An interventional study of OHE for children and OHE for parents in Oral Hygiene, sponsored by The University of Hong Kong. Not yet recruiting. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention
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.
The University of Hong Kong is the lead sponsor of 1,289 studies on the registry; 345 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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:
Behavioral: OHE for children
Behavioral: OHE for children · Behavioral: OHE for parents
Behavioral: OHE for children · Behavioral: OHE for parents · Behavioral: OHE interactive game kits
OHE information on favourable dental care routines will be introduced.
A set of OHE materials will also be distributed to parents, illustrating how to prevent dental caries and periodontal diseases for parents.
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.
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)。
Time frame: Baseline, 3, 6, and 12 months.
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).
Time frame: Baseline and 12 months.
Caries activity
Caries activity will be assessed using the Cariostat kit (Hebei Gang Da Medical Technology Co., Ltd).
Time frame: Baseline, 3, 6, and 12 months.
Dental anxiety (cooperation with dental check-up)
Frankl Behavior Rating Scale
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, and 12 months.
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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