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Reminder-based Educational Mobile Intervention for for Maternal Oral Health Literacy and Preschoolers' Dental Health (REMIND)

2026年8月16日 更新者:Pani Matin Anugrah

The Effectiveness of a Notification- and Reminder-Based Educational Application in Improving Maternal Oral Health Literacy and the Dental Health Status of Preschool Children in Pancoran Mas

The goal of this clinical trial is to determine the effectiveness of educational application based on notification and reminder in improving maternal oral health literacy and the dental and dental health status of preschool children among mother-preschool child pairs (children aged <7 years) in Pancoran Mas, Depok City.

The primary research questions to be addressed in the main trial are:

  • Does the application group improve mothers' oral health literacy (measured using the REALD-30 questionnaire) more than the printed booklet group?
  • Does the application group improve children's oral health status, as measured by oral hygiene (Debris Index-Simplified [DI-S]) and gingival condition (modified Gingival Index [mGI]), more than the printed booklet group?
  • What is the level of usability (ease of use) of the application as perceived by mothers who use it?

The researchers will compare a group of mothers who receive education through the application with a group of mothers who receive education through a printed booklet to determine whether the application produces greater improvements in maternal oral health literacy and children's oral health outcomes.

Participants will be asked to:

  • Complete the REALD-30 questionnaire at baseline (pretest) and at the end of the program (posttest), with a one-month interval between assessments.
  • Accompany their children for DI-S and mGI examinations at baseline (pretest) and at the end of the program (posttest), with a one-month interval between assessments, conducted by a calibrated dentist.
  • Receive and study dental health education materials delivered progressively, one chapter per week, through either the application (intervention group) or a printed booklet (control group). Subsequent chapters will be unlocked in the following week.
  • Complete a daily checklist documenting their child's tooth-brushing activities every morning and evening throughout the study period.
  • For participants in the application group only: receive daily notifications/reminders and personalized educational messages (based on quiz scores and checklist compliance levels), and complete the Mobile App Usability Questionnaire (MAUQ) at the end of the program.

研究概览

详细说明

Study Design and Setting:

This study employed a quasi-experimental design with a pretest-posttest non-equivalent control group approach and was conducted in parallel between the intervention and control groups in seven preschool in Pancoran Mas , Depok City, Indonesia, between July and December 2024. Participant allocation was non-randomized. The sample size was calculated using the analytical formula for comparing numerical between two independent groups. The final sample size was determined to be 100 participants in each group, yielding a total analytical sample of 200 mother-child pairs. Participants were recruited through a non-probability purposive sampling method at the village and school levels.

Intervention:

The study compared two educational media containing identical content on tooth anatomy, oral hygiene practices, oral diseases, and the development of dental caries (four chapters):

  • Application (Peri Bugi): An interactive mHealth application featuring daily notifications and reminders, supplemented with a rule-based AI system that personalizes the frequency of educational messages according to quiz performance and compliance with the toothbrushing checklist.
  • Booklet: A printed text-based educational material designed for self-directed learning.

Study Protocol:

  1. Application Development. The development process included conceptual planning (objectives, target users, framework, and REALD-30-based content), UI/UX wireframe design, development of the four educational chapters, and prototype creation.
  2. Expert Evaluation. Four experts (two computer science experts and two experts/master's students in community dentistry) evaluated the feasibility and usability of the prototype online via Zoom using the System Usability Scale (SUS) questionnaire. The evaluation results were used to revise and improve the application.
  3. Pilot Study. Twenty end users (10 in the application group and 10 in the booklet group) tested the intervention over a two-week period. Baseline assessments included the REALD-30 questionnaire for mothers and the Oral Hygiene Index-Simplified (OHI-S) for children.
  4. Main Effectiveness Trial

    • Baseline Assessment: All participants completed a pretest to assess baseline conditions. Mothers completed the REALD-30 questionnaire, while children underwent DI-S and mGI examinations performed by calibrated dentists.
    • Intervention Period: Participants in the intervention group used the Peri Bugi application, whereas those in the control group used the printed booklet. Educational materials were delivered progressively, with one chapter released each week over a four-week period. Participants were also required to complete morning and evening toothbrushing checklists. Coordination regarding chapter release schedules was conducted through WhatsApp groups.
    • Post-Intervention Assessment: One month after baseline, all participants completed a posttest involving the same assessments administered at baseline. In addition, participants in the intervention group completed an application usability assessment.

Assessment Tools:

Oral Health Literacy: The REALD-30 questionnaire (Lee et al., 2007) was used to assess mothers' oral health literacy through recognition of dental terminology. Scores were converted to a 0-100 scale, with higher scores indicating better oral health literacy. The questionnaire was administered at both pretest and posttest.

Children's Oral Health Status: The Debris Index-Simplified (DI-S) was used to assess oral hygiene status, while the Modified Gingival Index (mGI) was used to evaluate gingival health. Both measurements were conducted at pretest and posttest by calibrated dentists.

Application Usability: The Mobile Health App Usability Questionnaire (MAUQ) (Zhou et al., 2019), consisting of three subscales and a 7-point Likert scale, was administered to participants in the intervention group at posttest. Lower scores indicated better usability according to the scoring system applied in this study.

