Oral HealthNCT07097324
Interactive Video- and Game-Based Oral Health Education for 11-Year-Old Schoolchildren
A study testing Video- and Game-Based Oral Health Education and Conventional Oral Health Talk in people with Oral Health, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The goal of this cluster randomised controlled trial is to learn if an interactive video- and game-based oral health education intervention helps improve oral health outcomes among 11-year-old schoolchildren in Pulau Pinang, Malaysia. Read more about this study
- Who is it for?
- Ages 11 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Video- and Game-Based Oral Health Education and Conventional Oral Health Talk
- 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
- 220 participants
- Where
- 1 siteMalaysia
- Study dates
- 4 Aug 2025to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schoolchildren who are Malaysian citizens.
- Schoolchildren born in year 2014.
- Schoolchildren studying at government national primary schools under the Ministry of Education Malaysia.
- Schoolchildren who are able to understand, read and write in Malay language.
Who cannot join
- Schoolchildren with underlying chronic medical conditions.
- Schoolchildren wearing intra-oral appliances.
- Schoolchildren with learning or intellectual disabilities.
- Schoolchildren with impaired manual dexterity.
- Schoolchildren with visual or hearing impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Interactive Video- and Game-Based Oral Health Education Intervention Among 11-Year-Old Schoolchildren in Pulau Pinang: A Cluster Randomised Controlled Trial
The goal of this cluster randomised controlled trial is to learn if an interactive video- and game-based oral health education intervention helps improve oral health outcomes among 11-year-old schoolchildren in Pulau Pinang, Malaysia. The main questions it aims to answer are:
- Does the intervention improve oral hygiene status?
- Does the intervention improve oral health knowledge, attitudes and hygiene practices?
- Does the intervention reduce the frequency of consuming foods that can cause tooth decay (cariogenic foods)?
Read more
Investigators will compare a group that receives the video- and game-based oral health education intervention along with a conventional oral health talk to a group that receives only the conventional oral health talk. This will help determine whether the video- and game-based oral health education intervention is more effective than the conventional oral health talk alone.
Participants will:
- Receive either three weekly sessions of the video- and game-based oral health education intervention in addition to a conventional oral health talk, or only the conventional oral health talk.
- Take part in assessments, including a clinical examination to check oral hygiene status and a self-administered questionnaire on oral health knowledge, attitudes, hygiene practices and frequency of cariogenic food consumption. These assessments will take place at three time points: before the intervention, one month after and three months after the intervention is completed.
Read the detailed description
This is a two-arm, parallel-group, single-blinded, cluster randomised controlled trial evaluating the effectiveness of an interactive video- and game-based oral health education intervention among 11-year-old schoolchildren in Pulau Pinang, Malaysia.
The allocation follows a 1:1 ratio. One district will be randomly selected and assigned to the intervention group, and another to the control group, using computer-generated random numbers in IBM SPSS Statistics for Windows, Version 29. Within each district, two government national primary schools will be randomly selected, and from each school, two classes will be randomly chosen. All eligible students in the selected classes, with written parental/guardian consent and written participant assent, will be included.
The control group will receive a conventional oral health talk provided through the school dental service. The intervention group will receive three weekly video- and game-based oral health education sessions delivered by the principal investigator, in addition to the conventional oral health talk.
Assessments will be conducted at three time points: pre-intervention, one month post-intervention and three months post-intervention. The primary outcome is oral hygiene status, while secondary outcomes include oral health knowledge, oral health attitudes, oral hygiene practices and frequency of cariogenic food consumption. Oral hygiene status will be assessed by a calibrated clinician using the Simplified Debris Index (DI-S) while secondary outcomes will be assessed using a validated self-administered questionnaire. The trial is single-blinded, with clinical examiners blinded to group allocation.
Sample size was calculated using G*Power software version 3.1.9.7 for repeated measures Analysis of Variance (ANOVA) (between factors). Assuming an effect size of 0.25, α = 0.05, power = 0.8 and a correlation of 0.5 among repeated measures, the required sample size is 86 participants. After adjusting for a 20% attrition rate and a design effect of 2 for cluster randomisation, the final sample size is 216 participants (108 per group).
