NCT07139561

Brief Summary

This study evaluates a 16-week parent-focused digital intervention to improve oral health practices in children aged 6-10 through daily reminders, quizzes, challenges, gamification, and behavior tracking, supported by an optional moderated WhatsApp group for peer engagement and motivation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 17, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 17, 2025

Last Update Submit

August 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Oral health practices

    Oral health practices by using the WHO Child Oral Health Questionnaire: o assess children's oral health practices through a structured set of questions. These questionnaires typically cover knowledge, attitude, and practices related to oral hygiene, including frequency of brushing, use of fluoride toothpaste, and dental visits. The score is used to evaluate the overall oral health practices of the child, often categorized as good, fair, or poor.

    4-months

  • Oral Hygiene

    Oral Hygiene will be assessed by the presence of debris (plaque) and calculus (tartar) on selected tooth surfaces, measured by the Simplified Oral Hygiene Index (OHI-S) Individual Debris Index (DI-S) and Calculus Index (CI-S): Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale: 0: No debris or calculus is present. 1: Debris or calculus covers less than one-third of the surface. 2: Debris or calculus covers between one-third and two-thirds of the surface. 3: Debris or calculus covers more than two-thirds of the surface. Good: 0.0 - 1.2 Fair: 1.3 - 3.0 Poor: 3.1 - 6.0

    4-months

Secondary Outcomes (2)

  • Plaque score

    4-months

  • Gingival score

    4-months

Study Arms (2)

Control

NO INTERVENTION

The control group will be given no intervention other than they will receive routinely

Intervention arm

EXPERIMENTAL

Oral Health in Hands - Parent Digital Program: The intervention includes daily reminders with two brushing cues and one snack tip to reinforce habits. Weekly quizzes with 3-5 questions assess knowledge, while photo/video tasks such as "Show your foam smile" or "Healthy lunchbox challenge" keep engagement high. Gamification features badges for streaks like a 7-day brushing badge or snack swap champion. Parents track brushing, flossing, and snack swaps via a 1-tap tracker, supported by an optional moderated WhatsApp group.

Behavioral: Oral Health in Hands - Parent Digital Program

Interventions

The 16-week parent-focused digital intervention aims to improve oral health practices in children aged 6-10 by empowering parents through structured, engaging, and cost-effective activities. Parents receive daily reminders, including two brushing cues and one snack tip, to reinforce healthy routines. Weekly quizzes with 3-5 questions enhance knowledge retention, while interactive photo or video tasks such as "Show your foam smile" or "Healthy lunchbox challenge" promote family involvement and fun. Gamification strategies include awarding digital badges for streaks, such as the 7-day brushing badge and snack swap champion, to maintain motivation. Parents track brushing, flossing, and snack swaps using a simple 1-tap tracker, ensuring easy and consistent reporting. An optional moderated WhatsApp group provides a platform for sharing tips, photos, and encouragement, fostering a supportive peer community. The intervention combines education, habit formation, and social support to sustainab

Intervention arm

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents or primary caregivers of children aged 6-10 years.
  • Child must be free from major systemic illnesses or developmental disabilities that could interfere with oral hygiene practices.
  • Parent/caregiver owns a smartphone with access to WhatsApp or similar digital platform.
  • Ability to read or understand Urdu or English instructions.
  • Willingness to participate for the full 12-week duration and provide informed consent.

You may not qualify if:

  • Children with serious medical conditions (e.g., immunodeficiency, congenital anomalies) that may affect oral health.
  • Parents or children currently enrolled in another oral health education or digital intervention program.
  • Children who have received professional oral health education or structured interventions within the past 4 months.
  • Parents/caregivers unwilling or unable to comply with digital reporting and participation requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

White house grammar School

Chak Number Two North Branch, Punjab Province, 54590, Pakistan

Location

Baqai Medical complex school

Karachi, Sindh, 74600, Pakistan

Location

Saleem ullah fahmi memorial school unit 1

Karachi, Sindh, 74600, Pakistan

Location

Saleem ullah fahmi school baqai Medical complex gharo, Karachi

Karachi, Sindh, 74600, Pakistan

Location

Related Publications (5)

  • Li X, Xu ZR, Tang N, Ye C, Zhu XL, Zhou T, Zhao ZH. Effect of intervention using a messaging app on compliance and duration of treatment in orthodontic patients. Clin Oral Investig. 2016 Nov;20(8):1849-1859. doi: 10.1007/s00784-015-1662-6. Epub 2015 Dec 2.

    PMID: 26631059BACKGROUND
  • Lee JA, Choi M, Lee SA, Jiang N. Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review. BMC Med Inform Decis Mak. 2018 Feb 20;18(1):12. doi: 10.1186/s12911-018-0591-0.

    PMID: 29458358BACKGROUND
  • Machado RA, de Souza NL, Oliveira RM, Martelli Junior H, Bonan PRF. Social media and telemedicine for oral diagnosis and counselling in the COVID-19 era. Oral Oncol. 2020 Jun;105:104685. doi: 10.1016/j.oraloncology.2020.104685. Epub 2020 Apr 10. No abstract available.

    PMID: 32291154BACKGROUND
  • Abduljalil HS, Abuaffan AH. 'Knowledge and practice of mothers in relation to dental health of pre-school children. Adv Genet Eng. 2016;5:1-7. https://doi.org/10.4172/2169-0111.1000153.

    BACKGROUND
  • Alqarni AA, Alfaifi HM, Aseeri NA, Gadah T, Togoo RA. Efficacy of a Self-Designed Mobile Application to Improve Child Dental Health Knowledge among Parents. J Int Soc Prev Community Dent. 2018 Sep-Oct;8(5):424-430. doi: 10.4103/jispcd.JISPCD_195_18. Epub 2018 Oct 8.

    PMID: 30430070BACKGROUND

MeSH Terms

Interventions

Oral Health

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Central Study Contacts

MUHAMMAD ARSHED, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Investigators and outcome assessors will be blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: It is two arm randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 17, 2025

First Posted

August 24, 2025

Study Start

August 18, 2025

Primary Completion

February 15, 2026

Study Completion

February 18, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals

Locations