogue Scale. Gingival index. Timepoint: 1 month. Method of measurement: Visual examination of gingiva and recording its status in the data collection form. Esfahan University of Medical Sciences Approved 2022-11-19 Ethics Commiitee of Isfahan University of Medical Sciences Department of Oral Public Health, School of Dentistry Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)