All data will be analysed using IBM SPSS Statistics for Windows, Version 29. Descriptive statistics will summarise the data. Pre-intervention between-group comparisons will be conducted using the Pearson chi-square tests for categorical variables and independent t-tests for numerical variables. Mixed ANOVA will be used to assess and compare oral hygiene status, oral health knowledge, oral health attitudes, oral hygiene practices and frequency of cariogenic food consumption within and between the intervention and control groups at various time points (pre-intervention, one month post-intervention and three months post-intervention). If needed, mixed Analysis of Covariance (ANCOVA) will be performed to adjust for potential confounding factors. When significant effects are observed, post-hoc pairwise comparisons will be conducted to identify specific time points with significant differences. A significance level of p<0.05 will be applied.
- Conditions
- Oral Health
- Being tested
- Video- and Game-Based Oral Health Education, Conventional Oral Health Talk
- Keywords
- Education, Dental, Health Knowledge, Attitudes, Practice, Oral Hygiene, Oral Health, Child
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video- and Game-Based Oral Health EducationBehavioural
A video- and game-based oral health education intervention will be delivered to the participants in the intervention group over three weekly sessions. In the first session, participants will watch a video that highlights key messages on oral health, including the importance of oral health, the consequences of poor oral health and recommended oral health practices. This will be followed by an interactive quiz to reinforce the content of the video. In the second session, a video demonstrating proper tooth brushing and flossing techniques will be shown. Participants will then practice these techniques using tooth models. The third session will feature a video on cariogenic food consumption, followed by an interactive educational game in which participants identify non-cariogenic foods.
Conventional Oral Health TalkBehavioural
A conventional oral health talk will be delivered to participants in both the control and intervention groups. The talk will cover key messages on oral health, including the importance of oral health, consequences of poor oral health and recommended oral health practices.
| Study group | Role | What they receive |
|---|---|---|
| Video- and Game-Based Oral Health Education | Experimental | Participants in the intervention group will receive three video- and game-based oral health education sessions, each delivered one week apart by the principal investigator, in addition to the conventional oral health talk provided through the school dental service. Receives: Behavioral: Video- and Game-Based Oral Health Education; Behavioral: Conventional Oral Health Talk |
| Conventional Oral Health Talk | Active comparator | Participants in the control group will receive a conventional oral health talk provided through the school dental service. Receives: Behavioral: Conventional Oral Health Talk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Hygiene Status Assessed Using the Simplified Debris Index (DI-S)
The Simplified Debris Index (DI-S), a component of the Simplified Oral Hygiene Index, will be used to assess the change in oral hygiene status. Six tooth surfaces-buccal of upper and lingual of lower first molars, and labial of upper right and lower left central incisors-will be examined. A no. 5 dental explorer will be used to detect debris, scored as follows: 0 = No debris or stain present; 1 = Soft debris covering not more than one third of the tooth surface being examined or the presence of extrinsic stains without debris regardless of surface area covered; 2 = Soft debris covering more than one third but not more than two thirds of the exposed tooth surface; 3 = Soft debris covering more than two thirds of the exposed tooth surface. The debris scores will be totaled and divided by the number of surfaces assessed to obtain the average score (DI-S), which is classified as 'good' (0-0.6), 'fair' (0.7-1.8) or 'poor' (1.9-3.0).
Measured: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
Secondary outcomes (2)
Change in Oral Health Knowledge, Attitudes and Hygiene Practices Assessed Using a Self-Administered Questionnaire Adapted from the Health Promotion Questionnaire Index (HPQI)
Oral health knowledge, attitudes and hygiene practices will be assessed using a validated self-administered questionnaire adapted from the Health Promotion Questionnaire Index (HPQI). The knowledge domain has 11 positively worded items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with total scores ranging from 11 to 55. The attitude domain includes 15 items rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). Items 1 to 12 are positively worded, while items 13 to 15 are negatively worded and reverse scored. Total scores range from 15 to 60. The hygiene practice domain has 4 items with 'Yes' or 'No' responses, scored as 1 and 0, respectively. Total scores range from 0 to 4. Scores for knowledge, attitude and hygiene practice will be converted into percentages and categorised as 'poor' (<60%), 'moderate' (60%-79%) or 'good' (80%-100%).