Assessment Tools:

  • Oral Health Literacy: The REALD-30 questionnaire (Lee et al., 2007) was used to assess mothers' oral health literacy through recognition of dental terminology. Scores were converted to a 0-100 scale, with higher scores indicating better oral health literacy. The questionnaire was administered at both pretest and posttest.
  • Children's Oral Health Status: The Debris Index-Simplified (DI-S) was used to assess oral hygiene status, while the Modified Gingival Index (mGI) was used to evaluate gingival health. Both measurements were conducted at pretest and posttest by calibrated dentists.
  • Application Usability: The Mobile Health App Usability Questionnaire (MAUQ) (Zhou et al., 2019), consisting of three subscales and a 7-point Likert scale, was administered to participants in the intervention group at posttest. Higher scores indicated better usability according to the scoring system applied in this study.

研究类型

介入性

注册 (实际的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • West Java
      • Depok、West Java、印度尼西亚
        • Seven preschools in Pancoran Mas

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Mothers with a child aged 3-7 years (preschool-aged child).
  • Mothers who own a smartphone and are able to download and install applications.
  • Mothers who have internet access and actively use the internet.
  • Mothers who are willing and cooperative to participate in the study from enrollment until study completion.
  • Preschool children aged 3-7 years.
  • Children enrolled in a preschool located in Pancoran Mas, Depok City.

Exclusion Criteria:

  • Mothers who were unwilling to sign the informed consent form.
  • Mothers or children with physical or mental disabilities (e.g., Down syndrome, hearing impairment, visual impairment, cerebral palsy, or other developmental or physical disabilities).
  • Children with congenital diseases or congenital anomalies.
  • Children with systemic diseases, such as congenital heart disease, epilepsy, thalassemia, hemophilia, or other systemic medical conditions.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Group (Peri Bugi Mobile Application)
Mothers in this group received oral health education through the Peri Bugi mHealth application, a notification- and reminder-based platform equipped with a rule-based AI system that personalized the frequency of educational messages based on quiz scores and compliance with the toothbrushing checklist. Educational materials consisting of four chapters were delivered progressively, with one chapter released each week over a four-week period. In addition, participants received toothbrushing reminder notifications at 6:30 a.m. and 8:00 p.m.
Peri Bugi is an mHealth-based oral health education application developed for Android and iOS devices. The application comprises five main features: Literacy (a four-chapter flipbook containing oral health educational content), Quiz, Toothbrushing Song, Toothbrushing Checklist, and Settings. It provides daily reminder notifications and utilizes a rule-based artificial intelligence (AI) system to personalize dental health education messages based on users' quiz performance and adherence to the toothbrushing checklist.
有源比较器:Control Group (Printed Booklet)
Mothers in the control group received oral health education through a printed booklet containing content equivalent to that provided in the application. The educational materials, consisting of four chapters, were delivered progressively, with one chapter provided each week over a four-week period for self-directed learning.
A printed text-based oral health education booklet comprising four chapters with content equivalent to that provided in the Peri Bugi application. The booklet was intended for self-directed learning and did not incorporate any notification, reminder, or personalized educational messaging features

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Maternal Oral Health Literacy Score (REALD-30 Questionnaire)
大体时间:Baseline (pretest) and 1 month post-intervention (posttest)
Change in mothers' oral health literacy, measured using the Rapid Estimation of Adult Literacy in Dentistry (REALD-30) questionnaire. Scores range from 0 to 30, with each correctly recognized dental term scored as 1 and each incorrectly recognized term scored as 0. Higher scores indicate better oral health literacy. Changes in scores are assessed by comparing pretest and posttest measurements.
Baseline (pretest) and 1 month post-intervention (posttest)
Children's Oral Hygiene Status (DI-S)
大体时间:Baseline (pretest) and 1 month post-intervention (posttest)
Change in the oral hygiene status of preschool children, measured using the Debris Index-Simplified (DI-S) based on the extent of soft debris present on the surfaces of index teeth (score range: 0-3 per tooth surface). Lower scores indicate better oral hygiene. Examinations are performed by calibrated dentists. Changes are assessed by comparing pretest and posttest measurements.
Baseline (pretest) and 1 month post-intervention (posttest)
Children's Gingival Health Status (m-GI)
大体时间:Baseline (pretest) and 1 month post-intervention (posttest)
Change in the gingival health status of preschool children, measured using the Modified Gingival Index (mGI) based on the severity of gingival inflammation. Lower scores indicate healthier gingival conditions. Examinations are conducted by calibrated dentists. Changes are assessed by comparing pretest and posttest measurements.
Baseline (pretest) and 1 month post-intervention (posttest)

次要结果测量

结果测量
措施说明
大体时间
Application Usability Score (MAUQ)
大体时间:1 month post-intervention (posttest)
Mothers' perceptions of the usefulness and ease of use of the Peri Bugi application, measured using the Mobile Health App Usability Questionnaire (MAUQ). The MAUQ consists of three subscales: ease of use and satisfaction, system information arrangement, and efficiency, using a 7-point Likert scale. Lower scores indicate better usability according to the scoring system used in this study. This outcome is assessed only among participants in the intervention group.
1 month post-intervention (posttest)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Risqa Rina Darwita, Prof.、Indonesia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月15日

初级完成 (实际的)

2024年12月3日

研究完成 (实际的)

2024年12月9日

研究注册日期

首次提交

2026年8月16日

首先提交符合 QC 标准的

2026年8月16日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月16日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 61/Ethical Approval/FKGUI/IX/2
  • PKS 149/UN2.RST/HKP.05.00/2025 (其他赠款/资助编号:Universitas Indonesia PUTI Q1 Equity Grant 2025)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be made publicly available in order to maintain the confidentiality and privacy of participants (mothers and preschool-aged children), in accordance with the requirements of the ethics approval.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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