NCT07125560

Brief Summary

The goal of this intervention study is to study the effectiveness of the oral health education module (MyBRUSH) in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing among 12-year-old children. This study also aims to study the effectiveness of the MyBRUSH module in improving dental plaque among 12-year-old children. The main questions it aims to answer are:

  • A questionnaire will be used to assess knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing. This assessment will be done at four time points (baseline, evaluation-1, evaluation-2, and evaluation-3), with a one-month interval between each time point.
  • A group of participants will receive intervention based on MyBRUSH module and another group of participants will receive intervention based on BEGIN. Each intervention activity will be done after each evaluation assessment is completed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

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

Study Start

First participant enrolled

March 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

August 9, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

ToothpastesToothbrushingChildrenIntervention effectiveness

Outcome Measures

Primary Outcomes (2)

  • Knowledge, attitude, and behavior

    Assessment of knowledge, attitude, and behavior on toothpaste use and toothbrushing using a questionnaire

    Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)

  • Dental plaque score

    Dental plaque score based on Silness and Löe plaque index

    Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: MyBRUSH module

Control group

ACTIVE COMPARATOR
Behavioral: BEGIN program

Interventions

MyBRUSH moduleBEHAVIORAL

oral health education module that comprises of booklet for educational material, oral health talk, toothbrushing demonstration and return demonstration, and small group discussion

Intervention group
BEGIN programBEHAVIORAL

BEGIN program that comprise of toothbrushing demonstration and return demonstration

Control group

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Malaysian citizen
  • Children born in 2013, who would be 12-year-old in 2025
  • Children using toothpaste during toothbrushing

You may not qualify if:

  • \- Children with special educational needs based on the Ministry of Education (MOE) Malaysia definition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

SJKC Pai Sheng

Kunak, Sabah, 91207, Malaysia

Location

SK Kampung Selamat

Kunak, Sabah, 91207, Malaysia

Location

SK Mostyn

Kunak, Sabah, 91207, Malaysia

Location

SK SKIM Kokos

Kunak, Sabah, 91207, Malaysia

Location

SK Balung

Tawau, Sabah, 91000, Malaysia

Location

SK Bombalai

Tawau, Sabah, 91000, Malaysia

Location

SK Holy Trinity

Tawau, Sabah, 91000, Malaysia

Location

SK Jambatan Putih

Tawau, Sabah, 91000, Malaysia

Location

MeSH Terms

Conditions

BehaviorDental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Mohd Ritzuan Abdul Multalib

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dental Officer

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 15, 2025

Study Start

March 5, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, CSR

Locations