Measured: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
Change in Frequency of Cariogenic Food Consumption Assessed Using the Self-Administered Malay-Language Cariogenic Food Frequency Questionnaire (M-CFFQ)
Frequency of cariogenic food consumption will be assessed using the self-administered Malay-Language Cariogenic Food Frequency Questionnaire (M-CFFQ). Originally developed for parental reporting, the M-CFFQ has been validated for self-administration by 11-year-old schoolchildren. It includes 37 food items across 15 different types of cariogenic foods. Responses range from 'never/rarely' to '2 to 3 times daily', scored from 1 to 7. The total cariogenic food frequency (CFF) score, ranging from 37 to 259, is calculated by summing the scores of all items; higher scores indicate more frequent consumption of cariogenic food. CFF scores for individual food items are also calculated using a weighted formula based on response percentages and scale ratings. Food items are then categorised as 'least consumed' (0%-29.9%), 'moderately consumed' (30.0%-79.9%), or 'highly consumed' (80.0%-100%).
Measured: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start4 Aug 2025
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Oung Ker Yue, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097324
- Sponsor's protocol ID
- USM/JEPeM/KK/25030264
- Other IDs
- NMRR ID-25-01175-JV3
- Status last verified
- Jan 2026
- First submitted
- 24 Jul 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared upon reasonable request and in accordance with applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Interactive Video- and Game-Based Oral Health Education Intervention Among 11-Year-Old Schoolchildren in Pulau Pinang: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07097324
- Acronym / sponsor ID
- USM/JEPeM/KK/25030264
- Conditions
- Oral Health
- Keywords
- Education, Dental, Health Knowledge, Attitudes, Practice, Oral Hygiene, Oral Health, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 31 Jul 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.
The goal of this cluster randomised controlled trial is to learn if an interactive video- and game-based oral health education intervention helps improve oral health outcomes among 11-year-old schoolchildren in Pulau Pinang, Malaysia. The main questions it aims to answer are:
- Does the intervention improve oral hygiene status?
- Does the intervention improve oral health knowledge, attitudes and hygiene practices?
- Does the intervention reduce the frequency of consuming foods that can cause tooth decay (cariogenic foods)?
Investigators will compare a group that receives the video- and game-based oral health education intervention along with a conventional oral health talk to a group that receives only the conventional oral health talk. This will help determine whether the video- and game-based oral health education intervention is more effective than the conventional oral health talk alone.
Participants will:
- Receive either three weekly sessions of the video- and game-based oral health education intervention in addition to a conventional oral health talk, or only the conventional oral health talk.
- Take part in assessments, including a clinical examination to check oral hygiene status and a self-administered questionnaire on oral health knowledge, attitudes, hygiene practices and frequency of cariogenic food consumption. These assessments will take place at three time points: before the intervention, one month after and three months after the intervention is completed.
Detailed description
This is a two-arm, parallel-group, single-blinded, cluster randomised controlled trial evaluating the effectiveness of an interactive video- and game-based oral health education intervention among 11-year-old schoolchildren in Pulau Pinang, Malaysia.
The allocation follows a 1:1 ratio. One district will be randomly selected and assigned to the intervention group, and another to the control group, using computer-generated random numbers in IBM SPSS Statistics for Windows, Version 29. Within each district, two government national primary schools will be randomly selected, and from each school, two classes will be randomly chosen. All eligible students in the selected classes, with written parental/guardian consent and written participant assent, will be included.
The control group will receive a conventional oral health talk provided through the school dental service. The intervention group will receive three weekly video- and game-based oral health education sessions delivered by the principal investigator, in addition to the conventional oral health talk.
Assessments will be conducted at three time points: pre-intervention, one month post-intervention and three months post-intervention. The primary outcome is oral hygiene status, while secondary outcomes include oral health knowledge, oral health attitudes, oral hygiene practices and frequency of cariogenic food consumption. Oral hygiene status will be assessed by a calibrated clinician using the Simplified Debris Index (DI-S) while secondary outcomes will be assessed using a validated self-administered questionnaire. The trial is single-blinded, with clinical examiners blinded to group allocation.
Sample size was calculated using G*Power software version 3.1.9.7 for repeated measures Analysis of Variance (ANOVA) (between factors). Assuming an effect size of 0.25, α = 0.05, power = 0.8 and a correlation of 0.5 among repeated measures, the required sample size is 86 participants. After adjusting for a 20% attrition rate and a design effect of 2 for cluster randomisation, the final sample size is 216 participants (108 per group).
