NCT07774910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 16, 2026

Last Update Submit

August 16, 2026

Conditions

Keywords

Notification and reminder applicationRule-based Artificial IntelligenceDental health educationMaternal oral health literacyOral health hygienePreschool childrenMothers

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline (pretest) and 1 month post-intervention (posttest)

  • 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.

    Baseline (pretest) and 1 month post-intervention (posttest)

  • 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.

    Baseline (pretest) and 1 month post-intervention (posttest)

Secondary Outcomes (1)

  • Application Usability Score (MAUQ)

    1 month post-intervention (posttest)

Study Arms (2)

Intervention Group (Peri Bugi Mobile Application)

EXPERIMENTAL

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

Control Group (Printed Booklet)

ACTIVE COMPARATOR

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

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.

Intervention Group (Peri Bugi Mobile Application)
Printed BookletBEHAVIORAL

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

Control Group (Printed Booklet)

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seven preschools in Pancoran Mas

Depok, West Java, Indonesia

Location

Related Publications (7)

  • 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.

    PMID: 35841512BACKGROUND
  • 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.

    PMID: 30973342BACKGROUND
  • 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.

    PMID: 17557680BACKGROUND
  • 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.

    PMID: 31628171BACKGROUND
  • 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.

    PMID: 29739842BACKGROUND
  • 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.

    PMID: 39604904BACKGROUND
  • 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.

    PMID: 32824693BACKGROUND

Study Officials

  • Risqa Rina Darwita, Prof.

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator / Master's Student

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 19, 2026

Study Start

July 15, 2024

Primary Completion

December 3, 2024

Study Completion

December 9, 2024

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations