Oral HygieneNCT07916896
Game-based Oral Health Promotion
A study testing OHE for children, OHE for parents and OHE interactive game kits in people with Oral Hygiene, run by The University of Hong Kong.
Trial summary
Parents and caregivers play a key role in shaping children's oral health-related behaviours. However, traditional oral health education (OHE) is not engaging for young children. Game-based learning provides an interactive and enjoyable approach that may improve children's interest, motivation, and understanding. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- OHE for children, OHE for parents and OHE interactive game kits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2026to 1 Mar 2029
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- i) aged between 3 and 6 years;
- ii) able to cooperate with intra-oral examinations;
- iii) without intellectual or developmental disabilities; and
- iv) without severe systemic diseases.
Who cannot join
- i) children with developmental disabilities or severe systemic diseases;
- ii) children with severe dental anxiety who are unable to cooperate with intra-oral examination or health education activities;
- iii) children who have recently received other oral health education interventions;
- vi) left-behind children, or children who do not live with their parents; and
- v) children whose legal guardians are not their own parents.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Parent-Child Interactive Game-based Oral Health Promotion for Preschool Children
Parents and caregivers play a key role in shaping children's oral health-related behaviours. However, traditional oral health education (OHE) is not engaging for young children. Game-based learning provides an interactive and enjoyable approach that may improve children's interest, motivation, and understanding. Parent-child interactive games may also encourage communication, shared learning, and behaviour reinforcement at home.
Therefore, the proposed study aims to investigate the efficacy of parent-child interactive game (PCIG)-based OHE in promoting oral health among preschool children. A total of 282 children will be recruited from kindergartens. They will be randomly allocated into three groups with a 1:1:1 ratio, and receive the following interventions: i) Conventional OHE for children only; ii) Conventional OHE for children and parents; and iii) Interactive game-based OHE for children and parents.
The primary outcome is children's oral hygiene status, while the secondary outcome is caries status, caries activity, oral health-related behaviours, dental anxiety, and screen time. We anticipate that children in Group 3 will have better oral hygiene status, lower caries incidence, reduced caries activity, more favourable oral health-related behaviours, lower dental anxiety, and less screen time. If proven effective, family-based OHE can be recommended on a large scale to improve oral health at the family level.
- Conditions
- Oral Hygiene
- Being tested
- OHE for children, OHE for parents, OHE interactive game kits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHE for childrenBehavioural
OHE information on favourable dental care routines will be introduced.
OHE for parentsBehavioural
A set of OHE materials will also be distributed to parents, illustrating how to prevent dental caries and periodontal diseases for parents.
OHE interactive game kitsBehavioural
A package of OHE game kits for toothbrushing, dietary instruction, and min-dentist role-play will be provided, and children will be encouraged to be mini dentists who teach their parents how to brush their teeth and choose tooth-friendly foods.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Behavioral: OHE for children |
| Group 2 | Active comparator | Not described Receives: Behavioral: OHE for children; Behavioral: OHE for parents |
| Group 3 | Experimental | Not described Receives: Behavioral: OHE for children; Behavioral: OHE for parents; Behavioral: OHE interactive game kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene
Six index teeth (#55B, #51B, #65B, #75L, #71B, and #85L) will be selected to assess the oral hygiene status using the Simplified Debris Index (DI-S)。
Measured: Baseline, 3, 6, and 12 months.
Secondary outcomes (7)
Dental caries
Caries status will be evaluated by the number of decayed, missing due to caries, and filled teeth (dmft), following the criteria proposed by the World Health Organization (WHO, 2013).
Measured: Baseline and 12 months.
Caries activity
Caries activity will be assessed using the Cariostat kit (Hebei Gang Da Medical Technology Co., Ltd).
Measured: Baseline, 3, 6, and 12 months.
Dental anxiety (cooperation with dental check-up)
Frankl Behavior Rating Scale
Measured: Baseline, 3, 6, and 12 months.
Dental anxiety percieved by children
A 5-point Likert Facial Image Scale (FIS) will be used to assess a child's dental anxiety during a dental visit
Measured: Baseline, 3, 6, and 12 months.
Dental anxiety perceived by parents
Dental anxiety will be reported by parents using a simplified 5-item instrument, Modified Dental Anxiety Scale (MDAS).
Measured: Baseline, 6, and 12 months.
Oral health-related behaviours
Toothbrushing frequency (twice daily or not), toothbrushing duration (less than 2 min, 2 min or more), snacking frequency (once daily or less, twice daily, three times per day, or over 3 times) will be reported by parents via questionnaires.
Measured: Baseline, 6, and 12 months.
Screen time
The duration of time (h) a child spends in watching video or using digital devices will be reported by parents via questionnaires.
Measured: Baseline, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start21 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU Ni, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916896
- Sponsor's protocol ID
- UW 26-402
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Child Interactive Game-based Oral Health Promotion for Preschool Children
- ClinicalTrials.gov ID
- NCT07916896
- Acronym / sponsor ID
- UW 26-402
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 21 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 4 Nov 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.
Parents and caregivers play a key role in shaping children's oral health-related behaviours. However, traditional oral health education (OHE) is not engaging for young children. Game-based learning provides an interactive and enjoyable approach that may improve children's interest, motivation, and understanding. Parent-child interactive games may also encourage communication, shared learning, and behaviour reinforcement at home.
Therefore, the proposed study aims to investigate the efficacy of parent-child interactive game (PCIG)-based OHE in promoting oral health among preschool children. A total of 282 children will be recruited from kindergartens. They will be randomly allocated into three groups with a 1:1:1 ratio, and receive the following interventions: i) Conventional OHE for children only; ii) Conventional OHE for children and parents; and iii) Interactive game-based OHE for children and parents.
The primary outcome is children's oral hygiene status, while the secondary outcome is caries status, caries activity, oral health-related behaviours, dental anxiety, and screen time. We anticipate that children in Group 3 will have better oral hygiene status, lower caries incidence, reduced caries activity, more favourable oral health-related behaviours, lower dental anxiety, and less screen time. If proven effective, family-based OHE can be recommended on a large scale to improve oral health at the family level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: OHE for children |
| Group 2 | Active comparator | Behavioral: OHE for children, Behavioral: OHE for parents |
| Group 3 | Experimental | Behavioral: OHE for children, Behavioral: OHE for parents, Behavioral: OHE interactive game kits |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- i) aged between 3 and 6 years;
- ii) able to cooperate with intra-oral examinations;
- iii) without intellectual or developmental disabilities; and
- iv) without severe systemic diseases.
Key exclusion criteria (5 listed)
- i) children with developmental disabilities or severe systemic diseases;
- ii) children with severe dental anxiety who are unable to cooperate with intra-oral examination or health education activities;
- iii) children who have recently received other oral health education interventions;
- vi) left-behind children, or children who do not live with their parents; and
- v) children whose legal guardians are not their own parents.
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 |
|---|---|---|
| OHE for childrenOHE information on favourable dental care routines will be introduced. | Behavioural | Group 1, Group 2, Group 3 |
| OHE for parentsA set of OHE materials will also be distributed to parents, illustrating how to prevent dental caries and periodontal diseases for parents. | Behavioural | Group 2, Group 3 |
| OHE interactive game kitsA package of OHE game kits for toothbrushing, dietary instruction, and min-dentist role-play will be provided, and children will be encouraged to be mini dentists who teach their parents how to brush their teeth and choose tooth-friendly foods. | Behavioural | Group 3 |
Primary outcome
Oral hygiene
Time frame: Baseline, 3, 6, and 12 months.
Six index teeth (#55B, #51B, #65B, #75L, #71B, and #85L) will be selected to assess the oral hygiene status using the Simplified Debris Index (DI-S)。
7 secondary outcomes
Dental caries
Time frame: Baseline and 12 months.
Caries activity
Time frame: Baseline, 3, 6, and 12 months.
Dental anxiety (cooperation with dental check-up)
Time frame: Baseline, 3, 6, and 12 months.
Dental anxiety percieved by children
Time frame: Baseline, 3, 6, and 12 months.
Dental anxiety perceived by parents
Time frame: Baseline, 6, and 12 months.
Oral health-related behaviours
Time frame: Baseline, 6, and 12 months.
Screen time
Time frame: Baseline, 6, and 12 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 4 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing OHE for children, OHE for parents and OHE interactive game kits in people with Oral Hygiene, run by The University of Hong Kong.
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 4 inclusion and 5 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ni ZHOU ((0852) 2859 0255, nizhou@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral hygiene (time frame: Baseline, 3, 6, and 12 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 4 Nov 2026.