An interventional study of SmileConnect in Children, Family Engagement and Oral Health Behavior Change, sponsored by Universiti Putra Malaysia. Not yet recruiting at 1 site in Pakistan. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Health services research
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.
967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 150 across 824 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →Universiti Putra Malaysia is the lead sponsor of 145 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Parents receive a theory-driven digital oral health programme via WhatsApp, including educational messages, reminder prompts, short videos, interactive quizzes, parent-child brushing activities, and behavioural support in addition to routine oral health education.
Behavioral: SmileConnect
Parents and children receive routine oral health education currently provided through schools or community health services, with no additional digital family engagement.
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.
Children's oral hygiene status
Children's oral hygiene status will be measured by Oral Hygiene Index-Simplified (OHI-S). Six index teeth examined. Debris Index (0-3) + Calculus Index (0-3); total score 0-6. Lower scores indicate better oral hygiene. Excellent: 0-1.2; Fair: 1.3-3.0; Poor: 3.1-6.0.
Time frame: 6 Months
Parent-supervised twice-daily toothbrushing
Number of days/week supervised (0-7) or Yes/No for morning and bedtime brushing. Higher scores indicate better supervision.
Time frame: 6 Months
Child toothbrushing frequency
Times brushed/day (0-3+). Categorized as \<2/day or ≥2/day.
Time frame: 6 Months
Toothbrushing technique
Checklist (e.g., 10-12 steps). Score 0-10 or 0-12. Higher scores indicate better brushing technique.
Time frame: 6 Months
Dietary behaviours (sugary foods/drinks)
Frequency/week or/day. Lower frequency indicates healthier dietary behaviour.
Time frame: 6 Months
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)
The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) are measured by validated 4-item psychometric survey scales using a 5-point Likert scale ranging from 1 ("completely disagree") to 5 ("completely agree"), with a total score of 4-20 or a mean score. Higher scores indicate greater acceptability. There are no official cut-off scores or universal norms yet.
Time frame: 6 Months
Fidelity
Percentage (%) of intervention components delivered as planned. Higher percentages indicate better fidelity.
Time frame: 6 Months
Reach
Reach will be assessed as the proportion of eligible parents who enroll in and are exposed to the digital family engagement intervention. Measures will include: (1) participation rate, calculated as the number of parents enrolled divided by the number of eligible parents approached, multiplied by 100; (2) intervention exposure rate, calculated as the proportion of enrolled parents who successfully receive at least one WhatsApp intervention message; and (3) retention rate, calculated as the proportion of enrolled parents who remain contactable and continue participation at 6 months. Higher percentages indicate greater reach.
Time frame: 6 months
Digital Engagement
Measured using indicators such as messages delivered, messages read, videos opened/viewed, quizzes completed, reactions or replies, and completion of weekly activities. Indicators may be reported separately and combined into a prespecified engagement score. Higher values indicate greater engagement.
Time frame: 6 months
Plan to share: No — Individual participant data (IPD) will not be shared at this time due to ethical, institutional, and participant confidentiality considerations. Aggregate study results will be published, and any future data-sharing requests will be considered in accordance with applicable ethics approvals and institutional policies.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.
Of 567 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 8 months is below that.
Counting every sponsor, half of 585 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.