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Not yet recruitingNCT07139561Updated Aug 24, 2025

A Digital Intervention to Improve Oral Health Practices

An interventional study of Oral Health in Hands - Parent Digital Program in Digital Intervention and Oral Health Behavior Change, sponsored by Universiti Putra Malaysia. Not yet recruiting at 4 sites in Pakistan. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study 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.

Read the detailed description

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.

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Conditions studied

  • Digital Intervention
  • Oral Health Behavior Change
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In context

Lead sponsor

Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.

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

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Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
800 participants (estimated)

Study arms

  • No intervention
    Control

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

  • Experimental
    Intervention arm

    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

  • BehavioralOral Health in Hands - Parent Digital Program

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4-months

  2. 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

    Time frame: 4-months

Secondary outcomes

  1. Plaque score

    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

    Time frame: 4-months

  2. Gingival score

    Gingival score assessed by the gingival score index: 0: Normal gingiva, no inflammation. 1: Mild inflammation - slight color change and edema (swelling), no bleeding on probing. 2: Moderate inflammation - redness, edema, glazing, and bleeding on probing. 3: Severe inflammation - marked redness, edema, ulceration, and tendency towards spontaneous bleeding. The index typically uses a scale of 0 to 3, with 0 representing normal gingiva and higher scores indicating increasing severity of inflammation

    Time frame: 4-months

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Study locations

4 sites
  • White house grammar School
    Khanpur, Punjab Province 54590, Pakistan
  • Baqai Medical complex school
    Karachi, Sindh 74600, Pakistan
  • Saleem ullah fahmi memorial school unit 1
    Karachi, Sindh 74600, Pakistan
  • Saleem ullah fahmi school baqai Medical complex gharo, Karachi
    Karachi, Sindh 74600, Pakistan
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References and documents

Publications

  • 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. PubMed 26631059 ↗
  • 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. PubMed 29458358 ↗
  • 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. PubMed 32291154 ↗
  • 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.
  • 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. PubMed 30430070 ↗

Individual participant data

Plan to share: No — Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07139561
Lead sponsor
Universiti Putra Malaysia
Responsible party
Arshed Muhammad (PhD, Universiti Putra Malaysia) — Principal investigator
First posted
Aug 24, 2025
Start date
Aug 18, 2025 (estimated)
Primary completion
Feb 15, 2026 (estimated)
Completion
Feb 18, 2026 (estimated)
Last update
Aug 24, 2025

Study contacts

MUHAMMAD ARSHED, PhD
Contact
drarshedchaudhary@gmail.com
+923337474464

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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