ChildrenNCT07736443
Effective Implementation Control Trial
A study testing SmileConnect in people with Children and Family Engagement, run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Family Engagement, Oral Health Behavior Change
- What is being tested?
- SmileConnect
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
- Parent or caregiver is willing to receive WhatsApp messages throughout the intervention period.
- Parent or caregiver provides written informed consent; child provides assent where age-appropriate.
Who cannot join
- 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.
- Child requires urgent medical or dental care that would preclude participation, as judged by the study dentist (children identified with urgent dental needs during screening will be referred for appropriate care and their eligibility will be determined by the study protocol).
- More than one eligible child from the same household is enrolled; in such cases, one child will be selected according to the study protocol to maintain independence of observations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Baqai Medical University
Karachi, Sindh, 75340
Mehwish Kiran, MBBS, MPH, 03337474464, kiranmehwish47@gmail.com
About this study
Official title: A Theory-Driven Digital Family Engagement Intervention to Improve Children's Oral Health: A Hybrid Effectiveness-Implementation Cluster Randomized Controlled 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.
- Conditions
- Children, Family Engagement, Oral Health Behavior Change
- Being tested
- SmileConnect
- Keywords
- Children, Parents, Family Engagement, Children's oral health, family engagement, parents, caregiver engagement, WhatsApp, digital health, mHealth, oral health promotion, oral hygiene,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmileConnectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Theory-Driven WhatsApp Family Engagement Intervention | Experimental | 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. Receives: Behavioral: SmileConnect |
| Usual Oral Health Education | No intervention | Parents and children receive routine oral health education currently provided through schools or community health services, with no additional digital family engagement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (4)
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.
Measured: 6 Months
Child toothbrushing frequency
Times brushed/day (0-3+). Categorized as <2/day or ≥2/day.
Measured: 6 Months
Toothbrushing technique
Checklist (e.g., 10-12 steps). Score 0-10 or 0-12. Higher scores indicate better brushing technique.
Measured: 6 Months
Dietary behaviours (sugary foods/drinks)
Frequency/week or/day. Lower frequency indicates healthier dietary behaviour.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Schools will serve as the unit of randomization and will be randomly allocated in a 1:1 ratio to either the intervention or control arm using a computer-generated randomization sequence. Parents of children attending intervention schools will receive a theory-driven WhatsApp-based family engagement programme consisting of oral health education, behaviour-change messages, reminders, short videos, interactive activities, and parent-child toothbrushing challenges in addition to routine school oral health education. Parents of children in control schools will receive routine school oral health education only. Clinical and behavioural outcomes will be measured among participating children at baseline and follow-up by blinded, calibrated assessors. The trial will also evaluate implementation outcomes, including acceptability, adoption, feasibility, fidelity, reach, and sustainability, using a Hybrid Type 2 effectiveness-implementation design.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736443
- Sponsor's protocol ID
- BMUUUUU
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-Driven Digital Family Engagement Intervention to Improve Children's Oral Health: A Hybrid Effectiveness-Implementation Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07736443
- Acronym / sponsor ID
- BMUUUUU
- Conditions
- Children, Family Engagement, Oral Health Behavior Change
- Keywords
- Children, Parents, Family Engagement, Children's oral health, family engagement, parents, caregiver engagement, WhatsApp, digital health, mHealth, oral health promotion, oral hygiene,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Schools will serve as the unit of randomization and will be randomly allocated in a 1:1 ratio to either the intervention or control arm using a computer-generated randomization sequence. Parents of children attending intervention schools will receive a theory-driven WhatsApp-based family engagement programme consisting of oral health education, behaviour-change messages, reminders, short videos, interactive activities, and parent-child toothbrushing challenges in addition to routine school oral health education. Parents of children in control schools will receive routine school oral health education only. Clinical and behavioural outcomes will be measured among participating children at baseline and follow-up by blinded, calibrated assessors. The trial will also evaluate implementation outcomes, including acceptability, adoption, feasibility, fidelity, reach, and sustainability, using a Hybrid Type 2 effectiveness-implementation design.
| Arm | Type | Receives |
|---|---|---|
| Theory-Driven WhatsApp Family Engagement Intervention | Experimental | Behavioral: SmileConnectParents 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. |
| Usual Oral Health Education | No intervention | –Parents and children receive routine oral health education currently provided through schools or community health services, with no additional digital family engagement. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
- Parent or caregiver is willing to receive WhatsApp messages throughout the intervention period.
Key exclusion criteria (6 listed)
- 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.
- Child requires urgent medical or dental care that would preclude participation, as judged by the study dentist (children identified with urgent dental needs during screening will be referred for appropriate care and their eligibility will be determined by the study protocol).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmileConnectSmileConnect 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. | Behavioural | Theory-Driven WhatsApp Family Engagement Intervention |
Primary outcome
Children's oral hygiene status
Time frame: 6 Months
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.
4 secondary outcomes
Parent-supervised twice-daily toothbrushing
Time frame: 6 Months
Child toothbrushing frequency
Time frame: 6 Months
Toothbrushing technique
Time frame: 6 Months
Dietary behaviours (sugary foods/drinks)
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmileConnect in people with Children and Family Engagement, run by Universiti Putra Malaysia at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Muhammad Arshed, MBBS, MPH, PhD (+923337474464, drarshedchaudhary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's oral hygiene status (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.