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Effective Implementation Control Trial

NCT07736443 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-07-30

No results posted yet for this study

Summary

This study will evaluate the effectiveness and implementation of a theory-driven, WhatsApp-based family engagement intervention designed to improve oral health among primary school children. Parents or primary caregivers will be randomly assigned (individually or by school, depending on the study design) to either receive the digital intervention or usual care. The intervention will deliver structured oral health education, behaviour-change messages, reminder prompts, short videos, interactive quizzes, and parent-child brushing activities through WhatsApp over a predefined intervention period (e.g., 6-12 months).

The primary effectiveness outcomes will include improvements in children's oral hygiene status (e.g., OHI-S, Plaque Index, Gingival Index, and dental caries where appropriate) and oral health behaviours such as twice-daily toothbrushing and reduced sugary snack consumption. Secondary outcomes may include parental oral health literacy, self-efficacy, and supervised brushing practices.

Alongside effectiveness, the study will assess implementation outcomes-including acceptability, feasibility, adoption, fidelity, reach, and sustainability-to determine whether the intervention can be successfully integrated into routine school and community oral health programmes. Findings will provide evidence on both whether the intervention works and how it can be implemented and scaled in low- and middle-income countries.

Conditions

  • Children
  • Family Engagement
  • Oral Health Behavior Change

Interventions

BEHAVIORAL

SmileConnect

SmileConnect is a theory-driven, WhatsApp-based family engagement programme designed to improve children's oral health by supporting parents with structured educational content, behaviour-change messages, reminder prompts, short videos, interactive quizzes, parent-child toothbrushing activities, motivational feedback, and reinforcement strategies. The intervention is grounded in behavioural science and aims to promote sustainable oral hygiene practices while facilitating scalable implementation within school and community settings.

Sponsors & Collaborators

  • Universiti Putra Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07736443 on ClinicalTrials.gov