Effective Implementation Control Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversiti Putra Malaysia
About this trial
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.
Eligibility criteria
Qualifiers
Parent or primary caregiver of a child enrolled in a participating primary school.
Child aged 5-12 years (or the age range specified by the study).
Parent or caregiver owns or has regular access to a smartphone with an active WhatsApp account.
Parent or caregiver is able to read and understand the study language(s) (e.g., Urdu and/or English).
Disqualifiers
Parent or caregiver declines or withdraws informed consent.
Child has a medical, developmental, or cognitive condition that would prevent participation in routine oral health assessments or toothbrushing activities, as determined by the investigators.
Child is currently participating in another oral health intervention or clinical trial that could influence the study outcomes.
Parent or caregiver plans to relocate or anticipates being unavailable during the study follow-up period.
Trial design
Treatments tested in this trial
- SmileConnect
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov