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CompletedNCT07774910REMINDUpdated Aug 19, 2026

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

An interventional study of Peri Bugi Mobile Application and Printed Booklet in Application, Oral Health and Oral Health Literacy, sponsored by Pani Matin Anugrah. Completed at 1 site in Indonesia. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Pani Matin Anugrah · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2024, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
3 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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.
02

Conditions studied

  • Application
  • Oral Health
  • Oral Health Literacy
  • Oral Hygiene

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Keywords

  • Notification and reminder application
  • Rule-based Artificial Intelligence
  • Dental health education
  • Maternal oral health literacy
  • Oral health hygiene
  • Preschool children
  • Mothers
03

In context

Literacy

201 studies on the registry are indexed under Literacy; 69 are open to participants now.

This study's enrollment of 200 is above the median of 124 across 170 interventional studies indexed under Literacy.

Browse Literacy studies →

Lead sponsor

This is the only study on the registry with Pani Matin Anugrah as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Mothers who were unwilling to sign the 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Peri Bugi Mobile Application

  • Active comparator
    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.

    Behavioral: Printed Booklet

Interventions

  • BehavioralPeri Bugi Mobile Application

    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.

  • BehavioralPrinted Booklet

    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

06

What researchers measure

Primary outcomes

  1. Maternal Oral Health Literacy Score (REALD-30 Questionnaire)

    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.

    Time frame: Baseline (pretest) and 1 month post-intervention (posttest)

  2. Children's Oral Hygiene Status (DI-S)

    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.

    Time frame: Baseline (pretest) and 1 month post-intervention (posttest)

  3. Children's Gingival Health Status (m-GI)

    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.

    Time frame: Baseline (pretest) and 1 month post-intervention (posttest)

Secondary outcomes

  1. Application Usability Score (MAUQ)

    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.

    Time frame: 1 month post-intervention (posttest)

07

Study locations

1 site
  • Seven preschools in Pancoran Mas
    Depok, West Java, Indonesia
08

References and documents

Publications

  • Shirmohammadi M, Razeghi S, Shamshiri AR, Mohebbi SZ. Impact of smartphone application usage by mothers in improving oral health and its determinants in early childhood: a randomised controlled trial in a paediatric dental setting. Eur Arch Paediatr Dent. 2022 Aug;23(4):629-639. doi: 10.1007/s40368-022-00731-9. Epub 2022 Jul 16. PubMed 35841512 ↗
  • Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500. PubMed 30973342 ↗
  • Lee JY, Rozier RG, Lee SY, Bender D, Ruiz RE. Development of a word recognition instrument to test health literacy in dentistry: the REALD-30--a brief communication. J Public Health Dent. 2007 Spring;67(2):94-8. doi: 10.1111/j.1752-7325.2007.00021.x. PubMed 17557680 ↗
  • Lozoya CJS, Giblin-Scanlon L, Boyd LD, Nolen S, Vineyard J. Influence of a Smartphone Application on the Oral Health Practices and Behaviors of Parents of Preschool Children. J Dent Hyg. 2019 Oct;93(5):6-14. PubMed 31628171 ↗
  • Nolen SL, Giblin-Scanlon LJ, Boyd LD, Rainchuso L. Development and Testing of a Smartphone Application Prototype for Oral Health Promotion. J Dent Hyg. 2018 Apr;92(2):6-14. PubMed 29739842 ↗
  • Wu K, Yin W, Liang X, Zou L, Yang Z. The influence of parents' oral health literacy and behavior on oral health of preschool children aged 3-6 years- evidence from China. BMC Oral Health. 2024 Nov 28;24(1):1445. doi: 10.1186/s12903-024-05213-6. PubMed 39604904 ↗
  • Adil AH, Eusufzai SZ, Kamruddin A, Wan Ahmad WMA, Jamayet NB, Karobari MI, Alam MK. Assessment of Parents' Oral Health Literacy and Its Association with Caries Experience of Their Preschool Children. Children (Basel). 2020 Aug 18;7(8):101. doi: 10.3390/children7080101. PubMed 32824693 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07774910
Lead sponsor
Pani Matin Anugrah
Responsible party
Pani Matin Anugrah (Principal Investigator / Master's Student, Indonesia University) — Sponsor-investigator
First posted
Aug 19, 2026
Start date
Jul 15, 2024
Primary completion
Dec 3, 2024
Completion
Dec 9, 2024
Last update
Aug 19, 2026

Study contacts

Risqa Rina Darwita, Prof.
principal investigator · Indonesia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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