All data will be analysed using IBM SPSS Statistics for Windows, Version 29. Descriptive statistics will summarise the data. Pre-intervention between-group comparisons will be conducted using the Pearson chi-square tests for categorical variables and independent t-tests for numerical variables. Mixed ANOVA will be used to assess and compare oral hygiene status, oral health knowledge, oral health attitudes, oral hygiene practices and frequency of cariogenic food consumption within and between the intervention and control groups at various time points (pre-intervention, one month post-intervention and three months post-intervention). If needed, mixed Analysis of Covariance (ANCOVA) will be performed to adjust for potential confounding factors. When significant effects are observed, post-hoc pairwise comparisons will be conducted to identify specific time points with significant differences. A significance level of p<0.05 will be applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video- and Game-Based Oral Health Education | Experimental | Behavioral: Video- and Game-Based Oral Health Education, Behavioral: Conventional Oral Health TalkParticipants in the intervention group will receive three video- and game-based oral health education sessions, each delivered one week apart by the principal investigator, in addition to the conventional oral health talk provided through the school dental service. |
| Conventional Oral Health Talk | Active comparator | Behavioral: Conventional Oral Health TalkParticipants in the control group will receive a conventional oral health talk provided through the school dental service. |
Who may qualify
- Ages
- 11 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Schoolchildren who are Malaysian citizens.
- Schoolchildren born in year 2014.
- Schoolchildren studying at government national primary schools under the Ministry of Education Malaysia.
- Schoolchildren who are able to understand, read and write in Malay language.
Key exclusion criteria (5 listed)
- Schoolchildren with underlying chronic medical conditions.
- Schoolchildren wearing intra-oral appliances.
- Schoolchildren with learning or intellectual disabilities.
- Schoolchildren with impaired manual dexterity.
- Schoolchildren with visual or hearing impairments.
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 |
|---|---|---|
| Video- and Game-Based Oral Health EducationA video- and game-based oral health education intervention will be delivered to the participants in the intervention group over three weekly sessions. In the first session, participants will watch a video that highlights key messages on oral health, including the importance of oral health, the consequences of poor oral health and recommended oral health practices. This will be followed by an interactive quiz to reinforce the content of the video. In the second session, a video demonstrating proper tooth brushing and flossing techniques will be shown. Participants will then practice these techniques using tooth models. The third session will feature a video on cariogenic food consumption, followed by an interactive educational game in which participants identify non-cariogenic foods. | Behavioural | Video- and Game-Based Oral Health Education |
| Conventional Oral Health TalkA conventional oral health talk will be delivered to participants in both the control and intervention groups. The talk will cover key messages on oral health, including the importance of oral health, consequences of poor oral health and recommended oral health practices. | Behavioural | Conventional Oral Health Talk, Video- and Game-Based Oral Health Education |
Primary outcome
Change in Oral Hygiene Status Assessed Using the Simplified Debris Index (DI-S)
Time frame: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
The Simplified Debris Index (DI-S), a component of the Simplified Oral Hygiene Index, will be used to assess the change in oral hygiene status. Six tooth surfaces-buccal of upper and lingual of lower first molars, and labial of upper right and lower left central incisors-will be examined. A no. 5 dental explorer will be used to detect debris, scored as follows: 0 = No debris or stain present; 1 = Soft debris covering not more than one third of the tooth surface being examined or the presence of extrinsic stains without debris regardless of surface area covered; 2 = Soft debris covering more than one third but not more than two thirds of the exposed tooth surface; 3 = Soft debris covering more than two thirds of the exposed tooth surface. The debris scores will be totaled and divided by the number of surfaces assessed to obtain the average score (DI-S), which is classified as 'good' (0-0.6), 'fair' (0.7-1.8) or 'poor' (1.9-3.0).
2 secondary outcomes
Change in Oral Health Knowledge, Attitudes and Hygiene Practices Assessed Using a Self-Administered Questionnaire Adapted from the Health Promotion Questionnaire Index (HPQI)
Time frame: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
Change in Frequency of Cariogenic Food Consumption Assessed Using the Self-Administered Malay-Language Cariogenic Food Frequency Questionnaire (M-CFFQ)
Time frame: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. Data can be shared upon reasonable request and in accordance with applicable data protection regulations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video- and Game-Based Oral Health Education and Conventional Oral Health Talk in people with Oral Health, run by Universiti Sains Malaysia at 1 site in Malaysia.
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: finished, as of the sponsor's last update on 14 Jan 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Hygiene Status Assessed Using the Simplified Debris Index (DI-S) (time frame: Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention). 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 14 Jan 2026.