NCT06543186

Brief Summary

To evaluate the effectiveness of pre- and post-intervention of oral health education using three interventions (conventional methods, mHealth, and the Metaverse platform) on the oral health status, knowledge, practices, and attitudes among secondary school students in Malaysia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

July 26, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

metaverseimmersive technologyvirtual reality

Outcome Measures

Primary Outcomes (3)

  • Oral health knowledge

    Level of oral health knowledge. Descriptive, association and correlation

    Pre-intervention (baseline) and immediately after the intervention

  • Oral health practise

    Level of oral health practise. Descriptive, association and correlation

    Pre-intervention (baseline) and immediately after the intervention

  • Oral health attitude

    Level of oral health attitude. Descriptive, association and correlation

    Pre-intervention (baseline) and immediately after the intervention

Study Arms (3)

Conventional oral health education

EXPERIMENTAL

For the conventional oral health education, the trained and calibrated dentist will provide health education to the selected participants in this group by chalk and talk method, PowerPoint presentations, models and charts so that it can make the sessions more interactive. The duration of the session will be around 60-90 minutes. Pre-assessment will be taken prior to the lecture. Post assessment will be taken after the lecture to assess the oral health knowledge, practise and attitude.

Other: Oral health education lecture

Oral health education via mHealth using WhatsApp

EXPERIMENTAL

For the oral health education intervention via mHealth, WhatsApp medium will be used to disseminate oral health educational material. Before the commencement of the study, the participants will be asked for their phone number in the respondent sheet and permission will be sought from both participants and their teachers and parents/guardians. Then, a WhatsApp group will be created consisting of the selected participants for this intervention. The participants in WhatsApp group will further receive WhatsApp instant messages. These participants will grouped and placed in class. These messages will be sent in both Malay and English language. The duration of the session will be around 60-90 minutes. Pre-assessment will be taken prior to the dissemination of oral health education on WhatsApp. Post assessment will be taken afterwards to assess the oral health knowledge, practise and attitude.

Other: Oral health education via mHealth on WhatsaApp

Metaverse platform called Metaverse for Oral Health Education (Meta-OHE)

EXPERIMENTAL

For oral health education intervention via Meta-OHE, it will be done via computer in a computer lab. The participants will be gathered in their school's computer lab with the health of the teacher. Participants will be assigned a computer to each of them. Then, they will be asked to sign in into Mitoworld platform using their respective email address on https://mitoworld.io/world/w/2808/meta-ohe to access Meta-OHE. They will be asked to enter the Meta-OHE portal. The students are permitted to freely explore and follow the instruction to visit each section of the Meta OHE and interact with each other. They will also be assigned a few tasks for them to complete on the platform to ensure all the oral health education materials are being covered. The duration of the session will be around 60-90 minutes. Pre-assessment will be taken prior to their access to Meta-OHE. Post assessment will be taken afterwards to assess the oral health knowledge, practise and attitude.

Other: Oral health education via Metaverse platform on Meta-OHE

Interventions

Conventional oral health education will be given by trained and calibrated dentists.

Conventional oral health education

For the oral health education intervention via mHealth, WhatsApp medium will be used to disseminate oral health educational material

Oral health education via mHealth using WhatsApp

For oral health education intervention via Meta-OHE, it will be done via computer.

Metaverse platform called Metaverse for Oral Health Education (Meta-OHE)

Eligibility Criteria

Age15 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged 15-16 years old in 2024
  • voluntarily wish to participate in the research with consent from their legal guardians
  • enrolled in a co-education school (providing education to both boys and girls)
  • willing to commit to the program
  • can understand both Malay and English
  • participating schools must possess the necessary computer facilities to facilitate this aspect of the study

You may not qualify if:

  • aged less or more than 15-16 years old in 2024
  • not voluntarily wish to participate in the research with consent from their legal guardians
  • not enrolled in a co-education school (providing education to both boys and girls)
  • not willing to commit to the program
  • can't understand both Malay and English
  • participating schools does not possess the necessary computer facilities to facilitate this aspect of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maktab Rendah Sains MARA Bentong, MRSM Bentong

Bentong, Pahang, 28700, Malaysia

RECRUITING

Faculty of Dentistry, Universiti Teknologi MARA

Sungai Buloh, Selangor, 47000, Malaysia

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be assigned to one of the intervention groups based on designated locations within their schools: the main hall for the conventional oral health education group, classrooms for the WhatsApp group, and the computer lab for the Meta-OHE group. The interventions will be administered simultaneously to all groups by trained and calibrated researchers to minimize study contamination. This simultaneous approach ensures that each group receives the intervention under comparable conditions, thereby enhancing the reliability and validity of the study outcomes.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 7, 2024

Study Start

August 1, 2024

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All the information obtained in this study ARE STRICTLY CONFIDENTIAL will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. When publishing or presenting the study results, the participants' identity will not be revealed without your expressed consent. Individuals involved in this study, qualified monitors and auditors, and governmental or regulatory authorities may inspect the study data, where appropriate and necessary. All the data will be kept in a password protected folder that only can be access by the researcher. To obtain such information, a formal email need to be sent to the researcher at amirulfaiz2308@gmail.com (personal email) or 2022622294@student.uitm.edu.my (university email). Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 years

Locations