NCT07097324

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

July 24, 2025

Last Update Submit

January 12, 2026

Conditions

Keywords

Education, DentalHealth Knowledge, Attitudes, PracticeOral HygieneOral HealthChild

Outcome Measures

Primary Outcomes (1)

  • 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).

    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)

    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)

    Pre-Intervention, One Month Post-Intervention and Three Months Post-Intervention

Study Arms (2)

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.

Behavioral: Video- and Game-Based Oral Health EducationBehavioral: 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.

Behavioral: Conventional Oral Health Talk

Interventions

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.

Video- and Game-Based Oral Health Education

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.

Conventional Oral Health TalkVideo- and Game-Based Oral Health Education

Eligibility Criteria

Age11 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulau Pinang State Education Department

Pulau Pinang, Malaysia

Location

MeSH Terms

Conditions

Behavior

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

August 4, 2025

Primary Completion

December 5, 2025

Study Completion

December 5, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data can be shared upon reasonable request and in accordance with applicable data protection regulations.

Locations