Digital InterventionNCT07139561
A Digital Intervention to Improve Oral Health Practices
A study testing Oral Health in Hands - Parent Digital Program in people with Digital Intervention and Oral Health Behavior Change, run by Universiti Putra Malaysia at 4 sites in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Intervention, Oral Health Behavior Change
- What is being tested?
- Oral Health in Hands - Parent Digital Program
- 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
- 800 participants
- Where
- 4 sitesPakistan
- Study dates
- 18 Aug 2025to 18 Feb 2026
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan4 sites
Baqai Medical complex school
Karachi, Sindh, 74600
Mehwish Raheem, MPH, O3137774464, kiranmehwish47@gmail.com
Saleem ullah fahmi memorial school unit 1
Karachi, Sindh, 74600
Muhammad Rashed, MPhil, 00923337474991, stunning003@gmail.com
Saleem ullah fahmi school baqai Medical complex gharo, Karachi
Karachi, Sindh, 74600
Samreen, BDS, 03150228348, muhammad.raashed.eph@gmail.com
White house grammar School
Khanpur, Punjab Province, 54590
shahzain shahzain, MBBS, 03337474464, shahzainmomn009@mail.com
About this study
Official title: Oral Health in Hands: A Digital Intervention to Improve Oral Health Practices in Children
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.
- Conditions
- Digital Intervention, Oral Health Behavior Change
- Being tested
- Oral Health in Hands - Parent Digital Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health in Hands - Parent Digital ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be given no intervention other than they will receive routinely |
| Intervention arm | Experimental | 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. Receives: Behavioral: Oral Health in Hands - Parent Digital Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-months
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
Measured: 4-months
Secondary outcomes (2)
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
Measured: 4-months
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
Measured: 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion18 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Digital InterventionStudies 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
- It is two arm randomized control trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 800 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
- NCT07139561
- Sponsor's protocol ID
- BMU-BBC
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals
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 26631059Lee 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 29458358Machado 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 32291154Abduljalil 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health in Hands: A Digital Intervention to Improve Oral Health Practices in Children
- ClinicalTrials.gov ID
- NCT07139561
- Acronym / sponsor ID
- BMU-BBC
- Conditions
- Digital Intervention, Oral Health Behavior Change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 18 Feb 2026 (estimated)
- First posted
- 24 Aug 2025 (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 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- It is two arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be given no intervention other than they will receive routinely |
| Intervention arm | Experimental | Behavioral: Oral Health in Hands - Parent Digital ProgramOral 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Oral Health in Hands - Parent Digital ProgramThe 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 | Behavioural | Intervention arm |
Primary outcome
Oral health practices
Time frame: 4-months
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.
Oral Hygiene
Time frame: 4-months
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
2 secondary outcomes
Plaque score
Time frame: 4-months
Gingival score
Time frame: 4-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 24 Aug 2025.
- Results publication: PubMed 26631059Li 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.
- Results publication: PubMed 29458358Lee 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.
- Results publication: PubMed 32291154Machado 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.
- Results publicationAbduljalil 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.
- Results publication: PubMed 30430070Alqarni 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.
- Individual participant dataSharing planned: No. Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health in Hands - Parent Digital Program in people with Digital Intervention and Oral Health Behavior Change, run by Universiti Putra Malaysia at 4 sites 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 5 inclusion and 4 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 MUHAMMAD ARSHED, 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?
Oral health practices (time frame: 4-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07139561, which also lists 5 linked publications.
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 24 Aug 2025.